21 C.F.R. § 1.1

General

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(a) The provisions of regulations promulgated under the Federal Food, Drug, and Cosmetic Act with respect to the doing of any act shall be applicable also to the causing of such act to be done.

(b) The definitions and interpretations of terms contained in sections 201 and 900 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 and 387) shall be applicable also to such terms when used in regulations promulgated under that act.

(c) The definition of package in § 1.20 and of principal display panel in §§ 101.1, 201.60, 501.1, 701.10 and 801.60 of this chapter; and the requirements pertaining to uniform location, lack of qualification, and separation of the net quantity declaration in §§ 101.7(f), 201.62(e), 501.105(f), 701.13(f) and 801.62(e) of this chapter to type size requirements for net quantity declaration in §§ 101.7(i), 201.62(h), 501.105(i), 701.13(i) and 801.62(h) of this chapter, to initial statement of ounces in the dual declaration of net quantity in §§ 101.7(j) and (m), 201.62(i) and (k), 501.105(j) and (m), 701.13(j) and (m) and 801.62(i) and (k) of this chapter, to initial statement of inches in declaration of net quantity in §§ 201.62(m), 701.13(o) and 801.62(m) of this chapter, to initial statement of square inches in declaration of net quantity in §§ 201.62(n), 701.13(p) and 801.62(n) of this chapter, to prohibition of certain supplemental net quantity statements in §§ 101.7(o), 201.62(o), 501.105(o), 701.13(q) and 801.62(o) of this chapter, and to servings representations in § 501.8 of this chapter are provided for solely by the Fair Packaging and Labeling Act. The other requirements part of this part are issued under both the Fair Packaging and Labeling Act and the Federal Food, Drug, and Cosmetic Act, or by the latter act solely, and are not limited in their application by section 10 of the Fair Packaging and Labeling Act.

[42 FR 15553, Mar. 22, 1977, as amended at 58 FR 17085, Apr. 1, 1993; 75 FR 73953, Nov. 30, 2010; 78 FR 69543, Nov. 20, 2013; 81 FR 59131, Aug. 29, 2016]

Notes of Decisions

Cited in 3 cases (1 in the last 5 years), 1978–2024 · leading case: Holk v. Snapple Beverage Corp., 574 F. Supp. 2d 447 (D.N.J. 2008).

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Holk v. Snapple Beverage Corp., 574 F. Supp. 2d 447 (D.N.J. 2008). · cites it 2× “21 C.F.R. § 1.1 et seq.; see 21 U.S.C. § 341 (“Whenever in the judgment of the Secretary such action will promote honesty and fair dealing in the interest of consumers, he shall promulgate regulations fixing and establishing for any food .”

J. E. Bernard & Co. v. United States, 80 Cust. Ct. 111 (Cust. Ct. 1978). “) and regulations of the Food and Drug Administration promulgated thereunder (21 C.F.R. 1.1, et seq.), which law and regulations restrict the distribution of such devices in the United States to hospitals or to patients pursuant to a prescription of a physician.”

In re: Fosamax (Alendronate Sodium) Prods. Liabi v., 118 F.4th 322 (3rd Cir. 2024). “), and its corresponding regulations (codified at 21 C.F.R. §§ 1.1 , et seq.). 6 appears on the labels of prescription drugs that are marketed in the United States.”

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