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CFSAN/Office of Nutritional Products, Labeling and Dietary Supplements
November 4, 2004
FDA's strategy for dietary supplements outlines the steps the agency plans to take to continue implementing and enforcing the Dietary Supplement Health and Education Act of 1994 (DSHEA). The strategy sets forth a series of research and measures, including guidance, regulations, and science-based compliance and enforcement mechanisms.
The strategy focuses on three areas:
With this strategy, FDA hopes to improve the transparency, predictability, and consistency of the agency's scientific evaluations of dietary supplement product and ingredient safety. The actions outlined in the strategy are also designed to protect consumers against unsafe dietary supplements and dietary supplements making unauthorized, false, or misleading claims. FDA expects that this improved transparency will help engage stakeholders in the development of further measures to implement DSHEA.
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:
FDA is also taking five steps to help ensure that dietary supplements do not pose a significant or unreasonable risk to consumers:
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.
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:
November 4, 2004: FDA Announces Major Initiatives for Dietary Supplements