REGULATION OF DIETARY SUPPLEMENTS

To advocate that Congress grant authority to the Food and Drug Administration (FDA) to (1) require that dietary supplements undergo FDA approval for evidence of safety and efficacy; (2) mandate FDA-approved dietary supplement labeling that includes disclosure of excipients; (3) mandate FDA-approved patient information materials that describe safe use in a clear, standardized format, including the potential for interaction with medications and cautions for special populations; and (4) establish and maintain an adverse-event reporting system specifically for dietary supplements, and require dietary supplement manufacturers to report suspected adverse reactions to the FDA; further,

To oppose direct-to-consumer advertising of dietary supplements unless the following criteria are met: (1) federal laws are amended to include all the requirements described above to ensure that dietary supplements are safe and effective; (2) evidence-based information regarding safety and efficacy is provided in a format that allows for informed decision-making by the consumer; (3) the advertising includes a recommendation to consult with a health care professional before initiating use; (4) any known warnings or precautions regarding dietary supplement–medication interactions or dietary supplement–disease interactions are provided as part of the advertising; and (5) the advertising is educational in nature and includes pharmacists as a source of information.

(Note: Dietary supplement as used in this policy is defined by the Dietary Supplement Health and Education Act of 1994, as amended; 21 U.S.C. 321.)

Rationale

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), manufacturers are prohibited from marketing adulterated or misbranded products, and the Food and Drug Administration (FDA) has authority to take action if adulterated or misbranded dietary supplements reach the market. To ensure a safe market for dietary supplements, the FDA needs the authority to require manufacturers to conduct safety and efficacy testing for dietary supplements, provide labeling and information about the content of the product and its safe use, and report suspected adverse reactions to FDA.

In 2007, the FDA announced final regulations requiring current Good Manufacturing Practices (GMPs) for dietary supplements that include testing ingredients and the final product. While the FDA does require all manufacturers to adhere to GMPs, not all supplement manufacturers are GMP certified.

Under the current regulatory and legislative regime, direct-to-consumer advertising of dietary supplements should not occur unless specified criteria are met. Dietary supplement advertising should be strictly regulated by the FDA and the Federal Trade Commission (FTC) to ensure it is truthful and substantiated. The FDA and FTC have published guidance for industry concerning dietary supplement claims. The FDA is primarily responsible for claims on product labeling, while FTC has primary responsibility for claims in advertising, including print and broadcast ads, infomercials, catalogs, and similar direct marketing materials.