ETHICAL CONCERNS IN THE DIETARY SUPPLEMENTS BUSINESS

ETHICAL CONCERNS IN THE DIETARY SUPPLEMENTS BUSINESS Geok Lin Khor Universiti Putra Malaysia “$23 Billion and Counting: Nutrition Industry Braces for a Competitive Future” (NBJ, 1998) Natural organic, beverages foods Supplements vitamins, botanicals sports, minerals specialty Natural Skin, hair personal care $7.7 billion $12.5 billion $2.8 billion WHAT IS A DIETARY SUPPLEMENT? Dietary Supplement Health and Education Act (DSHEA, 1994)/FDA • • • • A dietary supplement is taken by mouth intended to supplement the diet It contains one or more of the following dietary ingredients: vitamins, minerals, herbs, amino acids, enzymes, organ tissue, metabolites, extracts or concentrates. Dietary supplements can be in the form of pills, tablets, capsules, liquids or powders Its label clearly states that it is a dietary supplement INCREASING DEMAND FOR DIETARY SUPPLEMENTS WORLD-WIDE: SOME REASONS • Greater access to complementary and alternative medicine • Disenchantment with conventional health care including its increasing cost INCREASING DEMAND FOR DIETARY SUPPLEMENTS • Epidemiological shift from infectious to non-communicable chronic diseases • Demographic shift to increasing proportions of older population • Effective distribution and sale channels for dietary supplements US CONSUMER SALE CHANNELS Retail stores Mass market 7,200 natural food stores 7,800 nutrition supplements stores 30,000 supermarkets 100,00 grocers, drug stores, etc Direct sales Mail order: 300 catalog companies Multilevel marketing: 240 companies Medical and alternative health practitioners ETHICAL CONCERNS 1. Regulatory Issues (a) Lack of legal control (b) Poor enforcement of regulations (c) Loop-holes/ambiguity in regulations (d) Who regulates Internet sites on nutrition products? REGULATION OF DIETARY SUPPLEMENTS IN US The Dietary Supplements Health and Education Act (DSHEA) was established in 1994 to provide the legal framework specifically for dietary supplements REGULATORY DILEMMA • Under the DSHEA, no claim can be made for a dietary supplement to treat, cure or mitigate a disease. • However, a dietary supplement can make claims that it affects or maintain the structure or function of the body HEALTH CLAIM OR STRUCTURE/FUNCTION CLAIM? • “Helps mood disorders” • “Helps to rejuvenate and repair cartilage” • “Improves memory and concentration” • “Immune enhancer” • “Improve digestion” • “Relieves symptoms of menopause” ETHICAL CONCERNS 1. Regulatory Issues 2. Misleading/Unsubstantiated Health Claims “A health claim characterizes the relationship of any food, nutrient or substance to a disease or a health-related condition” (FDA/NLEA 1990) FDA OCT 2000 FINAL RULE REGARDING OMEGA-3 FATTY ACIDS • There is not significant scientific agreement among experts that such evidence supported a health claim for omega-3 fatty acids and coronary heart disease (CHD) • Thus, a health claim stating that “Omega-3 fatty acids may reduce the risk of CHD” is misleading FDA OCT 2000 FINAL RULE REGARDING OMEGA-3 FATTY ACIDS •Labeling should not recommend intakes of more than 2 gram per day of omega-3 fatty acids (EPA and DHA) • This would provide an added safety margin for consumers to remain below the 3 gram per day level ETHICAL CONCERNS 1. Regulatory Issues 2. Misleading Health Claims 3. Safety Issues: e.g. Use of Herbs/Botanicals • WHO estimates that 65-80% of the world’s population use traditional medicine as their primary form of health care • The use of herbal medicine, the dominant form of medical treatment in developing countries, has been increasing in developed countries in recent years Britain France Germany Denmark Holland Sweden Certain specific forms of herbal medicines are exempt from medicines license Official list allows over 200 plants to be sold by pharmacists Over 250 herbal medicines freely available after their safety and efficacy were established Herbal remedies sold as food supplements REGULATIONS OF HERBAL MEDICINES IN AUSTRALIA • Herbal medicine accounts for ~26% of “complementary and alternative medicine” (CAM) • Estimates for the national cost of both CAM preparations and practitioner visits is one billion dollars • Estimates 57% of Australians are using CAM each year (MJA, 1999) TOXIC CONTAMINATION IN HERBAL PRODUCTS • Example: Aristolochic acids are potent carcinogens and nephrotoxins • Over 100 cases of nephropathy reported in US, Canada and Europe in the year 2000 • Small amount ingested may show no adverse symptoms for years until serious irreversible effects occur e.g. renal failure • There are about 600 species of plants that contain this toxin, many of which originate from China Should More Control Be Introduced? • Under the Australian Therapeutic Goods Act 1989, alternative medicines can be “listed” for a small fee, without evaluation, provided that no specific claim is made for efficacy and there is no available evidence of problems with quality or safety • More than 4,500 herbal preparations are on this list • Less than 5 are registered as a result of a full evaluation of safety and efficacy ETHICAL CONCERNS 1. Regulatory Issues 2. Misleading Health Claims 3. Safety Issues: e.g. Herbs/Botanicals 4. Health Care Providers: Conflict of Interest? CONFLICT OF INTEREST? “Don’t these pharmacists look and see what you’re selling? Maybe they’re no longer in control of the store. Maybe they’re just behind the counter, and anything in front of that counter goes. But it’s time for that profession to take responsibility for what it’s selling.” (Dr David Kessler, FDA Commissioner 1990-97 Symp. Dietary Supplements and Herbal Remedies, 1998) RECOMMENDATIONS OF THE AM DIETETIC ASSOC (1999) 1. Ensuring consumer access to safe dietary supplements that are truthful and not misleadingly labeled should be the overarching goal of FDA’s dietary supplement strategy 2. Have separate categories for dietary supplements and the botanicals –latter would require more scrutiny or limits HEALTH CLAIMS • Palm oil tocotrienols may prove to be effective agents in the prevention and/or treatment of breast cancer • Cranberry juice promotes urinary tract health –its proanthocyanidins prevent the adhesion of E. coli to uro-epithelial cells CLASSIFICATION OF ADVERSE EFFECTS ASSOCIATED WITH HERBAL MEDICINE (Drew & Myers, MJA, 1998) Intrinsic • Type A: Predictable toxicity, over dosage, interaction with drugs • Type B: Idiosyncratic reactions e.g. allergy, anaphylaxis • • • • • • • Extrinsic Failure of good manufacturing practices Misidentification Lack of standardization Contamination Substitution Adulteration Incorrect preparation Inappropriate labeling and/or advertising STANDARDIZAION OF BOTANICAL PRODUCTS • The concept of standardization is a process that stretches from the field to the finished product • Model for quality is pharmaceuticals rather than foods • Characterization is more difficult for a botanical than for a single chemical ingredient pharmaceutical, especially when the active compound is unknown HERBAL MEDICINE • After 5 years of unprecedented growth in the US, the herb market has begun to decline • Possible explanations: variations in quality, consumer expectations, increasingly hostile media (“herbs are untested, unsafe; their benefits are unsubstantiated; must be standardized to be effective and reliable”) Food Marketing Institute (1998) • 82% of US shoppers reported that in 1997 they sought out and purchased products after being attracted by low-fat claims • 64% bought a low-cholesterol product • 57% bought a low salt product • It appears that claims on products have the ability to affect purchasing behaviour National Institute of Nutrition of Canada, 1999 • Study reported majority of Canadians do read labels • 81% report using the ingredient list • 78% read the nutrition panel • 75% report using the nutrient content claims • Overall, 92% perceived health claims as fairly useful or very useful FINDINGS OF FDA RESEARCH • Reported that claims on food labels have a limited ability to educate consumers about specific health benefits * Claims that provided new information to consumers showed more positive effects than a highly familiar claim NEUTRACEUTICALS AND FUNCTIONAL FOODS • Represent one of the fastest growing markets in developed countries •In Canada, this industry is estimated to generate between $1.8 to $2 billion per year NEUTRACEUTICALS • Are products that have been isolated or purified from foods • Generally sold in medicinal forms not usually associated with food • Demonstrated to have a physiological benefit or to provide protection against chronic disease (Health Canada 1998) FUNCTIONAL FOODS • Similar in appearance to conventional foods and are consumed as part of the usual diet • Have demonstrated physiological benefits, and/or reduce the risk of chronic disease beyond basic nutritional functions (Health Canada 1998) Health Canada Final Policy Decision 1998 Structure/function and risk reduction claims for foods should be permitted, while all other products claiming to cure, treat, mitigate or prevent illness should continue to be regulated as drugs • The FDA has stated its confidence that the existing regulations for foods are sufficient There remains no legal definition of nutraceutical or functional food • Companies must decide on intended use (conventional food or dietary supplement) USDA’s Approach on Neutraceuticals and Functional Foods • In 1998, USDA’s Agricultural Reserch Service (ARS) hosted conference on “Food, Phytonutrients and Health” • In 2000, USDA augmented ARS funding of research related to functional foods to ~$44 millions • In 2000, the Cooperative State Research, Education and Extension Service of USDA awarded $9.2 millions in grants to address knowledge gaps in functional foods Toxicological Aspects of Nutraceuticals/Functional Foods • Certain food products including herbals and proteins have been demonstrated to elicit adverse symptoms such as acute and chronic toxicity or allergy • Studies designed to ascertain the safety of increased consumption of new concentrates and isolates are lacking because these are natural, food-derived substances Use of Functional Foods in the Treatment of Obesity • In the mid-19th century, acidic foods like vinegar, pineapple and grapefruit were touted as fat-melting agents • Presently, several functional foods are sold for weight control including low-calorie, highcalcium diet, & catechin-rich green tea extract • The ideal functional food would need to control calorie intake, while providing psychological and physiological satiety AMERICAN DIETETICS ASSOCIATION POSITION PAPER ON FUNCTIONAL FOODS • ADA recognizes tea as a functional beverage • Tea is a rich source of flavonoids that are powerful natural antioxidants • Animal and human studies provide support to epidemiological evidence of decreased risk of myocardial infarction, cardiovascular mortality, and several types of caner in populations consuming diets high in tea or dietary flavonoids POTENTIAL OF FUNCTIONAL FOODS AGAINST CANCER • Many compounds proposed for use in functional foods or as nutraceuticals are antioxidants • Care must be taken since antioxidants have been shown to have prooxidant properties in vivo • Carotenoids, phenolics and flavonoids can be either agonist or antagonist • Cannot assume that because it is found in nature that the increased intake of a chemical can, in isolation be protective CLAIMS AS FUNCTIONAL FOODS Food • • • • • • • Canola/rapeseed: Vegetables: Flax seed: Oats & barley: Citrus juices: Green tea: Wine: Active Ingredient Phenolics Phytosterols Lignans Beta glucan (soluble fibre) Flavonoids , limonoids Flavonoids Anthocyanins DEFINITIONS: • Claims related to essential nutrient diseases or deficiencies are not health claims • Terms such as hypoallergenic, lactose-free, wheat-gluten free, and dietetic are not health claims The FDA Modernization Act 1997 • Added a second way for industry to include new health claims • Permits distributors & manufacturers to use claims if such claims are based on current, published, authoritative statements from certain scientific bodies, as well as from the National Academy of Science DIET-DISEASE RELATIONSHIPS CLAIMS PERMITTED BY FDA • • • • • • • • Calcium and osteoporosis * Dietary fat and cancer Sodium and hypertension* Dietary fibre & coronary heart disease Saturated fat & cholesterol & CHD* Fruits & vegetables and cancer * Folate & neural tube birth defects Sugar and dental caries * GMF: AVENTIS’ STARLINK CORN • Korean FDA recalled half of its tortilla imports from Mission Foods because they contain Aventis’s corn • Aventis’ corn found illegally in Japan • Mission Foods and Azteca Million recalled all products with yellow GM corn, including taco shells, corn chips and corn flour • Evidence of Aventis’ corn causing allergic reaction (NBJ Weekly Nov, 2000) DOES THE DSHEA PLACE TOO MUCH TRUST ON MANUFACTURERS? • Manufacturers and distributors do not need to register with FDA or get FDA approval before producing or selling dietary supplements • The manufacturer is expected to make sure the label information is truthful and not misleading • The manufacturer is also responsible for making sure that all the dietary ingredients in the supplements are safe DIETARY FIBER AND COLORECTAL CANCER • FDA concludes that the evidence is strong that there is not a relationship between dietary fiber and colorectal cancer • A dietary supplement that bears a claim about dietary fiber and reduced risk of colorectal cancer will be subject to regulatory action as a misbranded food and as a misbranded drug and as an unapproved new drug (1993; 2000)