21 C.F.R. § 740.1
Establishment of warning statements
(a) The label of a cosmetic product shall bear a warning statement whenever necessary or appropriate to prevent a health hazard that may be associated with the product.
(b) The Commissioner of Food and Drugs, either on his own initiative or on behalf of any interested person who has submitted a petition, may publish a proposal to establish or amend, under subpart B of this part, a regulation prescribing a warning for a cosmetic. Any such petition shall include an adequate factual basis to support the petition, shall be in the form set forth in part 10 of this chapter, and will be published for comment if it contains reasonable grounds for the proposed regulation.
Notes of Decisions
Cited in 5
cases (3 in the last 5 years), 1976–2024 · leading case: Guido v. L'Oreal, USA, Inc., 284 F.R.D. 468 (C.D. Cal. 2012).
Guido v. L'Oreal, USA, Inc., 284 F.R.D. 468 (C.D. Cal. 2012). “needed for your hair type,” “do not rinse,” and “[f]or the sleekest look, style using brush and blowdryer” are deceptive to the average reasonable consumer in light of Serum’s alleged flammability; • Whether a reasonable consumer would expect that Serum would contain a warning…”
Consumers Union of United States, Inc. v. Dep't of Health, Educ. & Welfare, 409 F. Supp. 473 (D.D.C. 1976). “See 21 C.F.R. §§ 740.1 , 740.10 (1975). The mechanics of the review process were probed and certain weaknesses pointed out by FDA, such as potential conflicts of interest in the expert panel and lack of public involvement.”
Bojko v. Pierre Fabre USA Inc. (N.D. Ill. 2023). “And Defendant does not explain how Plaintiffs’ claim that the Products’ labels fail to warn consumers about the presence of benzene is different from or in addition to the requirement in 21 C.F.R. § 740.1 (a). 6 “Conflict preemption applies when there is an actual conflict…”
Jamie Potts v. Johnson & Johnson Consum. Inc. (D.N.J. 2021). “Plaintiffs also contend that JJCI failed to inform consumers of material information regarding the safety of the Products in violation of 21 C.F.R. § 740.1 , which requires a manufacturer to include in its product labels, “a warning statement whenever necessary or appropriate to…”
In RE: Hair Relaxer Mktg., Sales Practices, & Prods. Liab. Litig. (N.D. Ill. 2024). “[510 at 9] (discussing 21 C.F.R. § 740.1 (a), which requires cosmetic products “bear a warning statement whenever necessary or appropriate to prevent a health hazard that may be associated with the product”).”
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