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The Dietary Supplement Health and Education Act of 1994
DSHEA gave the FDA authority to block the sale of any dietary supplement that was found to pose a significant or unreasonable risk of illness or injury when used as directed. In November 2004, the FDA announced three major regulatory initiatives aimed at further implementation of DSHEA.
Regulatory Strategy
The FDA plans to improve its decision making process about the safety of dietary by expanding the scientific evidentiary database it uses to make such decisions. The FDA will work closely with private groups and other federal agencies, such as the National Institutes of Health Office of Dietary Supplements and the National Center for Complementary and Alternative Medicine, to achieve this goal. If the FDA concludes that a dietary supplement is unsafe, it can remove the product from the market. The FDA can also issue public health advisories and require dietary supplement label changes.
Open Public Meeting
An open public meeting was held on November 15, 2004 to allow for public comments on the type of evidence manufacturers should provide the FDA regarding a new dietary ingredient. Dietary supplements do not need FDA approval prior to marketing. However, any dietary ingredient that was not marketed in the U.S. prior to October 15, 1994 requires pre-market notification to the FDA of its safety. The manufacturer must provide the FDA with evidence showing that the dietary ingredient is safe before the product can be sold.
Guidance for Dietary Supplement Industry on Structure/Function Claims
The FDA plans to provide written guidance to dietary supplement manufacturers as to the amount, type, and quality of evidence a manufacturer must have to substantiate a structure/function claim. Under DSHEA, a manufacturer is permitted to make nutritional support claims that describe a dietary supplement's effects on the structure or function of the body. For example, a manufacturer can claim that its product promotes or maintains a healthy circulatory system. The FDA's goal is to give manufacturers a standard for what constituted adequate substantiation of safety.
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