Drugs or dietary supplements: FDA's enforcement of DSHEA

Journal of Public Policy and Marketing

Volumn 17, Issue 2, 1998, Pages 296-302

  Mason, Marlys J ^a  

^a UNIVERSITY OF UTAH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 0032286793     PISSN: 07439156     EISSN: 15477207     Source Type: Journal    
DOI: 10.1177/074391569801700212     Document Type: Article

References (35)

1. Cataxinos, Edgar R. (1995), "Regulation of Herbal Medications in the United States: Germany Provides a Model for Reform," Utah Law Review, 561 (2), 561-92.
2. Commission on Dietary Supplement Labels (1997), Report to the President, the Congress, and the Secretary of the Department of Health and Human Services, 35 (November).
3. Dietary Supplement Health and Education Act (1994), Public Law No. 103-417, 108 Stat. 4325.
4. Food and Drug Administration (1997), "Dietary Supplements Containing Ephedrine Alkaloids; Proposed Rule," 62 Fed. Reg. 30677-30724.
5. _ (1998), "FDA Determines Cholestin to be an Unapproved Drug," FDA Talk Paper, (May 20).
6. Food and Nutrition Science Alliance (1997), "FANSA Releases Statement About Dietary Supplement Labeling," Journal of the American Dietetic Association, 97 (July), 782-83.
7. Gilhooley, Margaret (1997), "Herbal Remedies and Dietary Supplements: The Boundaries of Drug Claims and Freedom of Choice," Florida Law Review, 49 (December), 665-724.
8. Harmon, Sean (1996), "Melatonin Mania: Can the FDA Regulate Hormonal Dietary Supplements to Protect Consumer Interests in Light of the Dietary Supplement Health and Education Act of 1994?" Dayton Law Review, 22 (Fall), 77-99.
9. Hatch, Orrin G. (1994), "Congress Versus the Food and Drug Administration: How One Government Health Agency Harms the Public Health," Journal of Public Policy & Marketing, 13 (Spring), 151-52.
10. Hill, Daniel (1997), "Take a Pill!" Brandweek, 38 (December 1), 22-25.
11. Information Access Company (1998a) "FDA Checked on Supplement Ban," Supermarket News, 48 (June 29), 62.
12. _ (1998b), "Dietary Supplements Industry Mulls Proposed Labeling Rules," Chemical Marketing Reporter, 253 (June 22), 31.
13. Kushner, Gary Jay, Martin J. Hahn, and Andrea M. Bruce (1997), "The FDA Prescribes Cautious Labels," The National Law Journal, (July 7), B9.
14. Mason, Marlys (1998), "Marketing Dietary Supplements: Who is Minding the Store?" in 1995 Marketing and Public Policy Conference Proceedings, A. Andreason, A. Simonson, and N.C. Smith, eds. Chicago: American Marketing Association, 45-53.
15. McNamara, Stephen H. (1995), "Dietary Supplements of Botanicals and Other Substances: A New Era of Regulation," Food and Drug Law Journal, 50, 341-48.
16. _ (1996), "FDA Regulation of Ingredients in Dietary Supplements After Passage of the Dietary Supplement Health and Education Act of 1994: An Update," Food and Drug Law Journal, 51, 313-18.
17. National Association of Attorneys General (1997), "States Turn to Go After 'Herbal Ecstasy'," Consumer Protection Report, (October/November), 11.
18. National Council for Improved Health v. Shalala (1995), 1995 U.S. Dist. LEXIS 10212, 94 Civ. 509G, (D. UT).
19. _ (1997), 1997 U.S. App. LEXIS 21180, 95-4151 (10th Cir.).
20. Nordenberg, Tamra (1997), "Seizers Keepers, Criminal Weepers: International Nutrition Inc. Cannot Relabel Unapproved New Drugs as Dietary Supplements," FDA Consumer, 31 (September/October), 32-33.
21. Nutrilab v. Schweiker (1983), 1983 U.S. App. LEXIS 25121, 82-276, 82-2747 (7th Cir.).
22. Nutritional Health Alliance v. Shalala (1998), 1998 U.S. App. LEXIS 9791, 97-6246 (2d Cir.).
23. Pharmacia & Upjohn v. Generation Health d/b/a/ Pharmanex (1997), 1997 U.S. Dist. LEXIS 12518, 97 Civ. 259 (W. D. MI).
24. Pharmanex Inc. v. Shalala (1998), 1998 U.S. Dist. LEXIS 7950, 97 Civ. 0262K (D. UT).
25. Pinco, Robert G. and Paul D. Rubin (1996), "Ambiguities of the Dietary Supplement Health and Education Act of 1994," Food and Drug Law Journal, 51, 383-99.
26. Silverglade, Bruce A. (1994), "The Vitamin Wars - Marketing, Lobbying, and the Consumer," Journal of Public Policy & Marketing, 13 (Spring), 152-54.
27. _ (1996), "Regulating Dietary Supplement Safety Under the Dietary Supplement Health and Education Act: Brave New World or Pyrrhic Victory?" Food and Drug Law Journal, 51, 319-21.
28. _ (1998), "Regarding the FDA's Proposed Rule on Dietary Supplement Label Claims," press release, Center for Science in Public Interest (April 24) [http://www.cspinet.org/new/newsups.htm].
29. Smith, Elizabeth A. (1998a), "FDA to Clarify Claims for Diet Supplements," Drug Topics, 142 (June 1), 42.
30. _ (1998b), "Food or Drug? FDA, Pharmanex Debate Status of Cholestin," Drug Topics, 142 (June 15), 57.
31. Stewart, Tod L. (1996), "Getting High with a Little Help from the Feds: Federal Regulation of Herbal Stimulants," The Journal of Pharmacy and Law, 6, 101-15.
32. Stolberg, Sheryl Gay (1998a), "Judge Rebuffs Drug Agency on Effort to Ban Diet Supplement," New York Times, (June 17), A15.
33. _ (1998b), "Drug Regulators Make Push to Rein in Herbal Remedies," New York Times, (June 10), Al.
34. Vignuolo, Peter A. (1997), "The Herbal Street Drug Crisis: An Examination of the Dietary Supplement Health and Education Act of 1994," Seton Hall Legislative Journal, 21, 200-31.
35. Young, Anthony L. and I. Scott Bass (1995), "The Dietary Supplement Health and Education Act," Food and Drug Law Journal, 50, 285-92.