“Those look like candy!”: Emerging and Alternative Tobacco Products

Artwork by Catherine M. © 2010American Academy of Pediatrics (AAP) Children's Art Contest. Support for the 2009 and 2010 AAP Children's Art Contest was from the Flight Attendant Medical Research Institute.

WELCOME

Continuing Medical Education Credit• The American Academy of Pediatrics (AAP) is accredited by the Accreditation

Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

• The AAP designates this live activity for a maximum of 1.50 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

• This activity is acceptable for a maximum of 1.50 AAP credits. These credits can be applied toward the AAP CME/CPD Award available to Fellows and Candidate Members of the American Academy of Pediatrics.

• The American Academy of Physician Assistants (AAPA) accepts certificates of participation for educational activities certified for AMA PRA Category 1 Credit™from organizations accredited by ACCME. Physician assistants may receive a maximum of 1.50 hours of Category 1 credit for completing this program.

• This program is accredited for 1.50 NAPNAP CE contact hours of which 1.0 contain pharmacology (Rx) content per the National Association of Pediatric Nurse Practitioners (NAPNAP) Continuing Education Guidelines.

At the conclusion of this activity, participants should be able to:

• Describe emerging and alternative tobacco products, including the physical appearance, and the risk involved with each type of product.

• Articulate how to discuss emerging and alternative tobacco products with patients and families in a pediatric practice setting.

• Explain how emerging and alternative tobacco products are regulated.

• Describe how the tobacco industry tries to position and/or market emerging and alternative tobacco products.

“Those look like candy!”: Emerging and Alternative Tobacco Products

Artwork by Catherine M. © 2010American Academy of Pediatrics (AAP) Children's Art Contest. Support for the 2009 and 2010 AAP Children's Art Contest was from the Flight Attendant Medical Research Institute.

WELCOME

Disclosure Statement

• Neither I nor any member of my immediate family has a financial relationship or interest (currently or within the past 12 months) with any entity producing health care goods or services consumed by, or used on, patients related to the content of this CME activity.

• I do not intend to discuss an unapproved/investigative use of a commercial product/device.

Registration Questions: Common Themes

• Can describe products: 57%

• Can discuss in practice: 22%

• Can describe how products are regulated: 27%

• Can describe industry marketing: 68%

Registration Responses: Are dissolvablessold in your town? (and where is that?)

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AK AZ CA CO CT DC FL GA IA ID IL IN KS KY LA MA MD ME MI MNMO

I think they are: 22% Unsure: 37%I know they are: 25% No: 15%

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OH OK

OR PA SC SD TN TX UT

VA WA WI

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Continued…

I think they are: 22% Unsure: 37%I know they are: 25% No: 15%

Susanne Tanski, MD, MPH, FAAP

Disclosure Statement

• Neither I nor any member of my immediate family has a financial relationship or interest (currently or within the past 12 months) with any entity producing health care goods or services consumed by, or used on, patients related to the content of this CME activity.

• I do not intend to discuss an unapproved/investigative use of a commercial product/device.

Prevalence of All Tobacco Use

• Estimates differ depending on the survey

• Differing surveys have begun asking different products– MTF now asking snus, dissolvables

• Cigarettes remain the most often used tobacco product

Percentage of US High School Students Who Reported Current Cigarette Use,* 1991 – 2011

* Smoked cigarettes on > 1 of the 30 days preceding the surveyNational Youth Risk Behavior Surveys, 1991 – 2011 (High school)Monitoring the Future, 1991-2011 (grades 8, 10, 12)

Current Cigarette Use:Monitoring the Future, 2011

2011: 12th grade: 18.7%10th grade: 11.8%8th grade: 6.1%

Alternative Tobacco Products

• Little Cigars and Cigarillos

• Hookah

• Roll Your Own

• Smokeless (Dip)

• Snus

• Dissolvables

• E-cigarettes (ENDS)

• *NEW Lozenges

Percentage of High School Students Who Currently Used Tobacco,* 1997 – 2011

National Youth Risk Behavior Surveys, 1997–2011

*Current cigarette use, current smokeless tobacco use, or current cigar use.† Decreased 1997–2007, no change 2007-2011, p < 0.05.

NSDUH, 2010

COMBUSTED PRODUCTS

What causes the harm from smoking?

• No known decrease in risks of smoking andy tobacco: irrespective of cigarette, cigar or hookah

• Risks are dose-dependent, as with cigarettes

Percentage of High School Students Who Currently Smoked Cigars,* 1997 – 2011†

National Youth Risk Behavior Surveys, 1997–2011

* Smoked cigars, cigarillos, or little cigars on at least 1 day during the 30 days before the survey.† Decreased 1997–2005, no change 2005–2011, p < 0.05

Little Cigars

2011 past month use:12th graders: 13.1%

(unchanged from 14% 2010)Males: 17.8%Females: 8%

In-Store Placement: Eye Level is Buy Level

https://snus.tobaccopleasure.com/modules/security/Login.aspx

Hookah

2011 past YEAR use, 12th graders: 18.5% (up from 17.5% in 2010)

Males: 20%Females: 17%

Hookah• Different from cigarette smoking, perceived by many

as “safer” due to “water filter”

• Waterpipe/Hookah use episode: ~30 minutes (vs ~5)– ~100 puffs of 500 ml of smoke each (50 liters total)

• A cigarette ~10 puffs of 50 ml each (0.5 liters)

– ~2.96 mg nicotine vs 1.74 mg in average cigarette– ~800 mg tar compared to ~22.3 mg for cigarette– ~145 mg CO compared to ~17.3 mg for cigarette

• Thus, a single waterpipe use episode can yield slightly more nicotine than a single cigarette, and about 36 times the tar and 8 times the CO

NON-COMBUSTED PRODUCTS

Percentage of High School Students Who Currently Used Smokeless Tobacco,*

1995 – 2011†

* Used chewing tobacco, snuff, or dip on at least 1 day during the 30 days before the survey.† Decreased 1995–2003, no change 2003–2011, p < 0.05.

National Youth Risk Behavior Surveys, 1995–2011Monitoring the Future, 1995-2011

Smokeless Tobacco Use:Monitoring the Future, 2011

• However, smokeless is almost entirely a male behavior: – 4.9%, 11.5% and

14.2% in grades 8, 10, and 12 for males vs. 1.9%, 1.9% and 1.8% among females

Smokeless: Snuff and Chew (Spit tobacco)

• Smokeless Tobacco– YRBS: use among HS boys currently at 12.8%– In some states markedly higher: Kentucky 28.1%, West

Virginia 25.5%, Oklahoma 23.8% Wyoming 22.1%.

• This does NOT include newer forms of tobacco

• There are new products for smokeless in some markets…

New Dips

Smokeless tobacco and fatal myocardial infarction or stroke

Snus

Snus- A spit-less tobacco packaged in small teabag-like pouches. Modeled after a Swedish product

• Marlboro snus – tested starting 2007 in plastic packs, now in smaller foil packs

• Camel snus – Ads now appear nationally in magazines

2011: Snus among 12th graders 7.9% annual, MTF

Snus

Snus

Snus: Cobranding

Snus: Cobranding

Evidence from Swedish smokeless tobacco (snus)

Consumption of cigarettes and snus, Sweden

Current tobacco use, men and women, aged 25-64 in northern Sweden 1986-99

Snus use and cancer risk

Dissolvable Tobacco

Dissolvable Tobacco

• Comparably, nicotine content in NRT lozenges is 2mg or 4mg

• Cigarette nicotine varies by smoking technique and brand ~ 1.9mg

• Limited markets– 2011 MTF, 12th graders

1.5% annual prevalence

Dissolvable Tobacco

Dissolvables look a lot like candy

Risks/Benefits of Dissolvables

• Variation across products in nicotine content and TSNAs – Lower delivery of nicotine for some products– Heavy metals are present in some

• Abuse liability– Lower for current DTPs than for conventional cigarettes or smokeless

• Cessation: may reduce cigarettes, but not completely substitute

• Health Risk: – “Exclusive use should be less hazardous than cigarettes”– No current epidemiologic data, however

FDA TPSAC Report on Dissolvable Tobacco Products, March 2012. www.fda.gov

e-Cigarettes(aka Electronic Nicotine Delivery Systems)

Nicotine Levels in Electronic Cigarettes

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Electronic cigarette: users profile, utilization, satisfaction and perceived efficacy

Effect of e-Cigarette on smoking reduction and cessation:

a prospective 6-month pilot study

Adults vs. High School Seniors

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Verve Nicotine Lozenges

• “VERVE discs are a new kind of tobacco product designed to appeal to adult smokers interested in innovative types of spit-free tobacco product alternatives to cigarettes.

• Adult tobacco product consumers put the product in their mouth, chew on it and should properly dispose of it when they are done.

• Currently, VERVE discs are in limited distribution at select stores in Virginia.”

• Parent Company = Altria

Why are we worried about alternative products?

Is nicotine harmful?

• Local (minor) effects at point of delivery– Common and related to route of administration– Usually mild and transient– No serious long-term effects

• Suspected major effects– Theoretical concerns that NRT may cause:

• Acute myocardial infarction• Stroke• Malignancy• Fetal anomaly

– No evidence of these effects in practice

Plasma nicotine concentrations from different sources

* arterial level

Minutes

Cutting down: the health consequences of reduced daily cigarette consumption

So What Should We Do?• ASK about all forms of tobacco, and be SPECIFIC

– Some anecdotal evidence that youth do not consider dissolvables to be tobacco

– Many youth do not know what they are smoking in Hookah (may be tobacco, may not be…)

– Ask about FREQUENCY and QUANTITY, as that may help anchor questions about addiction/loss of autonomy

• ADVISE all tobacco users that there is no SAFE form of tobacco, and they should QUIT COMPLETELY– For those unwilling to quit, there IS evidence that non-

combusted forms of tobacco have less health impact

So What Should We Do? (con’t)

• ASSIST – Mylastdip.com offers free, research-tested self help

program for smokeless users (dip, or spit tobacco)– There are no current studies on helping people quit new

forms of tobacco– May not be very different from pharmaceutical-grade

NRT…

Remember the Adolescent…

• Most adolescent tobacco users do not think they will become addicted– Many think they will use tobacco and be able to quit easily– Many females think they will use until they start having

kids, then stop– It is UNCLEAR at this time how the newer tobacco

products will influence trajectories of tobacco use over time

– The greatest concern is that these newer products will initiate nicotine addiction, and users will progress to more hazardous combusted products

Stay Tuned…

• Population Assessment of Tobacco and Health Study– Starting in 2013, will survey longitudinally and include

youth– Will provide some answers regarding harms and

trajectories, but this will take years

• AAP Richmond Center– Will be monitoring research as it is released, and will be

able to provide resource information

Mark Gottlieb, JD

Disclosure Statement

• Neither I nor any member of my immediate family has a financial relationship or interest (currently or within the past 12 months) with any entity producing health care goods or services consumed by, or used on, patients related to the content of this CME activity.

• I do not intend to discuss an unapproved/investigative use of a commercial product/device.

• How emerging tobacco products are regulated.

• What types of regulatory actions are possible.

• What has happened to date and where.

Regulation of New and Emerging Tobacco Products

• June 22, 2009 – Family Smoking Prevention and Tobacco Control Act became law.

• Gave FDA exclusive regulatory authority over the manufacturing, marketing and sale of tobacco products.

Federal Regulation

• The Act covers cigarettes, smokeless, and new products. – Restricts sales of cigarettes and smokeless tobacco retail

sales to youth (under 18);– Restricts marketing to youth (e.g., no brand sponsorship of

sporting or entertainment events);– Prohibits claims of reduced harm and use of descriptors

such as “mild,” “light,” or “low;” and– Ban flavored cigarettes except menthol.

Federal Regulation

• Regulation is through the FDA’s Center for Tobacco Products, established under the Act.

• FDA has broad powers to issue regulations.– Tar and nicotine; marketing; warnings; menthol.

• It may not ban the sale of cigarettes or other currently regulated tobacco products.

Federal Regulation

• The FDA currently asserts its regulatory authority over:– Cigarettes;– Cigarette tobacco (roll-your-own tobacco); and– Smokeless tobacco,

• Under section 901(b) of the Family Smoking Prevention and Tobacco Control Act.

Federal Regulation

• The FDA has regulatory authority over a wide range of products, but have not yet exercised that authority.

• These include:– Cigars, little cigars, and cigarillos;– Shisha (hookah tobacco);– Pipe tobacco;– Dissolvables; and– E-Cigarettes

Federal Regulation

• The FDA announced in April 2011 that it intends to propose extending (“deeming”) its authority to all tobacco products, including cigars.

• Proposed rule expanding the definition of covered tobacco products was published in Fall, 2011.

• “FDA expects to issue a deeming regulation in summer 2012 to cover other tobacco products.”

• No further action has been taken.

Federal Regulation

FDA and e-Cigarettes09/2008– FDA put a hold on two shipments of e-cigarettes at Los Angeles International Airport. 10/2008- FDA officials issued notices of detention on the grounds that shipments belonging to Smoking Everywhere Inc. appeared to be "adulterated, misbranded or otherwise in violation" of the Food Drug and Cosmetic Act. Would require drug approval.12/2008– FDA issues correspondences concluding that e-cigarettes, “appear to be intended to affect the structure and function of the body, and to prevent, mitigate, or treat the withdrawal symptoms of nicotine addiction.”

FDA and e-Cigarettes3/2009 – FDA issues Refusal of Admission and adds 3 additional manufacturers to its Import Alert.4/2009 – Smoking Everywhere v. FDA (later Sottera, Inc. v. FDA).12/2010– Judge Richard Leon ruled that the Food and Drug Administration (FDA) can regulate e-cigarettes only as a tobacco product, not as a drug.10/2011– FDA “intends to regulate other nicotine-containing products , including electronic cigarette products that do not make a therapeutic claim, in the future.”

FDA and Dissolvables

Family Smoking Prevention and Tobacco Control Act – Sec 907(f): Dissolvable Tobacco Products

• ‘(1) REFERRAL; CONSIDERATIONS- The Secretary shall refer to the Tobacco Products Scientific Advisory Committee for report and recommendation, under section 917(c)(4), the issue of the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children.

FDA and Dissolvables

• Tobacco Products Scientific Advisory Committee - July 2011 – January 2012

• March 2012 –The Nature and Impact of the Use of Dissolvable

Tobacco Products on the Public Health:

– “Given the substantial uncertainties and the potential for either risks or benefits, the TPSAC could not reach a conclusion as to the potential point of balance between potential risks and benefits of DTPs on public health.”

Dissolvables

FDA and Little Cigars/Cigarillos

• Maybe. Sec. 900 of Food Drug and Cosmetic Act:The term “cigarette” means a product that is a tobacco product . . . and includes tobacco, in any form, that is functional in the product, which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette or as roll-your-own tobacco.

Are little cigars regulated by FDA?

Guidance to Industry and FDA Staff: 9/22/09 Flavor Ban

Q: Under what, if any, circumstances would FDA consider cigars, including little cigars, to be in violation of the ban in section 907(a)(1) of the FDCA?

A: The ban applies to all tobacco products with certain characterizing flavors that meet the definition of a “cigarette” in section 900(3) of the FDCA even if they are not labeled as “cigarettes” or are labeled as cigars or as some other product. If a product is labeled as a cigar or as some other tobacco product and the agency determines that the product meets the definition of cigarette in section 900(3), then consistent with its enforcement policy, a warning letter will be issued to the firm to provide it with notice of its violation of the FSPTCA. The warning letter provides the firm with 15 business days to respond prior to the agency’s initiation of further regulatory action against the firm and/or its tobacco product.

Flavor ban includes: herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee.

There is no record of active enforcement actions

Are little cigars regulated by FDA?

• Awaiting “deeming” regulation to extend FDA regulations to potentially include e-cigarettes, cigars, pipe tobacco, little cigars, shisha, dissolvables, and others.

• FDA regulates snus as smokeless tobacco.

• FDA could consider flavored little cigars as cigarettes in violation of flavor ban, but has not yet done so.

Summary of Federal Regulation

• States are able to pass laws or issue regulations to restrict the sales of any tobacco product.

Regulation at the State Level

• To date, there has been little action at the state level:– CA, CO, MN, NH, NJ, and UT - prohibit the sale of e-cigarette

to minors;– Maine banned sales of flavored cigars (except premium

large cigars) in July, 2009.;– New Jersey extended its workplace and other smoking

restrictions to include e-cigarettes (2010).– Utah e-cigarette smoking and hookah bar ban (to go in

effect in 2017).

Regulation at the State Level

1. Flavor Bans

2. E-Cigarette Bans

3. Hookah Regulations

4. Minimum Cigar Sales

Regulation at the Local Level

• Flavor Bans– 2009 New York City banned flavored tobacco products

other than cigarettes.• Any fruit, chocolate, vanilla, honey, candy, cocoa, dessert,

alcoholic beverage, herb or spice flavor is prohibited. Menthol, mint or wintergreen is permitted.

• Existing hookah bars are exempted for shisha sales.

– January, 2012- Providence, RI enacts similar ban.

• Both local flavor bans resulted in legal challenges from tobacco industry that are still pending.

Regulation at the Local Level

• E-Cigarette Bans– Boston: Banned sales of e-cigarettes to minors and

included e-cigarette use in its ban on smoking in the workplace (2011);

– Many other communities have or are considering similar action.

Regulation at the Local Level

• Hookah Regulations– Regulation focuses on smoking in the

workplace restrictions.• Common exemption for “tobacconists” or

“retail tobacco shops;”

– San Francisco, Glendale, & others in CA;– Lexington, KY;– Tacoma-Pierce County Health Department (WA) is

going to court to shut down hookah bars for violating state clean indoor air laws.

Regulation at the Local Level

• Minimum Cigar Sales– Boston, MA - Minimum pack size – 4 cigars.– PG County, MD - Minimum pack size – 5 cigars.– Baltimore City - Minimum pack size – 5 cigars.

Regulation at the Local Level

• Maine: Bans the sale of cigars with characterizing flavors except: Premium cigars.

• Boston: a) Bans blunt wraps (survived court challenge and appeal); b) Minimum pack size – 4 cigars.

• PG County, MD - Minimum pack size – 5 cigars.

Local Cigar Bans

• FDA has broad authority but it may take some time for it to begin to regulate these products;

• States can ban sales or restrict product use;

• Local action is available in many states by ordinances or health regulations;

• Tweaking current laws may reduce use and impact of emerging tobacco products.

Regulation of Emerging Products

Questions?

Artwork by Robin G. © 2010 American Academy of Pediatrics (AAP) Children's Art Contest. Support for the 2009 and 2010 AAP Children's Art Contest was from the Flight Attendant Medical Research Institute.

More on Emerging Products

• www.aap.org/richmondcenter– Tools and Information tab

AAP Richmond Center• Visit us: www.aap.org/richmondcenter

– New: Tobacco coding fact sheet for medical offices– State-specific resources– Funding opportunities– Tobacco control listserv– Downloadable PowerPoint presentations– Pediatric tobacco control resource guide

• Contact us: richmondcenter@aap.org

www.facebook.com/aaprichmondcenter

ReferencesSlide 12: National Youth Risk Behavior Surveys, 1991 – 2011, Monitoring the Future, 1991-2011

Slides 13, 20, 22, 26, 30, 40: Monitoring the Future, 2011

Slide 15: National Youth Risk Behavior Surveys, 1997–2011

Slide 16: National Survey on Drug Use and Health, 2010

Slide 19: National Youth Risk Behavior Surveys, 1991 – 2011

Slide 25: National Youth Risk Behavior Surveys, 1995–2011, Monitoring the Future, 1995-2011

Slide 27: National Youth Risk Behavior Survey, 2011

Slide 29: Bofetta, BMJ 2009; doi:10.1136/bmj.b3060

Slide 36: Foulds, Tobacco Control 2003;12:349-359

Slide 37: Rodu, J Int Med 2002;255:102-7

Slide 38: Luo et al, Lancet 2007;329:2015

Slide 48: Goniewicz et al, NTR 2012 doi: 10.1093/ntr/nts103

Slide 49: Etter and Bullen, Addiction 2011 (online)

Slide 50: Polosa et al, BMC Public Health 2011;11:786

Slide 51: youth- Monitoring the Future, 2011; adult- Social Climate Survey of Tobacco Control 2010 (cigarette, cigar, smokeless data unpublished)

Slide 53: Food and Drug Administration Tobacco Product Scientific Advisory Committee March 1-2 2012 DRAFT report on Dissolvable Tobacco Products-http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/UCM293691.pdfSlide 55: Henningfield NEJM 1995;333:1196

Slide 56: Tverdal, Tobacco Control 2006;15:472–480