DSHEA

The Dietary Supplement Health and Education Act (DSHEA) of 1994 is the US federal law that defines the regulatory framework for dietary supplements. Under DSHEA, supplements are regulated as a category of food, not drugs, meaning they do not require pre-market FDA approval for safety or efficacy. Manufacturers are responsible for ensuring product safety and labeling accuracy. The FDA can only take action against unsafe products after they reach the market. DSHEA allows structure/function claims with proper disclaimers but prohibits disease claims. Critics argue DSHEA provides insufficient consumer protection, while proponents value consumer access to supplements.