FDA Announces New Dietary Supplement Regulatory Enforcement Strategy

Date: Nov 12, 2004

On November 9, 2004, the Food and Drug Administration (FDA) officially announced a new "strategy for dietary supplements" under which it will continue implementing and enforcing the Dietary Supplement Health and Education Act of 1994 (DSHEA). This strategy has three prime components: (1) monitoring and evaluating product and ingredient safety; (2) assuring product quality; and (3) monitoring and evaluating product labeling. These areas are addressed in turn below. This initiative is the largest and most ambitious public announcement yet of Agency priorities concerning dietary supplements. It continues a trend of increasing FDA enforcement activity in the supplement area, which was particularly prominent earlier in 2004 with FDA's action to prohibit ephedrine alkaloids in dietary supplements and Warning Letters sent to marketers of products containing androstenedione.

The dietary supplements strategy document, which can be found at http://www.cfsan.fda.gov/~dms/ds3strat.html, notes that FDA intends to focus its efforts on products marketed for weight loss. In fact, this focus appears to have started even before the announcement of the new strategy. In mid-August 2004, FDA sent a Warning Letter to a marketer of weight-loss products asserting that the claims being made for it were not adequately substantiated. In late October 2004, FDA sent virtually identical letters to nine other companies marketing dietary supplements promoted to help consumers lose weight. In each case, FDA asserted that the weight loss claims were not adequately substantiated.

As part of the new strategy, FDA also released a Draft Guidance for Industry on the scientific data necessary to substantiate "structure/function claims" (among certain others) made for dietary supplements. The substantiation guidance document is discussed in more detail in the article available here.

A. Monitoring/Evaluating Ingredient/Product Safety

FDA plans to be more vigorous in monitoring the safety of dietary ingredients and dietary supplements, working closely with a number of partners. The process will begin with "signal detection," or identifying an issue of concern. Signals of a possible safety concern may come from a range of sources, including (1) Federal, State, and local counterparts; (2) adverse event reports; (3) foreign regulatory actions; (4) media reports; (5) information from consumer groups; and (6) consultation with experts. The Agency will determine when the quality or quantity of these signals raises a reasonable concern that health problems may result from ingestion of a dietary ingredient or dietary supplement. FDA may then seek an independent expert third party review and evaluation of the risks and benefits of the ingredient or supplement.

Supplements containing "new dietary ingredients" (NDIs) will be the subject of additional attention from FDA. The Agency plans to bring enforcement action against marketed dietary supplements containing NDIs for which (1) the required "new dietary ingredient notification" (NDIN) has not been submitted or (2) there is insufficient information to establish that the ingredient will reasonably be expected to be safe under its labeled conditions of use. There are a number of unresolved issues associated with determining whether a substance a substance qualifies as a NDI, and FDA has provided relatively little guidance in this area. In an effort to improve the industry's understanding of FDA's interpretation of the requirements, the Agency is holding a public meeting on NDI issues on November 15, 2004.

B. Assuring Product Quality

FDA's primary vehicle for assuring product quality is through the development of current good manufacturing practice (cGMP) regulations. A proposed rule detailing the cGMP expectations was published on March 13, 2003 (68 Fed. Reg. 12158).

The industry-wide standards would specify requirements for personnel, design and construction of physical plants, equipment and utensils, quality control protocols, recordkeeping, holding and distribution, and handling consumer complaints. The rule seeks to address issues associated with the manufacturing, packaging, and holding of dietary ingredients and dietary supplements, such as subpotency, superpotency, contamination with filth, bacteria, microbial organisms or drug ingredients, variation in tablet size or color, mis-filled containers, mislabeling, and use of improper packaging. The proposal is based in part on dietary supplement cGMP standards developed by various industry groups and trade associations. Although FDA found that these proposals were a useful starting point, the Agency did not believe that any of them were sufficient without additional modification.

FDA now anticipates publishing a final regulation in "early" 2005. Once the final rule is in place, FDA intends to develop an outreach and implementation program to educate the industry and other affected parties about the requirements. This program will also include inspection and enforcement mechanisms to ensure that dietary supplement manufacturers comply with the cGMP final rule.

C. Monitoring/Evaluating Product Labeling

FDA specifically outlines a number of steps it plans to take with respect to claims made in the labeling of dietary supplements. The Agency reports that it will continue to identify and take action against claims that are not supported by scientific evidence. The Draft Guidance for Industry (discussed above) on data to support structure/function claims is a second step. FDA intends to take enforcement action against products that pose the greatest risk to consumers whose labeling fails to reveal material facts (such as known drug interactions, adverse effects, contraindications, or other information necessary for consumers to safely use the product or understand its labeling). FDA plans to collect and analyze samples of marketed products to verify that the contents are consistent with the labeling. Finally, FDA intends to review the "Supplement Facts" box on product labels to determine whether the substances listed as dietary ingredients can be lawfully marketed in dietary supplements.


Overall, the new "strategy for dietary supplements" and the Draft Guidance for Industry on claims substantiation represent much higher-visibility regulatory policies with respect to dietary supplements. Product manufacturers can expect FDA to increase its scrutiny of claims made for dietary supplements and to be more aggressive in pursuing enforcement action against products that do not meet the current standards.

For further information about FDA's new strategy for the regulation of dietary supplements, please contact Frederick A. Stearns at 202-434-4288 or via e-mail at stearns@khlaw.com.