A free market for dietary supplements: Issues surrounding DSHEA's exceptions to the labeling exemption for third-party literature

Food and Drug Law Journal

Volumn 62, Issue 1, 2007, Pages 151-163

  Zigler, Jeffrey ^a  

^a Southern Methodist University   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CONSUMER; COURT; DIET SUPPLEMENTATION; DRUG INDUSTRY; DRUG LABELING; DRUG LEGISLATION; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; MARKET; REVIEW;

DIETARY SUPPLEMENTS; HEALTH PROMOTION; HUMANS; LITERATURE; MARKETING OF HEALTH SERVICES; PRODUCT LABELING; UNITED STATES;

EID: 33947115461     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (88)

1. In Central Hudson Gas & Electric Co. v. Public Service Comm., 447 U.S. 557 (1980), the court devised a test regarding regulations affecting commercial speech. Such governmental regulations do not violate the First Amendment if: 1) the regulated speech concerns an illegal activity; 2) the speech is misleading, or 3) the government's interest in restricting the speech is substantial, the regulation in question directly advances the government's interest, and the regulation is no more extensive than necessary to serve the government's interest.
2. Lochner v. New York, 198 U.S. 45 (1905) (A state's limitation of employment in bakeries to 60 hours per week was struck down as unconstitutional, based on principles of freedom of contract gleaned from the First and Fourteenth Amendments' substantive due process.).
3. Id. at 74.
4. In West Coast Hotel Co. v. Parrish, 300 U.S. 379 (1937), the Supreme Court overturned Lochner based on principles of public health concerns regarding Washington state's minimum wage law for women. As long as an economic regulation is "reasonable in relation to its subject and is adopted in the interests of the community," the requirements of due process are met. This represents an early attempt at adopting the Court's current Central Hudson analysis.
5. Damon Root, Unleash the Judges: The libertarian case for judicial activism. (July 2005) http:// www.reason.com/0507/fe.dr.unleash.shtml.
6. See NLEA of 1990, Pub. L. No. 101-535, 104 Stat. 2353 (1990) (codified in part at 21 U.S.C. § 343(i), (q) and (r));
7. see H.R.REP. No. 101-538, at 7 (1990), reprinted in 1990 U.S.C.C.A.N. 3336, 3337.
8. 21 U.S.C. §403(a).
9. Id.
10. Nutritional Health Alliance v. Shalala, 144 F.3d 220, 223-4 (2d Cir (1998)).
11. Id.
12. 21 U.S.C. § 321(ff).
13. Id. at (m).
14. Dietary Supplement Health and Education Act of 1994, (Dec. 1995) http://www.cfsan.fda. gov/~dms/dietsupp.html.
15. 21 U.S.C. § 343-2(a).
16. See Dietary Supplement Health and Education Act of 1994, EL. 103-417, 103rd Congress.
17. S. REP. 103-410 at 33.
18. Report of the Commission on Dietary Supplement Labels, vi.
19. H.R. 4282, 109th Cong., (2005), 4.
20. Id.
21. GovTrack.us: Independently Tracking the United States Congress http://www.govtrack.us/congress/bill.xpd?bill=h109-4282.
22. See 324 F.Supp.2d 547 (2004) (When a claim is made that a dietary supplement diagnoses, mitigates, treats, cures or prevents a specific disease or class of diseases, the supplement becomes a drug under 21 U.S.C. § 321(g)(l) of the FDCA.).
23. S. Rep. 103-410 at 25.
24. Id.
25. Id. at 24.
26. Id. at 25-26.
27. Id. at 25 (Language such as "it should be emphasized that..." preface statements containing Congress' more specific, and apparently primary concern that regulations regarding dietary supplements remain relaxed.) (emphasis added).
28. Id. at 26.
29. Thompson v. Western States Medical Center, 535 U.S. 357, 378 (2002).
30. S. REP. 103-410 at 26.
31. See U.S. v. 24 Bottles Sterling Vinegar and Honey Aged in Wood Cider Blended With Finest..., 338 F.2d 157 (2d Cir (1964)) (The display and sale of books in the same shop as the product did not constitute misbranding, even where such books misleadingly recommended as a remedy for various ailments, as there was no immediate connection of the books with sale of the product.).
32. Id. at 158-159.
33. S. REP. 103-410 at 25.
34. Virginia State Bd. of Pharmacy, 425 U.S. at 771-72 (1976);
35. Central Hudson, 447 U.S. at 571 (1980).
36. Reno v. American Civil Liberties Union, 521 U.S. 844, 894 (1997) (citing Forsyth County v. Nationalist Movement, 505 U.S. 123, 130(1992)).
37. Bates v. State Bar of Arizona, 433 U.S. 350, 351 (1977).
38. S. REP. 103-410, 103rd CONG., 2ND SESS. (1994), p. 33.
39. State of Fla., Dept. of Health and Rehabilitative Services v. Friends of Children, Inc., 653 F.Supp. 1221, 1229 (N.D. Fl (1986)).
40. See Id.
41. Id.
42. See S. REP. 103-410, 103rd CONG., 2ND SESS. at p. 26.
43. Nutritional Health Alliance, 144 F.3d at 223-224 (citing 21 C.F.R. §§ 101.13-101.14, 101.70).
44. See 324 F.Supp.2d 547.
45. Id. at 564.
46. Wallach, 04-CV216 at 21.
47. SeeFDA Investigations Operations 2006 http://www.fda.gov/ora/ inspect_ref/iom/iomtc.html.
48. Pearson v. Shalala, 164 F.3d 650, 652-3 (D.C. Cir (1999)).
49. Tinsley Media, LLC v. Pickens County, GA, WL 2917561 (11th Cir (2006)).
50. 21 U.S.C. § 343-2(c).
51. See Wallach v. Crawford, 04-CV216 (2005).
52. See Rubin v. Coors Brewing Co., 514 US. 476 (1995);
53. Bolger v. Youngs Drug Products Corp., 463 U.S. 60 (1983)
54. Virginia State Bd. of Pharmacy v. Virginia Citizens Consumer Council, 425 U.S. 748 (1976).
55. Virginia State Bd. of Pharmacy, 425 U.S. at 789.
56. Id. at 765.
57. Id. at 763.
58. See Rubin, supra;
59. Bolger, supra
60. Virginia State Bd. of Pharmacy, supra (In determining the constitutionality of a government regulation affecting commercial speech, which concerns lawful activity that is not misleading, a court must apply the remaining prongs of the Central Hudson test.).
61. Central Hudson, supra.
62. Central Hudson, supra.
63. See DSHEA of 1994.
64. 21 U.S.C. § 343-2(a)(2-4).
65. 535 U.S. 357, 378 (2002).
66. Id. at 359.
67. Wallach, 04-CV216 at 22.
68. Id. at 16.
69. Id. at 6.
70. Central Hudson, supra (emphasis added).
71. Wallach, 04-CV216 at 15.
72. Caputo, 288 F.Supp.2d at 920-1.
73. Id.
74. See High Tech Gays v. Defense Indus. Sec. Clearance Office, 909 F.2d 375 (9th Cir (1990)). (The class of "homosexuals" clearly qualifies as a suspect category, triggering strict judicial scrutiny of any governmental discrimination against them.).
75. See DSHEA of 1994, P.L. 103-417, 103rd Congress.
76. Wallach, 04-CV216 at 15.
77. Id. at 16.
78. Id. at 17.
79. Id. at 19.
80. 15 U.S.C. § 45, 52, 55 (1980).
81. Working Agreement Between The FTC and FDA, 4 Trade Reg. Rep. (1971).
82. Enforcement Policy Statement on Food Advertising, (May 1994) http://www.ftc.gov/bcp/policys tmt/ad-food.htm#5.
83. Id.
84. Dietary Supplements: An Advertising Guide for Industry, 24 http://www.ftc.gov/bcp/conline/ pubs/buspubs/dietsupp.pdf.
85. Jeff Hilton, What Every Marketer Should Know About FTC Advertising Compliance, http://www. imgbrandwire.com/articlelibrary/2004/marketer.htm.
86. Id. at 25; Dietary Supplements: An Advertising Guide for Industry (http://www.ftc.gov/bcp/conline/pubs/buspubs/dietsupp.htm#Application)
87. Nutritional Health Alliance v. Shalala, 144 F.3d 220,223 (2d Cir 1998)
88. Id.