Under the Federal Food, Drug, and Cosmetic Act products may be regulated both as “drugs” and as “cosmetics” because the statutory definitions are not mutually exclusive. Although there are some similar statutory provisions governing drugs and cosmetics, more restrictions and requirements are attached to products classified as drugs than to products classified solely as cosmetics. The limits of the drug definition have been tested in court more frequently than the limits of the cosmetic definition. This article discusses the statutory definitions of “drug” and “cosmetic,” the associated legal requirements, and judicial and administrative interpretations of these definitions. The article then presents an approach to making drug/cosmetic determinations.
S. Rep. No. 361, 74th Cong., 1st Sess. (1935), reprinted in Dunn, Federal Food, Drug, and Cosmetic Act 239–240 (1938); United States v An Article. Sudden Change, 409 F2d 734, 739 (2d Cir 1969).
2.
Federal Register1971; 36(Aug 26): 16934.
3.
Federal Register1972; 37(Apr 11): 7151–7152.
4.
See 21 CFR Part 330; Federal Register1972; 37(May 11): 9464. Misbranding determinations are also made in OTC review rulemakings.
5.
The criteria for evidence of safety and effectiveness set forth in §505(d) must also be met for drugs to meet the general recognition requirements of §201(p) and escape new drug status. Weinberger v Hynson, Westcott & Dunning, Inc, 412 US 609, 629–30, 632 (1973); 21 CFR §330.10(a)(4)(ii).
United States v An Article of Cosmetic. Beacon Castile Shampoo, No. C71–53 (ND Ohio, Nov 6, 1973), reprinted in Kleinfeld et al., Federal Food, Drug, and Cosmetic Act Judicial Record 1969–1974 at 149.
9.
Dunn, supra n1, at 239.
10.
United States v An Article. Sudden Change, 409 F2d 734 (2d Cir 1969); United States v An Article of Drug. “Line Away”, 415 F2d 369 (3d Cir 1969).
11.
AMP, Inc v Gardner, 389 F2d 825 (2d Cir), cert, denied, 393 US 825 (1968); United States v Dianovin Pharmaceuticals, Inc., 342 F Supp 724 (D.P.R. 1972), aff'd, 475 F2d 100 (1st Cir), cert. denied, 414 US 830 (1973); United States v Articles of Drug, 263 F Supp 212 (D Neb 1967); United States v 39 Cases, 192 F Supp. 51 (ED Mich 1961).
12.
National Nutritional Foods Ass'n v Mathews, 557 F2d 325, 337–38 (2d Cir 1977); National Nutritional Foods Ass'n v FDA, 504 F2d 761, 788–89 (2d Cir 1974), cert. denied, 420 US 946 (1975).
13.
United States v 48 Dozen Packages, 94 F2d 641 (2d Cir 1938).
14.
409 F2d at 739.
15.
United States v Articles of Drug. Foods Plus, Inc., 362 F2d 923, 926 (3d Cir 1966); United States v Millpax, Inc., 313 F2d 152, 154 (7th Cir), cert. denied, 373 US 903 (1963); Nature Food Centres, Inc. v United States, 310 F2d 67, 69 (1st Cir 1962), cert. denied, 371 US 968 (1963); United States v Hohensee, 243 F2d 367, 370 (3d Cir), cert. denied, 353 US 976 (1957).
16.
409 F2d at 739.
17.
The District Court in Sudden Change had concluded that the product did not affect the structure of the body. The appellate court found it “unnecessary to reach the issue of actual physical effect.” 409 F2d at 739 n2.
18.
Letter dated June 17, 1976, from Sam D. Fine to Richard F. Kingham.
19.
Letter dated November 22, 1982, from Richard J. Ronk to Robert S. McQuate.
20.
655 F2d 236 (DC Cir) (1980).
21.
655 F2d at 239, quoting National Nutritional Foods Ass'n v Matthews, 557 F2d 325, 333 (2d Cir 1977).
22.
655 F2d at 239.
23.
504 F2d at 789.
24.
655 F2d at 240.
25.
557 F2d at 336. For discussions of the “food“/ “drug” distinction in the context of 21 USC §321(g)(1)(C), see Nutrilab, Inc. v Schweiker, 713 F2d 335 (7th Cir 1983) and American Health Products Co. v Hayes, 574 F Supp 1498 (SDNY 1983), aff'd, 744 F2d 912 (2d Cir 1984).
26.
409 F2d at 740.
27.
409 F2d at 741–42.
28.
409 F2d at 741.
29.
415 F2d at 372.
30.
United States v An Article of Drug. “Helene Curtis Magic Secret”, 331 F Supp 912 (D Md 1971).
31.
331 F Supp at 917.
32.
Action on Smoking and Health v Harris, 655 F2d at 237–38.
