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Question

Why doesn’t FDA stop unsafe supplements from reaching the market?

    OPSS' Answer

    By law, dietary supplement manufacturers are responsible for ensuring that their dietary supplement products are safe before they are marketed. Unlike drug products, there are no provisions in the law for FDA to "approve" dietary supplements for safety or effectiveness before they reach the consumer. Once a product is marketed, FDA must show that a dietary supplement is "unsafe" before it can take action to restrict a product's use or remove it from the marketplace. Evidence comes largely from reports of adverse events submitted by healthcare providers consumers, and manufacturers (who must report any serious adverse event). FDA also monitors the marketplace for potentially illegal products (that is, products that may be unsafe or make false or misleading claims) through inspections, complaints, and again, reports of adverse events. For extensive information about how FDA deals with dietary supplements, see their website section on Dietary Supplements.

    Last reviewed 17 April 2014

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