Health, Education, and Welfare · Cover Design: Jack Pardue VOL. 13 NO. 10 DECEMBER 1979-JANUARY 1980 Microbe Sleuthing in Minneapolis Scientists supply methods, expertise, screening,

Pat r ic ia Rober ts Har r is

Secretary, U.S. Department ofHealth, Education, and Welfare

Julius B. Richmond, M.D.Assistant Secretary for Health

Jere E. Goyan, Ph.D.Commissioner of Food and Drugs

Wayne L. PinesAssoc ia te Commiss ione rfo r Pub l i c A f fa i r s

Roger W. Miller/Editor

Harold C. Hopkins/Editorial Director

Jesse R. N icho ls /Ar t D i rec tor

FDA Consumer (436210) is the official magazineof the Food and Drug Administration, Rock-ville, Md. 20857, and is published monthly, except for combined issues for July-August andDecember-January. Subscriptions should beordered from and made payable to SUPERINTENDENT OF DOCUMENTS, GovernmentPrinting Office, Washington, D.C. 20402, at$12.00 a year ($15.00 foreign mailing). Second-class postage paid at Washington, D.C., andadditional mailing offices. POSTMASTER:Send address change to FDA Consumer/HFI-20,5600 Fishers Lane, Rockville, Md. 20857.

Address for editorial matters: FDA Consumer,HFI-20, Food and Drug Administration, 5600Fishers Lane, Rockville, Md. 20857.

Text of articles published in FDA Consumer maybe republished without permission. Credit toFDA Consumer as the source is-appreciated.Use of funds for printing this publication approved by the Office of Management andBudget November 1, 1972.

FDA Consumer was previously known as FDAP a p e r s .

Section 705 [375] of the Food, Drug, and Cosmet i c Ac t :

(a) The Secretary shall cause to be publishedfrom time to time reports summarizing alljudgments, decrees, and court orders whichhave been rendered under this Act, includingthe nature of charge and the dispositionthe reo f .

(b) The Secretary may also cause to be disseminated information regarding food, drugs,devices, or cosmetics in situations involving, inthe opinion of the Secretary, imminent dangerto health, or gross deception of the consumer.Nothing in this section shall be construed toprohibit the Secretary from collecting, reporting, and illustrating the results of the investigations of the Department.

Cover Design: Jack Pardue

V O L . 1 3 N O . 1 0 D E C E M B E R 1 9 7 9 - J A N U A RY 1 9 8 0

Microbe Sleuthing in MinneapolisScientists supply methods, expertise, screening, and researchto assure that foods, drugs, and cosmetics are free of microbiological contamination.

United Front to Fight Cancer-Causing ChemicalsUnder a new coordinating plan, 35 Federal agencies willpull together in a program to control cancer-causing chemicals.

The X Raying of AmericaWhat FDA is doing to help reduce the millions of unneededdiagnostic x rays that increase the threat of cancer in theU.S. population.

Assessing Childbirth DrugsPossible effects of anesthesia on the fetus during deliveryconcerns some, but FDA and other authorities see no causefor worry.

Overcoping With ValiumThe heavy use of a minor tranquilizer for minor anxietiesand the reports of addiction raise questions about overpres-cribing.

New Bill of Rights for Human VolunteersRevised regulations provide for subjects in drug tests to begiven relevant information about risks, objectives, alternat ives.

Update

News Highlights

Regional Reports

S t a t e A c t i o n s

S e i z u r e s

Notices of Judgment

Inside Front Cover: The presence of unwanted bacteria in food couldmean problems in processing and handling. Counting bacterial coloniesin food samples is one task of FDA's Minneapolis Center for Microbiological Investigations. What else this one-of-a-kind field laboratory doesis covered in the article Microbe Sleuthing in Minneapolis, beginning onpage 4.

F D A C o n s u m e r / D e c . 1 9 7 9 - J a n . 1 9 8 0 / 1

Update

L e t t e r w r i t e r s Ta k e V i t a m i n s

In March of this year, FDA published a report ofan expert advisory committee on the use of vitaminsand minerals as over-the-counter drugs. The panelsaid that nine vitamins and three minerals were safeand effective to treat andlor prevent deficiency diseases, but that they should be used "when the needfor such therapy has been determined by a physician." What else the panel said was reported in Vitamins Over the Counter: Take Only WhenNeeded, in the April 1979 FDA Consumer. Here'san update.

If anyone wants to set off a letterwriting campaign, the most effective way, apparently, is to usethe words "regulate vitamins and minerals." Publication of the report and recommendations of thepanel on vitamins and minerals in the March 16F e d e r a l R e g i s t e r u n l e a s h e d a fl o o d o f m a i l t oFDA. An OTC Drug Evaluation Division spokesman estimates that approximately 5,700 lettershave come in expressing fears that the panel report will lead eventually to the regulation of thosevitamins and minerals sold as dietary supplements.

The bulk of these letters have been addressed tothe hearing clerk, but hundreds have been answered by the OTC Drug Evaluation Division. Allwill become part of the official public record onthe panel's report. Those who write directly to theDivision receive a clarification statement assuringthem that the report "does not affect the consumer's ability to purchase vitamins and mineralsfor use as dietary supplements."

The panel report also sparked the introductionof legislation to limit the authority of the Secretaryof Health, Education, and Welfare to regulate vitamin and mineral drug products for over-the-counter human use. Introduced by CongressmanLawrence McDonald, the bill would prohibit theSecretary from promulgating the proposed rule applicable to vitamin and mineral products or anyother rule or regulation or any other action thatwould have the same effect as the proposed rule.T h e b i l l h a s b e e n r e f e r r e d t o t h e S u b c o m m i t t e e o n

Health and Environment of the House Committeeon Interstate and Foreign Commerce.

Prevention, a monthly magazine aimed athealth food advocates, calls the panel report "Anew antivitamin effort by FDA." In a questionand answer column in the September issue, themagazine suggests that if the proposed rule, whichis attributed to FDA, is passed it could mean thata prescription would be needed to buy vitaminsand minerals in drugstores.

Readers were urged by the magazine to write toCongressman Henry Waxman, chairman of theHealth and Environment Subcommittee, to request that hearings be held on the McDonald bill.

2 / Dec. 1979-Jan. 1980 / FDA Consumer

C e r t i fi c a t i o n E n d e d f o r U - 8 0 I n s u l i n

The many steps FDA goes through to insure thepurity and potency of insulin was the subject of anarticle, in the April 1977 FDA Consumer, titled:Insulin Standards: Precision With a Purpose.Here's an update.

As of March 24, 1980, FDA will no longer certify 80 unit (U-80) insulin products. This action isbeing taken to reduce the potential for patient error that results from having insulin available intwo different high concentrations. After that dateU-100 insulin will be the only high concentrationproduct to be certified. However, any batches ofU - 8 0 i n s u l i n c e r t i fi e d b e f o r e M a r c h 2 4 w i l l b e a llowed to stay on the market until they becomeo u t d a t e d .

The proposal to discontinue certification of U-80insulin was first made in the Federal Register of 'July 28, 1978. The proposal also invited commentson the need for retaining a low-potency insulinproduct on the market. Comments on this proposal are still being evaluated and will be discussed in a future Federal Register not ice i fFDA decides some action is needed. The final ruleon U-80 products was published in the September25 , 1979 , Federa l Reg is te r.

Hair Dye Label Warning Regulation

An article, Hair Dyes, a Look at Safety andRegulation, in the June 1978 issue of FDA Consumer, noted a scientific finding by the NationalCancer Institute, in 1977, that an ingredient used inmany permanent '"coal-tar" hair dyes caused cancerin laboratory test animals. The article reportedFDA's regulatory proposal to require manufacturers who produce hair dyes containing the ingredient, 4-methoxy-m-phenylenediamine (4MMPD) orits sulfate, 4MMPD sulfate, to place a warningstatement on the label. Here's an update.

Permanent hair dye products that contain the ingredient 4-methoxy-m-phenylenediamine(4MMPD) or its sulfate, 4MMPD sulfate, must, ifshipped after April 16, 1980, include a warning onthe label of the product's cancer-causing potential.The new FDA regulation, published in the Federal Register, on October 16, 1979, requires thislabel warning:

"Warning—Contains an ingredient that can penetrate your skin and has been determined to causecancer in laboratory animals."

The chemicals are also known as 2,4 diaminoan-isole (2,4 DAA) and 2,4 diaminoanisole sulfate(2,4 DAA sulfate). Many hair dye makers began

discontinuing use of the ingredient in their products after FDA proposed the warning label in January 1978, but a few continue to use thesechemicals. Meanwhile, FDA is evaluating similarNational Cancer Institute data covering severalother ingredients in coal-tar hair dyes, including 4-amino-2-nitrophenol, 2-nitro-p-phenylenediamine,4-chloro-m-phenylenediamine, and toluene 2,4 diamine. If FDA concludes that any of these maycause cancer in humans, the Agency may requireproducts containing them to bear similar warningl a b e l s .

Coal-tar hair dyes were exempted from theadulteration section of the Food, Drug, and Cosmetic Act of 1938. Manufacturers may marketthese products as long as they warn consumers onthe label of possible skin irritation and to avoiduse around the area of the eyes. FDA is on recordurging repeal of this exemption.

Some permanent hair dye products in shades ofblack and brown may still contain high levels of4MMPD and 4MMPD sulfate and some productsin vivid warm shades, such as reddish or goldenblond, may contain lower concentrations. Thesechemicals are never used in temporary tints or rinses or in semi-permanent hair dyes.

FDA withdrew its proposal to require warningposters in establishments that dye hair, noting thedifficulty of enforcing such a regulatory requirement because the Agency does not inspect theseestablishments. FDA said customers can ask suchestablishments to show them the labels of dyeproducts to be used and that publicity about thelabel warning regulation will serve to alert manyconsumers who have their hair dyed in theseplaces.

FDA Consumer / Dec. 1979-Jan. 1980 / 3

M i c r o b eSleuthing InMinneapolisSome microbes belong in our food supply, others definitely do not. Scientistsat the Minneapolis Center for Microbiological Investigations, a unique FDAfield laboratory, help assure that notonly food, but also drugs, cosmetics,and medical devices, are free of harmfulmicroorganisms.

by Annabel Hecht

A microbe, according to Webster,is a very minute organism. Somem i c r o b e s a r e n a t u r a l i n h a b i t a n t s o ff ood and a re essen t i a l f o r t he c reat ion o f such de lec tab les as cheeseand yogurt. Others are distinctly undesirable and their presence is a cluethat a food product has been contami n a t e d .

Analyzing various foods to determine how many microbes exist, andto set standards for how many can besafely allowed, is one of the majortasks of the Minneapolis Center forMicrobiological Investigations, a one-of-a-kind FDA field laboratory situated in the heart of that Minnesotacity.

Each year, FDA surveys a groupof products in its continuing program

to assure a safe food supply. Of part i c u l a r c o n c e r n a r e t h o s e w i t h t h e

greatest potential for harm, such asfoods that do not have to be cooked,and eggs and egg products.

Samples for testing at the Minneapolis lab are collected at variousstages during processing, startingwith the raw material and ending

The granular appearance in the lowersection of this petri dish (below) is aclue to the exact identity of a Salmonella organism, the "bug" that causessome types of food poisoning. Thisclumping of cells occurs only when aS a l m o n e l l a c u l t u r e i s m i x e d w i t h a n t iserum containing the antigens towhich a particular type of Salmonellaw i l l r e a c t .


Dr. Jo-Ann Maltais (left) feeds dataon the characteristics of an unknownb a c t e r i u m i n t o t h e N u m e r i c a l Ta x o n

omy System. The computerized system wi l l send back c lues as to the

possible identity of the organism.

Gene Peterson (below) prepares distilled water for use in the virologylaboratory.

FDA Consumer / Dec. 1979-Jan. 1980 ! 5


One of the 12 million eggs in the bottle at the far right willgrow into a worm like that in Richard Rude's specimen bottle (above). This particular specimen came from a pig, butthis parasite, known as Ascaris, can live in the human intestine and grow to 18 inches in length. Eggs come from uteriof worms (bottle second from right) and can get into thehuman food chain via sewage sludge as a fertilizer (bottlefar left).

with the finished product. Analysisincludes an "aerobic plate count,"that is, a visual count of the numberof bacterial colonies that develop in ameasured amount of the food thathas been incubated in a nutrient medium. Microbiologists also look for"indicator organisms," microbes suchas Escherichia coli (E. coli) andStaphylococcus aureus, whose presence indicates the food has becomecontaminated through improper handling or underprocessing.

What the Center learns about themicrobiological quality of the variousfood products is then translated intoremedial action to correct food safetyproblems as well as into qualitystandards for the food industry.

The Minneapolis Center has beendoing microbiological analyses sinceOctober 1, 1968, starting out with 10microbiologists "at the bench" in apilot program. At the time, interestwas in the safety of the relativelynew breed of food—frozen and processed convenience items. The pioneer microbiologists in the pilotprogram started out with frozencream pies and cooked peeled shrimpas their principal foods. They werelooking for Salmonella in the pies,and pathogens, or disease-causingagents, in the shrimp. Samples of imported domestic cheese, dried protein products, and edible gelatinwere also included in the pilot prog r a m .

One reason Minneapolis was selected for the project was its accessibility by air—an essential factorwhere frozen food samples are con

cerned. Another was a backyard thatincluded two large municipal healthdepartments, a large and highly developed State diagnostic laboratory,and the University of Minnesota withits noted Department of Microbiology, Department of Food Science,and medical technical training prog r a m s .

During the 2 months of the test,the infant Center proved that by useof a team approach and the application of assembly line techniques, allother FDA labs could be outdistanced in microbiological examinations. In February 1969, the Agencyannounced that the National Centerfor Microbiological Analysis, as itwas then called, was in business.

The program of the Center, now afield laboratory under FDA headquarters' direction, has been greatlyexpanded to include the microbiologyof drugs, foods, medical devices, andcosmetics; sterility of drugs and medical devices; viruses; and parasites infoods. As its program has changed,so has its name. The substitution of"Investigations" for "Analysis" in itsname underscores the role of theCenter as a research, rather than ascreening, laboratory.

Sterility of drugs and devices,ranging from prepackaged disposablesyringes and surgical masks to artificial joints, has become a major concern to the Center. At one time,sterilization of reusable devices wasthe responsibility of the institutionusing them. Today, much of the material used is disposable, and it hasbecome the manufacturers' responsi

bility to assure the sterility of theseprepackaged items. One of the lab'stasks is to determine if thecompany's sterilization process is adequate. The lab, for example, teststhe "spore strips," or biological indicators that are included in the packages, against the standardsestablished by the U.S. Pharmacopeia. These strips are pieces of material impregnated with microorganisms that should be killed during thesterilization process. If they are not,it would mean the product probablyis not sterile.

Sterility and particulates in largevolume parenterals—fluids to be administered via the veins or muscles—are also under investigation in Minneapolis. Center scientists are adapting an automatic particle counter thatmeasures particles using a light-blocking system. It can detect almostinvisible contaminants in these fluids.

One of the newer areas of researchin the Minneapolis lab, or anywhereelse, is the study of parasites in vegetables. With the current practice ofrecycling sewage waste for fertilizer aconcern has developed about what isin this waste, or sludge, as well ashow it affects plants grown in it and,ultimately, the people who eat theplants.

The interest in sludge has causedthe Minneapolis scientists to take aclose look at the dirt that clings tofreshly harvested vegetables. In thatdirt, parasites may reside—parasitesso small that they defy detection byordinary means. But some of theseparasites may be worms that can live

FDA Consumer I Dec. 1979-Jan. 1980 / 7

Automation will never replace the skill of the microbiologist in detecting the presence of staphylococcusenterotoxins, microorganisms responsible for foodpoisoning (right).

James Danielson (below) focuses an automatic colonycounter to get an instant count of the number of bacteria in a food sample. Several such machines are beingevaluated for possible use in the Minneapolis Center.


In the parasitology lab, Janet Codor(left) searches for microscopic eggsand larvae of intestinal roundworms indirt that was washed from fresh veget a b l e s .

Gordon Oxborrow (right) prepares torun spore test strips through a sterilizer to make certain that these devices, used to verify the sterility ofprepackaged disposable medical supplies, meet established standards.

in human intestinal tracts. The job ofthe scientists is to develop methodsof isolating those virtually invisiblemicroorganisms. So far, the bestm e t h o d s e e m s t o b e a c o m b i n a t i o n o f

centrifuging to eliminate excesswater, then treating the remainingparticles with the chemical formalino r e t h e r.

The lab a l so ca r r ies ou t a Sa lmonella serology program to identify organisms that are responsible for suchdiseases as typhoid and paratyphoidfevers, dysentery, and food poisoning. Salmonella can be detected int h e l a b o r a t o r i e s i n v a r i o u s F D A d i strict offices, but Salmonella comes ina thousand varieties and it's up tothe Minneapolis group to pinpointthe precise type to help determineexactly where the organism camef r o m .

Pinning the right name tag on theSalmonella bug is a matter of usingserology—the study of blood serumactions. Salmonella organisms produce antigens, or agents that causeantibodies to develop in blood or tissue. By mixing the unknown organism with a series of commerciallyprepared "antiserums" containingthese antibodies, the microbiologistcan tell the "name of the beast" bythe way its antigens react with thea iU ibod ies .

T h e b l u e b l o o d o f t h e h o r s e s h o ecrab is also put to use at the Minneapolis lab. A substance in thatblood—LAL, which stands for limu-lus amoebocyte lysate—is used to de

tect endotoxins in drugs. Endotoxinsare poisons released by certainorganisms when they grow or die.T h e L A L c l o t s w h e n i t c o m e s i n c o ntact with the endotoxins indicating,the presence of the poison.

The Center also is the only FDAfield lab that does testing for staphyl o c o c c u s e n t e r o t o x i n s i n f o o d . E n t e r -otoxins are poisons that do theirdirty work in the intestines.

N o t a l l i d e n t i fi c a t i o n o f m i c r o b e s i sdone by peering through a microscope. Computers play a role in providing precise and efficientidentification of microorganisms bymeans of a program called the Numerical Taxonomy System. Taxonomy is the science of classifyingorganisms in specific categories ortaxons, according to patterns of occ u r r e n c e o f c e r t a i n f e a t u r e s . To i d e n

tify unknown bacteria isolated from afood, drug, or cosmetic sample, scientists characterize them as to theirunique physical or chemical featuresand compare this information withdata in the computer. The computerthen indicates a "best- l ikel ihood"identification and suggests additionalt e s t s f o r f u r t h e r c o n fi r m a t i o n . S u c h a

computer-based system is now operating FDA-wide and is currentlybeing evaluated by the Minneapolisl a b a n d o t h e r F D A d i s t r i c t s .

The lab also is carrying out a 2-year study in one other area of microbiology that can be automated,that is, the counting of bacterial colon i e s i n m a t e r i a l t h a t h a s b e e n i n c u

b a t e d i n s h a l l o w c o n t a i n e r s c a l l e dP e t r i d i s h e s . A n u m b e r o f m a c h i n e shave been developed that scan thePetri dish and report what they seei n a n i n s t a n t r e a d - o u t . N o c o n c l us i o n s h a v e b e e n r e a c h e d o n w h e t h e ro n e m a c h i n e i s b e t t e r t h a n a n o t h e ror whether any are more efficientt h a n t h e h u m a n m a c h i n e .

Quality control is yet another areaof expertise at the Minnesota Center.Under the Check Sample program,the Center sends samples of foodcontaining predetermined concentrations of contaminants to participatingFDA, State, and foreign labs foranalysis. The accuracy of their analyses is an indication of how goodtheir testing methods are. Whenproblems are found, changes can berecommended to bring the lab up tos t a n d a r d .

In addition to the regular researchactivities, the 33-member staff of theMinneapolis Center assists otherFDA laboratories when microbiological loads get too heavy or whenemergencies arise. For instance, theCenter has played a part in a varietyof emergency investigations, including the Bon Vivant soup affair, cholera in oysters (they were able toassist the FDA districts in locatingthe exact bed the infected molluskscame from), and a case of nonsterilemorphine encountered by the Department of Defense.

Annabel Hecht is a writer for FDA'sOffice of Public Affairs.


United fitont To fightCancer-causing Chemicals

The Federal Government plans to concert the efforts of 35agencies and departments to control chemicals that causecancer and reduce their threats to public health. It's allmainly a matter of coordination and deliberate actions thatwill identify the chemical culprits and develop systematicways to control them.

Anew government-wide plan has been adopted for thecontrol of cancer-causing chemicals that threaten thefood, air, water, and places where people live and work.

The new policy applies to all concerned Federal agencies which today conduct their regulatory activities undera total of 21 laws.

The policy, announced September 28, strives for moreuniformity and coordination between agencies in the regulation of chemical carcinogens, and sets up new criteriafor regulatory actions.

It is the work of the Regulatory Council, which wascreated more than a year ago by President Carter, andwhich is comprised of 35 agency and cabinet departmentrepresentatives.

Primarily affected are the Food and Drug Administration, the Environmental Protection Agency, the Consumer Product Safety Commission, the OccupationalSafety and Health Administration, and parts of the Departments of Agriculture and Transportation.

The policy does not affect the specific responsibilitiesmandated to each agency by law. Rather, it calls uponthe agencies to use the new criteria to improve their coordination, avoid duplication of each other's efforts, andachieve cost effectiveness in their actions to combat canc e r .

The new policy affects procedures for determiningwhich chemicals may cause cancer and for setting priorities to undertake regulatory action.

Under the new policy. Federal agencies would:• Continue to use animal tests to identify chemicals

that may cause cancer in humans and would not awaitepidemiological findings of actual occurrence in humansbefore taking action;

• Place primary responsibility for testing on chemicalmanufac tu rers ;

• Make assessments of the degree of risk to people,including estimates of the potential size of the populationthreatened with exposure; (Risk to particular populationgroups, such as children, would have to be considered.)

• Have to analyze the economic impact of regulatoryproposals and give priority to protecting the public health"without imposing unnecessary or unreasonable burdensupon the economy."

The Council's report noted that if the social and economic costs are slight, agencies can strive for total elimination of a carcinogenic threat to people. But in mostinstances, it added, the new policy regards the concept of"zero risk" as not being "routinely achievable."

Priorities also would be influenced by consideration ofwhether regulatory action would reduce human exposureand whether it would reduce not only the risk of cancerto people but also other hazards to humans and to thee n v i r o n m e n t .

Regulatory Council Chairman Douglas M. Costle,head of EPA, said the new policy provides the variousagencies with a "consistent strategy" for their control efforts and allows them to use the same scientific base fort h e i r a c t i o n s .

"It's regulatory reform," he added, "that makes thehealth protection efforts of the Government as a wholework more smoothly without interfering with the missions of individual agencies or casting into doubt the validity of their actions and analyses."

FD A C o n su m e r / D e c . 1 9 7 9 - Ja n . 1 9 8 0 / I I

T h e X O f A m e r i c a

Up to 30 percent of the 278 million medicai and dental diagnostic x rays made ceives an x ray exam that simply isyeariy really aren't needed, and since any x ray increases a person's risk of not necessary—is not going to pro-getting cancer, these excess radiations are an unnecessary perii to public vide any useful diagnostic informa-health. So says FDA's John C. Villforth, director of the Bureau of Radio- tion to the physician—then there islogical Health, who outlines the health problems and excess medical costs that no benefit to offset the small but realresult from ignorance, laxity, and misplaced medical judgments involving x risk to the patient's long-term health.rays and telis what the Agency is doing to reduce the threat. The second reason FDA is con

cerned about the overuse of x rays isthe financial burden imposed on the

QOne of the Bureau of Radi- Why is this a concern for American public. According to our. ological Health's major pro- . FDA? best estimates, about 125.000 medicalgrams is to reduce people's exposure A For two reasons. First, any x x-ray machines in the U.S. are usedto radiation from medical and dental I\ . ray absorbed by our bodies to perform some 186 million exami-X rays. Does this mean that patients has the potential for harm. Any ex- nations yearly. In addition, aboutare receiving too much radiation posure carries with it an increased 145,000 dental x-ray units are usedwhen they get an x ray, or that pa- risk of certain long-term ill effects, for some 92 million examinations.tients are getting too many x rays? such as cancer, that may show up 10 We estimate the total annual cost ofA We're talking about both sit- or 20 years later. There can also be these x-ray procedures to be over $6, uations. Surveys show that effects on future generations if a pa- billion. So, if we are correct in ourthere are many unnecessary x-ray tient's reproductive organs are ex- estimate that as much as 30 percentprocedures being performed in this posed to the radiation. of x-ray procedures may not becountry. Perhaps as many as 30 per- Of course the amount of radiation needed, that means the overuse of xcent of the 278 million diagnostic x- a patient gets from most ordinary x- rays could add as much as $2 billionray procedures performed last year ray examinations is small enough that a year to our national health caremay not have been necessary. the risk of harmful effects is statisti- bill. With spiraling health care costs

Other information shows that, in cally very low. This means that in the a major national concern, this clearlymany cases, patients undergoing case of x-ray examinations that are is a situation that demands attention,medically necessary x-ray examina- medically necessary—for example,tions may be receiving more radia- when a doctor must x ray a fractured Can you estimate the magni-tion than is needed to get a good bone to set it properly—the relatively . tude of the cancer risk to thequality film. small increased risk of long-term ad- public from overuse of x rays?So we're really talking about two verse effects is more than offset by A Scientists who study therelated problems—one of x-ray over- the medical benefit from the x ray. r\.. health effects of low-level ra-use and the other of overexposure. On the other hand, if a patient re- diation do not completely agree on


. . Any exposure carries with it an increased risk ofcertain long-term effects, such as cancer, that may showup 10 or 20 years later. There can also be effects on future generations if a patient's reproductive organs are exposed . . .

the magnitude of the risk. But onemight expect that the number of cancer deaths from all the x rays we receive annually in this country wouldprobably be from about a thousandup to several thousand per year. So,if we could significantly reduce thenumber of unnecessary x rays andthe careless administration of xrays—let's say by one-third—then wecould eliminate perhaps as many as1,000 cancer deaths a year.

QYou said there are two sides• to the coin of x-ray overuse.Let's discuss the first part of the problem—overexposure during medicallynecessary x-ray exams. How does thathappen?

A The overexposure could be. the result of inadequate x-rayequipment or poor techniques on thepart of the people operating it.

Q Can't FDA regulate a certain. level of safety for x-rayequipment?

A The Agency has indeed. placed requirements on x-rayequipment. Most notably an FDAperformance standard, covering all x-ray equipment manufactured sinceAugust 1974, requires that these machines be made in a way that minimizes exposure to patients.

For example, we learned throughstud ies done in 1964 and 1970 tha t x -

ray machine operators did not alwaysmake the necessary adjustments tolimit the size of the x-ray beam tothe area of the x-ray film. In manycases a larger area of the patient'sbody was being exposed to radiationthan was necessary. So, in our equipment performance standard, we required that x-ray machines havedevices that automatically limit thesize of the beam to the area of thefi l m .

QWhat about the problem of, operator technique? It seemsthat would be more difficult to correctthan the equipment problem.

A That's right. You can com-. pare the problem to automobile safety. Regulations to improvethe safety of the automobile itselfdon't assure that it will be drivensafely. But FDA, working with Stateradiation control agencies, has takensteps to improve operator performa n c e .

QHow much can eqidpment. performance and operatortechniques affect the amount of radiation a patient receives?

A One measurement of the. problem is demonstrated by

the estimated 5 to 10 percent of diagnostic x-ray films that must be repeated because of underexposure,overexposure, or some other error.This means that, in addition to theunnecessary exposure from these repeats, approximately 23 to 45 millionof the 460 million medical x-ray filmsexposed annually are wasted.

In addition, surveys we've performed with the State radiation control agencies have shown that theamount of radiation that would bereceived by identical patients, eachgetting the same x-ray procedure,can vary tremendously depending onwhich medical facilities perform theprocedure.

As a result of those findings, weand our colleagues in the State radiation control agencies have developedquality assurance programs to improve operator practices. One suchprogram covers dental x rays. Stateand local radiation officials workwith dentists and dental auxiliaries toimpress upon them the desirability ofimproving the quality of their x-rayprocedures. They stress the importance of proper exposure of the filmand proper film processing to reducethe dose to the patient and to avoidthe need for repeat x rays. This program has been able to reduce the average exposure of the patient by 40


"One measurement of the problem is demonstrated bythe estimated 5 to 10 percent of diagnostic x-ray filmsthat must be repeated because of underexposure, overexposure, or some other error."

percent. And we've seen similar results in a comparable program formammography—x rays to detectbreas t cance r.

QWhat accounts for this reduc-, tion in x-ray doses for mammography?

Alt's a combination of better. equipment and better technique. On the equipment side, probably the most important factor has todo with improved x-ray films and theuse of better intensifying screens.Use of such screens in mammography provides a sharper, clearer, moredefined image on the film at a muchlower dose of x rays to the patientthan previously had been possible.

Incidentally, I think that althoughthese improvements in films andscreens would have eventually comeabout anyway, they may well havehappened more rapidly because ofwidespread concern on the part ofprofessionals and consumers aboutradiation doses in mammography.It's a good' example of acceleratedtechnological progress in response toa widely acknowledged public need.

Even with the reduced doses,though, we believe women and theirphysicians should still be carefulabout when to use mammography.It's an extremely effective diagnostic

tool. But there is general agreementthat it shouldn't be used indiscriminately, especially for women under50 who have no symptoms or familyhistory of breast cancer—that is,women who are not considered "highrisk." This is because of concernthat, in certain patients, mammography may do more harm than good: itmay increase a patient's risk of cancer in the process of detecting thed i s e a s e .

Of course, if a woman has symptoms of breast cancer, then mammography may be indicated at anyage, and her doctor is the best judgeof whether the x ray is needed.When we talk about guidelines formammography based on age groups,we're addressing only women withoutsymptoms .

QSo excessive use of x-ray, screening procedures on people without symptoms is an exampleof the "other side of the coin": theunnecessary exposure to radiation thatoccurs when an x ray is not diagnosti-cally useful. What other factors contribute to making an x-ray examunnecessary?

A One is the lack of scientific. data as to when an x-ray examination is warranted. It 's often difficult to predict whether a particular

X ray will be diagnostically useful ina patient with a given set of symptoms and medical history. When indoubt, the physician tends to prescribe the x-ray examination. Andreinforcing this tendency is the desireof many patients for the reassurancethat a "normal" x ray gives—so the xray may be prescribed as a means ofallaying the patient's anxiety.

Concern over the possibility ofmalpractice suits also tends to increase the ordering of x rays. Physicians and hospitals often believe thatthey can protect themselves by ordering various diagnostic tests to "coverthemselves," even when they are already confident of the diagnosis.

Another contributing factor maybe economic benefit. One study hasshown that nonradiologists (physicians who don't specialize in x-raywork) who provide their own x-rayservices to patients used those services almost twice as often as physicians who referred patients toconsulting radiologists.

QDo you think that physicians. who request x rays are sufficiently aware of the risks involved int h e i r o v e r u s e ?

A I am not convinced that. these physicians have asmuch appreciation as they should for


"... A physician who has used x rays all his or herprofessional life will probably never see the cancers produced by that radiation or identify those cancers as having been caused by x rays. Consequently, the cause-effect relationship may not be obvious . . . ."

the possible negative consequences ofmedical x-ray exposure. One reasonfor this may be that a physician whohas used x rays all his or her professional life will probably never see thecancers produced by that radiation oridentify those cancers as having beencaused by x rays. Consequently, thecause-effect relationship may not beobvious to the physician and there isa tendency to feel that since the riskis statistical or probabilistic, it maynot even be real. So physicians mayview x-ray risk as something in therealm of epidemiology and mathematics, and not the direct result oftheir own practice of medicine.

Also, remember that physicianssee illnesses here and now, andthey're trained to treat what's immediate and what's causing discomfortor is life-threatening. In that context,they see every day the tremendousbenefits of diagnostic x rays in caringfor people. So it's understandablethat they might tend to dismiss thesmall statistical risk of radiation exposure, a risk that may not show upfor 20 years or more.

That means we need a constantprogram to make the physician, thedentist, and the x-ray machine operator more aware and appreciative ofthe consequences of radiation exposure. They must not only understand

the risk intellectually, they musttranslate that understanding intopractice.

QWhat can physicians do to re-. diice the radiation risk totheir patients?

A They can see that their x-ray. equipment is working properly. They can determine that the operators of the machines are properlytrained and certified, and that qualityassurance procedures are used to reduce the patient dose to the minimum needed to get an acceptablefi l m .

It's even more important that physicians who request x rays realizethat they are neither innocuous norfree. Each x ray procedure adds a little bit more to radiation exposure ofthe population, and to our nationalhealth care bill. Physicians whounderstand this will ask themselves ahard question each time they consider an x-ray examination: is this xray really necessary?

OFDA recently proposed rec-• ommendations for x rays ofwomen who might be pregnant. Whatis the concern there?

A When a woman who may be. pregnant is exposed to xrays, there is a risk of exposing an

unborn child as well. That couldcause a slightly increased risk of thechild getting leukemia or other childh o o d c a n c e r s .

So what we proposed were stepsthat doctors, x-ray technicians, andpatients themselves should take toprotect the unborn baby. The proposed recommendations apply to xrays of the abdominal area of pregnant women. Surveys show that eachyear 300,000 pregnant women in theU.S. receive abdominal area x raysthat directly expose the fetus to radiation. Many of these exams areneeded but some are not.

The Agency's proposal urgeswomen to tell their doctors if theyare or may be pregnant. It also urgesmedical personnel to stress to patients the need to volunteer such information. Women also should telltheir doctors about any recent x rayssimilar to the one being scheduled. Anew X ray may not be needed if a recent one can provide the informationthe doctor needs. Also, womenscheduled for abdominal area x raysshould postpone any planned pregnancy until after the examination.

The proposal recommends thatdoctors weigh alternative measureswhen a patient being considered foran abdominal x ray is pregnant. Forexample, the exam could be canceled


"Some patients harbor unrealistic expectations about thevalue of X rays and they may pressure physicians intoprescribing examinations that really aren't needed."

or postponed. Or it could be modified by using fewer exposures orm o r e r e s t r i c t e d v i e w s .

We're not advocating that no abdominal X rays be performed onpregnant women—when they'reneeded, the benefit certainly outweighs the risk. But we're urgingt h a t d o c t o r s fi n d o u t a b o u t awoman's pregnancy status, and thatthey weigh this in making the decision about an x ray.

Q Besides these suggestions for, women who may be pregnant, are there things other patientsshould do to help reduce their exposure to unnecessary x rays?

A Some patients harbor unreal-. istic expectations about thevalue of X rays and they may pressure physicians into prescribing examinations that really aren't needed.T h i s c o n t r i b u t e s t o t h e o v e r u s e o f x

rays. Patients should not demand anX ray if the doctor or dentist does notthink it is medically necessary.

The informed patient can play animportant role in helping to minimizehis or her own exposure. For example, the patient can ask about thepossibility of special shielding for thereproductive organs to prevent therisk of genetic defects in future offspring. And, as with women who

may be pregnant, all patients shouldalert the physician to previous similarx-ray examinations that could beused instead of repeating the x rays.FDA has an x-ray record card tohelp patients keep track of the x raysthey receive.

Finally, when an x ray is prescribed, patients should ask the doct o r o r d e n t i s t w h a t b e n e fi t w i l l b eachieved by the procedure.

Q Realistically, can a patient, challenge a doctor or dentistlike that and expect to accomplishanything? After all, most patientswould never dream of questioningtheir doctors' professional judgment.

A I don't think "challenge" is. really the right word. We'renot suggesting that people look upont h e i r d o c t o r s a s a d v e r s a r i e s w h o s e

professional judgment ought necessarily to be "challenged." Rather,what we're advocating is better communication between doctor and patient, the kind of communication inwhich questions are asked and answered freely, and in which both parties share important information.That way the doctor gets all the input needed for the best treatment,and the patient shares as much aspossible in the decisions that aregoing to affect his or her health.

QBut it seems that if physi-. dans, dentists, and technicians were doing all they should to reduce patient exposure to x rays, itwouldn 't be necessary for FDA tohave to embark on a massive program to educate patients to be concerned about this problem. Shouldn'tthe emphasis be placed on educationof health professionals?

A My philosophy before we be-. gan our consumer educationprogram was not to worry consumersabout things they should do to reduce their exposure to x rays. I felt itwould be unnecessary if everyone involved in the medical field were operating at optimum. But, in fact, thatis not happening. And it's just tooslow a process to wait for it to happen that way.

In the meantime, we can ask patients to help and to be partners inthe process. We can't afford to waituntil every person who operates anx-ray machine is a registered or certified technologist. We cannot affordto wait until every physician is fullycommitted to radiation protection. Itwould be too expensive and take toolong. So as an intermediate step, Ibelieve we must get the consumer toact constructively, with the healthprofessions, in reducing the overuseof X rays.

F D A C o n s u m e r i D e c 1 9 7 9 - J a n . 1 9 8 0 / 1 7

Assessing Chikllnrth Drugs

Oi January 19, 1847, Scottish physician James Young Simpsonpoured half a teaspoonful of chloroform onto a handkerchief and clappedit over the nose of a woman in labor.Twenty-five minutes later the womangave birth to the first child ever tocome into the world under this newlydiscovered anesthetic. The only problem, Dr. Simpson said in describing thecase, was convincing the woman—whoremembered her first delivery as 3 daysof pain^—that she had actually givenbirth while she slept.

Over the years, a wide variety ofmethods and medications for pain rel i e f h a v e b e e n i n t r o d u c e d i n t o t h e d e

livery room.Recently, though, many physicians

and laymen have begun to raise questions about the possibility of adversee f f e c t s o n t h e f e t u s f r o m a n e s t h e t i c sand pain relievers used during laborand delivery.

D e c i s i o n s a b o u t w h e t h e r m e d i c ations are to be used, and the kinds,should be made by the physician andpatient well in advance of delivery.They should be based on the mother'sphysical and emotional needs, and onthe potential risks involved for the infant. Since most expectant parents today have a range of options, somefamiliarity with the benefits and risksof various obstetrical medications canallow the patient to contribute to thatdecisionmaking. However, womenshould be aware that demanding a totally pain-free experience during laborand delivery may not be in the bestinterest of their babies.

Probably the most important pointto realize is that no drug is completelyrisk free. The expectant mother posesa special problem. The risks and benefits of drugs must be weighed not onlyfor her, but also for the baby, becausedrugs given to the mother during laborand delivery may affect the unbornc h i l d .

Drugs given to the mother can acton the respiration, circulation, or bloodpressure of the adult, which in turn canaffect the supply of oxygen the fetusrece ives . More d i rec t e f fec ts resu l tfrom the action of the drug itself on

the infant. The placenta, far frombeing a barrier between mother andchild, is a means of transfer betweenthe circulatory systems of the two. Virtually any drug given to the mother willpass into the infant to some extent.

Although the fetus can handle a certain degree of oxygen deprivation,called hypoxia, excessive oxygen deprivation can cause irregularities in fetalcirculation and respiration. In somecases an infant deprived of oxygen before birth will require resuscitation; inextreme cases, oxygen deprivation cancause brain damage or death, particularly in premature infants.

Anesthetics and some pain-relievingdrugs are central nervous system depressants. Administered to the mother,they pass through the placenta and directly affect the fetus. Use of thesedrugs presents the risk of slowing thefetus's heartbeat and causing respiratory depression in the newborn. Because the flow through the placenta isa constant exchange, the mother's syst e m — b e f o r e t h e b i r t h — c a n b r e a k d o w nand eliminate some of the drug for thechild. But a portion of the drug willremain in the child's system, and afterbirth the infant must break down andexcrete the remainder of the drug. Theinfant's liver (which would break downthe drug) and kidneys (which wouldeliminate the drug) are not fully functional at birth. It takes the child considerably longer to eliminate the drugt h a n i t d o e s t h e m o t h e r .

The Food and Drug Administration,the American College of Obstetriciansand Gynecologists, and the AmericanAcademy of Pediatrics all advise moderation and caution in prescribing drugsfor labor and delivery. These expertsdo not believe that delivery withoutmedication is better or safer than delivery with medication. Drugs are essent ia l in cer ta in d i fficu l t de l iver ies ,and even in an uncomplicated deliverya woman should not be denied a reasonable amount of pain relief, withminimal risk to the fetus. Such safe andeffective use can be achieved if the appropriate drugs are given only whenneeded, and then in minimal effectivedoses. A trend toward moderat ion in

the use of drugs has been evident inobstetric practices over the years. Forexample, the use of potent general anesthetics, administered intravenouslyor by inhalation to produce unconsciousness, has declined sharply overthe last 3 decades in major medicalc e n t e r s .

Local anesthetics, or regional blocks,are now most widely used for uncomplicated deliveries. Local anestheticsprovide pain relief by blocking certainnerve impulses, yet they allow themother to remain awake. Dependingon the site into which the anesthetic isinjected, they anesthetize smaller orlarger areas.

Often given in combination with anesthetics are analgesics (pain relievers), and sedatives and tranquilizers.These are believed to potentiate ormultiply, the effects of anesthetics, allowing smaller doses of the more pot e n t a n e s t h e t i c s t o b e a d m i n i s t e r e d .The most common analgesics used inobstetrics are morphine and its synthetic substitute, meperidine.

The Food and Drug Administration,in 1979, convened an advisory committee composed of its own and non-Government experts to study the effects of obstetric drugs on infants. Thecommittee concluded that all drugsused during labor and delivery maycause short-term adverse effects, suchas decreased muscle tone, inability tosuck, reduced responsiveness to stimulation, depressed breathing, and irregular heartbeat. The committeeconcluded that the effects of the drugsdisappeared after the first 10 days oflife, and that effects beyond that period had not been proven.

Seeking further study of both long-and short-term labor drug effects oninfants, the advisory committee established a subcommittee composed ofrepresentatives from the fields of obstetrics, pediatrics, anesthesiology, andbiostatistics, and consumers.

W h a t e v e r t h e o u t c o m e o f f u t u r estudies, the consensus of the medicalcommunity today is that risks from obstetrical analgesics and anesthetics canbe greatly minimized if these drugs areu s e d w i t h c a u t i o n a n d m o d e r a t i o n .

FDA Consumer / Dec. 1979-Jan. 1980 I 19

. . it is a matter ofconcern to see the prescribing of these drugsfor the ordinary situations of life. .

k M m

f m - . 'C';

Overcofrifig Wh^îumOf all the Rx pills popped, the minor tranquilizer Valiumleads the pack—which is disturbing the tranquility of thoseworriers, including FDA, who think that's more Valiumthan is needed, that doctors are prescribing too much of it,and some patients are taking too much just to cop outfrom real life. Some people are also getting hooked(there's even a ''Valium Anonymous"), and FDA is planning to advise physicians that Valium was not meant toabolish everyday stress.

"Sob, heavy world,sob as you spin,mantled in mist,remote from the happy."

W. H. Auden wrote those words more than a generationago in a poem titled "The Age of Anxiety."The poem gave that generation its name. But the Age

of Anxiety has given way to the Age of Coping, so to speak.And the new generation has found that one way to copeis through tranquilizers.

The most popular tranquilizer for coping, in the lastdozen years, has been Valium. It is not only the country'sleading minor tranquilizer but also the leading prescriptiondrug, with an estimated 45 million prescriptions written forit in 1978, the latest year for which figures are available.

The manufacturer and many medical practitioners havetouted Valium as a highly effective drug with a good safetyrecord and few side effects. But recently, those claims havecome to be questioned.

They have been questioned by some people for whomValium was prescribed but who ended up addicted to thedrug. Those claims have been questioned by enough healthprofessionals to merit a U.S. Senate subcommittee hearingand to prompt the manufacturer to begin preparing a patient package insert—an informational flyer—for the drug.

The concerns have been shared by the Food and DrugAdministration, which cites evidence that Valium is over-prescribed and abused and that it can bring on both physicaland psychological dependence.

Valium belongs to a class of drugs called the "minor"tranquilizers, used principally to treat anxiety and tension.In contrast, the "major" tranquilizers are used to treat severe psychotic disorders, such as schizophrenia. The "minor" tranquilizers have been around for about 25 years,starting with meprobamate—better known as Miltown—

which came on the market in 1955. Widely accepted by themedical profession to help patients cope with the stress ofeveryday life, Miltown was soon prescribed so frequentlythat it became a household word and alerted drug companies to the market potential for this class of drug.

One large Swiss pharmaceutical company, Hoffman-LaRoche, was spurred by the commercial success of meprobamate to try to come up with a better tranquilizer atits Roche Laboratories Division in Nutley, N.J., and aRoche chemist. Dr. Leo Sternbach, was assigned to thejob.

Instead of trying to change the molecular structure ofknown tranquilizers such as meprobamate—an approachthat has brought quick success to many a pharmaceuticalchemist working in other drug classes—Sternbach decidedto explore a new class of compounds, the benzodiazepines.Ultimately he developed two compounds that proved usefulas tranquilizers. The first that Roche introduced was Librium (generic name: chlordiazepoxide) and it promptlyoutsold Miltown after its introduction in 1960. Valium (generic name: diazepam), a second compound similar inchemical structure to Librium, was introduced in 1963 andproved to be 5 to 10 times as potent as Librium.

At the time of its introduction, Valium seemed remarkable because it showed little toxicity and minimal side effects—it appeared to be quite safe. Moreover, besideshaving tranquilizing and sedative actions, Valium acted asa muscle relaxant. Having an effectiveness that was coupledwith an apparently wide margin of safety, Valium was soonbeing successfully promoted to the medical profession.

In 1978, over 44 million prescriptions were written forValium. If 1980 follows the pattern of recent years, 10 to15 percent of all Americans will have taken Valium sometime during the year.

Hospital prescribing for Valium has also been heavy.According to a recent study, by Harvard University psychiatrist Carl Salzman, M.D., of prescribing at a typicallarge urban general hospital, Valium was often prescribedfor hospital patients if they complained of the least psychicdiscomfort. Dr. Salzman found that of 149 patients already

FDA Consumer I Dec. 1979-Jan. 1980 1 21

"If 1980 follows the pattern of recentyears, 10 to 15 percent of all Americanswill have taken Valium sometime duringthe year."

on tranquilizers, 49 were also given Valium.Though relatively nonlethal by itself, Valium taken alone

in large doses has been the suspected cause of some deaths.The greatest danger, however, lies in combining Valiumwith alcohol or some other drug. The National Institute ofDrug Abuse (NIDA) statistics for 1978 put Valium in combination with alcohol in third place as a cause of death, andsecond in frequency of mention by hospital emergencyrooms as an abused drug.

There is, strangely, a bright side to these statistics. Observers of the drug abuse scene point out that Valium, bydisplacing the far more lethal barbiturate drugs, serves askind of a safety net for those who walk the tightrope ofdrug abuse and suicide. They speculate that if diazepambecame unavailable and abusers switched back to barbiturates, the death toll would surely rise.

The abuse of Valium would seem to have little bearingon its standing as a safe and effective medication. But somesee a connection between medical attitudes toward Valiumand its abuse. Groups, such as the National ConsumersLeague, allege that the medical profession has been slowto recognize the addictive qualities of Valium and that thishas fostered a permissive attitude toward the benzodiazepines. The League maintains that Valium is not a "benignlittle anxiety-reducer," as the lax prescribing habits of somephysicians would indicate.

The issue has been difficult to resolve because of thequality of much of the available evidence. Countless medical papers and articles have attested to Valium's freedomfrom addictive properties. However, a study by Drs. BarryM. Maletsky and James Klotter, two west coast medicalinvestigators, casts doubt on the validity of many of thesereports.

Maletsky and Klotter in the International Journal ofThe Addictions, reviewed 27 articles in which Valium wasclaimed to be free of addicting properties and found "none(had) conducted sufficient controls to merit dismissing thisquestion." They added: "In fact, no trials of withdrawalwith systematic observations were attempted."

In an issue of the Drug Abuse & Alcoholism Newsletter, which is distributed as a reprint by Valium's maker.

Roche Laboratories, editor Sidney Cohen, M.D., opinesthat Valium's popularity—based on its effectiveness andperceived wide margin of safety—has prompted physiciansto prescribe it for lesser indications without adequate supervision. Dr. Cohen cites Valium prescribing abuses andnegligent practices by doctors, hospitals, patients, and pharm a c i s t s .

Richard Hughes and Robert Brewin in their recently published book. The Tranquilizing of America, cite researchsuggesting that benzodiazepines damage the brain. Theyinvite the conclusion that it would be better for medicineto eliminate Valium and seek other forms of treatment foremotional problems.

As can be expected for a subject as complex as the humanpsyche, there are opposing views among medical specialistsregarding the dependency potential of the benzodiazepines.Roche maintains that although dependence has occurred,in rare cases, from high therapeutic doses of Valium takenover prolonged periods, the vast majority of patients whotake Valium benefit from its therapeutic effects withoutdanger of dependence.

Psychiatric specialist Frank J. Ayd, Jr., M.D., editor ofthe International Drug Therapy Newsletter, wrote(in the October 1978 issue) that fewer than 500 cases ofdependence—including doubtful ones—have been reported. Even this minimal amount of dependence can bereduced. Dr. Ayd wrote, if physicians exercised prudencein prescribing these substances for patients with a historyof alcohol or drug abuse.

The report "Sedative-Hypnotic Drugs: Risks and Benefits," issued by the National Institute of Drug Abuse in1977 notes that all of the sedative-hypnotic drugs are similarwith respect to their ability to produce tolerance and physical dependency, "The benzodiazepines presently availablehave been shown to be quantitatively less likely to do thisthan the other agents, but this is still a problem," the reports a i d ,

FDA's Bureau of Drugs director. Dr. J. Richard Crout,pointed out to the Senate Subcommittee on Health lastSeptember:

"While there is no (medical) consensus on how to estab-


"Many critics of Valium blame overpro-motion by Roche Laboratories for theprescribing habits of some physiciansthat have led to some cases ofa d d i c t i o n . "

lish the optimal medical need for these drugs . . . one thingis certain, and that is that the persons most at risk of becoming dependent on the benzodiazepines are those whotake these drugs in relatively high doses for longer thanf o u r m o n t h s . "

Dr. Crout outlined the magnitude of that problem aloneby citing an estimate that the patients at risk constitutesome 15 percent of users.

Because the long-term usefulness of Valium and other"minor" tranquilizers has not been clinically verified, FDArequires manufacturers of these drugs to include the following information in the "physician labeling"—that is, thematerial prepared for distribution to physicians and otherhealth professionals:

"The effectiveness of (name of drug) in long-term use,that is, more than four months, has not been assessed bysystematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individualpatient."

The current labeling also warns that the "minor" tranquilizers can produce dependence, particularly when usedin high dosages for long periods of time. Signs and symptoms of withdrawal are similar to those associated withbarbiturate and alcohol withdrawal, such as convulsions,tremors, abdominal and muscle cramps, vomiting, andsweating. Physicians are advised to caution patients againstcombining tranquilizers with alcohol.

FDA is working on further revisions of the physicianlabeling to define their appropriate use more clearly. Theproposed revision would state that these drugs are usuallynot required for the treatment of anxiety associated withthe stress of everyday life.

In the meantime, the Agency is continuing to investigaterecent reports that Valium and other tranquilizers may produce dependence and subsequent withdrawal problems atnormal therapeutic doses.

While labeling sets the guidelines for medical usage,many people—particularly consumer advocates—are calling for information that would alert the public to the risksof the "minor" tranquilizers. Last summer, FDA proposedthe development of patient package inserts (FFFs), bro

chures written in easy-to-understand language describingthe uses, risks, and benefits of prescription drugs. The tranquilizers are among the first drugs for which FFFs will bewritten under the proposed program. Fublic comments onthe proposal are being studied by the Agency. FDA alsois working with the manufacturer of Valium on a patientinformation brochure. Last November, Roche reported thatit is spending $150,000 to field test the brochure, a processexpected to take 6 months.

Those who want to get off tranquilizer regimens shouldseek medical help. Demonstrating that many people dohave problems with Valium addiction, there is now a movement called "Valium Anonymous," founded by LelandAhern of Altoona, Fa., who experienced sharp withdrawalsymptoms after he stopped taking Valium. Ahern had beentaking Valium for 7 years at a prescription level of 15 milligrams a day. A former alcoholic, Ahern describes his farewell to Valium as "many, many times worse" than his withd r a w a l f r o m a l c o h o l .

Many critics of Valium blame overpromotion by RocheLaboratories for the prescribing habits of some physiciansthat have led to some cases of addiction. The pharmaceutical company's recent sponsorship of a 3-year program ofmedical education, "The Consequences of Stress," has beencalled by Tranquilizing of America authors Hughes andBrewin "a highly sophisticated sales campaign to sell Valium not only to doctors but directly to the public, whichwould violate FDA regulations, by expanding the marketto make stress—defined as 'both the ordinary and extraordinary pressure of life that confront every individual'—anil lness t reatable wi th Val ium."

At the Senate Subcommittee hearings, Dr. Crout notedthat for years there has been a continuing exchange betweenFDA and drug manufacturers to keep the advertising inl i n e .

Referring specifically to the benzodiazepines. Dr. Croutsaid that people dealing with the everyday stresses of lifedon't need these drugs. He added: "I think it is a matterof concern to us to see the drifting toward the prescribingof these drugs for the ordinary situations of life, and it isof great concern to see their promotion going that way."

FDA Consumer / Dec. 1979-Jan. 1980 1 23

New Bin Of RightsFor Htunan^bh in teersAnyone who agrees to participate in aresearch project should be fully informed about what it's all about.FDA recently proposed revisions inits "informed consent" regulations—that is, the rules that spell out thekind of information a research subjectmust be given.

24 I Dec. 1979-Jan. 1980 / FDA Consumer Photo courtesy National Institutes of Health.

It's a safe bet that the hapless heroine, strapped to a laboratory tablein a silent movie, never agreed to bethe subject of an experiment. Madscientists of fiction never botheredw i t h s u c h m u n d a n e m a t t e r s a s i nf o r m e d c o n s e n t .

Researchers today do bother andthose who use human volunteers intests of drugs, biologicals, and medical devices must follow FDA's regulations for informed consent. TheAgency has proposed changes inthose regulations to provide clearerprotection of the rights of humansubjects involved in research activities that fall within FDA's jurisdict i o n .

The revision came about because,among other reasons, the generalregulations had not been reviewedcomprehensively in the last 12 yearsand had lagged behind current philosophy and legislation, includingstringent requirements in the 1976Medical Device Amendments. Theproposed changes thus will make asingle set of informed consent requirements applicable to all investigators doing clinical studies on alltypes of FDA-regulated products.

In obtaining informed consent, theinvestigator will have to provide theprospective subject with 11 specific"elements" of information, accordingto the proposed regulations. Thesei n c l u d e a s t a t e m e n t t h a t t h e c l i n i c a l

study involves research and that aninstitutional review board has approved the solicitation of researchsubjects. An institutional reviewboard is a local committee set up toreview the ethical aspects of clinicalresearch projects. Subjects are to betold why the research is being done,the procedures that will be followed,reasonably foreseeable risks and discomforts as well as potential benefits.Alternative courses of treatment, ifany, that might be advantageous topatients who are research subjectsmust a lso be d isc losed.

Subjects are to be assured thatthey will be told if anything signifi

cant comes up during the researchthat might affect their willingness tocontinue in the study, and that anyquestions they have about the studywill be answered. They also are to betold the extent to which confidentiality of records will be maintained.

If the research involves more thanminimal risk, subjects are to be toldwhether compensation and medicaltreatment will be available if an injury occiits and they should knowwhom to call in emergencies. Finally,subjects are to be assured that participation is voluntary and refusal toparticipate involves no penalty.

In addition, investigators are toprovide five other pieces of information when it is appropriate. These inc l u d e i n f o r m a t i o n o n w h o i s

conducting the study, who is payingfor it, and how many people are participating.

I n f o r m e d c o n s e n t i s t o b e d o c umented by a written consent formsigned by the subject or the subject'slegal representative. The person signing the form will receive a copy of it.The consent form can be either awritten document containing all therequired information, or a "shortform" indicating that the required information has been given orally. Awritten summary of the oral presentation must have been approved bythe institutional review board, asmust the written consent document.

Most people today would considerit unthinkable to carry out researchon human subjects without their permission, yet the concept of "informed consent" is relatively new,having developed only in the lastquarter century. In 1938, when theFederal Food, Drug, and CosmeticAct became law, no conditions wereimposed on investigations of newdrugs other than that the drug undertest be labeled "for investigationaluse only," and that manufacturerskeep records on how much drug wassupplied and to whom. Between 1938and 1962, FDA regulations were silento n t h e m a t t e r o f i n f o r m e d c o n s e n t .

Following World War II, disclosure of brutal experiments in Naziconcentration camps forced a reeval-uation of the moral, ethical, and legal principles applied to research onhuman subjects. The Nuremberg warcrimes trials produced a set of 10basic principles, now called the Nuremberg Code of Ethics in MedicalResearch. First on the list was: "Thevoluntary consent of the human subject is absolutely essential."

In 1962, as Congress debatedamendments to the Federal druglaws, news of the thalidomide disaster in Europe broke into print. Oneof a number of unfortunate aspectsof the story is that many of the pregn a n t w o m e n i n t h e U n i t e d S t a t e swho received this drug were not toldthat it was experimental, that theywere research subjects, or that thesafety of the drug had not been est a b l i s h e d .

Lack of any Federal or State statutes covering experimental use ofdrugs led to the inclusion in the 1962Drug Amendments of language requiring investigators to certify thatthey will inform research subjectsthat they are being given investigational drugs and will obtain theirc o n s e n t . W h a t i n f o r m a t i o n w a s t o b e

given, or how consent was to be obtained, was not specified. In fact,FDA did not attempt to define thec o n t e n t o r f o r m o f i n f o r m e d c o n s e n tuntil 1966. Since that time, the concept of informed consent has been ina continual state of change.

The new proposal on informedconsent was published in the August14, 1979, Federal Register. In addition to asking for written comments, FDA sought the views ofinterested people through three informal public hearings held in Sept e m b e r a n d O c t o b e r . A f t e r

evaluating all comments the Agencywill issue final regulations that willbe as compatible as possible with informed consent regulations of theDepartment of Health, Education,a n d W e l f a r e .

FDA Consumer / Dec . 1979 -Jan . 1980 125

NewsHyniyits

Brewers Say They're Reducing Nitrosamines

FDA is now routinely checking domestic beers fornitrosamine content and will make results of such testspublic immediately upon completion, Dr. Jere Goyan,Commissioner of FDA, has announced. He made thisstatement upon receiving a report from the U.S. BrewersAssociation outlining the progress of domestic brewers inreducing the nitrosamine levels in beer and other maltbeverages.

Concern about nitrosamines results from findings thatsome nitrosamines can cause cancer in laboratory test ani m a l s . I n 1 9 7 8 i t w a s f o u n d t h a t t r a c e a m o u n t s o f n i t r o samines enter beer because of the process by which thebarley malt is dried. Nitrosamines are also produced intrace amounts in scotch whiskies because of the processing methods used.

Commissioner Goyan said that beers produced afterJanuary 1, if they contain nitrosamines at levels that canbe reliably detected—that is, about 5 parts per billion(ppb)—will be subject to regulatory action.

In announcing the brewers' report, FDA also reportedthat the Agency's tests for nitrosamines in scotch whiskysupported earlier findings made by a contractor testingscotches for the National Science Foundation (NSF). TheNSF study found trace amounts of nitrosamines—at anaverage of 1 ppb—in six of seven scotches tested. FDAtested 29 scotches and also found traces of nitrosamines,ranging from 0 to 2.3 ppb.

The Brewers Association's October 23 report cited asurvey it made of 44 brewing companies. The associationsaid 95 percent responded, representing 99 percent of themalt beverages brewed in this country.

All the companies reported that they had taken actionto change their brewing processes so as to reduce the formation of nitrosamines. The method used, the announcement said, consists mainly of reducing the temperature ofthe open flame used to dry the barley malt while lengthening the drying time.

Arming to Fight City HallPresident Carter apparently doesn't want any citizens

saying "you can't fight city hall" (or the local Federalbuilding). Consequently, he has issued an Executive order directing all Federal agencies to develop public participation programs for consumers.

The order, issued in September, requires each U.S.unit to develop a program with the following five elem e n t s :

• A professional consumer affairs staff authorized toparticipate on behalf of consumer interests in agencyrulemaking and legislation.• Procedures for participation by consumers them

selves in the development and review of agency policiesand programs.

• Training for consumers and agency staff membersand, as appropriate, technical assistance to consumersand their organizations.

• Procedures for systematically investigating and responding to consumer complaints.

• Development of consumer information materials.Each agency will be required to identify, in its budget,

the funding that it intends to allocate to these five categories.

The order didn't put FDA in a position of playingcatch-up ball, as noted in the words of Deputy Commissioner Sherwin Gardner: "Public participation has longbeen a part of the Agency's decision-making process, andwe have in place and operational a program that will respond directly to the President's order. It will provide uswith a firm foundation for expanding our efforts in cons u m e r a r e a s . "

FDA's program has included consumer exchanges bothon national and local levels, in which consumer leadersmeet with Agency officials for a public discussion of curren t i ssues .

The Department of Health, Education, and Welfare—parent to FDA—has had no such program. Consequently, Alex Grant, FDA's special assistant for consumer affairs, was temporarily assigned to Departmentheadquarters to direct the development of such a program. Grant's assignment, by HEW Secretary PatriciaRoberts Harris, had been requested by Esther Peterson,P r e s i d e n t C a r t e r ' s a d v i s e r o n c o n s u m e r a f f a i r s .

Better Pesticide Detection Proposed

FDA has released a report containing more than 50recommendations on how to improve its programs forprotecting the Nation's food supply from harmful residues of pesticides and industrial chemicals. Titled "FDAMonitoring Programs for Pesticide and Industrial Chemical Residues in Food," the report was prepared by theStudy Group on FDA Residue Programs.

The report contains an in-depth review of the Agency'sresidue monitoring and enforcement programs and theirrelationship to Environmental Protection Agency (EPA)and U.S. Department of Agriculture (USDA) programs.The more than 50 recommendations for FDA include thefollowing:

• Use a "surveillance index" that defines the relativehealth hazard posed by the many chemicals that mightcontaminate food, to guide FDA's monitoring of domestic and imported foods for chemical residues.

• Increase FDA field investigational efforts to ascertain actual pesticide use in crop production.

• Develop an improved system for identifying chemi-


cals in the food supply from environmental sources.• Restructure the FDA Total Diet Study, which esti

mates the total daily intake of many chemical residues inthe diet, to better reflect dietary differences by age, sex,and geographic location.

• Develop Agency-wide guidelines for responding toemergencies involving chemical contamination of food.

• Seek legislative authority to enable the Agency tobetter control and deter the marketing of foods containing illegal chemical residues.

• Provide more reports to the public on the results ofFDA monitoring programs.

• Improve coordination of FDA activities with thoseof other Federal agencies.

• Work more closely with States to share results oftheir monitoring programs and to more closely coordinate FDA-State monitoring activities.

• Expand FDA activities in organizations concernedwith the safety of pesticide residues in food in internat i o n a l c o m m e r c e .

The Study Group's report came about as a result ofhearings on toxic chemicals in food held in February 1978by the House Subcommittee on Oversight and Investigations. The subcommittee's conclusion, based mainly onearlier General Accounting Office reports, was that Federal programs conducted by EPA, USDA, and FDAshould be stronger and more effective.

In his testimony at the hearings, FDA's former Commissioner, Dr. Donald Kennedy, agreed with the subcommittee. The Study Group was set up in March 1978.

Copies of the Study Group's report may be obtainedby writing to John Wessel, Office of Regulatory Affairs(HFC-6), Food and Drug Administration, 5600 FishersLane, Rockville, Md. 20857.

S t o m a c h M e d i c i n e s D o u b t e d

There are no drug ingredients on the market that aresafe and effective as stomach acidifiers, a panel of non-Government experts recently reported. In fact, the panelsaid, achlorhydria (absence of hydrochloric acid in thestomach) and hypochlorhydria (subnormal amounts ofhydrochloric acid) do not produce any symptoms, whichmeans they cannot be self-diagnosed by patients. Thus,any ingredients used to treat these conditions would bec o n s i d e r e d n o t s a f e a n d e f f e c t i v e f o r o v e r - t h e - c o u n t e ru s e .

The Advisory Review Panel on OTC Miscellaneous Internal Drug Products, which made the report, is one of17 panels set up by FDA to evaluate over-the-counterdrugs. Stomach acidifiers was one of several categories ofdrug products reviewed by this group.

The Panel evaluated the following ingredients now onthe market to add acid to the stomach: betaine hydrochloride, glutamic acid hydrochloride, diluted hydrochloride, and a combination of betaine hydrochloride andpepsin. The first three were safe, the Panel said, butt h e i r e f f e c t i v e n e s s h a s n o t b e e n d e m o n s t r a t e d . A s f o r t h e

combination, no data were submitted, nor was the Panelaware of any that would substantiate claims that pepsin isa stomach acidifier or enhances the effects of betaine hyd r o c h l o r i d e .

The Panel also ruled out labeling claims, such as "forhydrochloric acid deficiency," "for replacement therapyin deficiencies of hydrochloric acid in gastric secretion,""stomach acid medication," or "digestant."

The Panel's report on stomach acidifiers was publishedin the October 19, 1979, Federal Register to stimulatediscussion, evaluation, and comment. The conclusions ofthe Panel represent their best scientific judgment, but donot necessarily reflect FDA's position. Interested peoplehave until January 17, 1980, to comment on the report.If, after reviewing the Panel report and the public comments, FDA accepts the Panel's recommendations, a regulation declaring stomach acidifier products to be newdrugs within the meaning of the Federal Food, Drug, andCosmetic Act will be proposed.

Ûpset Stomach' Claim Ok'dManufacturers of over-the-counter (OTC) antacids

could claim on the label that their product is for "upsetstomach" under a proposal made by FDA.

Another proposal would require the labels of antacidscontaining calcium and magnesium to carry a warningagainst use by people taking the antibiotic tetracycline.

The proposal to change the indications for antacid usecame after two manufacturers petitioned FDA to allowclaims other than "heartburn," "sour stomach," and"acid indigestion," the only indications permitted at present. FDA denied the petitions, but proposed on its owninitiative to allow antacids to be labeled "for relief of upset stomach associated with heartburn, sour stomach, oracid indigestion." The Agency believes consumers frequently associate stomach upset with hyperacidity.

The proposal was published in the September 21, 1979,Federal Register. Manufacturers can adopt this labeling now, subject to the possibility that FDA may changeits position or alter the wording of the indication.

The second proposal, published in the October 19,1979, Federal Register, would require antacid products containing calcium and magnesium to carry the druginteraction precaution: "Do not take this product if youare presently taking a prescription antibiotic drug containing any form of tetracycline. If you are not surewhether or not you are taking a tetracycline product contact your physician or pharmacist." At the present time,the interaction precaution is required only on OTCantacids containing aluminum.

FDA is proposing this change to make OTC antacid labeling consistent with labeling for prescription oral tetracyclines which advises against concomitant treatment withantacids containing the three ingredients. Products containing minimal amounts of aluminum, magnesium, orcalcium may be exempted from this label precaution ifnormal doses do not interfere with concomitant use oftetracyclines.

The proposed change in antacid labeling will becomeeffective 12 months after publication of the final regulat i o n .

FDA also is considering requiring a similar precautionary statement for OTC non-antacid internal drug products containing aluminum, magnesium, and calcium, andhas invited comment on this issue.


Regional Reports

When a Hurricane Calls

Hurricane Frederic, which punchedout the City of Mobile with winds upto 130 miles an hour, presented a serious problem common to most naturaldisasters today: the possibility thatfoods, drugs, medical devices, andother products damaged or contaminated during the disaster would findtheir way into the marketplace, creating health hazards for consumers.The need to prevent such an occurrence brought FDA onto the scene,ready for action.

The morning after the hurricane'sonslaught on the two-county Alabamacoastal area. Investigators Karen Ab-ney. Jack Douglas, Dennis Hudson,Mark Collins, and Erny Clausnitzer,their Government cars loaded withfood, water, lanterns, candles, campstoves, and other emergency supplies,arrived at the Mobile Resident Inspection Post prepared to act to preventdistribution of contaminated and unsafe products.

Robert Becker, Mobile's senior resident investigator, and Michael Divine, Atlanta District investigator,were waiting for assistance. Divine, intown for a routine inspection, hadbeen at Becker's house when the hurricane hit—sometime after 10 p.m. onSeptember 12.

In the first days after the disaster,the investigators worked under difficult conditions. Becker and EarlDavis (Montgomery resident-in-charge) supervised the operation, despite an unlighted office and haphazard telephone operations, which for atime permitted them to call out of theresident post but not to receive calls.Investigators sloshed from dawn todusk through flooded streets andcamped out at night in a motel with

out electricity, potable water, orenough beds.

On Saturday, September 15, a second FDA team arrived and also inspectors from the AlabamaDepartment of Agriculture and Industry. Investigator James Crumb, fromthe U.S. Department of Agriculture,arrived on Monday.

Working out of the Mobile office.State and Federal investigators traveled in teams to assigned areas. Themajor problems had been caused bythe wind, which toppled some 1,000electrical power poles, knocking outthe city's electricity and thus eliminating refrigeration capacity. The windalso blew off walls and roofs, leavingproducts exposed to the elements. Theroof was ripped off one medical supply wholesale warehouse, exposingsterilized equipment to the drivingrain. The firm had to junk $700,000worth of medical supplies, exposed tomold and mildew and about as farfrom sterile as they could get. Theroofs and walls of many warehousesand warehouse coolers collapsed. Onewall and part of the freezer at a foodstorage warehouse were blown off.When the warehouse was inspectedthe following week, the food hadthawed and was rotting and thus wascondemned by the city health department. About $100,000 worth of riceand beans, left exposed in anotherwarehouse, had to be destroyed. Approximately 60 small seafood retailersand wholesale establishments in thenearby town of Bayou La Batre wereswamped by 2 to 3 feet of water. Oneof the firms lost over 100,000 poundsof seafood.

Many damaged products were embargoed on the spot by the State in

vestigators. Some lots of flour andrice were converted to animal feed,but most of the products had to bedestroyed. Partially blocked roadsmade it difficult to transport contaminated merchandise to one of two sanitary landfills (both more than 25miles from town), where FDA investigators witnessed the destruction.

Most of the salvage operation wascompleted within 2 weeks. Duringthat time 16 FDA investigators (fromAtlanta, Montgomery, and Mobile)came and went, working 12- to 14-hour days along with seven State inspectors, a USDA compliance officer,civil defense authorities, and countyand city health officials. The MobileCounty Health Department maintained surveillance over the 1,450 restaurants and other retail food outletsin the area. The whole process wasmade easier by the cooperation of theaffected merchants, who assisted inevaluating and, when necessary, destroying their goods. Becker was stillchecking damaged firms well into October—but by then the rest had gonehome. In all, 94 retail pharmacies andover 200 wholesalers were inspected.

Some things will take longer to beput right. The oyster bed in Bayou LaBatre, now buried in thick mud, willtake at least 2 years to start producingagain. It will be 5 to 10 years beforethe pecan trees—many uprooted during the storm—will be in full production again. This year's pecan crop inthe Mobile area—one of the Nation'smajor pecan producers—was a complete loss. Firms in the two-countyarea lost over a million dollars worthof merchandise.


Regional Reports consists of information on inspections, product seizures,court proceedings, and other regulatory and administrative actions initiated by FDA 5 regional and districtfield offices across the country to provide protection to consumers underF e d e r a l l a w s .

R E G I O N I

Connecticut, Maine, Massachusetts,New Hampshire, Rhode Island,V e r m o n t

S e i z u r e o f a t r u c k l o a d o f f r o z e n

scallops was initiated by FDA's Bost o n D i s t r i c t a f t e r t h e D i s t r i c t l e a r n e dfrom the U.S. Department of Commerce that the scallops—stored in aGloucester, Massachusetts, warehouse—were decomposed. Districtinvestigators arrived at the warehouse to find the 152 cases of scal

lops being loaded onto a truckdestined for Wilmington, Massachusetts. They collected samples of themo l l usks and t he add ress o f t het r u c k ' s e x a c t d e s t i n a t i o n . W h e n l a b o

ratory analysis of the samples confirmed the product was decomposed,the District initiated seizure action.The scallops, valued at $8,800, wereordered destroyed by a Federal courtafter no one submitted a claim forthem within the specified period oft i m e .

R E G I O N I I

New Jersey, New York, Puerto Rico,Virgin Islands

A drug plant's labeling mixup involving two products, one a powerfulanti-cancer drug, introduced a potential threat to glaucoma patients.FDA's New York Distr ic t moni toreda recall of 8,000 bottles of a mislabeled drug after learning of the problem from the manufacturer, LederleLaboratories, Pearl River, NewYork. Lederle init iated the recallwhen a Pennsylvania pharmacist reported that tablets in a bottle labeledMethazolamide were the wrong

color. Methazolamide is Lederle'sbrand name for neptazane, a productused in the treatment of glaucoma.The firm analyzed a sample of thedrug received by the pharmacist andfound it was actually methotrexate—a powerful anti-cancer drug. Methotrexate is frequently toxic, especiallywhen used over long periods. Thefi r m ' s r e c o r d s s h o w e d t h a t t h e l o t i n

question had been distributed between January and March 1979 towholesalers and pharmacies acrossthe country, about 62 bottles goingto sales people as samples.

Approximately $250,000 worth offood was seized at a public storagewarehouse in Jersey City, New Jersey, after an inspection by FDA'sN e w a r k D i s t r i c t r e v e a l e d e x t e n s i v einsect infestation throughout the facility. The District recommended theseizure after investigators inspectedthe Fourteen Florence Street Warehouse Corp. and observed insectscrawling in lots of filbert nuts, kibbled carob, and cocoa liquor.

The Newark District witnessed thedestruction of 8,861 three-and-a-half-ounce jars of contaminated RevlonMilk Plus Six Face Moisturizer atRevlon Inc., Edison, New Jersey.The cosmetic product was recalled byRevlon's Corporate headquarters inNew York City after it was found tocontain Pseudomonas aeruginosa, abacterium that may cause swelling ofthe skin. The destroyed lot was valued at about $45,305.

Close cooperation between FDA'sB u f f a l o D i s t r i c t a n d t h e N e w Yo r k

Department of Agriculture and Mar

kets led to the seizure of over 7,000pounds of insect-infested raisins, valued at $7,000, from a firm in Pittsburgh, New York. During a routineinspection of Pittsburgh Grocery,Inc., FDA investigators found theraisins, which were packed in 30-pound cardboard boxes, contaminated with Indian meal moths, larvae, and pupae. At FDA's request,the New York Department of Agriculture and Markets placed an embargo on the raisins, and assisted inr e m o v a l o f t h e c o n t a m i n a t e d f o o dstuffs from the marketplace.

R E G I O N I V

Alabama, Florida, Georgia,Kentucky, Mississippi, NorthCarolina, South Carolina, Tennessee

A report of a shipment of defiledwhey led FDA's Atlanta District to awarehouse in Griffin, Georgia, wherea mass seizure of products resulted.Responding to a North Carolina Department of Agriculture report, FDAinvestigators traced a shipment of rodent-contaminated whey to the Griffin Grocery Co., Inc. An inspectionof the company turned up widespread rodent activity and poorhousekeeping practices. At FDA'srequest, the Georgia Department ofAgriculture embargoed beans, peas,and pet food products with a combined value of $4,250, pending Fede r a l s e i z u r e a c t i o n .

R E G I O N V I

Arkansas, Louis iana, New Mexico,Ok lahoma, Texas

Cont inenta l Gra in Co. , Beaumont ,Texas, sold 57 railroad cars of corn


to a salvage operator for reconditioning after analysis by FDA's HoustonSection revealed the grain was contaminated with aflatoxin. Aflatoxin isa naturally occurring, cancer-causingcontaminant produced by mold that,under certain conditions, grows onpeanuts, corn, wheat, rice, cottonseed, tree nuts, and other foods. Investigators from the Houston Sectioncollected samples from the 57 openrailcars after the Section was notifiedof the problem by the U.S. Department of Agriculture (USDA). Thesamples collected by both FDA andUSDA contained aflatoxin in excessof 20 parts per billion—the maximumlevel allowed under FDA regulat i o n s .

R E G I O N V I I

Iowa, Kansas, Missouri, NebraskaA complaint from a U.S. Depart

ment of Agriculture meat and poultry inspector to FDA's OmahaResident Post about insect-contaminated baking products led to the destruction of more than $3,000 worthof breading and batter mixes at afood manufacturer in Council Bluffs,Iowa. The inspector, who was checking meat and poultry at the Iowafirm, alerted the Omaha ResidentPost to insect contamination in acargo picked up from Golden Dipt,Inc., Millstadt, Illinois. The contamination was noted at the Iowa firm asthe products were being unloadedfrom the truck and was subsequentlybrought to the attention of theUSDA inspector. The entire load of200 fifty-pound bags of Golden DiptBatter Mix and 218 fifty-pound bags

of Golden Dipt Breading Mix wasdestroyed under supervision of FDAinvestigators. Kansas City investigators relayed their findings to FDA'sChicago District so that the districtcould investigate the cause of the ins e c t i n f e s t a t i o n .

R E G I O N V I I I

Colorado, Montana, North Dakota,South Dakota, Utah, Wyoming

Over 2,000 cases of canned orangejuice never made it to the South Dakota schools they were intended for.The 46-ounce cans of juice, cannedin Frostproof, Florida, for the U.S.Department of Agriculture's schoollunch program, were seized at aSouth Dakota warehouse because thecans were swollen and leaking. Theproblem was discovered by warehouse employees as they were unloading the cases from the deliveringrailroad car. The warehouse notifiedthe Sioux Falls Health Department,which in turn filed a complaint withFDA's Sioux Fails Resident Inspection Post. FDA investigators confirmed that the cans were leaking—although the cause was not determined—and initiated seizure of about$13,000 worth of the product.

R E G I O N I X

Arizona, California, Guam, Hawaii,N e v a d a

A pack of voracious rats provedtoo formidable for Far West FoodsFacility, San Francisco. Investigatorsfrom FDA's San Francisco Districtinspected the firm after learning fromthe Seattle District that a lot of ro

d e n t - c o n t a m i n a t e d w h e a t s t a r c h h a dbeen shipped from the firm. The investigators found the facility infestedwith rats. At one point, an investigator looked up to see four large ratseyeing him from a nearby ledge.During the inspection company employees filled in many of the rat burrows with cement. By the followingmorning the rats had chewed throught h i s m a t e r i a l .

The District initiated a mass seizure of all foods stored in the warehouse. Products that had not movedin interstate commerce were embargoed by the California Departmentof Health Services, Food and DrugSection. The lot of starch that hadprecipitated the inspection was returned to San Francisco and placedunder seizure. Far West Foods vacated the premises and filed a consent decree asking for permission torecondition some of the food.

FDA's Los Angeles District detained $29,000 worth of brazil nutsfrom Bolivia, which the AmericanPistachio Co., New York City,sought to import through the Port ofLos Angeles. The firm had declinedto have samples of the nuts analyzedas part of the U.S. Department ofAgriculture's voluntary aflatoxin testing program, so USDA requestedthat Los Angeles District take samples. Analysis of the samples revealed contamination by aflatoxin,and the nuts were detained.

A large number of shipments ofshark fin products and hoisin saucefrom Hong Kong were detained bythe Los Angeles District after routine

30 / Dec. 1979-Jan. 1980 i FDA Consumer

import inspections at the Port of LosAngeles revealed the products contained filth. The shark fin products,valued at $500,000, contained insectsand rodent hairs, and the hoisinsauce, worth over $200,000, contained feathers, rodent hairs, and ins e c t s .

R E G I O N X

Alaska, Idaho, Oregon, WashingtonThe 1979 sockeye salmon run in

Bristol Bay, Alaska, far exceeded expectations of fishing industry experts.Unfortunately, the harvest—of over1 8 m i l l i o n f i s h — a l s o e x c e e d e d t h e

processing capacity of Alaskan seafood processors. Large numbers offish deteriorated because of transpor

tation shortages, inadequate refrigeration facilities, and insufficient icingcapabilities. Investigation by FDA'sSeattle District of salmon shippedinto the Seattle area resulted in seizures of 36 lots of salmon involvingsome 9 companies. Almost 127,000pounds of frozen salmon and 250,000cans of salmon—worth about $700,-000—were seized at the District's request .

Farman Brothers Pickle Co., En-umclaw, Washington, destroyed 240gallons of brined cauliflower after aSeattle District investigator told thefirm's management that the vegetablew a s c o n t a m i n a t e d w i t h i n s e c t s . T h ec a u l i fl o w e r w a s i n t e n d e d f o r u s e i nthe firm's sweet pickle mix.

A s n a c k f o o d m a n u f a c t u r e r i n

Portland, Oregon, changed his waysafter a visit by an investigator fromF D A ' s P o r t l a n d R e s i d e n t P o s t . T h e

investigator examined all raw materials, both visually and with a black-light (a device used to detect urinestains), and found 660 pounds ofpopcorn kernels, cheese powder, ands a l t c o n t a m i n a t e d w i t h i n s e c t s a n drodent filth. The firm, MatthewsCandy Co., destroyed the contaminated foods, valued at about $900,and immediately began corrective action to prevent recurrence of suchproblems. The firm caulked openingsi n w a l l s a n d fl o o r s w h e r e i n s e c t s a n drodents could enter and purchased itsown blacklight to examine all rawm a t e r i a l s f o r c o n t a m i n a n t s .

State Actions

State Actions reports on importantregulatory and administrative actionsconducted by State and local government agencies to provide health andeconomic protection to consumers offoods, drugs, cosmetics, and medicaldevices.

Contaminated Cheese

State and Federal agencies joinedforces to stop the distribution ofcheese containing small pieces ofmetal and Teflon. Investigators fromthe U.S. Department of Agriculture(USDA) discovered the contamination during an inspection at CheeseCorp. of America, Inc., Amsterdam,New York, which was manufacturingpart-skim low moisture mozzarellacheese under a contract for theUSDA school lunch program. Thenonfat dry milk used in the cheesewas supplied by USDA. AfterUSDA rejected the cheese for theprogram, the firm shipped it to its

processing plant in Massachusettswhere it was shredded, repacked,and d is t r ibu ted. USDA a ler ted FDA,which in turn notified State authorities. Over 500 loaves of the cheese,about $3,000 worth, were embargoedby the New York Department of Agriculture and Markets. The Commonwealth of Pennsylvania embargoedanother $8,000 worth, later seized bya U.S. marshal at the request ofFDA's Philadelphia District.

Flour Embargoed

Insect contamination was the reason for the embargo of 159,450pounds of flour at Statesville FlourMills, Statesville, North Carolina. Investigators from the North CarolinaDepartment of Agriculture discovered the contamination during a routine inspection of the firm in whichinsects were observed in the millingequipment. When laboratory analysisrevealed approximately 200 insectfragments per 50 grams of flour, theState embargoed the product.

U n c l e a n C l a m s

The New Jersey Department ofHealth took action against two NewJersey companies that operate softshell clam depuration plants. Atthese plants clams are cleansed ofbacteria to make them safe to eat.The clams are submerged in cleanwater, which they pass through theirsystems, thus removing bacteriallycontaminated water. Companies performing this process must be licensedby the State. The Department suspended the Shellfish Certificate andFood License of Clamdiggers Clamming Co., Highlands, because thefirm was selling clams that had notbeen cleansed for the required 48-hour period. This was a second offense. The firm's license was suspended for 30 days and the companyfined $200. Shrewbury River Clams,also in Highlands, was fined $300 bythe Department after a State inspection revealed insanitary conditionsand deficient equipment at this depuration facility.


Seizures and Postal Service Cases

FILED SEIZURE ACTIONS charge violations of the Federal Food, Drug, and Cosmetic Act and are initiated based upon FDArecommendations. A seizure is commenced by the filing in the U.S. district court where the goods arelocated. A U.S. marshal is then directed by the court to take possession of the goods, removing theproduct from commerce, until the matter is resolved.

A total of 40 actions to remove from the consumer market products charged to be violative was reported in October. These actions included 25 offoods: 1 involved a charge concerning a poisonous and deleterious substance, and 24 involved charges concerning contamination. Others included 1of color additive, 12 of drugs (including 2 of veterinary), and 2 of medical devices.

P R O D U C T , D I S T R I C T & D A T E F I R M A N D P L A C E O F B U S I N E S S C H A R G E SF I L E D

FOOD/Poisonous and Deleterious Substances

Swordfish s teaks and fi l le ts /U .S . D is t r i c tCour t fo r the Eastern D is t r ic t o f Ca l iforn ia 8/30/79

Ben Kozloff, Inc./Chicago, 111. Contains the added poisonous and deleterious substance mercu ry.

FOOD/Contamination, Spoilage, Insanitary Handling

Beans, white, small, canned/U.S. District Beans shipped from Oakland, Calif., and Contained in swollen cans.Court for the District of Puerto Rico prepared in Puerto Rico.8/20/79

Carob, filberts, and cocoa liquor/U.S. Fourteen Florence Street Warehouse Held under insanitary conditions; insect contaminatedDistrict Court for the District of New Corp./Jersey City, N.J.Jersey 8/30/79

Cashew nuts/U.S. District Court for the Kane International/Larchmont, N.Y. Insect contaminated.Dis t r i c t o f M innesota 6 /25 /79

C a s h e w n u t s / U . S . D i s t r i c t C o u r t f o r t h e I m p o r t e d f r o m B r a z i l . "Dis t r i c t o f M innesota 8 /1 /79

Flour, beans, macaroni products, and Monitor y Boscio, Sucrs., Inc./Ponce, Held under insanitary conditions; article rodent and/oro t h e r f o o d s t o c k s / U . S . D i s t r i c t C o u r t P . R . i n s e c t c o n t a m i n a t e d ,for the Distr ic t of Puerto Rico 9/5/79

Flour, blending; high-gluten flour; and Linker Brothers Bakery Co., Inc./Louis- Held under insanitary conditions; and the high-glutenw h o l e w h e a t fl o u r / U . S . D i s t r i c t C o u r t v i l l e , K y. fl o u r w a s r o d e n t c o n t a m i n a t e d ,for the Western District of Kentucky8/23/79

Macaroni and cheese dinners/U.S. Dis- Shipped from Libertyville, 111. Held under insanitary conditions,t r i c t Cou r t f o r t he Eas te rn D i s t r i c t o f

Virginia 6/25/79Mozzarella cheese/U.S. District Court for Cheese Corp. of America, Inc./Amster- Contains plastic-like particles and metal fragmentsthe Eastern District of Virginia 8/28/79 dam, N.Y.

M o z z a r e l l a c h e e s e , p a r t - s k i m , l o w m o i s - " "tu re /U .S . D is t r i c t Cour t fo r the Nor thern Dis t r ic t o f New York 7 /23/79

Mushrooms, canned/U.S. District Court Industrias Internacionales de Alimentos Contained in swollen and leaking cans,for the Southern District of Florida 9/ S.A./Santo Domingo, Dominican Re-1 4 / 7 9 p u b l i c


PRODUCT, DISTRICT & DATEF I L E D

FIRM & PLACE OF BUSINESS C H A R G E S

Orange juice, canned/U.S. District Court Shipped from Frostproof, Fla. Decomposed and contained in swollen and leakingf o r t h e D i s t r i c t o f S o u t h D a k o t a 8 / 1 4 / 7 9 c a n s .

Popcorn/U.S. District Court for the Dis- Caribbean Snacks, Inc./Rio Piedras, P.R. Held under insanitary conditions; insect contaminated,trict of Puerto Rico 7/18/79

Salmon, frozen/U.S. District Court for Shipped from Anchorage, Kenai, and/or Contain decomposed fish,the Western District of Washington 8/ King Salmon, Alaska.2/79

S a l m o n , f r o z e n / U . S . D i s t r i c t C o u r t f o r " "the Western District of Washington 8/2/79









Shrimp, frozen/U.S. District Court for the Offered for import into United States. Decomposed and/or contaminated with insects and/orS o u t h e r n D i s t r i c t o f T e x a s 9 / 4 / 7 9 S a l m o n e l l a .

Shrimp, frozen/U.S. District Court for the Suvarndurg Fisheries/Harnai, India Prepared, packed, and held under insanitary condi-D i s t r i c t o f M a s s a c h u s e t t s 9 / 2 1 / 7 9 t i o n s ; c o n t a i n i n s e c t fi l t h .

C O L O R A D D I T I V E S

Candy novelties of marzipan/U.S. District Biermann Marzipan Co./North Bergen, Contain the nonconforming color additives FD&C RedC o u r t f o r t h e D i s t r i c t o f N e w J e r s e y 9 / N . J . N o . 2 a n d E x t e r n a l D & C O r a n g e N o . 3 .10/79

D R U G S / H u m a n U s e

Aspirin tablets/U.S. District Court for the The Pil l Mil l , Inc./Grand Rapids, Mich. Circumstances of manufacture, processing, packing.W e s t e r n D i s t r i c t o f M i c h i g a n 9 / 2 6 / 7 9 a n d h o l d i n g n o t i n c o n f o r m i t y w i t h c u r r e n t g o o d

manufacturing practice; label fails to bear expirationdate.

FDA Consumer / Dec. 1979-Jan. 1980 ! 33

PRODUCT, DISTRICT & DATEF I L E D

F I R M A N D P L A C E O F B U S I N E S S C H A R G E S

Betamethasone valerate cream/U.S. Distr ict Court for the Distr ict of New Jer

sey 7/16/79

Betamethasone valerate cream/U.S. Dist r ic t Cour t fo r the Nor thern Dis t r ic t o fI l l ino is 8/2/79

Cough syrup, and other drugstocks/U.S.Dis t r ic t Cour t fo r the Nor thern Dis t r ic tof Ohio 7/27/79

Dipyridamole tablets, furosemide tablets,doxylamine succinate combination tablets, hydroxyzine hydrochloride tablets, and other drugs/U.S. District Courtfor the Western District of Kentucky7/24/79

Furosemide injection/U.S. District Courtfor the Eastern District of Michigan 6/28 /79

Hydroxyzine hydrochloride tablets/U.S.D i s t r i c t C o u r t f o r t h e C e n t r a l D i s t r i c to f Cal i forn ia 7 /5/79

Methenamine mandelate tablets, and aspirin capsules/U.S. District Court forthe District of Oregon 9/18/79

P h e n o b a r b i t a l e l i x i r / U . S . D i s t r i c t C o u r tfor the Nor thern Dis t r ic t o f Ohio 7/27/79

Spironolactone with hydrochlorothiazidetable ts /U.S. Dis t r ic t Cour t for the Dist r ic t o f Mary land 6/27/79

Premo Pharmaceutical Laboratories, Inc./South Hackensack, N.J.

C. M. Bundy/Erlanger, Ky.

Pharmadyne Laboratories, Inc./Hacken-sack, N.J.

IMS, Ltd./South Elmonte, Calif.

Premo Pharmaceutical Labs, Inc./SouthHackensack, N.J.

Stanlabs Pharmaceutical Co./Portland,Oreg.


Premo Pharmaceutical Labs, Inc./SouthHackensack, N.J.

New drug without effective approved New Drug Application. Fails to bear adequate directions for useand not exempted due to lack of New Drug Applic a t i o n .

New drug without an effective approved New DrugApplication.

Circumstances of manufacture, processing, packing,and holding not in conformity with current goodmanufacturing practice.

New drugs without effective approved New Drug Applications.


Circumstances of manufacture, processing, packing,and holding fail to conform with current good manufacturing practice; false and misleading claims foradequate stability testing (expiration dates inadequately substantiated).



Equidantin nitrofurantoin suspension/U.S.D is t r i c t Cou r t f o r t he Eas te rn D i s t r i c tof Missour i 7/25/79

ZEV expectorant for horses and dogs,and other drugstocks/U.S. District Courtfor the Nor thern Dis t r ic t o f Ohio 7/30/7 9

DRUGS/Veterinary

Performance Products, Inc./St. Louis, Mo.


New animal drug and no approval of a New AnimalDrug Application was in effect with respect to its useor in tended use.


M E D I C A L D E V I C E S

Blended fiber device (synthetic hair fi-bers)/U.S. District Court for the Western District of Washington 6/15/79

In t raocu la r lenses /U.S. D is t r i c t Cour t fo rthe Eastern District of Virginia 6/14/79

United Laboratories, Inc./Maple Heights,O h i o

Coburn Optical Industries, Inc./ColonialHeights, Va.

Labeling fails to bear adequate directions for use.

Product is a Class III medical device without an effective

approved application; and person granted an exemption failed to comply with regulations.


Nbtices of Judgment

NOTICES OF JUDGMENT on Seizure Actions

FOOD/Poisonous and Deleterious Substances

Halibut, trimmed, frozen, at Bellingham, Dist. Wash.Charged 12-17-76: when shipped by Excursion Inlet Packaging Co.,Excursion Inlet, Alaska, the article contained the added poisonousand deleterious substance mercury; 402(a)(1). Consent decree authorized release to Wards Cove Packing Co., Inc., Seattle, Wash., forsalvaging. (F.D.C. No. 61059; S. No. 77-70-540 et al.; N.J. No. 1)

FOOD/Contamination, Spoilage, Insanitary HandlingBeans, black and red, dried, at New York, S. Dist. N Y.

Charged 3-9-79: while held by Summit Imports Corp., New York,N.Y., the articles contained rodent and/or insect filth and had beenheld under insanitary conditions; 402(a)(3), 402(a)(4). Consent decreeauthorized release to the dealer for salvaging. (F.D.C. No. 62104; S.No. 79-161-552 et al.; N.J. No. 2)

Beans, pink, dried, at Bayamon, Dist. P.R.Charged 3-21-79: while held by Goya De Puerto Rico, Inc., Bayamon, P.R., the article contained rodent filth and had been held underinsanitary conditions; 402(a)(3), 402(a)(4). Consent decree authorizedrelease to Tradewind Foods, Inc., Bayamon, P.R., for salvaging.(F.D.C. No. 62193; S. No. 79-157-236; N.J. No. 3)

Cornmeal, bread mix, flour, and popcorn, at New Bedford, Dist. Mass.Charged 2-23-79: while held by National Wholesale Co., New Bedford, Mass., the cornmeal contained rodent filth, and all of the articleshad been held under insanitary eonditions; 402(a)(3), 402(a)(4). Default decree ordered destruction. (F.D.C. No. 62161; S. No. 77-161-124; N.J. No. 4)

Cheese loaves, Swiss, Mozzareila, and brick, at Elkhart, N. Dist. Ind.Charged 1-22-79: while held by Ruffs Wholesale Foods, Inc., Elkhart, Ind., the Swiss cheese was decomposed, the other cheeses contained rodent filth, and all of the articles had been held underinsanitary conditions; 402(a)(3), 402(a)(4). Default decree ordereddestruction. (F.D.C. No. 62138; S. No. 79-182-451 et al.; N.J. No.5)

Flour, at Lynn, Dist. Mass.Charged 3-13-79: while in transit in a railcar, the article containedrodent filth and was held under insanitary conditions; 402(a)(3),402(a)(4). Consent decree authorized release to Boston & MainCorp., Boston, Mass., for salvaging. (F.D.C. No. 61993; S. No. 79-149-601; N.J. No. 6)

Flour, at Kannapolis, M. Dist. N.C.Charged4-17-78: while held by Independent Wholesale Grocery Co.,Kannapolis, N.C., the article was held under insanitary conditions;402(a)(4). Default decree ordered destruction. (F.D.C. No. 61726;S. No. 78-100-212; N.J. No. 7)

Flour, at Miami, S. Dist. Fla.Charged 3-5-79: while held by Star Bakery, Inc., Miami, Fla., thearticle contained rodent filth and had been held under insanitary conditions; 402(a)(3), 402(a)(4). Consent decree ordered destruction.(F.D.C. No. 62157; S. Nos. 79-166-463/7; N.J. No. 8)

Oat cereal, breakfast cereal, and otber foodstocks, at Houston, S. Dist.T e x .

Charged 9-22-78: while held by Texas Grocery Co. of Houston, Tex.,some lots of the articles contained insect filth, and all of the articleswere held under insanitary conditions; 402(a)(3), 402(a)(4). Consentdecree authorized release to the dealer for salvaging. (F.D.C. No.61898; S. No. 78-122-733 et al.; N.J. No. 9)

Pears, canned, commingled lots, at Milford, Dist. Del.Charged 3-8-79: while held for sale, the article was contained inabnormal cans (leaking, swollen, dented, and rusty)—402(a)(3); somecans of the article were unlabeled and lacked the name and place ofbusiness of the manufaeturer, packer, or distributor; lacked a quantityof contents statement; and lacked the name of the food and anyoptional ingredients, as prescribed by the definition and standard ofidentity for canned pears—403(e)(1), 403(e)(2), 403(g)(2). Default

decree ordered destruction. (F.D.C. No. 62197; S. No. 79-204-033-N.J. No. 10)

Popcorn, rice, and stuffing mix, at Raleigh, E. Dist. N.C.Charged 3-20-79: while held by Commercial Bonded Warehouse Co.,Raleigh, N.C., the popcorn and some lots of rice contained rodentfilth, and all of the articles had been held under insanitary eonditions;402(a)(3), 402(a)(4). Consent decree authorized release of the riceand the stuffing mix to Uncle Ben's, Inc., Houston, Tex., for salvaging, and authorized release of the popcorn to the dealer for salvaging.(F.D.C. No. 62198; S. No. 79-197-554; N.J. No. 11)

Rice, at Norfolk, E. Dist. Va.Charged 11-22-78: while held by Southgate Terminal Warehouse,Inc., Norfolk, Va., some lots of the article contained insect filth, andall lots had been held under insanitary conditions; 402(a)(3), 402(a)(4).Consen t dec rees au tho r i zed r e l ease o f va r i ous l o t s t o Come t R i ceMills, Inc., Houston, Tex., for salvaging, and authorized destructionof other lots. (F.D.C. No. 61958; S. No. 78-103-317 et al.; N.J. No.12)

Rice, and brown rice, at San Jose, N. Dist. Calif.Charged 5-3-79: while held by J. Wong's Oriental Foods, t/a PacificOil & Rice Co., San Jose, Calif., the brown rice contained rodentfilth—402(a)(3); the articles had been held under insanitary conditions—402(a)(4); and, when shipped by Riceland Foods, Stuggart,Ark., the label of the brown rice lacked the name and place of businessof the manufacturer, packer, or distributor—403(e)(1). Default decreeordered destruction. (F.D.C. No. 62256; S. No. 79-146-388; N.J. No.13)

Sbrimp, peeled and cleaned, frozen, at Chicago, N. Dist. 111.Charged 11-22-78: while in transit and while held for sale, the article,which was labeled in part "Nordan Brand Ready to Cook . . . FrozenSalad Shrimp Peeled and Cleaned . . . Packed by Gloucester ShrimpCo., Inc., Gloucester, Ma.," contained decomposed shrimp; 402(a)(3).The article was claimed by Gloucester Shrimp Co., Inc., Gloucester,Mass., who denied the charge. The parties served written interrogator ies on each other. The act ion came on for t r ia l before the cour t .Prior to the conclusion of the Government's evidence, a consent decree of condemnation and destruction was agreed upon. Pursuant tosuch decree, the article was destroyed. (F.D.C. No. 61954; S. Nos.78-157-374, 79-151-219; N.J. No. 14)

Soup mix, vegetable, dried, at San Francisco, N. Dist. Calif.Charged 3-9-79: when shipped by Dah Chong Hong Trading, NewYork, N.Y., the article, labeled in part "Chi Kong Brand China National Native Produce & Animal By-Products Import & Export Corporation Kwantung Branch Shekki Office," contained insects; 402(a)(3).Default decree ordered destruction. (F.D.C. No. 62185; S. No. 7^196-181; N.J. No. 15)

D R U G S / H u m a n U s e

Adrenal cortex injection, at Lakewood, C. Dist. Calif.Charged 6-20-78: when shipped by Lypho-Med., Inc., Chicago, 111.,the article was a new drug without an effective approved New DrugApplication; 505(a). Default decree ordered destruction. (F.D.C. No.61807; S. No. 78-153-378; N.J. No. 16)

Boric acid, isopropyl alcobol, flowers of sulfur, ethyl alcohol, and otherdrugstocks and drug components, at Knoxville, E. Dist. Tenn.Charged 12-13-76: while held by Davis Manufacturing Co., Inc., t/aUnited Pharmaceuticals, Inc., Knoxville & White Pine, Tenn., thecircumstances used for the articles' manufacture, processing, packing,and holding failed to conform with current good manufacturing practice; 501(a)(2)(B). The article was claimed by the dealer. Consentdecree authorized release to the dealer for salvaging. (F.D.C. No.61030; S. No. 77-34-321 et al.; N.J. No. 17)

Furosemide tablets, at San Mateo, N. Dist. Calif.Charged 3-29-79: when shipped by Pharmadyne Laboratories, Inc.,Hackensack, N.J., the article was a new drug without an effectiveapproved New Drug Application; 505(a). Default decree ordered destruction. (F.D.C. No. 62180; S. No. 79-179-687; N.J. No. 18)


Lyophrin kits (epinephrine bitartrate and a diluent, for combination asepinephrine bitartrate for ophthalmic solution), at Fort Worth, N.D i s t . Te x .Charged 3-1-79: while held by Alcon Laboratories, Inc., Fort Worth,Tex., who was labeling vials of interstate epinephrine bitartrate andpackaging it with vials of diluent, the strength of the article fell belowIts purported strength since, when reconstituted as directed on thearticle's label, the article was subpotent; 501(b). Default decree ordered destruction. (F.D.C. No. 62160; S. No. 79-181-225; N.J. No.19)

Pentylenetetrazol combination capsules, at Memphis, W. Dist. Tenn.Charged 1-25-79: when shipped by Alpha Pharmacal Co., St. Louis,Mo., the article (which was labeled in part "Edwards . . . Nico-VertCapsules . . . Pentylenetetrazol. . . Niacin . . . Dimenhydrinate Manufactured For Edwards Pharmacal Co., Memphis, Tennessee") hadbeen manufactured and processed under circumstances which werenot in conformity with current good manufacturing practice;501(a)(2)(B). Default decree ordered destruction. (F.D.C. No. 62102;S. No. 79^123-456; N.J. No. 20)

Phenoxymetbyl penicillin potassium, at Syracuse, N. Dist. N.Y.Charged 6-10-77: while held for sale by Bristol Laboratories, Div.Bristol-Myers Co., Syracuse, N.Y., the article was a kind of penicillinand no certificate, release, or exemption was in effect; 502(1). Thearticle was claimed by Bristol-Myers Co., Syracuse, N.Y., who deniedthe charges. The Government served written interrogatories on theclaimant. After having answered the interrogatories, the claimant entered into a consent decree of condemnation that ordered the art ic ledestroyed. (F.D.C. No. 61252; S. No. 77-58-076; N.J. No. 21)

Preltron oral glucuronolactone tablets, and Preltron sodium glucuronateinjection, at Pasadena, C. Dist. Calif.Charged 10-5-78: while held by Pasadena Research Laboratories,Inc., Pasadena, Calif., who had had the articles prepared with interstate components, the articles were new drugs without effective approved New Drug Applications—505(a); and the labeling of thearticles lacked adequate directions for use, and the articles were notexempted due to lack of effective approved New Drug Applications—502(f)(1). Default decree ordered destruction. (F.D.C. No. 61906; S.No. 78-153-227; N.J. No. 22)

Premo spironolactone with hydrochlorothiazide tablets, at Rockville Centre,E . D i s t . N . Y.Charged 4-27-79: when shipped by Premo Pharmaceutical Laboratories, Inc., South Hackensack, N.J., the article was a new drug without an effective approved New Drug Application; 505(a). Defaultdecree ordered destruction. (F.D.C. No. 62249; S. No. 79-139-878;N.J. No. 23)

Premo spironolactone with hydrochlorothiazide tablets, at Madison HeiRhls.E . D i s t . M i c h .Charged 2-28-79: when shipped by Premo Pharmaceutical Laboratories, Inc., South Hackensack, N.J., the article was a new drug without an effective approved New Drug Application; 5()5(a). Theîrticiewas claimed by the shipper who denied the charge. Subsequently, theclaimant made a business determination not to'market the drug andconsequently did not wish to contest the action. Upon stipulation ofthe parties, the claim and answer were withdrawn. A default decreeordered destruction. (F.D.C. No. 62179; S. No. 79-135-660; N.J. No.24)

Prochlorperazine time-disintegration capsules, at New Britain, Dist. Conn.Charged 5-21-79: when shipped by Pharmadyne Laboratories, Inc.,Hackensack, N.J., the article was a new drug without an effectiveapproved New Drug Application; 5()5(a). Default decree ordered destruction. (F.D.C. No. 62253; S. No. 79-196-753; N.J. No. 25)

Spironolactone with hydrochlorothiazide tablets, at Cincinnati, S. Dist.O h i o .Charged 3-9-79: when shipped by Premo Pharmaceutical Laboratories, Inc., South Hackensack, N.J., the article was a new drug withoutan effective approved New Drug Application; 505(a). Default decreeordered destruction. (F.D.C. No. 62178; S. No. 79-134-741; N.J. No.26)

Tincture of Merthiolate, Mercurochrome solution, boric acid powder, as

pirin tablets, and mineral oil, at West Haven, Dist. Conn.Charged 12-28-76: when shipped by Davis Manufacturing Co., Inc.,Knoxville, Tenn., the circumstances surrounding the articles' manufacture, processing, packing, and holding failed to conform with current good manufacturing practice; 501(a)(2)(B). Consent decreeauthorized release to the shipper for salvaging. (F.D.C. No. 61036;S. No. 77-56-961 et al.; N.J. No. 27)

DRUGS/VeterinaryAntibiotic Crumbles, 42% Pig Grower Concentrate meal, Swine Worm

Ban, 44% Heifer Supplement, 20% Chick Starter, Rabbit Family Ration, and other medicated feeds, at Owensboro, W. Dist. Ky.Charged 3-23-78: while held by Owensboro Milling Co., Owensboro,Ky., who had manufactured the medicated feeds using interstate components, the circumstances used for the articles' manufacture, processing, packing, and holding failed to conform with current goodmanufacturing practice; 501(a)(2)(B). Consent decree authorized release to the manufacturer for salvaging. (F.D.C. No. 61672; S. No.78-132-363; N.J. No. 28)

Cowpuncher "77" Mineral Mixture medicated supplement, at Ada, E.D i s t . O k l a .Charged 1-25-79: when shipped by L & M Mineral Co., Inc., Brown-wood, Tex., the article's strength differed from its purported strength(i.e., subpotent in ethylenediamine dihydroiodide)—501(c); and thearticle's labeling lacked adequate warnings against unsafe use (i.e. thearticle was labeled for use as a free-choice feed and therefore potentially unsafe dosages of iodine would not be controlled)—502(f)(2).Default decree ordered destruction. (F.D.C. No. 62126; S. No. 78-115-474; N.J. No. 29)

Ideal Calf Booster No. S. medicated with neomycin sulfate & ethylene-diamine dihydroiodide, at: Modesto E. Dist. Calif.Charged 1(1-31-78: while held by Ideal Laboratory (subsidiary ofWestern Feed Supplements), Modesto, Calif., the article, which thedealer had manufactured using interstate components, was a newanimal drug and no effective approved New Animal Drug Applicationwas in effect with respect to its use and intended use—501(a)(5); andthe article had been manufactured and processed under circumstancesthat failed to conform with current good manufacturing practice—501(a)(2)(B). Default decree ordered destruction. (F.D.C. No. 61928;S. No. 78-145-900; N.J. No. 30)

Iron preparation for oral use in suckling pigs, at Blue Springs, W. Dist.M o .

Charged 8-14-78: when shipped by Silak Co., Inc., Hospers, Iowa,the article, labeled in part "Durvet Duriron Oral Injection Iron forSuckling Pigs . . . Manufactured for Durvet, Inc., Blue Springs, Mo.,"was a new animal drug, and no approval of a New Animal DrugApplication was in effect with respect to its use or intended use (i.e.,"aids anemia control," and "promotes weight gain"); 501(a)(5). Default decree ordered destruction. (F.D.C. No. 61850; S. No. 78-167-628; N.J. No. 31)

N/S triple sulfa soluble powder for poultry, at Pipestone, Dist. Minn.Charged 2-28-79: while held by Northern States Laboratories, Pipestone, Minn., who manufactured the article using interstate sodiumsulfaquinoxaline, the article was a new animal drug, and no approvalof a New Animal Drug Application was in effect with respect to itsuse and intended use; 501(̂ a)(5). Default decree ordered destruction.(F.D.C. No. 62182; S. No. 79-187-643; N.J. No. 32)

Protein feed supplement liquid, medicated, at Lewiston, Dist. Utah.Charged on or about 5-31-72: when shipped from Idaho Falls, Idaho,the article contained the new animal drug diethylstilbestrol, and noapproval of a New Animal Drug Application was in effect with respectto the article—501(a)(6); the artic e's labeling lacked adequate directions for use including indications for use—502(f)(1); and the article'slabeling lacked adequate warnings against unsafe use, including awarning to discontinue use of the feed seven (7) days before slaughterand not to feed to breeding or dairy cattle; 502(f)(2). Consent decreeauthorized release to Stephen M. Bodily Farm, Lewiston, Utah, forsalvaging. (F.D.C. No. 57938; S. No. 33-412 F; N.J. No. 33)

Tylan premix, cblortetracycline medicated premix, 18% Pig Starter med-


icated feed, and other medicated feeds, premixes, and veterinary drugs,at Willmar, Dist. Minn.Charged 4-25-78: while held by Seeco, Inc., Willmar, Minn., whowas manufacturing various medicated products, the circumstancesused for the articles' manufacture, processing, packing, and holdingfailed to conform with current good manufacturing practice—501(a)(2)(B); certain premixes and medicated feeds containing sui-fathiazole or sulfamethazine were new animal drugs, and no NewAnimal Drug Application was in effect with respect to their use andintended use—501(a)(5). Consent decree authorized release to thedealer for salvaging and/or remanufacturing. (F.D.C. No. 61574; S.No. 78-129-001 et al.; N.J. No. 34)

M E D I C A L D E V I C E S

Diapulse electromagnetic energy generators, at Dallas, N. Dist. Tex.Charged 2-16-77: the labeling of the articles (which had been shippedby Diapulse Manufacturing Corp. of America, New York, N.Y.)lacked adequate directions for use for their intended purposes, andneither adequate directions for lay use nor adequate information foruse by licensed practitioners could be furnished; 502(f)(1). Fred B.Thomas, D.O., Dallas, Tex., filed an answer to the charges claiming:that, although the articles might be mislabeled, the articles were inno way harmful or dangerous to any organ of the human body; thattheir use can be for that of nothing more than a vibrator; and that theart icles had been removed from his medical cl inic before the seizureand were at his house for his personal use (one device) and in storage(other device). Subsequently, the Government moved to strike theanswer because the required claim to the articles had not been filed.No claim to the articles was filed. The court accordingly struck theanswer and entered a default decree ordering the articles destroyed.(F.D.C. No. 62056; S. No. 77-21-721; N.J. No. 35)

P/EmF electromagnetic energy generators, at Watertown, Dist. Conn.Charged 10-31-72 and amended 6-8-74: when shipped by DiapulseCorp. of America (DCA Leasing Corp.), New Hyde Park, N.Y., thelabeling of the articles contained false and misleading claims that thearticles (when operated as directed) were adequate and effective medical diathermy devices and were adequate as a treatment for bursitis,diverticulitis, fracture management, neuritis, osteoarthritis or hyper-tropic arthritis, otitis media, peripheral vascular disease, rheumatoidartnritis, and sprains and strains; and the articles' labeling lackedadequate directions for use for their intended purposes and were notexempted as prescription devices; 502(a), 502(f)(1). The articles wereclaimed by Wilber H. Caney, M.D., Watertown, Conn., who deniedthe charges, denied (for want of personal knowledge) that the articleshad been shipped in interstate commerce, and asserted that he hadfull knowledge of how to use the devices. The Government servedwritten interrogatories on the claimant, and the claimant served written interrogatories on the Government. The Government moved forsummary judgment and moved to amend the complaint. The claimantopposed the action on constitutional grounds. The court granted themotion to amend the complaint but deferred decision on the motionfor summary judgment. The Government renewed its motion for summary judgment. Without prejudice, the court denied the second motion for summary judgment, saying:

"Plaintiff has moved for the second time for summary judgment inthis forfeiture action for condemnation of allegedly misbranded devices, cf. 21 U.S.C. § 334, electronic instruments of a diathermy typewhich are known as P/EmF machines, seized in the early stages of suitat the Watertown, Connecticut, office of the adverse claimant herein.Dr. Wilbur H. Caney.

"On May 3, 1974, the Court entered an order deferring decision onthe government's initial motion for summary judgment to afford claimant an opportunity to furnish specific support for his opposition by,inter alia, possible 'affidavit setting forth facts to establish . . . thatthe devices were manufactured in Connecticut . . . .' United States v.Articles of device, etc.. Civil No. B-629 (D. Conn. May 3, 1974). Theaffidavit of one Witold J. McKelk was thereafter submitted, affirmingin part that the devices in suit were to his personal knowledge 'naan-ufactured . . . w i th in the State of Connect icut ' and ' in no fashion,entered into Interstate Commerce.' On that issue, the government's

evidence consisted of an FDA physicist's affidavit of February 27,1974, averring familiarity with the P/EmF machine, describing it asa slightly modified Diapulse device; the affiant, Robert J. Kennedy,represented that both Diapulse devices and conversion kits to modifysuch dev ices in to P /EmF mach ines were manufac tured in New Yorkand not in Connecticut, and concluded that the seized devices musthave been manufactured in whole or in part in New York. Plaintiff'scorresponding legal argument was that the requisite interstate elementis provided if either the finished product or a component has beenshipped in interstate commerce, cf., e.g.. United States v. DianovinPharmaceuticals, Inc., 475 F.2d 100, 102-103 (ICir.), cert, denied, 414U.S. 830 (1973). With the McKelk affidavit held to 'raise sufficientfactual issues', the government's motion was denied without prejudice. United States v. Articles of device, etc., Civil No. B-629 (D.Conn. July 8, 1974).

"That aspect of the record remains unamplified; on renewal of itsapplication for summary judgment, plaintiff has simply filed a copyof the Kennedy affidavit together with certain additional submissionsreflecting the amended complaint's expanded liability claims. Whiledefendant's evidence may be interpreted as not meeting plaintiff'spresentation head on, to preclude improvident resolution of contestedfacts on a motion for judgment as a matter of law 'the inferences tobe drawn from . . . underlying facts . . . must be viewed in the lightmost favorable to the party opposing the motion'. United States v.Diebold, Inc., 369 U.S. 654, 655 (1962). Although plaintiff's impatience is understandable and may on further inquiry prove well-founded, the line between a choice of permissible factual inferenceswhich may not properly be made in plaintiff's favor in these motionproceedings, see id., and the conclusion that 'there is no genuine issueas to any material fact', cf. Rule 56(c), Fed. R. Civ. P., is not soeffortlessly crossed.

"The instant motion for summary judgment is accordingly denied,again without prejudice."

After additional discovery, the Government again moved for summary judgment, which was again denied. The court said:

"In this forfeiture action, brought to condemn allegedly misbrandeddevices, 21 U.S.C. § 334, the United States brings its third motionfor summary judgment. The devices, known as P/EmF machines, areelectronic instruments of a diathermy type. They were seized at theWatertown, Connecticut, office of the claimant. Dr. William H. Caney, on December 21, 1972.

"In order to be entitled to forfeiture, the Government must satisfythe requirements of § 334. . . . The amended complaint charges thatthe literature accompanying the devices contained false and misleading statements and that it failed to give adequate directions for layuse. Either of these allegations, if proved, would establish that thedevices were 'misbranded' within the meaning of § 334, see 21 U.S.C.§ 352 and 21 C.F.R. § 1.106. In order to establish interstate shipment,the Government would show that these devices, although seized inConnecticut, were originally manufactured in New York.

"Whether the accompanying literature contained false and misleading statements raises questions of fact that are still in dispute. In theliterature were claims that the devices could be of therapeutic benefitin the t reatment o f var ious d iseases and condi t ions. Whi le the Government has presented affidavits from two experts who averred thatthe devices have no therapeutic value, in his own affidavit Dr. Caneyalleged that 'there is data and research material which establishes thediathermy effect of the P/EmF modality. . . .' Given these conflictingallegations, the Government is clearly not entitled to summary judgment on this issue.

"The remaining two issues in the case, however, raise closer questions for disposition on summary judgment. In challenging the adequacy of the accompanying instructions, the Government presentedevidence that the dangerousness of the P/EmF device makes adequateinstructions for lay use impossible to draft, see 21 C.F.R. § 1.106(a).Though in such situations a device may qualify for an exemption fromthis requirement, 21 C.F.R. § 1.106(a), the Government maintainsthat the devices in this case fail to meet the conditions necessary foran exemption. The claimant apparently makes no claim that the instructions that accompanied these devices would enable a layman touse them safely, nor does he claim that the devices are entitled to an

F D A C o n s u m e r / D e c . 1 9 7 9 - J a n . 1 9 8 0 1 3 7

exemption. He merely contests the application of regulations intendedto assure safe lay use to devices that at the time of their seizure werein the possession of a trained physician.

"The final question in this case is that of interstate shipment. Inresponse to Government affidavits indicating that the devices weremanufactured in New York and later shipped to Connecticut, theclaimant offered the affidavi t of Witold Mikelk, who sold the devicesto Dr. Caney, and who averred that they 'were manufactured . . .w i t h i n t he S ta te o f Connec t i cu t , ' and ' i n no f ash i on , en te red i n t oInterstate Commerce.' Ordinarily such an assertion would raise a clearquestion of fact that would preclude resolution by summary judgment.Here, however, a subsequent Government deposition of Mikelk suggests that his affidavit, despite its apparent clarity, establishes no morethan the fact that Mikelk 'manufactured' these devices in Connecticut

by altering other machines whose place of manufacture he did notknow or could not remember. That proposition, of course, is notincons is ten t w i th the Government ' s ev idence tha t the dev ices wereoriginally manufactured in New York.

"Given the claimant 's fa i lure to contest those facts relevant to theadequacy of the instructions accompanying the devices, that issue atbest raises a question of law. And, after the Government's depositionof Mikelk, the power of his affidavit to stave off summary judgmenton the issue of interstate shipment is substantially weakened. Whilesummary judgment may therefore be appropriate, a trial nonethelessappears the most appropriate way to resolve the latter issue, whichturns on facts still not entirely clear. Since testimony on that issue isnecessary, it seems sensible to give the claimant a final opportunityto clarify his position on the instructions accompanying the devices,and to present at trial any evidence on that point that he may have.Should these two questions be resolved in the Government's favor,it will be unnecessary to reach the more involved issue of the therapeutic efficacy of the P/EmF device.

"Accordingly, the Government's motion for summary judgment isdenied, and the issue of the therapeutic efficacy of the devices issevered for separate trial. Trial on the remaining issues will be scheduled at the first avai lable date."

Subsequently, trial of the action was scheduled. However, pursuantto an agreement by the parties the action was dismissed without prejudice to the Government's right to reinstate the action within 6months, and the articles were to remain under the custody of the courtduring such time. Within the set time, the Government moved toreinstate the action. After the action had been reinstated, the claimantmoved for a judgment on the pleadings, or, alternatively, should theclaimant's motion be denied, requested that his claim be withdrawn.The court denied judgment for the claimant, but permitted the claimant to withdraw his claim, saying:

"This is an in rem action seeking the forfeiture of allegedly mis-branded devices. Pursuant to the provisions of 21 U.S.C. 1 334, theFood and Drug Administration in 1972 seized certain electronic instruments of a diathermy type known as 'P/EmF' from the office ofthe claimant. Dr. Wilbur H. Caney. The amended complaint for forfeiture states that the seized machines in interstate commerce werefalsely labeled as adequate and effective diathermy devices for thetreatment of numerous medical problems including bursitis, fracturemanagement, diverticulitis, and rheumatoid arthritis.

"The claimant has now filed a motion to dismiss and in the alternative, should his motion be denied, a withdrawal of his claim. The'all or nothing' approach by the claimant is best explained by anabbreviated review of the lengthy procedural history of this case.

1

"Following the filing of the complaint for forfeiture in 1972, Dr.Caney submitted his claim as owner of the devices on January 4, 1973.After some preliminary discovery, the government moved for summary judgment on March 19, 1974, which was opposed by the claimanton the ground that the seizure violated the Fourth Amendment. OnMay 1, 1974, Judge Newman ruled that the seizure was not constitutionally proscribed and, treating claimant's moving papers as a motion to dismiss, denied relief to the claimant. However, the courtdeferred its ruling on the government's motion for summary judgmentto afford the claimant an opportunity to obtain affidavits in supporto f h i s con ten t i on t ha t t he i ns t rumen ts we re manu fac tu red i n Con

necticut and hence did not involve interstate commerce. In addition,the court suggested the claimant expand on his argument that thedevices had the required instructions for use.

" T h e r e a f t e r a n a f fi d a v i t o f o n e W i t o l d J . M i k e l k w a s s u b m i t t e dwhich a ffi rmed tha t the ins t ruments were 'manufac tured . . . w i th inthe State of Connecticut' and 'in no fashion, entered into InterstateCommerce.' The government countered with an affidavit of a physicistwho described the P/EmF machines as merely modified 'Diapulse'devices and represented that both the Diapulse devices and the conversion kits to modify them into P/EmF machines were manufacturedin New York and not in Connecticut. Therefore, he concluded, theseized articles had been manufactured in whole or in part in NewYork. On July 8, 1974, Judge Newman issued a supplemental rulingon the government's motion for summary judgment, denying it without prejudice because there existed sufficient factual issues."The cornplaint was then amended to allege 1) misbranding under

21 U.S.C. § 352(f)(1) (failure to provide adequate directions for use),and 2) rnisleading labeling in literature accompanying the machines,in violation of 21 U.S.C. § 352(a). The government's next motion forsummary judgment was denied, without prejudice, by Judge Newman,endorsing a ruling by Magistrate Latimer issued November 26, 1974.A third motion for summary judgment was denied by Judge Newmanon August 8, 1975, on the grounds that the claimant should have anopportunity at trial to prove that the instructions attached to themachines were adequate and that the devices did not move in inters t a t e c o m m e r c e .

"Subsequently, on June 8, 1976, the case was dismissed with leaveto reinstate within six months. On December 7, 1976, the governmentmoved to re file the case, which motion was granted on February 28,

I I"The claimant's instant motion to dismiss, which will be treated as

a motion for summary judgment, raises four issues to be decided asa matter of law. First, it is contended that the provisions of the Food,Drug, and Cosmetic Act in question here were designed to protectan unwary public when purchasing mislabeled devices and, therefore,the Act is not applicable in situations where the devices are used ina medical practitioner's office with no intention of sale to the public.The argument is without merit. Medical devices used by physiciansin treating patients have been declared by controlling authorities tobe within the reach of the Act. See United States v. Diapulse Corporation of America, 457 F.2d 25, 28 (2 Cir. 1972); cf. United StatesV. An Article of Food, 482 F.2d 581, 586 n. 3 (8 Cir. 1973); UnitedStates V. Ellis Research Laboratories, Inc., 300 F.2d 550, 552-553 (7Cir.),cert, denied 370U.S. 918(1962); United States \. Device Labeled'Cameron Spitler, Etc.', 261 F. Supp. 243, 246 (D. Neb. 1966).

"The claimant next asserts that the articles when seized had 'longsince come to rest' and therefore were not within the 'stream of commerce' as required by the Act. However, § 334(a)(1) subjects mis-branded devices to seizure and forfeiture 'while in interstate commerce,or at any time thereafter.' (Emphasis supplied.) See also United StatesV. Device Labeled 'Cameron Spitler, Etc. \ supra, 261 F. Supp at 246.

"The claimant's penultimate contention is that the machines areexempt from the Act because the government makes no claim thatthe 'labels' attached to the machines contained matter violative of thestatute. While it is true that § 321 (k) refers to a label 'upon theimmediate container,' the definition of 'labeling' set forth in § 321(m)includes 'any other written matter.' The government's moving papersspecifically state that the 'labeling' of the seized devices misbrandsthem and, therefore, violations of the Act are clearly charged. Seealso Kordel v. United States, 335 U.S. 345 (1948), wherein the SupremeCourt held that there could be a violation for misbranding within themeaning of the Act even though the 'labeling' consisted of pamphletsand circulars which were shipped separately from the drugs in questionand at di fferent t imes.

"The last argument raised by the claimant is nothing more than anobjection to the government's motion for permission to test the machines to determine their power output. The mere filing of such amotion is not a ground upon which a dismissal of the action is warr a n t e d . "

Since no other persons had appeared or claimed the article, a default

38 I Dec. 1979-Jan. 1980 / FDA Consumer

decree of condemnation was entered which authorized donation ofthe articles to FDA for exhibition, examination, testing, research, andother appropriate scientific and educational purposes. (F.D.C. No.58249; S. No. 13-896 F; N.J. No. 36)

Thermoslim heat-therapy unit, Dermaphoresis galvanic current generator,and Vihroelectronic 2 electric muscle-stimulator (i.e., 3 devices for anlontothermophoresis system), at Helena, Dist. Mont.Charged 8-21-78 and amended 12-19-78: the articles (which had beenimported from Bologna, Italy, by P-Ryton Corp., Long Island City,N. Y., and which were being promoted by Sleeping Giant Health Club,Inc., by means of the magazine reprint entitled "How I BanishedCellulite") were accompanied ,by labeling (i.e., the above reprint, thearticles' labels, and a pamphlet entitled "lontothermophoresis . . .Instructions for Use"), which was false and misleading as follows: (Thermoslim) the false and misleading claim for reducing the body by reasonof the identifying term "Thermoslim"; (Vihroelectronic) false andmisleading claims for reproportioning the body, as a reducing massage, and as a corrective gym massage; and (all three devices) falseand misleading claims for stimulating and improving circulation, helping dislodge the thick fat deposits under the skin, and giving musclesthe benefits of 2 hours of exercise—5()2(a); all devices' labeling lackedeither adeauate directions for lay use or adequate directions for useby licensed practitioners—501(f)(1); all devices' labeling lacked adequate warnings against unsafe use—502(f)(2); and all of the deviceswere dangerous to health when used as directed—502(j).

The articles were claimed by A. C. Leasing, Seattle, Wash., whodenied the charges. The claimant served written interrogatories onthe Government. The Government served requests for admissions,written interrogatories, and other discovery requests. After the complaint was amended to add the charges that the articles were dangerousto health when used as directed, the claimant moved to withdraw itsclaim. Pursuant to stipulation, the claimant was authorized to withdraw its claim and answer. Ultimately, a default decree condemnedthe articles and authorized their release to FDA. (F.D.C. No. 61839;S. No. 7^-139-104; N.J. No. 37)

Urinometer for use by diabetics, at Bloomington, Dist. Minn.Charged 10-30-78: the labeling of the article (which had been manufactured by Brothers Scientific Products, Inc., Chicago, III.) contained false and misleading claims for testing sugar levels in the urineof diabetics and false and misleading claims of being accepted by FDAand being approved by the medical profession; the article's labelinglacked adequate directions for use, and such directions could not bewritten for such intended use; and the article was dangerous to healthwhen used in the manner recommended and suggested in its labeling;502(a), 502(f)(1), 5()2(j). Default decree ordered destruction. (F.D.C.No. 61943; S. No. 79-129-392; N.J. No. 38)

Wuf-E-Nuf, electrified collars for dogs, in-process collars, and collar components, at Tucson, Dist. Ariz.Charged 6-23-77: while held by Tri-Tronics, Tucson, Ariz., who wasassembling the collars which were labeled in part "Tri-Tronics BarkTrainer Tucson, Arizona . . . Wuf-E-Nuf," the labeling of the articleslacked adequate directions for use; the articles lacked adequate warnings against unsafe use; and the articles were dangerous to healthwhen used as directed; 502(f)(1), 5()2(f)(2), 5()2(j). The dealer claimedthe articles and denied the charges. The claimant moved to dismissthe action for lack of jurisdiction, claiming that the devices seizedwere not subject to condemnation because they had not been shippedin interstate commerce or been contracted for shipment or sale ininterstate commerce. In denying the motion to dismiss, the courtconsidered the filed memorandum and found as follows:

"At this stage of the proceedings the Government has satisfied thejurisdictional requisite under 21 U.S.C. 334(a)(2). The Governmentdoes have the burden to prove at the proper time that condemnationis appropriate under the Act from the facts in this case."

The Government served written interrogatories on the claimant.Subsequently, the parties entered into a consent decree of condemnation which ordered the articles destroyed except for one collar whichwas to be preserved as a sealed exhibit. Although the claimant expressly denied the charges, the consent decree also enjoined the man

ufacture and/or distribution of all finished dog collars and replacementparts for dog collars labeled in part "Tri-Tronics Wuf-E-Nuf DogCollars" and all similarly designed dog collars. (F.D.C. No. 61271;S. No. 77-76-081; N.J. No. 39)

P R O P H Y L A C T I C S

Prophylactics, rubber. Sheik, at Brooklyn, E. Dist. N Y.Charged 6-8-78: the quality of the article, which had been shippedby Schmid Laboratories, Inc., Little Falls, N.J., and which was labeledin part "Sheik Plain End Non-Lubricated . . . Prophylactic . . . Manufactured by Schmid Laboratories, Inc., Little Falls, N.J.," fell belowits purported quality, due to holes; 501(c). Default decree ordereddestruction. (F.D.C. No. 61786; S. No. 78-140-689; N.J. No. 40)

N O T I C E S O F J U D G M E N T o n C r i m i n a l A c t i o n s

Action Warehouses, Inc. (trading and doing business at Chicago, III., andBrooklyn, N.Y.), and Edward F. Devitt, president, and Sokol & Co.(trading and doing business at Countryside, III.), Brooklyn, E. Dist.N . Y .

Charged 4-3-79: when shipped knowingly and unlawfully from Brooklyn, N.Y., to Countryside, 111., paprika (count 1) contained insect filthand had been held under insanitary conditions-̂ 02(a)(3), 402(a)(4);and, when shipped knowingly and unlawfully and with intent to defraud from Brooklyn, N.Y., to Countryside, 111., dried mushrooms(count 2) contained insects and had been held under insanitary conditions; 402(a)(3), 402(a)(4). Guilty pleas by corporations; fines.Guilty pleas by individual; fine and probation. (F.D.C. No. 62023;S. No. 73-062 G et al.; N.J. No. 41)

Bunco Labs, Inc., and Thomas B. Bond, Jr., president. Prospect, W. Dist.Ky.Charged 2-12-79 by grand jury: that the defendants knowingly failedto make, keep, and furnish a complete and accurate record of 36,500dosage units of their Cephlacap (butalbital) capsules—21 U.S.C.827(a)(3); that the individual defendant caused the shipment fromProspect, Ky., to Madison, Ind., of phendimetrazine tartrate timed-release capsules (105 mg.) without an effective approved New DrugApplication—505(a); and the individual defendant, a registered distributor of controlled substances, knowingly failed to make, keep,and furnish a complete and accurate record of approximately 11,200dosage units of phendimetrazine tartrate capsules which had beenreceived, sold, delivered, and otherwise disposed of, at the defendant's registered location and principal place of business, at Prospect,Ky.—21 U.S.C. 827(a)(3). Guilty plea by corporation to count involving Cephlacap capsules; fine. Nolo contendere plea by individualto the other two counts; fine. (F.D.C. No. 61940; S. No. 78-132-370et al.; N.J. No. 42)

Samuel Silverstein, t/a Silver Sweet Candies, Lawrence, Dist. Mass.Charged 3-27-78: peanuts, chocolate liquor, and chocolate coating,were held under insanitary conditions in a building accessible to insectsand were contaminated with insect filth—402(a)(3), 402(a)(4); and,when shipped, peanut butter cups contained insect filth and had beenprepared, packed, and held under insanitary conditions—402(a)(3),402(a)(4). Guilty plea; fine and probation. (F.D.C. No. 61314; S. No.77-06-362 et al.; N.J. No. 43)

NOTICE OF JUDGMENT on Injunction Action

Oregon Macaroni Manufacturing Co., Bobbie E. Burns, president, ArmandF. Favro, managerial advisor, and Alan W. Otto, plant manager,Portland, Dist. Oreg.Charged 12-11-75 in a complaint for injunction: that the defendantshad been manufacturing, packing, and holding macaroni productsfrom flour milled from interstate wheat and had been distributing suchmacaroni products in interstate commerce; that, while held for saleand when shipped in interstate commerce, such macaroni productshad been prepared, packed, and held under insanitary conditions;that the flour used for the macaroni products contained insect filth;that FDA inspections disclosed a number of specified insanitary conditions in the defendants' food processing facility at Portland, Oreg.;and that the defendants had been repeatedly warned of insanitary


conditions and practices in their food processing facility; 4()2(a)(3),402(a)(4).

Subsequently, the defendants assured the court that the firm wouldnot manufacture any product at the Portland, Oreg., plant and wouldnot ship any product until FDA approved the plant and approved theoperation, manufacture, sale, and distribution of the product. A consent decree of permanent injunction enjoined the complained of violations. Ultimately, the firm discontinued operations, its equipmentwas dismantled, its building was vacated, large quantities (23,500 lbs)of finished product were diverted for use as animal feed, and theaction was dismissed. (Inj. No. 720; S. No. 76-52-381 et al.; N.J. No.44)

N O T I C E O F J U D G M E N T o n M i s c e l l a n e o u s A c t i o n

Importation of amygdalin (Laetrile) for terminal cancer patient, and suitfor exception for such purpose, San Diego, S. Dist. Calif.Charged 1-11-77 by Ray Carnohan, cancer patient, San Diego, Calif.,and Michael O. Carnohan (son of Ray Carnohan), Santa Rosa, Calif.,against the United States of America and HEW Secretary DavidMathews and successor HEW Secretary Joseph A. Califano: that thedispensing of Laetrile to persons suffering from cancer was precludedupon the ground that Laetrile's efficacy had not been adequatelyproven and its use could have the result of precluding sufferers fromreceiving recognized treatments; that Ray Carnohan suffered frominoperable cancer of the pancreas, that Laetrile was his last hope, andthat plaintiff had a constitutionally protected right to Laetrile, so longas such election was taken with full knowledge of the FDA findingthat the treatment was of no value; that FDA had failed to producean administrative record to support its determination that Laetrilewas a new drug; and that the defendants should be enjoined frompreventing the importation and administration of Laetrile for the treatment of Ray Carnohan.

The court authorized the limited importation of Laetrile saying:"On January 17, 1977, this matter came on for hearing on plaintiff

Ray Carnohan's motion for temporary restraining order. The partieshave fully briefed the matter to the court's satisfaction and thereforethis court will treat the motion as one for preliminary injunction. Theplaintiff seeks to enjoin the Food and Drug Administration (FDA)from preventing the plaintiffs importation or interstate transportationof Laetrile for purposes of his own consumption under the terms ofthe Food, Drug and Cosmetic Act, including §5()5(a) of the Act, 21U.S.C. §355(a).

"Ray Carnohan is a terminal cancer patient, presently afflicted withinoperable cancer of the pancreas, and would be unresponsive to anyrecognized treatment presently available in the United States. MichaelO. Carnohan, son of Ray Carnohan, is not an attorney nor presentlysuffering from cancer and therefore is not properly a party to this suit,however the court has permitted Michael Carnohan to speak for RayCarnohan because of his father's present physical condition.

"Section 505(a) of the Act bars introduction into interstate commerce of a 'new drug' without an approved new drug applicationhaving been filed pursuant to the Act. There is not currently on filenor has there ever been on file with the FDA an approved new drugapplication. The FDA has classified Laetrile as a 'new drug' pursuantto 21 U.S.C. §321(p)(l). Once a substance is labelled a 'new drug',the responsibility to initiate approval procedures rests with the proponent of the new drug and not the FDA. Rutherford v. AmericanMedical Association, . . . FDA simply rules on the application ass u b m i t t e d .

"The FDA has imposed this burden on the proponent by initiallycalling Laetrile a 'new drug'without any apparent bases in factRutherford v. United States, . . . (the 10th Circuit remanded the caseto [the] district court requiring that the FDA develop a record supportive of the agency's determination). On January 4,1977, the districtcourt ordered that such an administrative record be developed within120 days from that date.

"The Ninth Circuit recognizes two tests for the issuance of a preliminary injunction. Under the recently adopted test, the moving partymay succeed if the harm is sufficiently serious and there is a fair chanceof success on the merits. . . .

"The plaintiff is presently receiving Laetrile in Mexico. The harmto the plaintiff is serious if the injunction is denied. He must eitherchoose to live the remainder of his life in Mexico away from his familyand friends or must commute daily to Mexico for his Laetrile treat

m e n t .

"Whether the plaintiff has a fair chance of succeeding on the meritsdepends on the results of the FDA administrative record. The TenthCircuit has held that whether Laetrile would be exempt as a 'newdrug' under the Food, Drug and Cosmetic Act is 'substantive, difficultand doubtful so as to support the granting of a preliminary injunction.'Rutherford v. United States, supra.

"This court must also consider whether public interest would beharmed by the granting of the preliminary relief sought. . . . Thegranting of a broad injunction would harm the public—'by weakeningaws calculated to prevent the victimization of those afflicted with

cancer and other conditions by playing on their desperation in themarketing of unproven and, possibly worthless remedies, but it couldalso further the growing tendency of those afflicted with this diseaseto engage in self treatment resulting in a delay in seeking early diagnosis and prompt treatment with forms of therapy that have established value.' Morgan v. Mathews ....

"Where a person is terminally ill with cancer and unresponsive toother treatments, the public harm is considerably reduced. Such aperson would not be avoiding other methods of treatment generallyrecognized by the medical profession. The plaintiff in this case is wellaware of the evidence tending to show that Laetrile is an unprovenremedy. To deny such a person his freedom of choice, when thereare no other remedies presently available, would appear grossly paternal ist ic to th is court .

"Therefore, an injunction should be granted to Ray Carnohan who,by conclusive proof, is shown to be terminally ill with cancer andunresponsive to any recognized treatment presently available in theUnited States. He has established the foregoing by affidavits of attending physicians licensed to practice medicine in the State of Cali f o r n i a .

"Accordingly, it is ordered, adjudged and decreed that the defendant, through any of its agents, servants and employees, especiallyincluding but not limited to the United States Customs Service andthe Department of Health, Education and Welfare, be enjoined frompreventing the plaintiff only, from purchasing and moving in interstatecommerce, and having for his own personal use, not for sale, barteror to be given away to any other person, an amount of Laetrile approved by this court, based on [an] affidavit by an attending physicianicensed to practice medicine in the State of California, not in excessof a three (3) month supply of Laetrile, pending completion of theadministrative record by the FDA.

"It is further ordered that the plaintiff give advance notification tothe defendant of the date, place and quantity of his transportation ininterstate commerce of such amount of Laetrile as above authorized.Such quantity shall further be declared to the customs authorities,and custom duty or tax, if any, due thereon, shall be paid.

"It is further ordered that, should the plaintiff pass away prior tothe expiration of the three month period, his next of kin, executor orperson charged with the posthumous care of his affairs shall immediately surrender any unused supplies of Laetrile to the Food andDrug Administration.

"All other requests of the plaintiff are denied."Ray Carnohan died; and the court found the action to be moot,

and accordingly ordered the action dismissed with prejudice. (Misc.No. 411; N.J. No. 45)

Notices of Judgment are given pursuant to section 705 of the FederalFood, Drug, and Cosmetic Act. Notices of Judgment report cases involvingseizure proceedings, criminal proceedings, and injunction proceedings.Seizure proceedings are civil actions taken against goods alleged to be inviolation, and criminal and injunction proceedings are against firms orindividuals charged to be responsible for violations. The cases generallyinvolve foods, drugs, devices, or cosmetics which were alleged to"be adulterated or misbranded or otherwise violative of the law when introducedinto and while in interstate commerce, or while held for sale after shipmentin in te rs ta te commerce.

Notices of Judgment are prepared by Food and Drug Division, Officeof the General Counsel, HEW.

Published by direction of the Secretary of Health, Education, and Welf a r e .

Jere E. Goyan, Commissioner of Food and DrugsWashington, D.C., December I, 1979

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