Which act addressed the requirements for dietary supplements to be more food-like than drugs?

The Dietary Supplement Health and Education Act (DSHEA) is the pivotal legislation that clarified the regulatory framework for dietary supplements, distinguishing them from conventional foods and drugs. Enacted in 1994, this act established that dietary supplements are to be treated more like food products than pharmaceuticals. Under DSHEA, dietary supplements do not require pre-market approval from the FDA, which is a requirement for pharmaceuticals, but they must be safe for consumption and properly labeled.

The act defines dietary supplements as products that contain a dietary ingredient (such as vitamins, minerals, herbs, amino acids) and emphasizes their role in supplementing the diet. This legislation also allows for certain health claims to be made on labels, provided they are truthful and not misleading. By classifying dietary supplements in this manner, DSHEA allows for greater flexibility in marketing and consumer access compared to drug products, supporting the notion that these products should be more food-like.

Other acts mentioned, such as the Kefauver-Harris Amendment and the Durham-Humphrey Amendment, pertain to the regulation of prescription and over-the-counter drugs, while the Orphan Drug Act focuses on drugs for rare diseases. These acts do not specifically address the classification of dietary supplements in relation to food and