Which factor significantly differentiates the supplement industry from pharmaceuticals regarding regulation?

The supplement industry is significantly differentiated from pharmaceuticals primarily in that manufacturers of supplements do not need to prove safety or efficacy before marketing their products. This regulatory framework stems from the Dietary Supplement Health and Education Act (DSHEA) of 1994. Under this law, dietary supplements are treated more like food products than drugs, meaning that the burden of proving safety and efficacy falls on the FDA only after an adverse event occurs, rather than before a product is marketed. This allows supplements to be introduced into the market without rigorous pre-market testing for safety or efficacy, which is a fundamental requirement for pharmaceuticals.

Conversely, pharmaceuticals must undergo a comprehensive process that includes clinical trials to demonstrate their safety and effectiveness before they can receive FDA approval for marketing. This contrasting approach highlights a significant regulatory distinction between these two industries, emphasizing the relative ease with which dietary supplements can enter the marketplace.