Abstract
The sports nutrition segment of the dietary supplement industry enjoyed nearly a decade of unfettered growth under federal legislation passed in 1994. A series of breakthroughs in the dietary supplement field led to the development and marketing of innovative products designed to enhance performance, build muscle, or lose excess fat. As the popularity of these products soared and evolved into a multi-billion dollar industry, the sports nutrition supplement market drew the attention of federal and state regulatory bodies and sports antidoping authorities. Growing concerns over potential health risks and unfair athletic advantages have spurred government regulators and legislators to heighten the scrutiny of this market, leading to recent legislative amendments and increased government enforcement action.
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Pub. L. No. 75-717, 52 Stat. 1040 (1938) [codified as amended 21 U.S.C. 301 et seq. (1994)].
Ibid, citing Senate Report No. 103-410, 103d Congress, 2d Session, Committee on Labor and Human Resources (October 8, 1994), at page 16.
Ibid, citing Senate Report No. 103-410, at page 22.
Provided that the Secretary then initiates on-the-record rulemaking to affirm or withdraw the declaration. See 21 U.S.C. § 342(f)(1).
21 U.S.C. § 331(a) and (v).
21 U.S.C. § 342(f)(1) and 350b(a).
21 U.S.C. § 342(f)(1)(A).
21 U.S.C. § 333(a)(1).
21 U.S.C. § 333(a)(2).
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).
21 U.S.C. § 350b(c).
21 U.S.C. § 350b(a).
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. See also, 21 CFR § 190.6.
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See generally, Legislation to Amend the Controlled Substances Act (Anabolic Steroids): Hearings on H.R. 3216 Before the Subcomm. on Crime of the House of Representatives Comm. on the Judiciary, 100th Cong., 2d Sess. 99, July 27, 1988; Steroids in Amateur and Professional Sports—The Medical and Social Costs of Steroid Abuse: Hearings Before the Senate Comm. on the Judiciary, 101st Cong. 1st Sess 736, April 3 and May 9, 1989; Abuse of Steroids in Amateur and Professional Athletics: Hearings Before the Subcomm. on Crime of the House Comm. on the Judiciary, 101st Cong., 2d Sess. 92, March 22, 1990; Hearings on H.R. 4658 Before the Subcomm. on Crime of the House Comm. on the Judiciary, 101st Cong., 2 nd Sess. 90, May 17, 1990.
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.
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Revised schedules are published in the Code of Federal Regulations, Part 1308 of Title 21, Food and Drugs.
21 U.S.C. § 844.
21 U.S.C. § 841(b)(1)(D).
For a comprehensive examination of the 1990 steroid legislation, see this author’s treatise, Legal Muscle: Anabolics in America (2002) (www.legalmusclebooks.com).
Androstenedione or “andro,” a precursor to the sex hormone testosterone, achieved national notoriety in 1998 when a bottle of the pills was spotted in the locker of St. Louis Cardinals slugger Mark McGwire.
Norsteroid prohormones, for example, can result in a positive test for nandrolone because both nandrolone and the norsteroid prohormones give rise to the urinary excretion of the metabolites norandrostenedione and norandrostenediol.
The problem of positive doping results from cross-contamination made national headlines when U.S. bobsledder Pavle Jovanovic was disqualified from the Salt Lake City Olympics for a test result he blamed on a cross-contaminated protein powder supplement and when research conducted at an IOC-accredited drug testing laboratory in 2002 found that 94 of the 634 samples contained substances not listed on the label that would trigger positive drug tests.
Examples: Anabolic Steroid Penalties: Hearings on H.R. 3866 Before the Subcomm. on Crime of the House of Representatives Comm. on the Judiciary, 108th Cong., 2 nd Sess., March 16, 2004; Consolidating Terrorist Watchlists: Hearings on H.R. 3866 Before the Subcomm. on Crime, Terrorism, and Homeland Security, House of Representatives Comm. On the Judiciary, 108th Cong., 2 nd Sess., March 25, 2004; Anabolic Steroid Control Act of 2004: Hearings on S. 2195 Before the Senate Comm. on the Judiciary, 108th Cong., 2 nd Sess., October 6th, 2004.
Public L. No. 108-358; 118 Stat. 1661 (2004).
The new compounds are androstanediol; androstanedione; androstenediol; androstenedione; bolasterone; calusterone; ∗1-dihydrotestosterone (a.k.a. “1-testosterone”); furazabol; 13β-ethyl-17α-hydroxygon-4-en-3-one; 4-hydroxytestosterone; 4-hydroxy-19-nortestosterone; mestanolone; 17α-methyl-3β,17β-dihydroxy-5α-androstane; 17α-methyl-3α,17β-dihydroxy-5α-androstane; 17α-methyl-3β,17β-dihydroxyandrost-4-ene; 17α-methyl-4-hydroxynandrolone; methyldienolone; methyltrienolone; 17α-methyl-∗1-dihydrotestosterone (a.k.a. “17α-methyl-1-testosterone”); norandrostenediol; norandrostenedione; norbolethone; norclostebol; normethandrolone; stenbolone; and tetrahydrogestrinone.
21 U.S.C. § 811.
Note that litigation may be required to explore what “pharmacologically related” means with respect to steroidal compounds, including whether a steroid’s anabolic capacity is inherent to its pharmacologic effect.
DHEA, or dehydroepiandrosterone, is a steroid hormone that serves as a metabolic precursor to the sex hormones estrogen and testosterone. It has become a popular dietary supplement among middle-aged and elderly consumers seeking improved vigor.
The errors in the 1990 law were exposed by coauthor Collins in Legal Muscle (see footnote 8). However, at least one typographic error appears in the new law: 13α-ethyl-17α-hydroxygon-4-en-3-one (a demethylated version of norbolethone) should read as 13β-ethyl-17β-hydroxygon-4-en-3-one. A new bill [S. 893] was introduced on April 25, 2005 to fix the problem (it also amends the chemical nomenclature for stanozolol).
Now listed only as methandienone.
Now listed only as 4-dihydrotestosterone.
Now listed only as clostebol.
A substance that does not appear in the Merck Index and appears to have resulted from a typographic error.
The definition of an anabolic steroid under the old law included, under subparagraph (xxviii), is “any salt, ester, or isomer of a drug or substance described or listed in this paragraph, if that salt ester, or isomer promotes muscle growth.” The new law says, “any salt, ester, or ether of a drug or substance described in this paragraph.” Note that the reference to muscle growth in the old law has been omitted [from what is now, in the longer list, subparagraph (xlx) of the new law] and that the word “isomer” has been replaced by “ether.”
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Collins, R., Kalman, D. (2008). Effect of Government Regulation on the Evolution of Sports Nutrition. In: Nutritional Supplements in Sports and Exercise. Humana Press. https://doi.org/10.1007/978-1-59745-231-1_1
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