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dietary supplement ingredients sold in the United States based on safety issues, (2) describe a process for developing a system of scientific reviews, (3) utilize the proposed framework to develop at least six scientific reviews or monographs as prototypes, and (4) revise the framework based on comments received.

The final Framework described in this report is the result of the committee’s deliberations over the last 30 months and comments received on the proposed framework issued in July 2002. This Framework includes guidance on considering the various categories of data, taking into consideration methods other expert bodies have used to categorize and review supplement safety issues.

REGULATORY BACKGROUND

Current regulatory approaches to the safety evaluation of dietary supplements in the United States are a product of several key pieces of legislation that span the twentieth century, culminating in the passage of DSHEA in 1994. Since the passage of the 1938 Federal Food, Drug, and Cosmetic Act (FDCA), FDA has wrestled with the most appropriate approach to regulating dietary supplements and several attempts have been met with resistance by industry as well as by segments of the public.

In 1958, the Food Additives Amendment to the FDCA defined food additives and provided that they must undergo a premarket approval process unless they were considered to be generally recognized as safe (GRAS) (Table ES-1). FDA subsequently attempted to regulate the botanical industry by alleging that individual botanical products were unapproved food additives; this approach was subsequently struck down by the courts, recognizing that the applicability of the provisions of the FDCA to products containing a vitamin, mineral, or botanical ingredient (whether it was considered a drug or a food, for example) depended on the product’s intended use, as determined usually by the labeling and advertising claims for the product.

Congress acted further to delineate FDA’s authority by passing DSHEA in 1994. DSHEA established the first comprehensive definition of dietary supplements as legally equivalent to foods (Box ES-1). Most importantly, DSHEA established a regulatory framework for dietary supplements that defined FDA’s authority over these products. FDA bears the burden of proof in determining that a dietary supplement ingredient presents a “significant or unreasonable risk of illness or injury” (see Box ES-2) rather than being authorized by statute to require the manufacturer to provide data supporting its safety, as is authorized for substances added to foods1 or for drugs.

1  

Food ingredients not declared or listed as GRAS.



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