Ambiguities of the Dietary Supplement Health and Education Act of 1994

Food and Drug Law Journal

Volumn 51, Issue 3, 1996, Pages 383-406

  Pinco, Robert G ^a   Rubin, Paul D ^a  

^a LLP   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CONSUMER; DIET SUPPLEMENTATION; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; LAW; LEGAL ASPECT; REVIEW;

ADVERTISING; DIETARY SUPPLEMENTS; HUMANS; LEGISLATION, DRUG; LEGISLATION, FOOD; PRODUCT LABELING; UNITED STATES; UNITED STATES FEDERAL TRADE COMMISSION; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0029738432     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (85)

1. PUB. L. No. 103-417, 108 STAT. 4325 (1994).
2. Id. § 2(13), 108 Stat. at 4326.
3. Id. § 2(15)(B), 108 Stat. at 4326.
4. The brief legislative history for the Act may be found at 140 CONG. REC. H11,173, H11,179 (daily ed. Oct. 6, 1994).
5. Pub. L. No. 103-417, §3(a), 108 Stat. at 4326-27 (codified at 21 U.S.C. § 321(ff) (Supp. 1996)) (emphasis added).
6. 60 Fed. Reg. 67,194 (Dec. 28, 1995).
7. DSHEA provides that dietary supplement products shall be labeled in accordance with the Act after December 31, 1996. Nevertheless, the FDA already has issued a Federal Register notice indicating that it is considering exercising its enforcement discretion and may not enforce DSHEA labeling provisions until January 1, 1998. 61 Fed. Reg. 16,423 (Apr. 15, 1996).
8. 60 Fed. Reg. at 67,201.
9. Id. at 67,199 n.2.
10. Pub. L. No. 103-417, § 3(a)(2), 108 Stat. at 4327 (codified at 21 U.S.C. § 321(ff)(2)).
11. United States v. Ten Cartons, More or Less, Of an Article . . . Ener-B Vitamin B-12, 888 F. Supp. 381 (E.D.N.Y.), aff'd, 72 F.3d 285 (2d Cir. 1995).
12. Pub. L. No. 103-417, § 3(a)(2). 108 Stat. at 4327 (codified at 21 U.S.C. § 321(ff)(2)(A)(i)).
13. Id. (codified at 21 U.S.C. § 321(ff)(2)(B)-(C)).
14. United States v. 42/194 kg. Drums Pure Vegetable Oil, 961 F.2d 808 (9th Cir.), cert. denied, 506 U.S. 940 (1992).
15. United States v. Two Plastic Drums. . . Black Currant Oil, 984 F.2d 814 (7th Cir. 1993).
16. Pub. L. No. 103-417, § 3(b)(3), 108 Stat. at 4327 (codified at 21 U.S.C. § 321(s)(6)).
17. Pub. L. No. 75-717, 52 Stat. 1040 (1938), as amended 21 U.S.C. §§ 301 et seq. (1994).
18. 21 U.S.C. § 321(m).
19. Classification as a new drug requires the submission and approval by the FDA of a new drug application before the product may be lawfully marketed.
20. See. e.g., United States v. Kordel, 164 F.2d 913 (7th Cir. 1947), aff'd, 335 U.S. 345 (1948); United States v. 250 Jars, etc., of U.S. Fancy Pure Honey, 218 F. Supp. 208 (E.D. Mich. 1963), aff'd, 344 F.2d 288 (6th Cir. 1965); United States v. Paddock, 68 F. Supp. 407 (D. Mo. 1946).
21. The legislative history provides that summaries are not acceptable, except for official abstracts of peer reviewed scientific publications. 140 CONG. REC. H11,173, H11,179.
22. Pub. L. No. 103-417, § 5, 108 Stat. at 4328 (codified at 21 U.S.C. § 343-2).
23. Id.
24. At present, it is expected that the same regulatory standards will apply to the two different types of structure/function statements (clauses 2 and 3), except that different types of substantiation will be required to support the statements.
25. Pub. L. No. 103-417, § 6, 108 Stat. at 4328-29 (codified at 21 U.S.C. § 343(r)(6)).
26. Id.
27. Id.
28. Id.
29. 140 CONG. REC. H11,173, H11,179.
30. 21 C.F.R. § 101.9(k)(5) (1996).
31. 21 U.S.C. § 321(g)(1)(C) (emphasis added).
32. S. REP. No. 361, 74th Cong., 1st Sess. 3 (1935), reprinted in 3 LEGISLATIVE HISTORY OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT AND AMENDMENTS 660.
33. See, e.g., Nutrilab v. Schweiker, 713 F.2d 335, 338 (7th Cir. 1983).
34. Id.
35. Pub. L. No. 103-417, § 3(a)(3), 108 Stat. at 4327 (codified at 21 U.S.C. § 321(ff)(3)).
36. This was confirmed by the FDA in its proposed dietary supplement labeling regulation. 60 Fed. Reg. at 67,210.
37. Nutritional Support Claims Will Not Be Defined in Proposed Reg, F-D-C REP. ("The Tan Sheet"), Sept. 25, 1995, at 6.
38. Since 1938, the FDCA has defined a drug as including "articles (other than food) intended to affect the structure or any function of the body of man." 21 U.S.C. § 321(g)(1)(C). The FDCA contains a similar definition for medical devices, except that devices do not achieve their primary intended purpose via chemical action. Id. § 321(h).
39. See, e.g., Nutrilab. 713 F.2d 335.
40. See, e.g., United States v. 23, More or Less Articles, 192 F.2d 308 (2d Cir. 1951).
41. Warning letter issued to Miracle Exclusives, Inc., WL 53-NYK-95 (June 8, 1995).
42. Pub. L. No. 103-417, § 6, 108 Stat. at 4328 (codified at 21 U.S.C. § 343(r)(6)).
43. Many companies have operated under the belief that the use of the word "maintains" (e.g., "maintains a healthy digestive system") will lead to characterization of a statement as a general well-being statement.
44. 21 U.S.C. § 321(g)(1).
45. Pub. L. No. 103-417, § 10, 108 Stat. at 4331 (codified at 21 U.S.C. § 321(g)(1)).
46. 21 C.F.R. § 101.14(a)(1).
47. Id. § 101.14(a)(6).
48. For example, the PDA's model health claim for dietary lipids and cancer states: "Eating a healthful diet low in fat may help reduce the risk of some types of cancers." Id. § 101.73(e)(2).
49. Id. § 101.72.
50. Id. § 101.79.
51. Pub. L. No. 103-417, § 6, 108 Stat. at 4328-29 (codified at 21 U.S.C. §343(r)(6)).
52. Under the OTC Drug Review, the requirement that ingredients be generally recognized as safe and effective requires more than proof of safety and efficacy - a general recognition is required.
53. 21 C.F.R. pt. 338.
54. Id. § 310.545(a)(8).
55. Id. pt. 340.
56. See, e.g., Structure/Function Claims May Be Used As Avenue Back To Market For Banned OTCs, F-D-C REP. ("The Tan Sheet"), Mar. 4, 1996, at 8.
57. Warning letter issued to Britcan, Inc., WL-55-5 (May 19, 1995).
58. 21 C.F.R. pt. 340.
59. Warning letter issued to Miracle Exclusives, Inc., WL 53-NYK-95 (June 8, 1995).
60. 21 C.F.R. pt. 338.
61. For certain ingredients, the FDA may not have reviewed data since the mid-1970s.
62. See infra text accompanying notes 65-67.
63. A negative safety determination, however, should convince most manufacturers to forgo the use of the ingredient in question unless the ingredient is used at substantially lower levels than those reviewed by the FDA, and the manufacturer has proof of safety.
64. 15 U.S.C. § 45 (1988).
65. Id. §§ 52, 55.
66. FTC Policy Statement on Advertising Substantiation, 48 Fed. Reg. 10,471 (Mar. 11, 1983).
67. See, e.g., In re Gracewood Fruit Company, FTC Dkt. No. C-3470, 1993 FTC LEXIS 295 (Oct. 26, 1993) (consent order).
68. C. Lee Peeler & Susan Cohn, The Federal Trade Commission's Regulation of Advertising Claims for Dietary Supplements, 50 FOOD & DRUG L.J. 349, 350-51 (1995).
69. United States v. General Nutrition, Inc., No. 94-686 (W.D. Pa. Apr. 28, 1994) (consent decree).
70. In re Body Wise International, Inc., FTC Dkt. No. C-3617, 1995 FTC LEXIS 291 (Oct. 4, 1995).
71. DSHEA Structure/Function Provisions Do Not Overrule State Laws, F-D-C REP. ("The Tan Sheet"), Oct. 2, 1995, at 22 (quoting Dan Sowards, Dir., Manufactured Foods Division, Texas Health Department).
72. U.S. CONST, art. VI.
73. Gibbons v. Ogden, 22 U.S. 1, 211 (1824).
74. Jones v. Rath Packing Co., 430 U.S. 519, 525 (1977).
75. Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947).
76. Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142-43 (1963).
77. Hillsborough County v. Automated Medical Labs., 471 U.S. 707, 713 (1985) (quoting Hines v. Davidowitz, 312 U.S. 52, 67 (1941)).
78. Jones, 430 U.S. at 538 (1977). There are some provisions within the FDCA, however, that do provide for express preemption. Among these are the provisions written into the Act under the Medical Device Amendments of 1976, Pub. L. No. 94-295, 90 Stat. 539, 574, and the Nutrition Labeling and Education Act of 1990, Pub. L. No. 101-535, 104 Stat. 2353, 2362. State actions that in effect establish new substantive requirements for products covered under these Acts will be preempted. See, e.g., King v. Collagen Corp., 983 F.2d 1130, 1134-35 (1st Cir.), cert. denied, 114 S. Ct. 84 (1993).
79. Jones, 430 U.S. at 540-41. But cf. Hillsborough County, 471 U.S. at 723 (holding that local blood-bank regulations are not preempted).
80. Hines v. Davidowitz, 312 U.S. 52, 67 (1941).
81. Pub. L. No. 103-417, § 2(15)(A), 108 Stat. at 4326. See also Cosmetic, Toiletry & Fragrance Ass'n v. Minnesota, 440 F. Supp. 1216, 1223 (D. Minn. 1977) (where goods are distributed nationally a state should not be able to require special packaging requirements).
82. Food and Dietary Supplement Consumer Information Act of 1995, H.R. 1951, 104th Cong., 1st Sess. § 7 (1995).
83. 60 Fed. Reg. 19,597 (Apr. 19, 1995) (emphasis added).
84. The Herbal Street Drug Labelization Bill, S. 1806, 104 Cong., 2d Sess. (1996).
85. Peeler & Cohn, supra note 67, at 354.