User:BD2412/Vaccine law resources/FDA Regulation

The regulation of vaccines by the U.S. Food and Drug Administration is a process governed by various statutes enacted by the United States Congress and interpreted by the U.S. Food and Drug Administration ("FDA").

A drug may be deemed unapproved under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355. Furthermore, this product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. § 352. The introduction or delivery for introduction of this product into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d), and misbranding of a product while it is held for sale after shipment of the drug or one or more of its components in interstate commerce is prohibited under section 301(k) of the FD&C Act, 21 U.S.C. § 331(k).

A vaccine may be deemed an unlicensed biological product under section 351 of the Public Health Service Act (PHS Act), 42 U.S.C. § 262. In order to lawfully market a drug that is also a biological product, a valid biologics license application (BLA) must be in effect under the PHS Act. 42 U.S.C. § 262(a). Such licenses are issued only after a demonstration that the product is safe, pure, and potent. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an investigational new drug (IND) application in effect as specified by FDA regulations. 21 U.S.C. § 355(i); 42 U.S.C. § 262(a)(3); 21 C.F.R. Part 312.

It is unlawful under the Federal Trade Commission Act of 1914, 15 U.S.C. 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless the seller possesses competent and reliable scientific evidence, generally including well-controlled human clinical studies, substantiating that the claims are true at the time they are made.

FDA page on Vaccines