'Gray marketing' supplements

Navigating the benefits and blind spots of U.S. supplementation regulation

In theory, dietary supplements in the U.S. are regulated – but not with the same scrutiny we expect for drugs or food additives. The regulatory system, shaped by the 1994 Dietary Supplement Health Education Act (DSHEA), permits supplements to be sold without FDA approval so long as they avoid claims to treat or cure disease. Because products can be sold without pre-approval or rigorous testing, supplementation is widely accessible but may come with little to no proof of safety or efficacy (Wallace & Koturbach, 2024).

The FDA’s role in supplement regulation is mainly reactive, intervening when adverse events occur or labeling and claims laws are violated. In contrast, research institutions such as the Office of Dietary Supplements (ODS) and the National Center for Complementary and Integrative Health (NCCIH) take a more proactive, research-oriented approach to strengthen the scientific foundation for supplement use. ODS has invested in public supplement ingredient and labeling databases…