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Unregulated Herbal Supplements:Facing the Menace

Ito Ay Hindi Gamot

Esperanza I. Cabral, MD.

Describe law regarding food supplements. Discuss commonly used food supplements, i.e.,

herbal medicines. Review the reasons why people are using herbal

medicines. Describe risks from the consumption of herbal

medicines. What we can do to keep patients safe.

Unregulated Herbal Supplements: Facing the Menace46th PCP Annual Convention, May 2, 2016

TERMS

Varying terms usedEXAMPLE: GINKGO IS VARIOUSLY CLASSIFIED AS:

Natural product [Canada]Food supplement [Phil; EU]Dietary supplement [US]Food w/ specific health use [Japan]Health function food [Korea]Functional food [China]Complementary medicine [Australia]Traditional medicine [Malaysia]Nutritional supplement, nutraceutical, herbal

supplement, health supplement, etc.

Health Supplement ASEAN definition Any product that is used to supplement a diet

to maintain, enhance and improve the healthy function of human body,

contains one or more of the ff: (a) Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, other bioactive substances.(b) Substances derived from natural sources, including animal, mineral and botanical materials.(c) Synthetic forms of (a) and (b).

presented in small oral doses and excludes parenterals (e.g., injectables, eyedrops).

Regulatory Issues

Dietary Supplement officially defined in the US in 1994 by the Dietary Supplement Health and Education Act (DSHEA) as a product taken by mouth that contains a dietary ingredient intended to supplement the diet.Dietary Ingredient - one or any combination of the following: Vitamin, Mineral, Herb or Botanical, Amino Acid, Enzymes, Tissues, Metabolite, Concentrate, Constituent, or Extract.

Herbs classified as dietary supplements Dietary supplements NOT regulated like drugs

because they are legally, not drugs Manufacturers can market supplements w/o

proof of safety or efficacy. Manufacturers responsible for product safety

No FDA approval needed to sell and FDA must prove the product unsafe to remove it from the market

No established dosage guidelines No purity restrictions

US: Structure/Function Statement

This product is not intended to diagnose, treat, cure or prevent a disease.

Herbalgram 2000;48:32-8

RA 9711 Food and Drugs Administration (FDA) Act of 2009 renames the Bureau of Food and Drugs

(BFAD) as Food and Drug Administration (FDA)

strengthens its regulatory powers, resources and capabilities to efficiently and expeditiously perform its mandate

http://192.168.0.16/WebCenter/BIIS2006/Intranet010206/login.cfm?message=|%20please%20login%20|&CFID=4284&CFTOKEN=55601390http://192.168.0.16/WebCenter/BIIS2006/Intranet010206/login.cfm?message=|%20please%20login%20|&CFID=4284&CFTOKEN=55601390

1. article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; 2. article (other than food) intended to affect the structure of any function of the body of humans or animals; or 3. article intended for use as a component of any article specified in clauses (1) or (2) but does not include devices or their components/ accessories.

Definition of a DRUG RA 9711


Vitamins & minerals classified as drug: a therapeutic claim made for the preparation

for a specific deficiency, state or disease strength per dosage form is >105% RDA for fat

soluble & >150% RDA for water soluble vitamins; any pharmaceutical form highly purified

Vitamins & minerals classified as food supplement: no therapeutic claim made for the preparation strength per dosage form is

Definition of Herbal Medicines

Finished medicinal products that contain as active ingredient(s), aerial or underground part(s) of plants or any plant material, or combination thereof, whether in the crude state or as processed forms

(A.O. 172 s.2004 Re: Guidelines on the Registration of Herbal Medicines)


Definition of Herbal Medicines contd.

Not intended for use in the diagnosis, alleviation, cure or treatment of disease, promotion of health or intended to affect or modify the structure or any function of the body of humans or animalsPreparations containing plant material(s)

combined with chemically defined therapeutically active substances, are NOT considered to be herbal medicines.


Definition: preparations from plant materials whose application is based on traditional experience of long usage of at least five (5) decades as documented in medical, historical and ethnological literature do not contain chemically defined

therapeutically active substance(s),

classified as food supplements/herbal medicines

TRADITIONALLY-USED HERBAL PRODUCTS(A.O. 184 s.2004: Guidelines on the Registration of Traditionally-Used

Herbal Products)


Yerba buenaClinopodium douglasii

Tsaang gubatEhretia microphylla

Ulasimang batoPeperomia pellucida

Niyog niyoganQuisqualis indica

SambongBlumea balsamifera

Ten Approved Traditionally Used Herbal Products

AmpalayaMomordica charantia

GuavaPsydium guajava

LagundiVitex negundo

GarlicAllium sativum

AkapulkoCassia alata

Ten Approved Traditionally Used Herbal Products

REGULATION OF HERBAL PRODUCTS

AO 184 S 2004: Guidelines on the registration of traditionally-used herbal products

Guidelines on the registration of herbal food products based on ASEAN harmonization of evaluation of health supplements and traditional medicines


Herbal Medicines Registration Requirements contd.

No product shall be registered as Herbal Medicine if: There is a valid report of adverse drug reaction

on the use of the plant material There is a valid report of abuse or dependence

potential on the use of the plant material. It contains chemically defined therapeutically

active substance(s) used in conventional/ western medicine.


Food Supplements

CA upholds DOH rule on 'no approved therapeutic claim' tag on supplementsBy: Brian Maglungsod, Interaksyon.com

December 21, 2014 11:21 PM

Department of Health: a legal victory for truth in advertising.

all food & dietary supplement products sold in the market should strictly carry on their labels the phrase Mahalagang paalala: Ang (name of product) ay hindi gamot at hindi dapatgamiting panggamot saanumang uri ng sakit

Sehat Badan is being sold illegally particularly in Mindanao for P180 per box.

Sehat Badan's Facebook page: claims it can "treat various diseases" such as asthma, allergy, and hypertension This claim is not approved by the Philippine FDA.

In 2014, the FDA ordered its food and drug regulation officers to confiscate the unregistered food supplement which contains sugar (sucrose and fructose), Diclofenac sodium, Paracetamoland Ibuprofen.

FDAs have foughtfor decades toregulate supplements, buthave been defeatedpolitically, andeconomically, bythe supplementindustry

The Egyptians first codified herbal remedies. Shennong, a mythical person, tested hundreds of herbs, passed knowledge about plants and poisons over 2,000 years ago to others.Herbal guide De Materia Medicawas written by a 1st century Greek physician, Dioscorides. In the Americas, herbalism, deeply tied to spiritualism among Native American tribes.

History of Herbal Remedies

Useful Supplements

Not all natural products are safe

Drug Food Supplement Interactions

St. Johns Wort: Amitryptiline, Anticonvulsants, Antihistamines, Benzodiazepines, CCBs, Chemotherapeutics, OCPs, Digoxin, Simvastatin, SSRIs, Warfarin

Milk Thistle: Metronidazole Black Cohosh: Iron, Hormones, Warfarin,

Salicylates Echinacea: Immuno-suppressants Saw Palmetto: Hormones (e.g., OCPs) Gingko biloba: Acetaminophen, Anticonvulsants,

Antidepressants, Aspirin, Thiazides Garlic: Aspirin, HIV medications, Warfarin

Safety Considerations

40 to 70% of patients do not inform physicians about use of alternative therapies

Adverse reactions not known to patients One or more chemical component of the

plant

Incorrect manufacturing process FDA does not require reporting of adverse

reactions from alternative therapies

Safety Considerations No Standardization

Nomenclature and chemical constituents vary

Mixtures are NOT standardized Lack of Good Manufacturing Practices Examples: ginseng, ephedra

Difficult to identify ingredients Lack of active ingredient Contamination

Herbal remedies not only waste funds, but on occasion poison and kill, and they do even greater harm to the fools who take them because they often at the same time are not treating a serious medical condition scientifically

Books could be filled with the controlled studies that have failed to find significant value to herbal remedies.*National Council Against Health Fraud, Inc.

Herbal Remedies NCAHF* warning

In the Philippines: Ito ay hindi gamot

Memory Plus Gold Optein Liveraide Lungcare Kidneycare Kolestrim Diabetrol Robust, Fitrum MX3 Sehat Bedan


CNS: ginkgo, St Johns wort, melatonin Eye: lutein CVS: policosanol, garlic, omega-3, resveratrol Skin: glutathione Liver: silymarin Kidney: balbas pusa Mens RH: tongkat ali, saw palmetto, lycopene Womens RH: black cohosh, oil of evening primrose Diabetes: ampalaya, banaba, turmeric, chromium Joint: glucosamine, chondroitin Tonic/immune: ginseng, echinacea


Comfrey Kargasok tea Apple cider Aloe Noni Barley Wheat grass Ashitaba


Narra Mahogany Pitupito Virgin coconut oil Malunggay Guyabano Mangosteen

If herbals have not been provento be effective for preventing, diagnosing or treating any disease and may be harmful,

Why do people keep taking them?

Major trends in the Philippines:

concern about drug safety issues concern about quality & cost of health

care health consciousness and awareness

of lifestyle related diseases demand for disease prevention

products and services in self medication with herbal

medicines demand for health and wellness

products

Herbal versusConventional Medication Disappointment with current conventional

therapies Fear of safety and long-term effects of drugs Lack of effective treatments/cures Belief that herbal products are safe because

derived from nature Peer influence Desire to have control of ones own health False claims from manufacturers

Herbal versusConventional Medication

Demand stimulated by aggressive marketing campaigns, including television & radio commercials, usually involving Filipino celebrities (even doctors).

Many people will keep taking food supplements

What can we do to make it less risky for them?

1. Resist the temptation to make money from gullible patients

2. Routinely ask patients about their use of herbal products/food supplements. Give them advice.

3. Report adverse effects to the FDA4. Write up and submit for publication

case reports in which patients have experienced adverse effects from herbal product use.

Clinicians

1. Do not assume that herbal remedies are safe just because they are natural.

2. Do not take herbal remedies if you are pregnant or attempting to become pregnant or breastfeeding. Dont give to children.

3. Do not take large quantities of herbal products or for prolonged periods.

4. Buy only products that identify active ingredients and state contraindications for use.

Give Advice to Consumers

5. There are dangerous herbs and advice not to take them.

6. Do not use herbal remedies without checking with your doctor.

7. Do not trust your health to practitioners who use unregulated titles such as herbalist, herb doctor, herbologist, Master Herbalist, Natural Health Counselor, etc.

8. Beware of exaggerated claims about the benefits of herbal remedies.

Advice to Consumers contd.

9. Herbal-pharmaceutical interactions do occur

10. Lack of standardization (variability in content and efficacy among brands)

11. Lack of quality control and regulation (contamination and misidentification)

12. Tell health service provider about herbal use

Advice to Consumers contd.

Thank You!

Unregulated Herbal Supplements Facing the Menace PCP 2016 Part 1Unregulated Herbal Supplements: Facing the Menace Ito Ay Hindi GamotSlide Number 2Slide Number 3 Health Supplement ASEAN definition Regulatory IssuesSlide Number 6Slide Number 7US: Structure/Function StatementSlide Number 9Slide Number 10Slide Number 11Slide Number 12Definition of Herbal Medicines contd.Slide Number 14Slide Number 15Slide Number 16Slide Number 17Slide Number 18Slide Number 19Slide Number 20Slide Number 21Slide Number 22Slide Number 23Slide Number 24Slide Number 25Slide Number 26Slide Number 27

Unregulated Herbal Supplements Facing the Menace PCP 2016 Part 2Slide Number 1Slide Number 2Slide Number 3History of Herbal Remedies Slide Number 5Useful supplementsSupplementsSlide Number 8Not all natural products are safeNot all natural products are safeDrug Food Supplement InteractionsSafety ConsiderationsSafety ConsiderationsHerbal Remedies NCAHF* warningIn the Philippines: Ito ay hindi gamotIn the Philippines: Ito ay hindi gamotIn the Philippines: Ito ay hindi gamotIn the Philippines: Ito ay hindi gamotSlide Number 19Slide Number 20Herbal versusConventional MedicationHerbal versusConventional MedicationSlide Number 23Slide Number 24Slide Number 25Slide Number 26Slide Number 27Slide Number 28

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Unregulated Herbal Supplements - Official Website of ...pcp.org.ph/documents/46th AC Lectures/Unregulated Herbal... · Unregulated Herbal Supplements: ... •Complementary medicine