21 U.S.C. § 344

Emergency permit control

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(a) Conditions on manufacturing, processing, etc., as health measure

Whenever the Secretary finds after investigation that the distribution in interstate commerce of any class of food may, by reason of contamination with micro-organisms during the manufacture, processing, or packing thereof in any locality, be injurious to health, and that such injurious nature cannot be adequately determined after such articles have entered interstate commerce, he then, and in such case only, shall promulgate regulations providing for the issuance, to manufacturers, processors, or packers of such class of food in such locality, of permits to which shall be attached such conditions governing the manufacture, processing, or packing of such class of food, for such temporary period of time, as may be necessary to protect the public health; and after the effective date of such regulations, and during such temporary period, no person shall introduce or deliver for introduction into interstate commerce any such food manufactured, processed, or packed by any such manufacturer, processor, or packer unless such manufacturer, processor, or packer holds a permit issued by the Secretary as provided by such regulations.

(b) Violation of permit; suspension and reinstatement

The Secretary is authorized to suspend immediately upon notice any permit issued under authority of this section if it is found that any of the conditions of the permit have been violated. The holder of a permit so suspended shall be privileged at any time to apply for the reinstatement of such permit, and the Secretary shall, immediately after prompt hearing and an inspection of the establishment, reinstate such permit if it is found that adequate measures have been taken to comply with and maintain the conditions of the permit, as originally issued or as amended.

Any officer or employee duly designated by the Secretary shall have access to any factory or establishment, the operator of which holds a permit from the Secretary, for the purpose of ascertaining whether or not the conditions of the permit are being complied with, and denial of access for such inspection shall be ground for suspension of the permit until such access is freely given by the operator.

(June 25, 1938, ch. 675, § 404, 52 Stat. 1048.)Executive DocumentsTransfer of Functions

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 11 cases (2 in the last 5 years), 1967–2025 · leading case: Gardner v. Toilet Goods Assn., Inc., 387 U.S. 167 (1967).

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Gardner v. Toilet Goods Assn., Inc., 387 U.S. 167 (1967). · cites it 2× “1048 , as amended, 21 U. S. C. § 344 (a) (conditions imposed on manufacture of food as the result of health requirements), § 406, 52 Stat.”

United States v. Nova Scotia Food Prods. Corp., David Sklar & Emanuel Sklar, & Nat'l Fisheries Inst., Intervenor-Appellant, 568 F.2d 240 (2d Cir. 1977). “Yet, so far as the category of harmful micro-organisms is concerned, there is only a single provision, 21 U.S.C. § 344 , which directly deals with “micro-organisms.”

United States v. RX Depot, Inc., 438 F.3d 1052 (10th Cir. 2006). “21 U.S.C. § 344 (g). Disgorgement, on the other hand, is only permitted after a party is found by- a court to be in violation of the Act and only at the court’s discretion.”

Nat'l Nutritional Foods Ass'n v. Weinberger, 376 F. Supp. 142 (S.D.N.Y. 1974). “§ 343 (j) (labeling requirements for special dietary foods) ; § 404(a), 21 U.S.C. § 344 (a) (emergency permit control system) ; § 406(a), 21 U.”

Nat'l Nutritional Foods Ass'n v. Weinberger, 512 F.2d 688 (2d Cir. 1975). “§ 343 (j), distribution of potentially contaminated foods, 21 U.S.C. § 344 (a)), including notice, comments by interested parties, promulgation of proposed rules, filing of objections, a public evidentiary hearing if requested by a “party adversely affected,” and a court of…”

Apotex, Inc. v. Shalala, 53 F. Supp. 2d 454 (D.D.C. 1999). “See 21 U.S.C. § 344 (b)(1). The FDCA requires the FDA to publish this information, and the FDA does so in a publication entitled “Approved Drug Products with Therapeutic Equivalence Evaluations” (commonly referred to as the “Orange Book”).”

Pac. Legal Found. v. Goyan, 500 F. Supp. 770 (D. Maryland 1980). “…base its decisions concerning the products it regulates solely on the record developed in those hearings. See, e. g., 21 U.S.C. § 344 (b); § 348(f); § 355(d), (e); § 360b(d), (e); § 360e(g); and § 371(e)(1). The FDA is also authorized “to promulgate regulations for the…”

Pac. Legal Found. v. Goyan, 664 F.2d 1221 (4th Cir. 1981). “, 21 U.S.C. §§ 344 (b), 348(f), 355(c)-(e), 360b(d)-(e), 360e(g), 371(e).”

United States v. 300 Oz. Gerovital Lotion (H3), & 25,000 Gerovital Tablets (H3), More or Less, 492 F. Supp. 114 (C.D. Cal. 1980). · cites it 2× “§ 355 (a), which triggers the condemnation proceedings under § 344, prohibits the introduction into interstate commerce of any new drug, unless there has been approval of a new drug application pursuant to 21 U.S.C. § 355 (b). A “new drug” is any drug “not generally recognized,…”

United States v. Murty Vepuri, 74 F.4th 141 (3rd Cir. 2023). “Section 355(b), in turn, sets forth the procedure by which the FDA evaluates and approves NDAs for non-generic drugs, and § 355(j) sets forth the procedure by 3 Section 331(d) prohibits the introduction into interstate commerce of any article in violation of 21 U.S.C. §§ 344 ,…”

United States v. Fishman, Giannelli (2d Cir. 2025). “Finally, Fishman challenges the district court’s orders requiring forfeiture of monies representing the street value of the adulterated drugs involved in the conspiracy.”

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