The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (m)(1), (4)(B), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§ 301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

Section was enacted as part of the Food and Drug Omnibus Reform Act of 2022, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Section is comprised of section 3401 of div. FF of Pub. L. 117–328. Subsec. (a)(2) of section 3401 of div. FF of Pub. L. 117–328 amended section 321 of this title. Subsecs. (c), (g)(1)–(4), (6), and (l) of such section 3401 amended section 350a of this title. Subsec. (k) of such section 3401 enacted section 350m of this title.

Pub. L. 117–328, div. FF, title III, § 3002, Dec. 29, 2022, 136 Stat. 5807, provided that: “In this title [see Short Title of 2022 Amendment note set out under section 301 of this title], except as otherwise specified, the term ‘Secretary’ means the Secretary of Health and Human Services.”