The case for a substantial evidence amendment to the informal rulemaking provision of the federal food, drug, and cosmetic act

Food and Drug Law Journal

Volumn 55, Issue 3, 2000, Pages 293-300

  Bachrach, Eve E ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

COSMETIC;

ARTICLE; CONSUMER; DEVICE; ECONOMIC ASPECT; FOOD; FOOD AND DRUG ADMINISTRATION; LEGAL ASPECT; ORGANIZATION; POLICY;

HUMAN; LEGISLATION, DRUG; LEGISLATION, FOOD; PRODUCT LABELING; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0033819167     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (63)

1. FDA website (visited Mar. 31, 2000) 〈www.fda.gov/opacom/faqs/genfaqs.html〉.
2. Pub. L. No. 75-717, 51 Stat. 1040 (1938) (codified as amended 21 U.S.C. §§ 301 et seq. (1994)).
3. 21 U.S.C. § 371(a) (FDCA § 701(a)).
4. Id. § 371(e) (FDCA § 701(e)).
5. Id. § 371(a) (FDCA § 701(a)).
6. The APA provides that, [t]he reviewing court shall -(2) hold unlawful and set aside agency actions, findings, and conclusions found to be -(A) arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law; (B) contrary to constitutional right, power, privilege, or immunity; (C) in excess of statutory jurisdiction, authority, or limitations, or short of statutory right; (D) without observance of procedure required by law; (E) unsupported by substantial evidence in a case subject to sections 556 and 557 of this title or otherwise reviewed on the record of an agency hearing provided by statute; or (F) unwarranted by the facts to the extent that the facts are subject to trial de novo by the reviewing court. In making the foregoing determinations, the court shall review the whole record or those parts of it cited by a party, and due account shall be taken of the rule of prejudicial error. Pub. L. No. 79-404, 60 Stat. 237 (1946) (codified at 5 U.S.C. §§ 551 et seq. (1994)).
7. 5 U.S.C. § 706(2)(A).
8. National Ass'n of Mfrs. v. United States Dep't of Interior, 134 F.3d 1095 (D.C. Cir. 1998); North Carolina v. Federal Aviation Admin., 957 F.2d 1125 (4th Cir. 1992); Rhode Island Higher Educ. Assistance Auth. v. Secretary, United States Dep't of Educ., 929 F.2d 844 (1st Cir. 1991).
9. 21 U.S.C. § 371(e) (FDCA § 701(e)).
10. United States v. Articles of Drug, 634 F. Supp. 435 (N.D. Ill. 1985); Pharmaceutical Mfrs. Ass'n v. Finch, 307 F. Supp. 858 (Del. 1970).
11. Under section 701(e)(2) and (3), a person who would be "adversely affected" by the action is given the opportunity to file formal objections to a proposed regulation, which stays the effective date. FDA is required to hold a public hearing and to issue a report containing detailed findings of fact, which becomes the basis for the regulation.
12. 21 U.S.C. § 371(e)(1) (FDCA § 701(e)).
13. 5 U.S.C. § 706(2)(E).
14. See id.;Universal Camera Corp. v. National Labor Relations Bd., 340 U.S. 474 (1951).
15. International Drilling & Energy Corp. v. Watkins, 920 F.2d 14 (Emer. Ct. App. 1990).
16. Corning Glass Works v. International Trade Comm'n, 799 F.2d 1559 (4th Cir. 1986).
17. th Cong., reprinted in CHARLES WESLEY DUNN, FEDERAL FOOD, DRUG AND COSMETIC ACT, A STATEMENT OF ITS LEGISLATIVE RECORD 1268 (1938); see generally Richard A. Merrill, FDA and the Effects of Substantive Rules, 35 FOOD DRUG COSM. L.J. 270 (1980).
18. th Cong., reprinted in CHARLES WESLEY DUNN, FEDERAL FOOD, DRUG AND COSMETIC ACT, A STATEMENT OF ITS LEGISLATIVE RECORD 1268 (1938); see generally Richard A. Merrill, FDA and the Effects of Substantive Rules, 35 FOOD DRUG COSM. L.J. 270 (1980).
19. H.R. 2139, 75th Cong., 3d Sess. (1938).
20. As recently as 1981, CHPA (then known as the Proprietary Association) routinely argued that FDA lacked authority under section 701(a) to issue binding substantive rules in the OTC Drug Review. The association maintained that the OTC Drug Review monographs were, at most, interpretive, and not legally binding. See, e.g., Comments of the Proprietary Association re Vaginal Contraceptive Drug Products for OTC Human Use; FDA Docket No. 80N-0280 (Mar. 12, 1981).
21. Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609 (1973); National Nutritional Foods Ass'n v. Weinberger, 512 F.2d 688 (2d Cir. 1975), cert. denied, sub nom., National Nutritional Foods Ass'n v. Matthews, 423 U.S. 827 (1975); Pharmaceutical Mfrs. Ass'n v. Food and Drug Administration, 484 F. Supp. 1179 (D.C. Del. 1980).
22. See 21 C.F.R. §§ 330-358 (1999).
23. See, e.g., Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body; Final Rule, 65 Fed. Reg. 1033-34 (2000): [D]ietary supplements that use structure/function claims may do so only under section 403(r)(6) of the act and are therefore subject to the disclaimer, notification, and other requirements in that section . . . . The agency acknowledges that it took a contrary position in the September 1997 final rule preamble [on nutrition labeling for foods] . . . . For a limited transition period, FDA does not intend to take enforcement actions against firms who have relied on the agency's September 1997 final rule preamble statements . . . . New structure/function claims are not subject to this transition period; any firm that makes a structure/function claim in the labeling of a dietary supplement after the effective date of this rule must comply with section 403(r)(6) of the act and section 101.93.
24. 21 C.F.R. § 10.85(d)(1)(j).
25. Pub. L. No. 94-469, § 19, 90 Stat. 2039 (1976) (codified at 15 U.S.C. § 2618(c)(1)(B)(i)).
26. H.R. CONF. REP. No. 94-1679, at 96 (1976).
27. Pub. L. No. 92-573, 86 Stat. 1207 (1972) (codified at 15 U.S. C. § 2058(f)(i)).
28. Pub. L. No. 94-284, § 20(b), 90 Stat. 515 (1976) (codified at 15 U.S.C. § 1193(e)(3)).
29. 15 U.S.C. § 57(a)(I)(B).
30. Id.
31. Pub. L. No. 95-620, Title VII, Part A, § 702, 92 Stat. 3331 (1978) (codified at 42 U.S.C. § 8412(c)(2)).
32. Pub. L. No. 91-596, § 6, 84 Stat. 1593 (1970) (codified at 29 U.S.C. § 655 (b) (1998)).
33. Id.
34. 29 U.S.C. § 655(f).
35. Pub. L. No. 94-295, 90 Stat. 539 (codified at 15 U.S.C. § 55 (1994); 21 U.S.C. §§ 301, 331, 334, 351, 352, 358, 360, 360c-360k, 374, 379a, 381 (1994)).
36. Id.
37. Pub. L. No. 103-417, 108 Stat. 4325 (codified at 21 U.S.C. § 301 note (1994)).
38. Pub. L. No. 104-121, 1996 U.S.C.C.A.N. (110 Stat.) 847 (codified at 5 U.S.C. §§ 801 and 802).
39. Id.
40. Daniel Cohen & Peter L. Strauss, Congressional Review of Agency Regulations, 49 ADMIN. L. REV. 95, 109-110 (1997).
41. 64 Fed. Reg. 13,254 (1999) (tobe codified at 21 C.F.R. §§ 201, 330, 331, 341, 346, 355, 358, 369, 701).
42. Id. at 13,288 (to be codified at § 201.66(d)(1)).
43. Id. (to be codified at § 201.66(d)(8)).
44. Id. at 13,287 (to be codified at § 201.66(c)).
45. Id. at 13,288 (to be codified at § 201.66(d)(4)).
46. Id. (to be codified at § 201.66(d)(6)).
47. Id. (to be codified at § 201.66(d)(7)).
48. Id. (to be codified at § 201.66(d)(2)(3)).
49. Label Readability Guidelines, CHPA (1991).
50. 62 Fed. Reg. 49,826, 49,839-40 (1997) (citing the preamble).
51. 21 C.F.R. § 101.2.
52. Id. § 101.36(i).
53. Id. § 701.3(j),(k), (n-p).
54. Id. § 501.2(c).
55. Id. § 352(c).
56. Id.
57. 64 Fed.Reg. 13,254, 13,264-65 (1999).
58. See id.
59. Id.
60. See id.
61. Id. at 13,265.
62. Id at 13,264.
63. 62 Fed. Reg. 49,826, 49,839 (1997) (codified at 21 C.F.R. § 101.36(i)). 63 21 U.S.C. § 352(c) (FDCA § 502(c)).