Dietary Supplements: Legislative and Regulatory Status

Publication Date: July 2002

Publisher: Library of Congress. Congressional Research Service

Author(s):

Research Area: Health

Type:

Abstract:

Congress enacted the Dietary Supplement Health and Education Act (DSHEA) of 1994. DSHEA addressed supplement definitions, safety, ingredient and nutrition labeling, supplement claims, good manufacturing practices, statements of nutritional support, new dietary ingredients, created a supplement commission, and established an Office of Dietary Supplements at the National Institutes of Health.

Since DSHEA’s passage, which changed the safety standard and placed the burden of proof for supplement safety on the agency, FDA has issued alerts on several supplements to warn consumers of possible safety problems. The agency has received hundreds of adverse reports allegedly caused by the use of ephedrine alkaloids, although no final action has been taken on regulating this product. The Inspector General has issued a report that evaluates and makes recommendations on the effectiveness of the supplement adverse event reporting system.

In January 2000, FDA issued a 10-year strategic plan for regulation of dietary supplements, which was a list of issues that the agency plans to address: safety, labeling, boundaries among product categories, enforcement, science-based decisionmaking, and stakeholder outreach. In December 2000, FDA announced it had contracted with the National Academy of Sciences to study and provide a protocol for the agency to use in reviewing supplement safety, as part of the 10-year plan. In May 2002, FDA submitted to Congress a report on the cost of implementing the strategic plan.

FDA’s regulation of supplements has been affected by Pearson v. Shalala, a lawsuit filed by supplement manufacturers who challenged FDA’s general health claims regulation of supplements and decision not to authorize four specific health claims. The U.S. Court of Appeals held that the First Amendment does not permit the agency to reject health claims that it determines to be potentially misleading, unless FDA also reasonably determines that no disclaimer would eliminate the potential deception. The court directed the agency to reconsider the four claims, and FDA has since allowed two claims with qualifiers.

The Federal Trade Commission (FTC) issued an advertising guide for the supplement industry in 1998. FTC addressed such issues as identifying claims and interpreting their meaning, claim substantiation and related issues, to ensure its enforcement efforts are as consistent as possible with the provisions of DSHEA and its enabling laws.

On an international level, the U.N.’s Codex Alimentarius has initiated an effort to provide standards and guidelines for vitamin and mineral products, which could serve as a blueprint for countries wishing to adopt standards into their own laws. The European Commission has proposed a directive for these same products which, if adopted by its member countries, would affect supplements sold in those nations.

Numerous bills addressing dietary supplement regulation have been introduced in the 107th Congress, although no further action has yet been taken on them.