Chapter[ III. The Governing Laws and Baseball Policies Regarding Possession or Use
of Performance Enhancing Substances ]
Section[ A. Laws Regarding Performance Enhancing Substances ]
A. Laws Regarding Performance Enhancing Substances
Since 1938, the Federal Food, Drug, and Cosmetic Act has prohibited distribution
of all prescription drugs except when a physician, based upon an individualized determination of
a proper course of treatment, has authorized use of a drug by a patient under the physician’s
supervision.55
In 1970, in reaction to a perceived epidemic of drug abuse in the United States,
Congress enacted the Controlled Substances Act, which among other things established criminal
53 Memorandum from Francis T. Vincent, Jr. to All Major League Clubs Re: Baseball’s
Drug Policy and Prevention Program, dated June 7, 1991, at 2.
54 Memorandum from Major League Baseball Office of the Commissioner to
Administrative Officials of Major League Baseball Clubs Re: Drug Education and Prevention
Program, dated Apr. 5, 1971, at 2.
55 Federal Food, Drug, and Cosmetic Act, c. 675, 52 Stat. 1040 (codified as amended at
21 U.S.C. § 353(b)(1)(B) (2004)).
18
penalties for drug offenses.56 The act created five schedules of controlled substances that
categorized pharmaceuticals and drugs of abuse based on their “potential for abuse, accepted
medical utility, and safety of use under medical supervision.” 57 The categories ranged from
Schedule I, which was reserved for drugs such as heroin that have “high potential for abuse,” “no
currently accepted medical use,” and a “lack of accepted safety,” to Schedule V, for drugs that
have a “currently accepted medical use” and a “low potential for abuse.”58
More recently, “[i]n recognition of the fact that illegal drug trafficking in anabolic
steroids and human growth hormone was becoming larger in scope and presenting an ever-
increasing health risk to young athletes, Congress addressed the issue with two amendments . . . ,
first in 1988 and then later in 1990.”59 The 1988 amendment added a provision making “the
distribution of anabolic steroids illegal unless (1) it was done pursuant to the order of a
physician, and (2) it was for the purpose of treating a disease.”60
The 1990 amendment, called the Anabolic Steroids Control Act of 1990, imposed
more stringent controls with higher criminal penalties for offenses involving the illegal
56 Comprehensive Drug Abuse Prevention and Control Act of 1970, Pub. L. No. 91-513,
84 Stat. 1236 (1970) (codified as amended in scattered sections of 21 U.S.C.); see Allan H. Selig
and Robert D. Manfred, Jr., The Regulation of Nutritional Supplements in Professional Sports,
15 Stan. L. & Pol’y Rev. 35, 37 (2004) (citing Annalise Smith, Comment, Marijuana as a
Schedule I Substance: Political Ploy or Accepted Science?, 40 Santa Clara L. Rev. 1137, 1146
(2000)).
57 Selig & Manfred, supra note 56, at 37.
58 21 U.S.C. § 812 (2000); see Selig & Manfred, supra note 56, at 37.
59 U.S. Department of Justice, United States Attorney Manual, Tit. 4, ch. 19 (Human
Growth Hormone/Steroids Statutory Overview).
60 Id.; see 1988 Anti-Drug Abuse Amendments, Pub. L. No. 100-690, 102 Stat. 4181
(1988).
19
distribution of anabolic steroids and human growth hormone.61 That enactment reclassified
anabolic steroids as Schedule III controlled substances, effectively raising penalties for their
illegal possession or distribution to levels similar to those applicable to narcotics.62
In addition, the unlawful distribution of human growth hormone was classified as
a felony punishable by up to five years imprisonment (or up to ten years imprisonment for
distribution to individuals under the age of 18). Those penalties also applied to distribution of
human growth hormone for a use other than treatment of a disease or as otherwise expressly
approved by the Food and Drug Administration.63 Human growth hormone has never been
approved by the FDA for cosmetic, anti-aging, or athletic performance purposes.64 Human
growth hormone was not included with steroids as a Schedule III controlled substance, however,
meaning that under current federal law, there is no criminal penalty for simple possession of
HGH.65 Several states have regulated human growth hormone as a controlled substance,
however, under their own versions of the Controlled Substances Act.66
61 Anabolic Steroids Control Act of 1990, Pub. L. No. 101-647, 101 Stat. 4789 (1990)
(codified as amended in scattered sections of 21 U.S.C.).
62 Selig & Manfred, supra note 56, at 37 (quoting Jeffrey Hedges, Note, The Anabolic
Steroids Act: Bad Medicine for the Elderly, 5 Elder L.J. 293, 297 (1997)).
63 Pub. L. No. 101-647, 101 Stat. 4789 (1990) (codified at 21 U.S.C. § 333(e) (1992)).
64 See Food and Drug Administration Import Alert No. 66-71, Detention Without
Physical Examination of Human Growth Hormone (HGH), also known as Somatropin (Jan. 23,
2007). In separate law enforcement proceedings in 2007, two pharmaceutical companies agreed
to settlements with federal prosecutors relating to off-label sales of human growth hormone (with
a physician’s prescription) for anti-aging, cosmetic, or athletic performance purposes. See
Michael S. Schmidt, Company Agrees to a Fine Over Shipments of H.G.H., N.Y. Times,
Sept. 19, 2007, at D5 (Specialty Distribution Services, Inc. agrees to $10.5 million fine and
deferred prosecution agreement); Press Release, Pfizer Inc., Pfizer Subsidiaries Reach $34.7
Million Settlement with DOJ (Apr. 2, 2007) (Pharmacia and Upjohn agreement to $15 million
fine and deferred prosecution agreement).
65 See 21 U.S.C. § 333(f)(1); see generally George Fan, Comment, Anabolic Steroid and
Human Growth Hormone Abuse: Creating an Effective and Equitable Ergogenic Drug Policy,
1994 U. Chi. Legal F. 439 (1994). In March 2007, Senator Charles E. Schumer introduced a bill
20
The 1988 and 1990 amendments did not apply to many potentially performance
enhancing nutritional supplements that were considered steroid “precursors,” the most well
known of which is androstenedione.67 Many of these substances have anabolic effects, and
possible harmful side effects, similar to those associated with regulated anabolic steroids. In
1994 Congress enacted the Dietary Supplement Health and Education Act (“DSHEA”) after the
Food and Drug Administration announced that it would tighten regulation of supplements in the
wake of a series of deaths that were attributed to the use of L-tryptophan, an amino acid.68
The DSHEA placed the burden on the FDA to prove that a supplement was unsafe
before its sale could be prohibited.69 Following the enactment of the DSHEA, supplements
claiming anabolic effects that were geared toward bodybuilders and other athletes became more
widely available.
to amend the Controlled Substances Act to add human growth hormone to Schedule III under
that Act. The bill has been referred to the Senate Judiciary Committee. S. 877, 110th Cong., 1st
Sess. (2007).
66 See, e.g., Colo. Rev. Stat. §§ 18-18-102, 18-18-205 (2007) (listing human growth
hormone as an anabolic steroid); Idaho Code Ann. § 37-2709(f) (2007) (“human growth
hormones” included on Schedule III); Minn. Stat. § 152.02 (2007) (“human growth hormones”
included in definition of anabolic steroids); R.I. Gen. Laws § 21-28-2.08 (2007) (listing human
growth hormone under Schedule III); W. Va. Code § 60A-2-208(c)(12) (2007) (listing “[h]uman
growth hormones or anabolic steroids” as “depressants” under Schedule III).
67 The 1990 amendments did apply to “immediate precursors” of a substance listed on
Schedule III, but supplement manufacturers found ways around this prohibition. See Selig &
Manfred, supra note 56, at 38 (discussing marketing claims for Equibolan, sold as a “legal
precursor to Boldenon,” an anabolic steroid).
68 Dietary Supplement Health and Education Act of 1994, Pub. L. No. 103-417, 108 Stat.
432 (1994) (codified as amended in scattered sections of 21 U.S.C.). Before the enactment of the
DSHEA, dietary supplements were subject to pre-market approval by the FDA unless they
qualified as a food or food additive that was generally recognized as safe, or claimed to affect the
“structure and function of the body” in a way that related only to taste, aroma, or nutrition. See
Selig & Manfred, supra note 56, at 38-40.
69 Selig & Manfred, supra note 56, at 41 (citing 21 U.S.C. § 342(f)(1) (2000)).
21
In 1988, androstenedione became the subject of national attention after a reporter
observed a container of the supplement in the locker of Mark McGwire of the St. Louis
Cardinals during his pursuit of the single-season home run record.70 The ability to purchase the
substance over-the-counter became a subject of intense discussion, and that off-season
Commissioner Selig and Donald Fehr, the executive director of the Players Association, agreed
to co-sponsor a scientific study into androstenedione’s anabolic effects.71
Further developments in professional sports also had an impact on the debate. In
August 2001, Korey Stringer, a lineman with the Minnesota Vikings, died after collapsing during
the team’s summer workouts. Then in February 2003, Baltimore Orioles pitcher Steve Bechler
died during spring training. Products containing ephedra, an amphetamine-like stimulant that
could be sold over-the-counter at the time, were linked to both deaths. In late 2003, the FDA
moved to regulate the sale of products containing ephedra.72 By the time of Bechler’s death, the
agency reportedly had been compiling data required under the DSHEA to show ephedra’s
dangerous side effects in order to ban the substance, but it had not yet completed that work.73
As a result of these and other incidents, both Congress and the FDA increased
their scrutiny of some supplements, including those, such as androstenedione, that were
70 See Steve Wilstein, Sports Spotlight: Home-Run Derby; ROGER THAT; Legendary
Season Grows with Every Prodigious Clout, Houston Chron., Aug. 16, 1998, at Sports 1.
71 See Benjamin Z. Leder, et al., Oral Androstenedione Administration and Serum
Testosterone Concentrations in Young Men, 283 JAMA 779, 782 (2000); John Fauber, “Andro”
Pill Found to Increase Testosterone Like Anabolic Steroids; Supplement May Boost Muscles,
Raise Health Risks, Milwaukee J. Sentinel, Feb. 9, 2000, at 1.
72 Press Release, Department of Health & Human Services, FDA Announces Plans to
Prohibit Sales of Dietary Supplements Containing Ephedra (Dec. 30, 2003).
73 Press Release, Food & Drug Administration, HHS Acts to Reduce Potential Risks of
Dietary Supplements Containing Ephedra (Feb. 28, 2003); Stephen Smith, FDA Proposes
Warning Label for Ephedra, Boston Globe, Mar. 1, 2003, at A1.
22
considered steroid precursors.74 In March 2004, acting under its interpretation of a provision of
the DSHEA, the FDA sent warning letters to twenty-three companies involved in selling
products that included androstenedione.75 In the press release announcing this action, Secretary
of Health and Human Services Tommy Thompson called on Congress to amend the Controlled
Substances Act to include androstenedione within the definition of restricted anabolic steroids.76
Commissioner Selig and his staff were advocates for stricter regulation of these
substances. In congressional testimony in June 2002, Robert D. Manfred, Jr., the executive vice
president for labor in the Commissioner’s Office, described the androstenedione study that had
been sponsored by Major League Baseball and the Players Association and urged Congress to
revise the DSHEA to reimpose regulation on supplements like androstenedione.77 In early 2004,
Selig and Manfred published an article in the Stanford Law and Policy Review explaining the
difficulties posed under baseball’s joint drug program (adopted effective as of September 30,
2002) as a result of the lax regulation of supplements that were steroid precursors.78
Don Fehr also expressed the Players Association’s support for governmental
action to address the problem of legal steroid precursors. In June 2002 congressional testimony,
74 See Selig & Manfred, supra note 56, at 42-43 & n.44 (citing Press Release, Department
of Health & Human Services, HHS Acts to Reduce Potential Risks of Dietary Supplements
Containing Andro (Mar. 11, 2004)).
75 Id.
76 Press Release, Department of Health & Human Services, HHS Acts to Reduce
Potential Risks of Dietary Supplements Containing Andro (Mar. 11, 2004).
77 See Steroid Use in Professional Baseball and Anti-Doping Issues in Amateur Sports:
Hearing Before the Subcomm. on Consumer Affairs, Foreign Commerce and Tourism of the
S. Comm. on Commerce, Science and Transp., 107th Cong. 5, 8-9 (2002) (statement of Robert D.
Manfred, Jr., executive vice president for labor relations, Major League Baseball); see also
Leder, et al., supra note 71, at 782; John Fauber, “Andro” pill found to increase testosterone like
anabolic steroid; supplement may boost muscles, raise health risks, Milwaukee J. Sentinel, Feb.
9, 2000, at 1.
78 Selig & Manfred, supra note 56.
23
Fehr noted that these substances legally could be purchased over-the-counter and that use of
some legal supplements could result in positive tests for steroids, a significant issue for the
Players Association in considering baseball’s proposal at the time to implement mandatory
random drug testing for steroids and other substances.79
In October 2004, Congress passed the Anabolic Steroid Control Act of 2004,
which amended the definition of “anabolic steroid” under the Controlled Substances Act to
include a number of supplements considered to be steroid precursors, including androstenedione,
but not DHEA (dehydroepiandrosterone) – another steroid precursor that is closely related to
androstenedione – and granted authority to the Drug Enforcement Administration to add other
steroid precursors to that definition in the future.80
Contents
Prev
Next
Last
