21 U.S.C. § 375
Publicity
The Secretary shall cause to be published from time to time reports summarizing all judgments, decrees, and court orders which have been rendered under this chapter, including the nature of the charge and the disposition thereof.
The Secretary may also cause to be disseminated information regarding food, drugs, devices, tobacco products, or cosmetics in situations involving, in the opinion of the Secretary, imminent danger to health or gross deception of the consumer. Nothing in this section shall be construed to prohibit the Secretary from collecting, reporting, and illustrating the results of the investigations of the Department.
2009—Subsec. (b). Pub. L. 111–31 inserted “tobacco products,” after “devices,”.
For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.
Notes of Decisions
Cited in 12
cases (1 in the last 5 years), 1961–2024 · leading case: Dimare Fresh, Inc. v. United States, 808 F.3d 1301 (Fed. Cir. 2015).
Dimare Fresh, Inc. v. United States, 808 F.3d 1301 (Fed. Cir. 2015). “In the present case, the public warnings issued by the FDA via the press releases and media briefing, although themselves not a regula *1310 tion, were based on a regulation promulgated pursuant to 21 U.S.C. § 375 (b), which allows the FDA to publicize information regarding…”
Seaside Farm, Inc. v. United States, 842 F.3d 853 (4th Cir. 2016). “A notice in the Federal Register emphasizes that “FDA’s implicit or explicit authority to disseminate information under [ 21 U.S.C. § 375 (b)] is not accompanied by any procedural requirements.”
Indus. Saf. Equip. Ass'n, Inc. v. Env't Prot. Agency, 837 F.2d 1115 (D.C. Cir. 1988). “§ 1412 , or the FDA’s warnings about poisonous foods, see 21 U.S.C. § 375 , the NIOSH and EPA powers would be crippled were these agencies not permitted to use the quick and cheap instrument of publicity.”
In-Possession, Cantrell Drug Co. v. United States (In re Cantrell Drug Co.), 585 B.R. 555 (Bankr. E.D. Ark. 2018). “Moreover, 21 U.S.C. § 375 provides that the Secretary may "cause to be disseminated information regarding .”
Ajay Nutrition Foods, Inc. v. Food & Drug Admin., 378 F. Supp. 210 (D.N.J. 1974). “To this effect 21 U.S.C. § 375 provides : (a) The Secretary shall cause to be published from time to time reports summarizing all judgments, decrees, and court orders which have been rendered under this chapter, including the nature of the charge and the disposition thereof.”
California Canners & Growers Ass'n v. United States, 7 Cl. Ct. 69 (Ct. Cl. 1984). “21 U.S.C. § 375 (b). It is of course appropriate to assume that the Government will be accurate in this publicity.”
Pharm. Mfrs. Ass'n v. Kennedy, 471 F. Supp. 1224 (D. Maryland 1979). “1(a)(2)), as well as under section 705(b), 21 U.S.C. § 375 (b), to provide information to the public concerning drugs in situations posing “imminent danger to health, or gross deception of the consumer.”
Mohr v. Targeted Genetics, Inc., 690 F. Supp. 2d 711 (C.D. Ill. 2010). “” 21 U.S.C. § 375 (b). Abbott states that, in addition to the foregoing regulations that apply to all BLA applications, even more stringent regulations apply to gene-therapy applications.”
Kukatush Mining Corp. v. Sec. & Exch. Comm'n, 198 F. Supp. 508 (D.D.C. 1961). “It was claimed in behalf of the Secretary of Health, Education and Welfare and the Commissioner of the Food and Drug Administration, against whom a suit for an injunction was brought, that they were acting under a statutory authority contained in 21 U.S.C.A. § 375 (b), to the…”
United States v. An Article of Device . . . Diapulse Mfg. Corp., 262 F. Supp. 728 (D. Conn. 1967). “Despite claimant’s sweeping allegations of various “press releases” and a “tirade of publicity by newspaper and radio” emanating from the FDA regarding the instant action, the record before the Court discloses only the following two instances of public mention of the Diapulse…”
Fisher Bros. Sales v. United States, 46 F.3d 279 (3rd Cir. 1995). “" 21 U.S.C. § 375 (b); see also 21 C.F.R. § 2.”
Doe v. United States Food & Drug Admin. (N.D. Cal. 2024). “, 21 U.S.C. § 375 (b).22 Given this regulatory backdrop, 18 the FDA contends that the plaintiff lacks standing because he does not link his injuries to mercury 19 poisoning, and he in any event cannot state a claim because there is no private right of action 20 against the FDA.”
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