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Recommendation: The FDA MedWatch toll-free telephone number should be provided on product labels to facilitate reporting of adverse events by consumers and health care professionals.

Premarket Notification of New Dietary Ingredients

Finding: DSHEA requires that a manufacturer or distributor of a new dietary ingredient notify FDA of its intention to market the ingredient at least 75 days before introducing it into interstate commerce. There appears to be ambiguity regarding the nature and amount of information that must be submitted to FDA for their review in the 75-day period.

Recommendation: To initiate the 75-day premarketing review period, both the distributor and the manufacturer should be required to provide FDA with all available data in their possession, both favorable and unfavorable, regarding safety of the product.

New Formulations and Processes

Finding: Under DSHEA, manufacturers and distributors of dietary supplements are required to provide FDA with information establishing the safety of their product only if it contains new dietary ingredients not marketed before October 1994. Dietary supplement ingredients marketed before 1994 are not subject to this requirement. Yet many dietary supplement ingredients on the market today, though not “new dietary ingredients,” are produced in a variety of ways. They have different formulations and are produced through very different processes than related dietary supplement ingredients in traditional products, or even other dietary supplement ingredients bearing the same name. Alterations in formulations and processing of substances that have a history of use as dietary supplements may result in markedly different bioactive substances of potential harm.

Recommendation: When the formulation or processing of a dietary supplement ingredient is changed, it should be considered a new dietary ingredient and subject to regulatory oversight as such.

FDA Proposed Good Manufacturing Practice Guidelines

Finding: While the focus of this report is on developing a framework to evaluate the safety of dietary supplement ingredients per se, and not on safety issues related to good manufacturing practice, these are inseparable because variability in content hampers the evaluation of safety. FDA recently proposed current good manufacturing practices (cGMPs), regulations that may be in place by the time this report is released, but the proposed regulations will not establish uniformity across different manufacturers of the same dietary supplement ingredients. The label verification program (USP, 2004) has been a step in the right direction, but this is a



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