CSPI On FDAs Dietary Supplement Initiative

Statement of CSPI Legal Affairs Director Bruce Silverglade

November 5, 2004

This cake took 10 years to bake and it still falls flat. The FDAs actions are a step in the right direction, but still leave the Agency in a reactionary mode. Consumers will remain unprotected from unsafe ingredients and unreliable claims.

Congress should require companies to obtain FDA authorization for all health-related claims before they are made. Under the system proposed by FDA, misleadingly labeled products could remain on store shelves for months or years before the Agency takes enforcement action. Moreover, the veracity of such claims will be judged by a weaker standard typically applied to advertising rather than the more stringent standard traditionally used to regulate labeling.

Additionally, Congress must require companies to report known serious adverse reactions from their products to the FDA so that the Agency can promptly protect consumers from hazardous ingredients. Ultimately Congress should require a systematic safety and efficacy review of all dietary supplement ingredients. Only then can consumers be assured that the supplements they take are safe and effective.


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