Effect of government regulation on the evolution of sports nutrition

Nutritional Supplements in Sports and Exercise

Volumn , Issue , 2008, Pages 3-31

  Collins, Rick ^a   Kalman, Douglas ^b  

^a Florida International University ^*

^b FLORIDA INTERNATIONAL UNIVERSITY   (United States)

Author keywords

Dietary Supplement Health and Education Act of 1994; Dietary supplements; Food and Drug Administration; FTC; Nutrition

Indexed keywords

EID: 78951489933     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1007/978-1-59745-231-1_1     Document Type: Chapter

References (48)

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2. [codified as amended 21 U. S. C. 301 et seq. (1994)].
3. Provided that the Secretary then initiates on-the-record rulemaking to affirm or withdraw the declaration. See 21 U. S. C. § 342 (f) (1).
4. 21 U. S. C. § 331 (a) and (v).
5. 21 U. S. C. § 342 (f) (1) and 350b (a).
6. 21 U. S. C. § 342 (f) (1) (A).
7. 21 U. S. C. § 333 (a) (1).
8. 21 U. S. C. § 333 (a) (2).
9. A "dietary ingredient" may be a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any of these. See 21 U. S. C. 321 (ff) (1).
10. 21 U. S. C. § 350b (c).
11. 21 U. S. C. § 350b (a).
12. See, FDA, Center for Food Safety & Applied Nutrition (CFSAN), "New Dietary Ingredients in Dietary Supplements", available at http://www.cfsan. fda.gov/~dms/ds-ingrd.html#whatis.
13. See also, 21 CFR § 190.6.
14. "To date, we have not published guidance defining the specific information that the submission must contain. Thus, you are responsible for determining what information provides the basis for your conclusion. " FDA, CFSAN, available at http://www.cfsan. fda.gov/~dms/ds-ingrd.html/.
15. FDA, CFSAN, Androstenedione Press Release, available at http://www.fda.gov/bbs/topics/news/2004/hhs-031104.html.
16. FDA, CFSAN, Androstenedione Warning Letters, available at http://www.cfsan. fda.gov/~dms/andrlist.html#letter/.
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23. See footnote 14. (FDA, CFSAN, available at http://www.cfsan.fda.gov/~dms/ ds-ingrd.html/.)
24. Pursuant to 21 U. S. C. 812 (b), a substance in Schedule III is to be placed there if: A) the drug or other substance has a potential for abuse less than the drugs or other substances in schedules I and II; (B) the drug or other substance has a currently accepted medical use in treatment in the United States; and (C) abuse of the drug or other substance may lead to moderate or low physical dependence or high psychological dependence.
25. John Burge, Legalize and Regulate: A Prescription for Reforming Anabolic Steroid Legislation, 15 Loy. L. A. Ent. L. J., 33, 45 (1994).
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27. 21 U. S. C. § 844.
28. 21 U. S. C. § 841 (b) (1) (D).
29. For a comprehensive examination of the 1990 steroid legislation, see this author's treatise, Legal Muscle: Anabolics in America (2002) (www.legalmusclebooks.com).
30. Public L. No. 108-358; 118 Stat. 1661 (2004).
31. 21 U. S. C. § 811.
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39. 15 USC 45 (a) (1) (2000).
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44. http://www.ftc.gov/opa/2005/07/xenadrine.htm/.
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