When consumers of the multi-billion dollar dietary supplements industry hear about violations exposed in FDA inspections, they may presume that supplements are regulated in a manner similar to pharmaceuticals, given that the FDA is tasked with regulating both. Control of dietary supplements, in fact, differs significantly from that of prescription and over-the-counter medications in ways consumers should understand.

While drug manufacturers are required to prove the safety and efficacy of a new drug before it may be sold in the U.S., current law does not require the safety of supplements to be proven before they are brought to market. In essence, the FDA regards new drugs as unsafe until they are proven otherwise (through clinical trials with human subjects), but regards new supplements as safe until they are proven otherwise (through reported adverse events and investigations).¹