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Nutritional products for specific health benefits— Foods, pharmaceuticals, or something in between?

1994; Elsevier BV; Volume: 94; Issue: 2 Linguagem: Inglês

10.1016/0002-8223(94)90238-0

1878-3570

Janet R. Hunt,

Biochemical Acid Research Studies

A category of compounds called nutraceuticals has been proposed as a new regulatory category separate from current US Food and Drug Administration (FDA) regulations for food or drugs. The Nutraceutical Research and Development Bill, proposed by the Foundation For Innovation in Medicine, would, if enacted, substantially loosen current criteria for health claims to consumers about nutritional products. However, the proposal conflicts with FDA regulations and the Nutrition Labeling and Education Act of 1990, which allow products to make health claims to consumers only when supported by significant scientific agreement. The nutraceutical proposal would also allow exclusivity of health claims based on proprietary research, in contrast to FDA regulations that health claims for foods should be based on public information and should not be brand specific. Federal regulations and funding should be encouraged to promote human research and clinical testing of the health benefits of foods and food components, in amounts available in the diet, without classifying these substances as drugs. Consumers will best be served by prohibiting health claims without sufficient research and prior approval and by allowing scientifically based health claims for all qualifying foods in a varied diet. The nutraceutical initiative was launched by The Foundation For Innovation in Medicine, chaired by Stephen L. DeFelice, MD. In 1989, DeFelice coined the term nutraceuticals, which he defined as:Any substance that may be considered a food or part of a food and provides medical or health benefits, including the prevention and treatment of disease. Nutraceuticals may range from isolated nutrients, dietary supplements, and diets to genetically engineered "designer" foods, herbal products, and processed products, such as cereals, soups, and beverages (1.The Nutraceutical Initiative: A Proposal for Economic and Regulatory Reform. The Foundation for Innovation in Medicine, Cranford, NJ1991Google Scholar, p 2). The term nutraceuticals has been used nonspecifically. For instance, it has been said to include four types of food: "genetically engineered foods (tomatoes, for example), raw food (carrots with β-carotene), processed food without added ingredients (oat-bran cereal), and processed food with added ingredients (calcium-fortified juice)" (2.Nutr Week. 1993; 16 (April): 7Google Scholar, p 7). Nutraceutical was proposed by The Foundation For Innovation in Medicine as a new regulatory term, "outside of the traditional regulatory concept of either a food or a drug" (3.Pszczola DE The nutraceutical initiative: a proposal for regulatory reform.Food Technol. 1992; (April): 77-79Google Scholar, p 77) to establish a new process for the review and approval of products and related health claims, and to provide exclusive marketing rights to such claims based on proprietary research. The term nutraceutical is not recognized by the FDA (4.Food Chem News. 1993; (February): 19-20Google Scholar), is not used in medical science literature, and did not appear in any titles or abstracts in the Medline database as of June 1993. On the other hand, it does appear in the Agricola database and in publications related to food technology and food marketing. It has also been used in the popular press by such publications as the New York Times and USA Today, which reflects an extensive media campaign by The Foundation For Innovation in Medicine. In Japan and in some European countries, food products sold for health benefits have been termed functional foods, or "processed foods, defined by the main 'functional ingredient' (oligosaccharides, fibres, minerals, etc), that are claimed to perform specific health roles such as preventing, treating and curing various diseases, and which fall into a category somewhere between food, dietary supplements and drugs" (5.Griffen G Talking straight: the benefits to industry of communicating advances in food science and diet philosophy.Trends Food Sci Technol. 1993; 4: 77-79Google Scholar, p 78). FDA defines foods as "products primarily consumed for their taste, aroma, or nutritive value," and drugs as products "intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure or a function of the body" (6.Food and Drug Administration Regulation of dietary supplements.Federal Register. June 18, 1993; 58: 33692Google Scholar, p 33692). Specific FDA regulations apply to medical foods, which are defined as products "intended for use under the supervision of a physician for specific dietary management of a disease or condition" (7.Food and Drug Administration Food labeling: mandatory status of nutrition labeling and nutrient content revision, format for nutrition label.Federal Register. January 6, 1993; 58: 2151Google Scholar, p 2151). Examples include enteral feeding solutions and products for individuals with phenylketonuria. The FDA plans to develop specific regulations for medical foods in the near future (7.Food and Drug Administration Food labeling: mandatory status of nutrition labeling and nutrient content revision, format for nutrition label.Federal Register. January 6, 1993; 58: 2151Google Scholar). Food additives, substances added to foods for specific physical or technical effects, require FDA approval of data that establish safety, including evidence that the additive will accomplish its intended effect (6.Food and Drug Administration Regulation of dietary supplements.Federal Register. June 18, 1993; 58: 33692Google Scholar). Sales of food products with health claims have been forecast as a major growth area in the food industry. Forty percent of new food products carry some kind of general or specific health claim (8.Shukla TP Nutraceutical foods.Cereal Foods World. 1992; 37: 665-666Google Scholar). From reduced-calorie foods to foods purported to prevent cancer and cardiovascular diseases, to "mood foods," the current retail market for all nutraceuticals has been estimated at $2.5 billion in 1988, with a projected annual growth rate of 17% to 20% (8.Shukla TP Nutraceutical foods.Cereal Foods World. 1992; 37: 665-666Google Scholar). Current FDA regulations allow only a few specific health claims that are well supported by publicly available scientific evidence and that can be used by all qualifying food products. There is no mechanism for exclusive health claims based on proprietary research, as exists for drugs. The Nutrition Labeling and Education Act mandates that "publicly available evidence" be used to support health claims for food, and the FDA has specified that such claims will not be brand specific (9.Food and Drug Administration Labeling: general requirements for health claims for food.Federal Register. November 27, 1991; 56: 60559Google Scholar). Proponents of nutraceuticals complain that this removes the financial incentive for companies to invest in research and development of nutritional products. The Foundation For Innovation in Medicine proposes that Congress enact a Nutraceutical Research and Development Bill that would permit 7 years of exclusivity in health claims for nutritional products based on proprietary research. A Nutraceutical Commission housed within FDA specifically for the review and approval of nutraceuticals would review, approve, and regulate new products and claims. The commission would be open and flexible in establishing study requirements and would classify submitted applications as either a medical nutraceutical (promoted to physicians only) or a consumer nutraceutical (promoted to physicians and consumers), depending on the request of its sponsor and the subsequent evaluation. A nutraceutical research grants program would be created specifically for nutraceutical clinical research, and would be administered by the National Institutes of Health (1.The Nutraceutical Initiative: A Proposal for Economic and Regulatory Reform. The Foundation for Innovation in Medicine, Cranford, NJ1991Google Scholar). Although DeFelice prefers the nutraceutical initiative, he has indicated that he "would support the passage of a Hatch/Richardson-type bill, which would allow the companies to make claims without pre-marketing clearing, and the FDA challenging them afterwards" (10.Marketletter. 1993; 8 (February): 24-25Google Scholar, p 25). This Dietary Supplement Bill (S 784/HR 1709), which was introduced by sponsors Sen Orrin Hatch (R, Utah) and Rep Bill Richardson (D, NM) on April 7, 1993, would exempt dietary supplements from the health claims provisions of the Nutrition Labeling and Education Act of 1990. The American Dietetic Association (ADA) has lobbied against this bill. Japan, Europe, and the United States, are currently considering how to best regulate such products. In Japan, regulations were approved in July 1991 for Food for Specified Health Use (FOSHU). These foods must have a clear medical and health benefit, should be a product that is normally consumed in ordinary diets (not pills or supplements), and must be labeled with medical benefits and precautions for cooking, use, and storage. The Japanese government is considering requiring sales of FOSHU products only in certified stores staffed by FOSHU nutritionists. No FOSHU products were approved in the first 18 months of the regulations (11.LaBell F Europe, Japan open doors to medicinal food products.Food Processing. 1993; (April): 60-63Google Scholar). Nutraceuticals promoters cite instances in Europe of exclusivity granted for research-based health claims. Maxepa (Laboratories Lincoln, France), a product containing long-chain n-3 fatty acids, was refused by the French government as a food with specific therapeutic claims, but was subsequently approved as a drug with market exclusivity to claims that it is effective in treating isolated or combined hypertriglyceridemia. The product can only be supplied as a prescription drug in pharmacies, and patients are 70% reimbursed by the government. "Sales have taken off, and seven out of 12 EEC [European Economic Community] countries have accepted Maxepa as a drug" (11.LaBell F Europe, Japan open doors to medicinal food products.Food Processing. 1993; (April): 60-63Google Scholar, p 60). The white paper describing the nutraceutical initiative calls for research requirements that are open and flexible, indicating that:epidemiological data may frequently provide significant evidence in addition to clinical studies…the focus will be on preventive or therapeutic results, and not necessarily the often economically prohibitive task of identifying whether or not any specific product component is the active one in isolation. The overriding requirement for supporting data will be that they must be appropriate and sufficient for accurate and reliable health claims, and demonstrate an acceptable level of risk to public safety. Whenever nutraceuticals are substances that are routinely consumed by the public and generally recognized as safe, there can be little or no requirement for pre-clinical testing (1.The Nutraceutical Initiative: A Proposal for Economic and Regulatory Reform. The Foundation for Innovation in Medicine, Cranford, NJ1991Google Scholar, p 8). Examples of nutraceuticals and clinical research support cited in the nutraceutical white paper (1.The Nutraceutical Initiative: A Proposal for Economic and Regulatory Reform. The Foundation for Innovation in Medicine, Cranford, NJ1991Google Scholar) are: the use of beta carotene to prevent lung cancer (12.Greenberg ER Baron JA Beck JR Carotenoids and cancer prevention.in: Saurat Retinoids: New Trends in Research and Therapy. Karger, Basel, Switzerland1985: 360-370Google Scholar), niacin to prevent recurrent heart attacks (13.Canner PL Berge KG Wenger NK Stamler J Friedman L Prineas RJ Friedewald W Fifteen-year mortality in Coronary Drug Project patients: long-term benefit with niacin.J Am Coll Cardiol. 1986; 8: 1245-1255Google Scholar), pyridoxine to treat and prevent depression (14.3rd ed. Clinical and Physiological Applications of Vitamin B-6. Current Topics in Nutrition and Disease. Vol. 19. Alan Liss, New York, NY1987Google Scholar), niacin to prevent recurrent heart attacks (13.Canner PL Berge KG Wenger NK Stamler J Friedman L Prineas RJ Friedewald W Fifteen-year mortality in Coronary Drug Project patients: long-term benefit with niacin.J Am Coll Cardiol. 1986; 8: 1245-1255Google Scholar), pyridoxine to treat and prevent depression (14.3rd ed. Clinical and Physiological Applications of Vitamin B-6. Current Topics in Nutrition and Disease. Vol. 19. Alan Liss, New York, NY1987Google Scholar), vitamin A to treat measles (15.Hussey GD Klein M A randomized controlled trial of vitamin A in children with severe measles.N Engl J Med. 1990; 3: 160-164Google Scholar), magnesium to treat hypertension (16.Resnick LM Gupta RK Laragh JH Oral magnesium supplementation in essential hypertension.Clin Res. 1991; 39 (Abstract): 433AGoogle Scholar), garlic to reduce arteriosclerosis (17.Kritchevsky D Effect of garlic oil on experimental artherosclerosis in rabbits.Artery. 1975; 3: 319-323Google Scholar), fish oil for hypertension (18.Knapp HP FitzGerald GA The antihypertensive effects of fish oil: a controlled study.N Engl J Med. 1989; 3: 1037-1043Google Scholar), calcium for hypertension as well as osteoporosis (19.Belizan JM Villar J Gonzalez L Campodonico L Bergel E Calcium supplementation to prevent hypertensive disorders of pregnancy.N Engl J Med. 1991; 3: 1399-1405Google Scholar), [and] antioxidants to reduce damage from heart attacks (20.Greenberg S Fishman WH Co-enzyme Q10: a new drug for cardiovascular disease.J Clin Pharmacol. 1990; 30: 596-608Google Scholar) (references 12.Greenberg ER Baron JA Beck JR Carotenoids and cancer prevention.in: Saurat Retinoids: New Trends in Research and Therapy. Karger, Basel, Switzerland1985: 360-370Google Scholar, 13.Canner PL Berge KG Wenger NK Stamler J Friedman L Prineas RJ Friedewald W Fifteen-year mortality in Coronary Drug Project patients: long-term benefit with niacin.J Am Coll Cardiol. 1986; 8: 1245-1255Google Scholar, 14.3rd ed. Clinical and Physiological Applications of Vitamin B-6. Current Topics in Nutrition and Disease. Vol. 19. Alan Liss, New York, NY1987Google Scholar, 15.Hussey GD Klein M A randomized controlled trial of vitamin A in children with severe measles.N Engl J Med. 1990; 3: 160-164Google Scholar, 16.Resnick LM Gupta RK Laragh JH Oral magnesium supplementation in essential hypertension.Clin Res. 1991; 39 (Abstract): 433AGoogle Scholar, 17.Kritchevsky D Effect of garlic oil on experimental artherosclerosis in rabbits.Artery. 1975; 3: 319-323Google Scholar, 18.Knapp HP FitzGerald GA The antihypertensive effects of fish oil: a controlled study.N Engl J Med. 1989; 3: 1037-1043Google Scholar, 19.Belizan JM Villar J Gonzalez L Campodonico L Bergel E Calcium supplementation to prevent hypertensive disorders of pregnancy.N Engl J Med. 1991; 3: 1399-1405Google Scholar, 20.Greenberg S Fishman WH Co-enzyme Q10: a new drug for cardiovascular disease.J Clin Pharmacol. 1990; 30: 596-608Google Scholar were cited in reference 1.The Nutraceutical Initiative: A Proposal for Economic and Regulatory Reform. The Foundation for Innovation in Medicine, Cranford, NJ1991Google Scholar). The references cited as evidence for these examples suggest that claims could be approved based on single scientific papers, review articles, or even an abstract. DeFelice has further indicated that:…the products must be effective, or probably effective, as demonstrated by published clinical trials. Clinical studies must be published in respected clinical journals. But they do not necessarily have to demonstrate definitive clinical activity, such as the effect of vitamin C in patients with scurvy. Strongly suggestive data are sufficient as we have seen with a psyllium-based cereal that lowers blood lipids and a mineral such as magnesium, which inhibits platelet aggregation and reduces insulin resistance in certain diabetics (21.DeFelice SL Nutraceuticals—opportunities in an emerging market.Scrip Magazine. 1992; (September): 14-15Google Scholar). Although most scientific, professional, or consumer organizations have not expressed a position on nutraceuticals, Bruce Silverglade, legal director of the Center for Science in the Public Interest, expressed concern about reducing the requirements for health claims: "With weaker scientific proof necessary to make health claims for nutraceuticals, you may end up with so many claims that consumers won't be able to make heads or tails of them" (22.Debrovner D Edible remedies.Am Druggist. 1992; : 36-40Google Scholar, p 40). In comments on FDA labeling regulations, ADA has supported FDA's proposal to require regulations for supplements to be as similar as possible to labeling regulations for food products. Independently, and as a member of the Food and Nutrition Labeling Group, ADA has written to senators and congressmen against passage of the Hatch/Richardson bill, on the grounds that it would provide consumers with less protection against unsafe dietary supplements and misleading labeling claims than is provided with the Nutrition Labeling and Education Act of 1990. The Nutraceutical Research and Development Bill proposed by the Foundation For Innovation in Medicine, which would weaken the scientific criteria for making health claims, conflicts with ADA's continued support of FDA regulation of consumer health claims (in accordance with the Nutrition Labeling and Education Act). Nutrition research has generally followed an open, academic process, free of proprietary claims. Exclusivity of health claims on products based on proprietary research when other products commonly consumed may be equally associated with the claimed health benefits could lead to consumer confusion. For example, if health claims of reduced risk of cancer were allowed for β-carotene, consumers may be best served if such claims are allowed for all foods with substantial amounts of bioavailable β-carotene, not just for the products of a single producer who funded supportive research. FDA regulations require that health claims made to consumers are based on public information and are not brand specific. Before developing a position on exclusivity of health claims for foods based on proprietary research, the ADA may wish to further explore the existing laws and regulations related to the patent process and the use of proprietary research, in particular regarding foods, medical foods, food additives, and drugs. Open, academic research, including human testing of isolated food components (eg, vitamins, minerals, amino acids, fatty acids, sugars, dietary fibers, and many other food components), has been fundamental to the development of nutrition science. Federal regulations (through FDA) and funding should be encouraged to promote human research and clinical testing of the health benefits of foods and food components, consistent with good science, safety, and the Nutrition Labeling and Education Act of 1990. Although compounds in foods that must be concentrated to obtain physiologic effects should be regulated as drugs, foods and purified food constituents in amounts commonly consumed should not be classified as drugs simply because they are being tested for potential health effects or disease prevention. Research should not be discouraged by requiring investigative new drug procedures for substances in amounts available in the diet.