Unregulated Herbal Supplements:

Transcription

1 Unregulated Herbal Supplements: Facing the Menace Ito Ay Hindi Gamot Esperanza I. Cabral, MD.

2 Unregulated Herbal Supplements: Facing the Menace 46 th PCP Annual Convention, May 2, 2016 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.

3 TERMS Varying terms used EXAMPLE: 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.

4 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).

5 Regulatory Issues

6 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.

7 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

8 US: Structure/Function Statement This product is not intended to diagnose, treat, cure or prevent a disease. Herbalgram 2000;48:32-8

9 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

10 Definition of a DRUG RA 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.

11 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 <105% RDA for fat soluble & <150% RDA for water soluble vitamins oral preparation only no additional pharmacologically active ingredients

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

13 Definition of Herbal Medicines cont d. 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 animals Preparations containing plant material(s) combined with chemically defined therapeutically active substances, are NOT considered to be herbal medicines.

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

15 Ten Approved Traditionally Used Herbal Products Yerba buena Clinopodium douglasii Tsaang gubat Ehretia microphylla Ulasimang bato Peperomia pellucida Niyog niyogan Quisqualis indica Sambong Blumea balsamifera

16 Ten Approved Traditionally Used Herbal Products Ampalaya Momordica charantia Guava Psydium guajava Lagundi Vitex negundo Garlic Allium sativum Akapulko Cassia alata

17 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

18 Herbal Medicines Registration Requirements cont d. 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.

19 Food Supplements

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24 CA upholds DOH rule on 'no approved therapeutic claim' tag on supplements By: Brian Maglungsod, Interaksyon.com December 21, :21 PM 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 dapat gamiting panggamot sa anumang uri ng sakit Department of Health: a legal victory for truth in advertising.

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29 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, Paracetamol and Ibuprofen.

30 FDAs have fought for decades to regulate supplements, but have been defeated politically, and economically, by the supplement industry

31 History of Herbal Remedies 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 Medica was written by a 1 st century Greek physician, Dioscorides. In the Americas, herbalism, deeply tied to spiritualism among Native American tribes.

32 Useful Supplements

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35 Not all natural products are safe

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38 Drug Food Supplement Interactions St. John s 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

39 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

40 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

41 Herbal Remedies NCAHF* warning 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.

42 In the Philippines: Ito ay hindi gamot Memory Plus Gold Optein Liveraide Lungcare Kidneycare Kolestrim Diabetrol Robust, Fitrum MX3 Sehat Bedan

43 In the Philippines: Ito ay hindi gamot CNS: ginkgo, St Johns wort, melatonin Eye: lutein CVS: policosanol, garlic, omega-3, resveratrol Skin: glutathione Liver: silymarin Kidney: balbas pusa Men s RH: tongkat ali, saw palmetto, lycopene Women s RH: black cohosh, oil of evening primrose Diabetes: ampalaya, banaba, turmeric, chromium Joint: glucosamine, chondroitin Tonic/immune: ginseng, echinacea

44 In the Philippines: Ito ay hindi gamot Comfrey Kargasok tea Apple cider Aloe Noni Barley Wheat grass Ashitaba

45 In the Philippines: Ito ay hindi gamot Narra Mahogany Pitupito Virgin coconut oil Malunggay Guyabano Mangosteen

46 If herbals have not been proven to be effective for preventing, diagnosing or treating any disease and may be harmful, Why do people keep taking them?

47 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

48 Herbal versus Conventional 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 one s own health False claims from manufacturers

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

50 Many people will keep taking food supplements What can we do to make it less risky for them?

51 Clinicians 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 FDA 4. Write up and submit for publication case reports in which patients have experienced adverse effects from herbal product use.

52 Give Advice to Consumers 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. Don t 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.

53 Advice to Consumers cont d. 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.

54 Advice to Consumers cont d. 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

55 Thank You!