Why doesn’t the FDA stop unsafe supplements from reaching the market?
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 the FDA to "approve" dietary supplements for safety or effectiveness before they reach the consumer. Once a product is marketed, the 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). The 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 the FDA deals with dietary supplements, see their website section on Dietary Supplements.