Fact Sheet on
FDA's Strategy for Dietary Supplements

FDA will work collaboratively with Federal and other partners to develop the evidentiary base FDA uses to make safety and enforcement decisions. The process begins with "signal detection," or identifying an issue of concern. Signals of a possible safety concern can come from a variety of sources. When the quality or quantity of these signals indicates that there may be a public health problem, FDA may then seek input from a third party review. FDA intends to consider any independent report and other evidence as appropriate in addressing safety concerns about dietary supplements and their ingredients.

FDA's actions will be based upon the totality of evidence, including pharmacology of the substance, scientific literature, adverse event reports, and evidence based reviews. FDA has a variety of options for pursuing its public health mission, including making a determination of unreasonable risk, issuing health advisories, educating consumers, conducting research, and requiring labeling changes.

FDA is concerned that some dietary supplement manufacturers are marketing products that contain "new dietary ingredients" that require a premarket notification without first complying with that requirement. The manufacturer or distributor of a dietary supplement containing a "new dietary ingredient" must provide FDA with information that is the basis for the manufacturer's belief that the product is reasonably expected to be safe.

Strategy: The strategy includes monitoring those dietary supplements FDA believes contain a "new dietary ingredient." FDA is taking four steps to help ensure that dietary supplements that contain new dietary ingredients are not adulterated:

1. convene a public meeting to obtain comment on issues pertaining to new dietary ingredients, including what information should be included in new dietary ingredient notifications;
2. bring enforcement actions against marketed dietary supplements that contain new dietary ingredients for which a required notification has not been submitted; and
3. bring enforcement actions against marketed dietary supplements that contain a new dietary ingredient and are adulterated because there is no history of use or other evidence of safety establishing that the dietary ingredient will reasonably be expected to be safe when used under the conditions recommended or suggested in the labeling of the dietary supplement.

FDA is also taking five steps to help ensure that dietary supplements do not pose a significant or unreasonable risk to consumers:

1. improve the evidentiary base for safety and enforcement decision-making through collaboration with Federal and other partners
2. implement a transparent and systematic process for evaluating safety concerns about dietary ingredients and dietary supplements;
3. use the FDA website as an information resource for consumers and conduct other outreach efforts to give consumers access to reliable scientific information about the safety of specific dietary ingredients and dietary supplements;
4. educate consumers and health care providers on how to report to FDA adverse events or other product complaints; and
5. encourage manufacturers, marketers, and distributors of dietary supplements to report adverse events associated with use of their products.

DSHEA gives FDA the authority to develop regulations that will help ensure that dietary supplements (and dietary ingredients) are of high quality, do not contain contaminants or impurities, and are labeled to accurately reflect the ingredients in the product.

On March 13, 2003, FDA published a proposed rule on current good manufacturing practice (cGMP) for dietary supplements. This proposed rule would help prevent superpotent and subpotent products, wrong ingredients in dietary supplements, the presence of contaminants (e.g., bacteria, pesticide, glass, and lead), under-filled containers, foreign material in a dietary supplement container, improper packaging, and mislabeling.

Strategy - Publication of a dietary supplement cGMP final rule is one of the agency's highest priorities. FDA staff are currently reviewing and evaluating the more than 1,600 pages of comments on the proposed rule.

• Publish cGMP final rule early next year;
• Develop outreach plan for healthcare professionals and industry; and
• Enforce compliance with the cGMP final rule once it becomes effective.

Whether consumers are purchasing dietary supplements to improve their appearance, promote general health, or help them maintain a healthier lifestyle, consumers can fall victim to products with unsubstantiated claims that cheat them out of their money and steer them away from products that are proven to achieve the results they are seeking. Some products encourage consumers to self-treat for a serious disease without benefit of a medical diagnosis or treatment. Products sold as dietary supplements that bear a claim to treat, mitigate, or cure a disease are drugs and are subject to regulation as such.

Dietary supplements that bear unsubstantiated structure/function claims in their labeling can also defraud and harm consumers. For example, unsubstantiated claims for a dietary supplement may encourage consumers to substitute the supplement for a product or health promotion strategy whose benefit is backed up by scientifically accurate information.

Strategy: FDA is taking five actions to help ensure that dietary supplement labeling is truthful and non-misleading:

1. Continue to identify and take action against dietary supplements making claims that are not supported by scientific evidence.
2. Develop and publish a draft guidance addressing what constitutes adequate scientific substantiation for structure/function claims and claims of a benefit related to a nutrient deficiency disease. This draft guidance document is intended to describe the amount, type, and quality of evidence a manufacturer should have to substantiate claims of these types.
3. Identify and take enforcement action against products whose labeling fails to reveal material facts, targeting those products that pose the greatest risks to consumers.
4. Obtain and analyze samples of dietary supplements in the marketplace to verify that the contents are consistent with the labeling.
5. Review Supplement Facts panels on dietary supplement labels to determine whether the substances listed as dietary ingredients can be lawfully marketed in dietary supplements.