Which statement about FDA regulation of dietary supplements is true?

• A. They are regulated under FDCA with adulteration/misbranding laws, not premarket approval.
• B. They require FDA drug approval before marketing.
• C. They must prove efficacy to marketing.
• D. They have no labeling requirements.

Answer: (A)

Dietary supplements are treated as foods under the FDA’s Federal Food, Drug, and Cosmetic Act, with regulation centered on adulteration and misbranding rather than premarket drug approval. They don’t need FDA’s drug approval before they’re marketed, which means no premarket showing of safety or efficacy is required like it is for drugs. Instead, manufacturers must ensure proper labeling and that products aren’t misleading or unsafe; after marketing, FDA can take action if a supplement is adulterated or misbranded. Under DSHEA, a new dietary ingredient may require a safety notification to FDA before marketing, but even then this is about safety review, not drug-style approval. Claims on the label must be limited to structure/function statements (with a disclaimer that FDA has not evaluated the claim) and cannot assert that the product diagnoses, cures, treats, or prevents disease without going through drug approval. With these points in mind, the statement that they are regulated under the FDCA with adulteration/misbranding laws, and not subject to premarket drug approval, is the true description.