Public Health Nutrition: 2(1), 35–38 35 What is the research base for the use of dietary supplements? Malden C Nesheim* Cornell University, Ithaca, New York, USA Submitted 2 August 1998: Accepted 15 October 1998 Abstract The market for dietary supplements in the USA was estimated as about 11.8 billion dollars in 1997 with a growth rate of 10–14 % projected in the next 3 years. Data from the Food and Drug Administration collected in 1995 indicate that over 55 % of adults surveyed used some type of dietary supplement. The marketing of dietary supplements in the USA has been essentially deregulated by the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA). This legislation defined dietary supplements, made manufacturers responsible for the safety of supplements and allowed certain statements of nutrition support to be made on supplement labels. The US Congress in passing the DSHEA indicated that supplements should be available on the market so that consumers could make decisions about their use for themselves and their families. Unfortunately, information about the research base for supplement claims is not readily accessible to health professionals and consumers. There is a need for authoritative reviews of the data underlying supplement claims to assist public health professionals in their role of providing advice to the public about dietary supplements. Keywords Dietary supplements Legislation Health claims Nutrition support claims Dietary supplements have become the hottest item in the nutrition-related marketplace. According to indus- try data 1 , the market for dietary supplements in the USA in 1997 was valued at 11.8 billion dollars, and has grown 12–16% in the past 3 years. Industry projections indicate an expected sales growth of 10–14% in the next 3 years 1 . Vitamins and minerals made up the major part of the market, with 51% of the sales, but sales of herbal products/botanicals amounted to 33% of the market in 1997 and represent the fastest growing segment 1 . Data collected by the Food and Drug Administration (FDA) in 1995 indicated that 55% of the adults surveyed used some type of dietary supplement 2 . Given the growth of the market, the FDA survey probably underestimates the number of users today. Though there are many contributing factors to the growth of the market, the marketing of supplements has been greatly facilitated by the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA) 3 . This legislation has had a major impact on the supplement industry because it has delineated the role of the FDA in regulating these products and has essentially deregu- lated the industry. Dietary supplements are defined in the DSHEA 3 as a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: (a) a vitamin; (b) a mineral; (c) a herb or other botanical; (d) an amino acid; (e) a dietary supplement used by man to supplement the diet by increasing the total dietary intake; or (f) a concentrate, metabolite, constituent, extract or combination of any ingredient described in (a–e). The law provides that a dietary supplement is a product that is labelled as a dietary supplement and is not represented for use as a conventional food or as a sole item of a meal or the diet. These products can be ingested as a capsule, powder, gelcap, tablet, liquid or other form. The DSHEA specifically excludes dietary supplements from regulation as food additives. As one can see, this definition is highly inclusive and contains many components nutritionists would not normally consider to have nutritional functions. The DSHEA makes manufacturers responsible for the safety of products marketed. There is no pre-marketing safety determination by the FDA and the burden of proof is on the FDA to show that a product is not safe. There is provision in the law that the Secretary of the HHS can declare a product an imminent hazard and remove it from sale. DSHEA allows manufacturers to make certain nutrition support statements on labels also without FDA approval. As specified in the legislation, these claims may be made if ‘the statement claims a benefit related to a classical nutrient deficiency disease and discloses the pre- valence of such disease in the United States, describes the role of a nutrient or dietary ingredient intended to affect the structure or function in q 1999 Nutrition Society *Corresponding author : Email MCN@Cornell.edu Downloaded from https://www.cambridge.org/core. 11 Dec 2021 at 16:24:12, subject to the Cambridge Core terms of use.