Current Issues Regarding Complementary and Alternative Medicine (CAM) in the United States, Part 2

or other botanicals, amino acids or a “concentrate, metabolite, constituent, extract, or combinations of these ingredients.”8,12 The DSHEA eliminated the requirement that the FDA review efficacy and safety data for these products—providing that no claims are made to diagnose, treat, cure, or prevent disease.1 This legislation also eased marketing restrictions for dietary supplements.2,3 According to the DSHEA, the regulatory classification of a natural product as either a drug or a dietary supplement is determined primarily by the intended use stated in its labeling.2 Although the labeling of a supplement is not permitted to claim to treat a specific disease or condition, marketing statements that suggest an effect on the “structure or function of the body” are allowed.2,8 For example, a dietary supplement containing Echinacea can be promoted as supporting immune health (as a function) but not as preventing or curing colds (treatment of a condition).8 Similarly, the label for a glucosamine supplement can state that it improves joint function and mobility, but it cannot claim to relieve symptoms of osteo arthritis.2 Although such general claims are allowed by the DSHEA, there has been concern that they create confusion for consumers.8 Nonetheless, the FDA’s attempt to hold health claims for dietary supplements even to the same scientific standard required for conventional foods was rejected in Pearson v. Shalala.8 The ruling in this court case stated that the FDA must allow such “qualified” health claims in labeling even if they are based on equivocal scientific evidence.8 The FDA is therefore restricted from policing “truth-in-labeling” for dietary supplements, and manufacturers are permitted to use vague terms to suggest therapeutic effects for nonspecific health problems, which consumers tend to interpret inaccurately as efficacy.4,18 The DSHEA, however, does require that manufacturers submit a New Dietary Ingredient (NDI) application to the FDA for approval 75 days in advance of marketing a new product.10 Products that met the definition of a dietary supplement and that existed before October 15, 1994, were allowed to remain on the market without submission of an NDI.2 After the FDA receives an NDI, it reviews the proposed dietary supplement and its intended use and determines whether it is reasonably safe for marketing.2 Although the FDA reviews NDI applications for potential safety problems, under the DSHEA, manufacturers are not required to submit product efficacy or safety data with the NDI application.2,8 Therefore, there is no burden on dietary supplement manufacturers to prove that their products are effective or safe.13 Instead, the DSHEA places the burden on the FDA to prove that a dietary supplement product or ingredient The author is a Consultant Medical Writer living in New Jersey.