How are dietary supplements primarily regulated by the FDA?

Dietary supplements are regulated by the FDA primarily in a manner similar to food, which means they are subject to less stringent pre-market standards compared to prescription drugs. Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, manufacturers of dietary supplements are responsible for ensuring the safety of their products before they are marketed, but they do not need to obtain FDA approval prior to selling them. This is in contrast to prescription medications, which must undergo rigorous clinical testing and receive FDA approval based on their safety and efficacy.

While the FDA does monitor dietary supplements post-market and has the authority to take action against those that are found to be unsafe or misleadingly labeled, the primary regulatory framework allows for a more lenient approach, akin to food products. This means that dietary supplements can be marketed without prior approval, provided that they are labeled as such and do not make false claims.

This regulatory structure distinguishes dietary supplements from controlled substances or pharmaceuticals, which face more stringent controls and testing requirements due to their potential risks and therapeutic claims.