FDA Proposes Manufacturing and Labeling Standards for all Dietary Supplements
March 7, 2003
The Food and Drug Administration (FDA) today took action to help Americans get accurately labeled and properly manufactured dietary supplements, through its "Proposed Rule for Dietary Supplement Current Good Manufacturing Practices" (CGMPs). FDA is submitting this proposed rule as part of the agency's ongoing effort to help Americans take more control over their own health.
FDA's Proposed Rule for Dietary Supplement Labeling and Manufacturing Standards
This proposed rule would establish the standards necessary to ensure that dietary supplements and dietary ingredients are not adulterated with contaminants or impurities and are labeled to accurately reflect the active ingredients and other ingredients in the product.
Specifically this proposal would:
Science-Based Consumer Protection
Previously, dietary supplements have not been subject to mandatory standards for manufacturing or labeling. Congress gave FDA the authority to develop and implement CGMPs as part of the Dietary Supplement Health and Education Act of 1994 (DSHEA).
The proposed rule addresses the quality of manufacturing processes for dietary supplements, and the accurate listing of supplement ingredients. It does not limit consumers' access to dietary supplements, or address the safety of their ingredients, or their effects on health when proper manufacturing techniques are used. Rather, the proposed rule creates a level playing field for the industry by ensuring that every firm uses high-quality manufacturing procedures and uses the same rules for describing their ingredients.
In December, FDA issued a report on its new policies for taking legal action against dietary supplements that make misleading health claims. Last week, to address concerns about the safety of ephedra, FDA announced a proposed warning label, issued warning letters on certain ephedra marketing practices, and announced a public comment period regarding potential further restrictions on ephedra products.
Under DSHEA, dietary supplement manufacturers have an essential responsibility to substantiate the safety of the dietary ingredients they use in manufacturing a product. Manufacturers are also responsible for determining that any representations or claims made about their products are substantiated by adequate evidence to show that they are not false or misleading. With this proposed rule, FDA will have the authority to determine standards that firms should apply in production and labeling.
This article was provided by U.S. Food and Drug Administration. Visit the FDA's website to find out more about their activities and publications.