Regulation of Herbal Dietary Supplements: Is There a Better Way?
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Regulation of Herbal Dietary Supplements: Is There a Better Way?
Drug Information Journal 46(5) 532-544 ª The Author(s) 2012 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0092861512452121 http://dij.sagepub.com
Annet Zakaryan, PhD, MS1*, and Irwin G. Martin, PhD1
Abstract This article outlines the importance of herbal dietary supplements regulation by providing a brief overview of history of supplement regulation in the US with emphasis placed on passage of the 1994 Dietary Supplement Health and Education Act (DSHEA) and post-DSHEA enforcement actions. This review also addresses international aspects of dietary supplement regulatory processes. The controversy surrounding the separation of structure/function claims from health claims is examined. Safety issues are summarized and the following proposals are offered to improve the herbal dietary supplements regulatory system. First, herbal dietary supplements should be subject to more strict regulation by the FDA, which means treating them more like pharmaceuticals and not like food. Only pre-market approval can guarantee consumer access to safe and effective product. Second, a suggested simplified procedure allows the registration of a traditional herbal dietary supplement. Third, due to the compositional diversity and complexity of botanical substances, every new submission of nontraditional herbal supplement must be processed on a case-by-case basis. Fourth, a mandatory post-marketing reporting system of all adverse events should be established rather than the current serious adverse event reporting scheme. And finally, legislative reform is needed to change the regulatory system of dietary supplements. Keywords dietary supplements, herbals, regulation, safety, law
Introduction In 1994 the US Congress enacted the Dietary Supplement Health and Education Act (DSHEA).1 The law created a new liberalized regulatory framework for the safety and labeling of dietary supplements and separated them from drugs and conventional foods. According to the DSHEA definition,1 a dietary supplement is ‘‘a product (other than tobacco) that is intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, a herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing total daily intake, or a concentrate, metabolite, constituent, extract or combination of these ingredients.’’ Dietary supplements come in a variety of forms such as tablets, capsules, liquids, soft gels, or powders.1 DSHEA places dietary supplements in a special intermediate product group ‘‘under the general umbrella of foods’’ rather than drugs and requires that every supplement be labeled as a dietary supplement so they are not confused with conventional food or food additives.2 Under the act’s classifications, all dietary supplements bypass the need to receive pre-market review and approval by FDA for use as food or food additives. Manufacturers of dietary supplements, unlike
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