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FDA Announces Initiatives for Regulating Dietary Supplements

Austin, TX (November 9, 2004)

The Food and Drug Administration (FDA) has issued new initiatives to more fully enforce the provisions of the Dietary Supplement Health and Education Act of 1994 (DSHEA). The new policy was posted on the FDA website along with a news release on Thursday November 4 2004.

The initiatives cover new enforcement strategies dealing with safety, a public meeting on new dietary ingredients, the forthcoming publication of good manufacturing practices (GMPs) for the dietary supplement industry, and the FDA’s intention to produce draft guidelines for what “constitutes adequate scientific substantiation for structure/function claims.”  The text of the release can be found on the FDA website, FDA Announces Major Initiatives for Dietary Supplements, as is the full text of the policy, “Implementation and Enforcement Strategy Document.” To see the FDA guidance document on enforcement of structure-function claims for dietary supplements, see "Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act (Draft Guidance)."

Mark Blumenthal. ABC Founder and Executive Director, said, “The FDA announcement is basically good news. It is a sign that the agency appears to want to ensure that it fully enforces the terms of the DSHEA. This is a sign that FDA’s future enforcement of the safety and claims regulations for dietary supplements will be more consistent and scientifically based.”

He added, “The timing of this FDA initiative is noteworthy, coming just a few weeks after the tenth anniversary of the passage of DSHEA. The FDA announcement is compelling evidence that the agency has not fully enforced the provision of DSHEA over the past ten years but that it intends to do so in the near future.”

The announcement includes information that FDA will hold a public meeting on new dietary ingredients (NDIs) on November 15, 2004. This is a result, in large part, of two major articles on this important issue that appeared in the past few months. The first, by Michael McGuffin and Anthony Young of the American Herbal Products Association, was published in the Food and Drug Law Journal (vol 59, no. 1) and the second, by Chris and Patrick Noonan, was published in HerbalGram 63, New Dietary Ingredients: DSHEA Provides Protection from Potentially Unsafe New Ingredients with no Prior Market History in the U.S.

Both NDI articles note that there is a need for more clarification by FDA on the important issue of NDI 75-day notifications, and that industry needs more formal guidance from the agency about this significant but poorly understood provision of DSHEA. Part of the FDA announcement deals with ensuring product quality. Blumenthal noted that a critical aspect of the announcement is the forthcoming publication of final GMPs for dietary supplements, which industry and the public have wanted for a long time.

An important part of the new initiative deals with claims substantiation whereby FDA intends to publish draft guidelines for documentation of structure/function claims for supplements. In addition, FDA stated that it “plans to identify and take enforcement action against products whose labeling fails to reveal material facts, targeting those products that pose the greatest risks to consumers.”

“This provision relates to the need for manufacturers to disclose risks that some products may pose to people with certain medical conditions or who are taking conventional medications,” said Blumenthal. He explained that ABC had initiated its Safety Assessment Program in 2002, a peer-reviewed evaluation of many of the most popular herbs in the market. He added, “ABC’s Safety Assessment Program is designed to assist manufacturers in providing consumers reliable information and guidance on how to use herbal supplements in a safe and responsible manner.” The ABC safety information is currently available on labels of the Nature’s Resource line from the Pharmavite, LLC, ABC’s partner in starting the safety program.

Founded in 1988, the American Botanical Council is the nation's leading nonprofit organization providing research and education regarding herbs and medicinal plants. ABC occupies an historic 2.5 acre site in Austin, Texas where it publishes HerbalGram, a peer-reviewed journal on herbal medicine, books for health professionals, and other educational materials.

Information contact: ABC at PO Box 144345, Austin, TX 78714-4345, ph: 512-926-4900, fax: 512-926-2345. Website: