Guidance Draft FAQs

There’s a part in the guidance that says a “drug” is any product that can “affect the structure or any function of the body of man”? Since dietary supplements make “structure/function” claims, doesn’t this mean they’re now considered drugs?

No. The part of the guidance quoted here is from the Food Drug and Cosmetic Act (FDCA) and contains a key phrase: “other than food.” DSHEA amended the FDCA to ensure that dietary supplements are regulated as foods, not drugs.