Which act regulates nutritional supplements and vitamins?

• A. Orphan Drug Act 1983
• B. Biologics Control Act 1902
• C. Dietary Supplement Health and Education Act 1994
• D. Pure Food and Drug Act 1906

Answer: (C)

Nutritional supplements and vitamins are regulated by the Dietary Supplement Health and Education Act of 1994. This law created a distinct category for dietary supplements, treated as a type of food rather than a drug. It sets labeling rules and allows structure/function claims with a disclaimer, while prohibiting disease treatment claims. Manufacturers must ensure safety and truthful labeling; FDA can take action against supplements that are adulterated, misbranded, or unsafe after they're on the market. Unlike drugs, these products do not require FDA premarket approval before sale, though new dietary ingredients introduced after the act's passage typically require FDA notification with safety information. The other acts regulate drugs or biologics or predate the dietary supplement framework, so they do not specifically regulate vitamins and supplements in the same way.