The Regulation of Sports Products as Dietary Supplements:  
Should the FDA HAVE STRICTER Requirements?

	Food and Drug Law: Professor Peter Barton Hutt

April 4, 2003

Carlotta Denise King
Harvard Law School 
Class of 2003

This paper is submitted in satisfaction of both the course requirement and the third year written work requirement.

Table of Contents

I. Abstract …………………………………………………………………………………..…..  	1

II.  Introduction ………………………………………………………………………………..	1

III.  The FDA’s Regulation of Dietary Supplements……………………………………..…. 	3

A.  The History of Dietary Supplement Regulation……………………………………….. 	3

B.  The Dietary Supplement Health and Education Act of 1994 ……..………………….. 	5
	
C.  Abuse of the System  …………………………………………………………..……… 	9

IV.  The Big Three Supplementary Concerns ………..………………………………………	12

A.  Ephedra ……………………………………………………………………………….	12

1. What is it? …………………………………………….………………………... 	13

2. What are the accusations? ………………………………..……………………. 	13

3. Problems with Ephedra in Real Life …………………….………………..……. 	14

4. Governmental Response …………………………………………………..……. 	17

B.  Androstenedione …..….………………………………………………………………..	18

1. What is it? ………………….…………………………………………………... 	18

2. What are the accusations? ………………………………….…………………. 	18

3. Problems with Androstenedione  in Real Life ………………….………………. 	20

4. Governmental Response ……………………………………………………..…. 	23

C. Creatine ……………………………………………………………………….……….	25

1. What is it? ………………………………………………………….…………... 	25

2. What are the accusations? …………………………………….………………. 	26

3. Problems with Creatine in Real Life …………….……….……………………. 	28

4. Governmental Response ………………………………………………………..	31

V.  The General Regulatory Problem for Sports Products ……………………………...  	32

VI. Regulation from Other Directions ……………………………………………….……...  	35

A. The Federal Trade Commission…………………………..……………………………  	36

B. The National Collegiate Athletic Association ……………………………….……….... 	39

C. Professional Athletic Associations …………………………………...…………..……. 	41

D. The International Olympic Committee ………………………………..………………. 	43

E. The World Anti-Doping Agency ……………………………..………………………… 	46

VII. Solutions to the Current System …..…………………………………………………...  	51

A. Concerns about the FDA’s Unwillingness to Act ……………….…………………….. 	51

B. Extending Food, Drug and Cosmetic Act to Sports Products ……………..………….. 	55

1. Foods ………………………………………………………………….….…… 	55

2. Food Additives ……………………….……………………………………….. 	56

3. Drugs …………………………………………………………………...…… 	60

C. Proposal for New Regulations ………………………………..……………………….. 	65

1. Product Definition …………...…………………………………..…………..… 	65

2. Product Safety ….…………………………………………..………………..… 	68

3. Nutritional Support Claims ……………………………………………..……… 	69

4. Labeling ……………………………………………….……………………….. 	71

5. Penalties ………………………………………………………………..………. 	72

VIII. Conclusion …………………………………………………………………………………	73

The Regulation of Sports Products as Dietary Supplements:  
Should the FDA have Stricter Requirements?

I. Abstract
	Since the Food and Drug Administration (“FDA”) has control over the regulation of dietary supplements, this paper discusses whether the current regulation is sufficient to guard the safety of the individuals using “sports products.”  Recently, the sudden deaths of a number of professional and collegiate athletes have been linked to the use of performance enhancing sports products, and despite other possible causes, many families and scholars have blamed dietary supplements for these lost lives.  Therefore, this paper purports to prove that the current FDA regulations are not stringent enough because they do not subject dietary supplements to the pre-market approval as with drugs and allow life-threatening products to enter and remain in the market.  For evidence, this paper compares different past and present FDA regulations, the scientific risks of the most popular sports supplements, the rigorous regulation by other associations, and the real life stories of athletes’ deaths.  In conclusion, this paper will demonstrate that the current drug requirements should apply to dietary supplements to give the FDA the ability to regulate further dietary supplements that warrant stricter regulation.
II. Introduction
“One death is a tragedy.  A million deaths is a statistic.” – Joseph Stalin
	Over 100 deaths and 1,500 health problems have been reported to the Food and Drug Administration (“FDA”) related to just one supplement used in a sports product.  These deaths encompass athletic men, women, and children; people who are not just statistics.  As with most ingested products, dietary supplements fall squarely within the FDA’s jurisdiction under the congressionally enacted Dietary Supplement Health and Education Act of 1994 (“DSHEA”).  However, the above-mentioned reports, which followed upon the heels of this legislation, demonstrate that more regulation is necessary to prevent these fatalities.  The problem is that scientists, medical professionals, and legislators alike disagree about the side effects of certain supplements and whether they can actually lead to death.  As a result, though the FDA has proposed regulations for dietary supplements that are more stringent, no new legislation or restrictions have resulted.  Unarguably, all sides are concerned with the prevention of avoidable deaths from supplements; however, the power and influence of supplement manufacturers is significant and in the absence of certainty about the side effects, new regulations are unlikely.  Fortunately, new legislation is not necessarily essential because the Federal Food, Drug and Cosmetic Act (“FDCA”) already provides the FDA with strict administrative controls over drugs.  Therefore, faced with such stark statistics and an already at-hand solution, it follows that the FDA either should subject all sports-related dietary products to this restraint or seek to pass a new regulation to prevent more people from becoming statistics.
	This paper considers the viability of more rigorous FDA regulations for sports related dietary supplements.  Part III discusses the FDA regulations currently in place.  It details the history of dietary supplement regulation, the past opposition and abuses of the regulation, and the Act that is the source of the current regulation.  Part IV exposes the truth of three dietary supplements typically found in sports products.  Specifically, it provides the origin, supposed side effects, and real life stories behind ephedra, androstenedione, and creatine as well as the governmental response to these recent incidents.  Part V elaborates on the overall problems of the current regulations and where there is room for reform.  Part VI examines the efforts of five groups, both inside and outside of athletics and the United States, to regulate sports products.  This section looks to the various restrictions implemented for different supplements as well as the extent to which these organizations have succeeded in their efforts.  Part VII provides solutions for how the FDA could employ existing legislation or generate new restrictions to provide sufficient regulation of sports products.  Part VIII concludes that the current FDA regulations are insufficient for the threat posed by supplements in sports products; thus, unless Congress and the courts are willing to allow the FDA to place dietary supplements under the more strenuous regulations for drugs, then it is necessary to pass new more stringent regulations.
III. The FDA’s Regulation of Dietary Supplements
A. The History of Dietary Supplement Regulation
Although Congress passed the first Federal Food, Drug and Cosmetic Act (“FDCA”) in 1938, it was not until 1958 when the FDA decided to regulate dietary supplements under the category of a food additive.  As a food additive, the FDA subjected dietary supplements to more stringent requirements than conventional food products.  However, the FDA decided that even these improved restraints were insufficient.  Therefore, to ensure the greater safety and effectiveness of supplement labeling and use, the FDA promulgated regulations specific to certain dietary supplements in the 1970s.  The supplements of utmost concern to the FDA were mineral supplements and high potency vitamins; thus, the FDA considered placing potency limits on these products to guarantee that the consumers received the best nutritional value. 
As expected, these strict constraints triggered a tremendous industry backlash, and caused Congress to enact the Proxmire Amendment to the FDCA in 1976.   This Amendment set new limits on the FDA’s freedom to regulate supplement advertising and labeling.  As a result, Congress prevented the FDA from imposing maximum levels of vitamin potencies in food and from, “classifying any vitamin or a mineral as a drug simply because it exceeds a potency level that is deemed to have a nutritionally sound rationale.”  The FDA changed the status of dietary supplements again, fourteen years later, through the enactment of the Nutrition Labeling and Education Act of 1990 (“NLEA”), which provided for standardized labeling requirements of conventional foods.  While manufacturers were allowed to make both nutritional support claims and health claims about their products, the NLEA subjected only the health claims to regulation, thus, permitting carte blanche on the vast majority of claims.  The effect of the NLEA on dietary supplements was to hold dietary supplements to the same standard as conventional foods.  Although the NLEA represented a was more exacting FDA standard than under the Proxmire Amendment, it was still extremely cautious and lenient because it prevented supplements from being classified as drugs.  
However, as with any slight increase in the FDA’s authority to control dietary supplements, Congress responded with its own regulations by enacting the Dietary Supplement Act of 1992.   The Act increased the independence of supplement manufacturers by limiting the FDA’s ability to apply the more severe regulations of the NLEA to dietary supplements.  More specifically, the Act demanded that the FDA establish regulations that would pertain solely to dietary supplements.  Nevertheless, in response to the congressional mandate, the FDA reiterated its position under the NLEA by proposing final rules that would continue to treat dietary supplements as conventional foods.  The culmination of this tug of war between Congress and the FDA came in 1994 when Congress passed the Dietary Supplement Health and Education Act of 1994.  In anticipation of the FDA’s proposed rules, Congresses passed these laws to codify its desire for reduced regulation of dietary supplements.   
B. The Dietary Supplement Health and Education Act of 1994
	The Dietary Supplement Health and Education Act of 1994 (“DSHEA”) essentially confirms the reduced FDA regulation of dietary supplements by defining dietary supplements in a category below that of conventional foods, food additives, or drugs.  While the safety of dietary supplements is a controversial subject, the DSHEA rests on the assumption that all dietary supplements are generally safe, and unless the FDA has evidence to prove otherwise, dietary supplements should face little regulation.  The explicit legislative intent for the passage of the DSHEA was that the, “Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers.”  Consequently, by the DSHEA exempting certain sports products from any pre-market evaluation, the FDA must tolerate the entry of some potentially unsafe or ineffective products into the market.  The specific DSHEA definition of a dietary supplement is as follows:
(1) a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: (A) a vitamin; (B) a mineral; (C) an herb or other botanical; (D) an amino acid; (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (F) a concentrate, metabolite, constituent, extract, or combination or any ingredient described in clause (A), (B), (C), (D), or (E). 
Furthermore, the DSHEA specifies that dietary supplements must be intended for ingestion in the form of a “tablet, capsule, powder, softgel, gelcap, or liquid form, or . . . if not intended for ingestion in such form, is not represented as conventional food and is not represented for use as a sole item of a meal or the diet.”  Therefore, by distinguishing dietary supplements and their ingestible form from conventional food products and food additives, the DSHEA essentially places dietary supplements in their own separate, regulatory category. 
While the DSHEA definition of dietary supplements may improve upon past attempts to define and regulate dietary supplements, there exist several distinct and identifiable weaknesses with the current laws.  For example, section 3(a)(1)(E) of the DSHEA specifically permits substances used to “supplement the diet” to be classified as dietary supplements.  The problems with this provision are that it is vague and subject to wide-ranging interpretation, it does not provide a detailed list or examples of what substances fit within this category, and it encompasses many products that are more appropriately classified under a different category.  Thus, if the manufacturer markets a sports product as a dietary supplement, the FDA treats it as such, even if the FDA previously approved the product as a new drug, biologic, or antibiotic, which the FDA strictly regulates.  In essence, this section of the DSHEA creates a substantial loophole by allowing some unknown substances to have unfettered access to the market because the DSHEA deems them dietary supplements.  This loophole is especially important in the sports product market because it creates a huge incentive for manufacturers to make sports products in one of the specified ingested forms, so that their products fall within the dietary supplement classification and so consumers can access them almost immediately.  Although there exists the possibility that the FDA could litigate the classification of a particular sports product, litigation is time-consuming, expensive, and not guaranteed to lead to a different result. 
The DSHEA does provide the FDA with some significant authority over sports products concerning their labeling and marketing requirements.  Specifically, the FDA can remove from the market any dietary supplement that does not comply with their guidelines based upon a finding that the product is adulterated or misbranded.  The labeling sections include provisions demanding that each dietary supplement provide the name of each ingredient,the quantity of the ingredient or the total quantity in the blend, and the statement that it is a dietary supplement.  Moreover, if the dietary supplement consists of any herbal elements, the label must list the plant or the part of the plant from which the ingredient comes. The general idea of these regulations is that if any supplement fails to meet the requisite standards of “quality, purity, or compositional specifications,” then it violates the DSHEA.  Under such circumstances, a manufacturer that does not comply with the regulations is subject to an enforcement action, where the FDA inspects the supplement under the more stringent requirements for foods or drugs. Unfortunately, the burden of proof rests on the FDA to demonstrate that it is proper to remove a particular dietary supplement from the market. 
 	In contrast to the more rigorous labeling provisions, the DSHEA has lenient guidelines for health claims and nutritional support claims made about performance-enhancing sports products.  In enacting the DSHEA, Congress purposefully did not mandate that the manufacturer establish any significant scientific support or agreement for dietary supplement health claims.  For instance, section 6(a) of the DSHEA provides that although dietary supplements are not drugs, their labels may describe, “the role of a dietary ingredient intended to affect the structure or function in humans.”  In addition, the only specific DSHEA requirements for nutritional support and health claims are that manufacturers be able to substantiate that their claims are truthful and not misleading, indicate that the FDA has not evaluated their claims, and state that the product does not diagnose, prevent, treat, or cure any disease.  Accordingly, the FDA attempts to regulate dietary supplements as drugs, when manufacturers begin to make claims that the DSHEA does not include in its “safe harbor” provisions.  Examples of statements within the “safe harbor” are declarations alleging a benefit “related to a classical nutrient deficiency disease,” describing how the supplement improves overall health, or making claims pertaining to “structure or function.”  When a manufacturer violates these restrictions, the FDA will take the product off the market by issuing a declaration that the claims amount to an assertion that the supplement is a drug.  Therefore, sports product manufacturers have extensive leeway to make wide-ranging product claims, even if these claims are confuse the consumer, so long as the manufacturer remains below the stipulated threshold level.   
C. Abuse of the Current System
These indulgent DSHEA regulatory standards have lent themselves to marked abuse by manufacturers.  The most notable example in recent years is that concerning San Diego-based Metabolife International, which is the leading producer of the ephedra-based appetite suppressant called Metabolife 356.  In general, manufacturers of weight-loss products containing ephedra have enjoyed booming sales; estimates indicate that these manufacturers net sales rose from $500 million in 1995 to about $3 billion by the end of the decade.  As the market leader, Metabolife International generated revenue from Metabolife 356 that exceeded $1 billion in 1999. 
In 1997, Metabolife added a toll-free number to its product label to give consumers a way to ask weight loss questions.  However, during a five-year period, Metabolife received more than 400,000 phone calls, many of which were customer complaints.  Consequently, the real controversy began late in 1997, when the FDA realized that Metabolife had withheld consumer reports about the adverse side effects and illnesses resulting from use of their supplement.  Within these reports, dozens of customers had made complaints alleging death, serious illness, or hospitalization and numerous complainants reported heart attacks, seizures, and strokes.  When Metabolife originally received the phone calls on its hotline, the answering nurses did encourage callers to consult a doctor and to stop taking the supplements, but Metabolife did not report these complaints to the FDA or follow-up with its customers.  Despite various attempts by the FDA to investigate, for years they were unable to obtain copies of the reports or even proof that the complaints existed.  A member of the FDA acknowledged the FDA’s lack of a credible threat when he stated that, “[s]ince at least 1997, the FDA has tried to get these adverse event reports from the industry.  We also unsuccessfully sought these reports through litigation.  Metabolife has refused and resisted us every step of the way.”  The fact that the FDA is supposed to control violations by dietary supplements, but manufacturers feel like they are able to disregard the FDA’s authority is one of the major problems with the DSHEA.
As a result, the US Department of Justice (“DOJ”) interceded in the Metabolife controversy and opened a criminal investigation to determine whether Metabolife lied to the FDA when they alleged that they had not received any reports of adverse health effects.  Due to the Justice Department’s investigation, Metabolife voluntarily submitted more than 14,700 consumer complaints regarding the negative side effects of Metabolife 356, which the company had received since 1997.  Lanny Davis, an attorney in Washington, DC, further affirmed the effect of the DOJ’s intervention when he revealed that following the DOJ’s inquiries, Metabolife International took the, “unusual step of asking to be regulated, asking for a mandatory reporting system” of health complaints.  Moreover, the company even offered to donate 5 cents from the profits of each bottle to fund a public education campaign and finance studies on the health effects of ephedrine.  Therefore, the DOJ had more success in seeking and achieving compliance than did the FDA.
However, the FDA met Metabolife’s spontaneous cooperation with skepticism; the FDA’s Deputy Commission, Dr. Lester Crawford, even called the company’s action “disingenuous.”  Dr. Crawford’s cynicism was due to that fact that the FDA had attempted to obtain information about the side effects of ephedrine from the dietary supplement industry since 1997 and “Metabolife has refused and resisted us every step of the way.”  The one positive result from the investigation is that Metabolife is now in the midst of dozens of lawsuits over its products containing ephedra.  Most recently, in November 2002, an Alabama jury ordered Metabolife to pay four plaintiffs $4.07 million for the heart attacks that they suffered after taking Metabolife 356.
IV. The Big Three Supplementary Concerns
While many different sports products concern the FDA and dietary supplement users alike, this section focuses on three: ephedra, androstenedione, and creatine.  These three compounds are main ingredients in a number of sports products and dietary supplements.  For athletes at any level concerned with maintaining their good physical condition and avoiding fatigue during a long season, the beneficial claims of products containing these supplements have been a significant draw.  However, many athletic associations have banned these substances and many others are considering it.  
A. Ephedra
 	Ephedra is the supplement that has received the most attention from the FDA, athletes, and the media.  As a result, various sports organizations, including the National Football League, the National Basketball League, the National Collegiate Athletic Association, and the International Olympic Committee, have already banned this substance.
1. What is it? – Ephedra is a traditional Chinese herb, also called Ma Huang, whose main ingredient is ephedrine.  Ephedra is a shrub-like plant usually found in the desert regions of central Asia, where desert inhabitants use it for medicinal purposes.  Around the world, people call ephedra by many names, such as squaw tea, Bishop’s tea, Chi Powder, and Mormon tea.  The molecular structure of ephedra is very similar to that of amphetamines; therefore, many athletes consider ephedra to be the legal form of amphetamines like PCP and Heroine.  Manufacturers also can produce Ephedra synthetically as pseudoephedrine, which is contained in some over-the-counter cold medicines.  Ephedra’s effect on the human body is to open the bronchial tubes, stimulate the central nervous system, and possibly increase the user’s heart rate, blood pressure, and metabolism.  Due to its energizing nature, many US manufacturers use ephedra in dietary sports products along with caffeine on the premise that it will increase the athlete’s metabolism, help them to loose weight, and boost their energy.  Since ephedra is a plant, manufacturers using it as an ingredient can market and sell their products as “all-natural food supplements” and not drugs.  Therefore, federal law prohibits any regulation of sports products containing ephedra or other similar supplements, unless the FDA can provide conclusive proof that these products are dangerous.
2. What are the accusations? – Since 1994, the FDA has received a significant number of reports from consumers alleging that products incorporating ephedra caused them heart attacks, seizures, strokes, and other health problems.  Statistically, the FDA has since collected reports of more than 100 deaths and more than 1,500 health problems among users of ephedra products.  Nevertheless, the FDA still disputes that these reports prove cause and effect relationship, meaning the FDA thinks that whether ephedra caused these deaths and illnesses is still up for debate.  To combat the FDA’s assertions, an article in USA Today cited Mark Blumental, founder of the American Botanical Council, a research and educational group, where he stated that, 
“An FDA review of 140 adverse-event reports associated with ephedra-containing supplements concluded that 43 of them (or 31%) were definitely or probably associated with ephedra use . . . Adverse effects include rapid heartbeat, insomnia, headaches, nausea, vomiting and trouble urinating.  High dosages (more than the 300 milligrams of ephedrine and related compounds a day) may produce a drastic increase in blood pressure and cardiac arrhythmia.”
Although the FDA contends that the loose restrictions on ephedra are due to a lack of available scientific information, there is largely accepted evidence substantiating ephedra’s harmful effects.  Consequently, even people within the supplement industry agree that the possible adverse effects from ephedra are severe and caution that they should not be sold to people under 18 years of age.
3. Problems with Ephedra in Real Life – Steve Bechler, a 23-year-old minor league pitcher for the Baltimore Orioles died on February 17, 2003 of heatstroke during a spring training workout.  The Broward County medical examiner, who examined Steve after his death, stated at a press conference on February 18, 2003 that ephedra was a contributing factor to his death.  Based on a bottle found in Steve’s locker, the suspicion is that he was taking regularly a supplement called Xenadrine – RFA 1 whose main ingredient in ephedra.  However, the medical examiner could not attribute Steve’s death simply to ephedra because additional factors may have played a role, such as Steve’s dieting to reduce his weight, his borderline hypertension, and his possible liver problems.
	While the Baltimore Orioles contend that they never authorized the use of ephedra by their players, Major League Baseball is one of the few major professional athletic organizations to have not banned ephedra, (the National Hockey League has not banned ephedra either).  In addition, before and after Steve Bechler’s death, many other professional baseball players, such as Mark McGwire and David Wells, admitted to their recurring use of products that contain ephedra.  Although William Goldiner, the Orioles’ team physician, favors a complete prohibition on the supplement, he notes that such a ban in hard to implement because ephedra is a legal substance in the US.  “This is not just a problem of Major League Baseball.  This is a problem of over-the-counter supplements that are dangerous and unregulated . . . We’re at the point where we don’t even know what’s in some of these things.”  
	Unfortunately, Steve Bechler’s story is just one of many stories about unexpected deaths due to ephedra.  Minnesota Viking football player, Korey Stringer, died July 31, 2000 from heatstroke during practice.  Since the medical examiner did not test Korey’s blood during the autopsy, he could not prove whether ephedra was in Stinger’s system.  However, the medical examiner found caffeine, a product used in many sports-related supplements, in Korey’s body and members of the Viking organization found a container of “Ripped Fuel,” a product containing ephedra, in Korey’s locker.  Therefore, while the medical evidence was inconclusive, it seems probable that Korey was in fact using the ephedra-based supplement.
Sadly, these ephedra-related deaths also have extended beyond professional athletes.  For example, US military bases worldwide banned the sale of ephedra products after over two dozen soldiers died who were taking the supplement.  Similarly, just a week before Steve Bechler’s death, Suffolk County, New York banned ephedra after a college student died who was using an energy booster containing ephedra.  Moreover, one of the most tragic incidents occurred in 1998, when Rosanna Porras, a 15-year-old girl, collapsed on a soccer field and died three days later of heart failure.  When the doctor pumped her stomach, they discovered that she had been using “Ripped Fuel,” the same supplement that was implicated in Korey Stringer’s death. Obviously, the athletic organizations, the individual athletes, the coaches, and the medical staff have a responsibility to better educate themselves and each other about the health risks of sports products. However, due to the extensive promotional advertising as well as the lack of sufficient regulation of quality control and labeling of products by the supplement industry, many athletes are confused or unaware about the risks associated with individual sports products.
4. Governmental Response – One positive result from these unfortunate tragedies is that now the government is reconsidering whether to implement restrictions on ephedra by requiring new labels warning of the possibility of death from consuming products containing ephedra.  The FDA is also looking into whether to decrease the allowable dosage of ephedra or whether a complete ban on ephedra products is necessary. However, as usual, this regulation and any others concerning ephedra are on hold until more evidence is gathered.  In the meantime, Tommy Thompson, the Secretary of Health and Human Services, has advised everyone, especially people that exercise vigorously, not to use ephedra.  Thompson remarked, “I would not take this, I would not give it to my family and I don’t know why anyone would take these products.  Why take the risk?”     
As a minimal step, the FDA did warn twenty-four supplement manufacturers, who marketed their ephedra containing products towards bodybuilders and athletes, to stop any misleading advertising within fifteen days because of a lack of evidence that ephedra increases athletic performance.  In addition, in separate efforts, the House Energy and Commerce Committee has promised that congressional hearings will take place to consider whether a ban on ephedra is necessary, and the consumer advocacy group, Public Citizen, is considering a lawsuit against the FDA to force them to make the substance illegal. Therefore, while the government has not issued any new restrictions, these unexpected deaths and the media attention they have received, have caused various governmental agencies and consumer organizations to reconsider what more stern regulation ephedra warrants.  
B. Androstenedione
1. What is it? – Domestically, scientists know very little about androstenedione (“andro”).  Andro, a substance found in pine trees, is a naturally occurring steroid hormone that is a precursor to testosterone and estrogen.  However, under its guidelines, the FDA classifies andro as a dietary supplement and not an anabolic steroid, like testosterone.  From a performance perspective, when androstenedione enters into in the body, the body breaks it down into testosterone or estrogen.  The increase in blood testosterone or estrogen levels that results from introducing androstenedione into the body may increase the user’s energy as well as possibly enhance recovery and muscle growth after exercise.
2. What are the accusations? – While andro is not an anabolic steroid, it breaks down into the steroid testosterone, which the Anabolic Steroids Control Act characterizes as a controlled substance.  Therefore, some of the accusations concerning andro relate to those of other anabolic steroids and make it a potentially hazardous performance-enhancing steroid.  For example, known risks of anabolic steroids include increased aggressiveness and severe mood disorders, increased risk of heart disease, increased risk of cancer, elevated cholesterol levels, and liver damage or dysfunction.  In addition, the ability of andro to separate into testosterone or estrogen can cause unique effects, such as the masculinization of females through clitoral hypertrophy, breast atrophy, and amenorrhea, and the feminization of males through breast development, decreased sperm counts, and shrinking of the testes. 
The most complete documented evidence about the effects of andro comes from East Germany, where East German officials actively relied on andro as a doping agent for their athletes.  Moreover, documents discovered after the German unification reveal that the Germans extensively experimented with andro.  The Germans even went so far as to develop a “nasal steroid application,” which all German athletes competing in the 1988 Seoul Olympics were mandated to use.  Within the East German records, similar side effects have been documented, including androgen-induced amenorrhea, severe ovarian cysts, advanced liver damage, and fetal malformation among pregnant women.
Since the athletic community knows so little about andro, due to lack of documentation and scientific evidence, they are demonstrably concerned about harmful side effects, which can possibly take years to manifest.  This delayed effect results because unlike most drugs, the adverse impact of steroid use usually appears a long time after the initial use.  However, even if the side effects appear later, when athletes ingest andro, a urinalysis test occurring soon thereafter will still result in a positive test for the illegal steroid testosterone.  The uncertainty of the side effects combined with these test results has led to the banning of andro by the NFL, the NCAA, and the International Olympic Committee.  Major League Baseball has not yet banned andro, but they have vowed to construct a policy on performance enhancing sports products.  
3. Problem with Andro in Real Life – Since the FDA has reported only two deaths related to androstenedione,death is not the major concern with androstenedione, but the other side effects and hazards are no less far reaching.  A book by Steven Ungerleider entitled “Faust’s Gold: Inside the East German Doping Machine,” gives the most complete account of how high ranking East German officials forced anabolic steroids on more than 10,000 unknowing young athletes from 1961 to 1988.  Ungerleider “details the extensive health problems that the female athletes suffered as a result of the ‘vitamins’ that they took, ranging from short-term concerns including raging libidos and unnatural hair-growth, to serious, long-term problems including depression, birth defects, heart failure and tumors.”  
These long-term adverse effects resulted in a number of German athletes bringing suit beginning in 1998 and continuing to the present.  For instance, on May 2, 2000, a trial began against multiple East German officials for the unknown doping of German athletes.  The plaintiffs were 142 former East German female athletes, all of whom had suffered long-term side effects from their unknowing intake of anabolic steroids, including androstenedione.  Fortunately, though this case is ongoing, many other trials have resulted in convictions of East German officials.  Thus, in a related trial, an East German medical official was “convicted of accessory to causing bodily harm in 109 cases and fined 45,000 marks (US$25,000/23,000 euros).”
In the United States, androstenedione has only recently seen widespread use.  Since the federal regulations classify andro as a dietary supplement, and not a steroid like testosterone, the FDA governs its use through the DSHEA.  However, the influx of US attention to andro began with the announcement in 1998 by Mark McGwire, a baseball player for the St. Louis Cardinals, that he used both andro and creatine.  During McGwire’s quest to shatter Roger Maris’ homerun record, he revealed his supplement use, which led to questions of whether the supplement had in fact enhanced his performance. Nevertheless, McGwire has not suffered any detrimental effects to his career after admitting that he utilized supplements because andro is legal in Major League Baseball; instead, he became an American icon and Time Magazine named him their Hero of the Year.  Therefore, due to the vast media attention given to McGwire and andro, sales of the supplement subsequently increased dramatically, especially among high school athletes.  Since this revelation, many other professional athletes have also exposed their dietary supplement use; the list includes, Sammy Sosa of Major League Baseball’s Chicago Cubs, Jeff Bagwell of Major League Baseball’s Houston Astros, and Shannon Sharpe of the National Football League’s Denver Broncos.  “At least 100 [other baseball players] in the majors and minors [also are using] at least one type of dietary supplement with the purpose of improving their athletic performance.”  Although General Nutrition Centers (also known as “GNC”) ordered its stores to stop selling androstenedione two months before McGwire’s declaration, within a year after McGwire’s announcement, GNC was again selling andro supplements and sports products. 
	Despite McGwire’s successes, other athletes have damaged or ended their careers by attempting to enhance their performances with andro.  Consequently, the prohibitions by some professional athletic associations and not by others have created debate over a double standard for different athletes.  For example, American shot-putter, Randy Barnes, tested positive for andro and as a result, he received a lifetime ban from track and field by the International Amateur Athletic Association.  Similarly, C.J. Hunter, another American shot-putter, tested positive for andro and his drug test results came out during the 2000 Summer Olympics.  Even though Hunter was not competing in the games, his positive test resulted in speculation about his wife, track star Marion Jones, who was having a record-breaking Olympic performance.  However, even if every sports association banned androstenedione that would not solve all the problems.  In a symposium on this subject, Mr. Adolpho Birch, Labor relations Counsel to the National Football League remarked, “You have androstenedione become a problem, we figure that out; next thing you know, androstenediole is in there because they have learned how to switch the markers a little bit and make a new substance that cannot be detected as quickly.”  Therefore, since the product manufacturers are adapting their products to changes in drug testing, before the sports organizations even become aware that a specific supplement is a problem, the solution to this regulation must come from up high, from Congress and the FDA.
4. Governmental Response – The general response by the FDA to consumer health concerns about androstenedione has been to do nothing.  As of the date of this paper, the FDA has not issued any warnings regarding andro or taken any measures to regulate it or other steroid precursors.  One of the only responses to questions about FDA inaction came from an associate commissioner to the FDA, William K. Hubbard, who said in a letter to the New York Times that the FDA was evaluating the “legal and scientific” issues.  Otherwise, the FDA has had no further comment on this issue.
In contrast to the FDA, Congress has focused new attention of these issues.  In fact, some members of Congress have proposed removing steroid precursors, like androstenedione, from the over-the-counter market and instead including these products in a category with other controlled substances.  Unfortunately, there is also some congressional opposition to further regulation headed primarily by Senator Orrin G. Hatch, Republican of Utah, and Senator Tom Harkin, Democrat of Iowa.  These two senators were the Congressmen who in 1994 sponsored the bill to approve the DSHEA and deregulate the dietary supplement industry. Therefore, Senators Hatch and Harkin contend that the FDA already has sufficient regulatory power over steroid precursors and all that is necessary is that the FDA employ their authority and take more forceful action.
Therefore, most governmental support for efforts to stop andro use has come from executive agencies in recognition of work by outside organizations, instead of from the FDA or Congress.  For example, Dr. Linn Goldberg of the Oregon Health & Science University in Portland started as organization known as ATLAS (Athletes Training & Learning to Avoid Steroids) in 1994 to educate high school students about the horrors of steroids and other performance enhancers.  Dr. Goldberg established his program because “steroids are one of the only drugs that's increasing (in use).”  Schools in more than 25 states have incorporated the program already, and due to a NCAA grant, colleges will now implement ATLAS on their campuses nationwide.  The ATLAS program, which encourages students to teach their peers, has won awards from the U.S. Department of Education, and the Department of Health and Human Services hails it as a model program. 
C. Creatine
1. What is it? – The chemical name for creatine is methyl guanidine-acetic acid and it consists of three amino acids: arginine, glycine, and methinine.  Generally, creatine is a compound that the human body already contains; the body combines the amino acids in the human liver, pancreas, or kidneys to make creatine.  On average, the human body uses about two grams of creatine per day.  However, creatine also can be incorporated into the human diet either from dietary supplements (usually in powder, liquid, or gum form) or from the nutrients in meat, milk, or fish. 
From a more scientific perspective, the human body contains most creatine within skeletal muscle, although smaller amounts of creatine are also present in the heart, brain, and testes.  Following ingestion (or synthesis) the blood transports the creatine into the skeletal muscles by special transporter molecules on the muscular surface, where it serves to increase muscle energy levels.  The availability of creatine affects the activity of these creatine transporters.  Therefore, creatine enhances the body’s energy by increasing the availability of ATP, the cell’s energy molecule.  Since the body’s strength is dependent on how rapidly ATP becomes available to the muscles during exercise, using creatine supplements increases strength.
Typically, people notice an improvement in their athletic performance when the creatine levels in their body increase by at least 20 percent.  Therefore, people who use synthetic creatine are seeking to restore muscle tissue after strenuous exercise and enhance athletic performance.  Many people also consume creatine to increase their lean body mass while adding muscle weight, but some of this gain is possibly water gain resulting from the movement of water from the blood into the skeletal muscle.  Nevertheless, creatine users have reported as much as 6.6 pounds of increased body weight during the first weeks of ingestion.  No one has studied yet what the benefits of long-term creatine use are on the body.  
Athletes can also find creatine in a variety of forms.  Due to the recent popularity of synthetic creatine to enhance athletic performance, retailers sell it as citrate, phosphate, or monohydrate salts.  The most commonly used form in athletics is creatine monohydrate, which is simply a molecule of creatine accompanied by a molecule of water.  Despite its greater popularity, a gram of creatine monohydrate does not contain any more creatine than a gram of either creatine citrate or creatine phosphate.
2. What are the accusations? – Since creatine has been around for such a relatively short time, there have not been any accepted studies on its long-term effects.  However, creatine is known to have a number of short-term side effects eon the body result in a number of known short-term side a number of short-term side effects on the human body.  First, the most noted side effect is that is causes dehydration.  The concern about dehydration is valid because much of the water in the human body follows creatine into skeletal muscle during intense exercise, which can deprive the remaining body tissues from the water they need.  If an individual does not remedy their dehydration, they can suffer from extreme heat exhaustion, especially when they exercise in hot environments.  Therefore, the severe dangers of dehydration from creatine use are most acute in sports like wrestling, where athletes strive to make weight before competing by restricting their fluid intake and sweating excess water from their system.
Consuming large doses or abusing creatine can also produce another series of side effects.  Specifically, “reports of gastrointestinal distress, stomach cramps, nausea and diarrhea have also been attributed to creatine use, especially when taken in large doses.”  However, if athletes detect the beginnings of these disorders early on, they can avoid these serious side effects.  These gastrointestinal pains most likely result from the undissolved creatine drawing water into the intestine; thus, completely dissolving the creatine by drinking 16 ounces of juice or water normally will circumvent the problem.  Consuming large amounts of sugary products while using creatine may also complicate gastric emptying and lead to the aforementioned illnesses.
 Additional health problems also occur from dehydration pursuant to creatine consumption.  The most frequent reports involve athletes suffering muscle cramps, strains, and pulls after using creatine.  These muscle injuries relate to an electrolyte imbalance that results from dehydration.  Likewise, further allegations from taking creatine supplements are that it causes undue stress on the kidneys.  Renal stress occurs most often during an athlete’s loading phase, where they take large amounts of creatine. The loading phase causes problems because in clearing unabsorbed creatine from the blood stream the kidneys must work very hard.  Therefore, people that are aware of pre-existing kidney disorders must abstain from creatine use altogether.
Medical specialists also associate creatine with a number of disputed bodily changes, not all of which are detrimental.  For example, some consumers have reported that creatine use improved their cholesterol levels, while others have asserted that creatine stimulated their production of new muscle proteins.  Neither of these supposed effects have scientific research to substantiate them.  Another major concern is that fluid retention from creatine use can increase a person’s blood pressure, but there is no consensus as to whether this side effect is attributable to creatine.  Furthermore, rumors also allege health risks that stem from the belief that creatine is another type of steroid.  Therefore, possible additional health problems include breast formation in men, a reduction in penis size, hair loss in men, hair growth in women, and stunted growth in children.  Lastly, there have been unexplained incidences of severe aggression or acne linked to the use of creatine.
3. Problem with Creatine in Real Life – Unlike ephedra and androstenedione, creatine is not a substance banned by the NFL, NBA, MLB, NFL, NCAA, or the Olympics.  Creatine has not resulted in such heightened regulation from outside sources because the FDA has not reported any deaths related to creatine.  As a result, for several years, a large number of professional and collegiate sports teams approved and often provided creatine to their athletes.  However, the NCAA has taken steps to caution collegiate athletes about the use of creatine.  The NCAA does permit athletes to consume protein powders as long as the supplement use does not exceed 30 percent of the athlete's daily calories.  However, the NCAA has now prohibited schools from distributing creatine, even though the NCAA is aware that college athletes can still buy supplements at the store. 
	This increased attention by the NCAA has resulted from a number of statistical and factual assertions.  One shocking statistic revealed by medical research is that between 1995-2001 an estimated 15 football players died from heatstroke where ephedra and/or creatine played a role.  However, the more tragic events relating to creatine occurred in 1997 and involved three college wrestlers.  During the course of one month (from November 9 to December 9), three college wrestlers at three different universities died, all of whom were taking supplements containing creatine.  The first death was 19-year-old Billy Saylor, a student at Campbell University.  Billy was a scholarship wrestler, who was attempting to lose six pounds to qualify for his first collegiate wrestling meet.  In his zealousness, Billy worked himself to exhaustion by running and riding a stationary bicycle and refused to drink any liquids.  Then, on November 22, Joseph LaRosa, a senior at the University of Wisconsin – La Crosse died of heatstroke after trying to lose four pounds.  At the time, 22-year-old Joseph was wearing a rubber suit and riding a stationary bicycle.  Lastly, Jeff Reese, a wrestler at the University of Michigan, died of heart failure and kidney malfunction.  Similar to Billy and Joseph, 21-year-old Jeff was also wearing a rubber suit and riding a stationary bicycle, while working out in a room heated to 90 degrees.
	While these three deaths were clearly unfortunate, the extenuating circumstances of how these boys died made proving that creatine was at fault difficult.  Although, as discussed above, creatine can dangerously dehydrate the body, each wrestler was purposefully dehydrating their body by working out at drastic levels and not consuming sufficient liquids.  Furthermore, at the time, the use of rubber suits and heated rooms by wrestlers was already a subject of controversy within the athletic community, due to numerous stories of athletes being light-headed or actually fainting after workouts.  However, many coaches contested the perception and contended that the use of heated rooms and rubber suits alone was not detrimental.  As confirmed by John Azevedo, coach of the top-ranked Calvary Chapel High School wrestling team, “I know kids use saunas.  They do it on their own, go to their own workout place.  A sauna isn't that big of a deal, if you're doing it right.  It can be therapeutic.” In addition, it was the scientists at the Centers for Disease Control and Prevention that suspected the connection with the dietary supplement creatine.  As a result, all of the conflicting arguments and evidence about creatine, made it impossible to attribute the deaths solely to the athletes' creatine use, but creatine was still a likely contributing factor.
The general problem with banning creatine is that, as mentioned above, it naturally exists in so many foods, which makes it very hard to test for in the body without achieving false positives.  Since there have not been enough studies on creatine’s long-term side effects when used as a supplement, the lack of clear data only leads to speculation and controversy.  A number of scientists have agreed that when taken within normal dosage, creatine should not pose any long-term health risks.  However, the problem on the other side is that no study has tested creatine for a period longer than three months and many athletes are using creatine well beyond the recommended dosages.  Therefore, because studies seem to agree that taking 20 grams a day of creatine (more than recommended) will cause the aforementioned kidney and liver damage due to the body having to excrete the excess, what is certain is that creatine does have some very dangerous side effects and it should receive greater attention and regulation.
4. Governmental Response – Immediately after the deaths of the three college wrestlers, the FDA conducted an investigation on the effects of creatine as a synthetic muscle-building supplement.  However, the FDA returned results saying that there was no identifiable evidence to directly link the use of creatine to the deaths of the students.  Furthermore, according to one supplement retailer, the FDA has concluded that creatine has no side effects at all.  Therefore, other than this minimal investigation and the concerns relating to labeling of dietary supplements in general, the FDA has taken no action against creatine.
V. The General Regulatory Problem for Sports Products
The biggest hurdle in regulating sports products is that they encompass a broad range of forms and intended uses; therefore, the FDA is unable to utilize just one regulatory classification.  The most basic type of sports products are sports drinks, such as Gatorade and AllSport, which contain large levels of electrolytes and carbohydrates to replace lost fluids during exercise.  Other products take the form of powders, bars, or pills, such as Metabolife 356, PowerBar, or Ripped Fuel, which most athletes take to provide additional nutrients before or after exercise.  Thus, in addition to the difficulty of categorizing individual sports products differently is the problem that often consumers will use the same product for multiple purposes, which would mandate that the FDA classify and restrict certain supplements under multiple regulations. 
Under the current DSHEA framework, the regulations concerning dietary supplements depend on the specific form of the sports product and not its function.  Thus, the FDA regulates sports products that take the form of sports drinks or bars as conventional foods, whereas the FDA regulates powders and pills as dietary supplements.  The FDA’s use of disparate regulations with different sports products generates anomalous results because under this structure, the FDA regulates sports drinks and bars under the more rigorous provisions for foods, even thought these products are usually safer since they contain vitamins, minerals, and proteins.  In contrast, sports powders and pills frequently consist of dangerous amino acids and herbal ingredients, but because the DSHEA classifies them as dietary supplements, the FDA subjects them to those moderate standards rather than the strict pre-market drug approval or even the conventional food standards used for drinks and bars.  Therefore, the FDA is perpetuating inconsistency by regulating certain safe sports products more strictly, while subjecting some more dangerous sports products leniently.
The effects of the FDA’s hypocrisy on athletics are that it endangers the health and safety of the athletes as well as the fairness of athletic competition because manufacturers market these dangerous sports supplements explicitly to athletes.  Since advances in medicine and technology are providing athletes with innumerable ways to chemically boost their performance, the incentives favor competitors that are willing to use supplements to win at all costs and gain an unfair advantage.  In contrast, the athlete that wants to compete fairly and drug-free, has much less of a chance at winning.  On the other side, the win-at-all-costs athlete is physically jeopardizing his health in a way that the supplement-free athlete is not.
Moreover, there are large societal costs, which result from the uneven use of sports products.  For example, as illustrated by Mark McGwire’s record, even American heroes can cause the public to lose faith in the integrity of athletes and of organized sports as a whole.  Therefore, as in the case of Marion Jones, when honest athletes do compete, their victories are still subject to public doubt.  In addition, the use of performance-enhancing sports products by elite professional athletes sends a message to children that supplement use goes hand-in-hand with becoming a champion.  As a result, an alarming number of school-age kids are ingesting products containing ephedra and other dangerous supplements in an effort to become superior athletes. 
As discussed below, various efforts by parties both within the US and internationally are underway to reform the image and integrity of sports as well as to educate athletes of all ages about the long-term health risks of using dietary supplements.  More specifically, organizations such as World Anti-Doping Agency and US Anti-Doping Agency are implementing increased drug testing measures for banned substances to restore the level playing field among athletes by ensuring that all competitors are free of banned substances.  However, because many of these efforts conflict with the laws imposed by the FDA, American athletes are subject to a double standard; the athletes must use supplements to be competitive domestically, while use of the supplements will have them banned from competition internationally.  Moreover, the erroneous labeling by some supplement manufacturers makes it difficult for even the aware athlete to be sure that whatever they are taking is not a banned substance.  As long as the FDA continues to employ regulatory standards below the levels of other international organizations and competitions, US athletes will remain in this unenviable position.
Lastly, there is a growing argument within Congress that a large part of the regulatory problem is that while Congress has allocated sufficient authority to the FDA over sports products, the FDA has not accurately applied its current resources.  Therefore, certain members of Congress argue that there exists an erroneous public conception that the FDA lacks sufficient authority over sports products. The argument follows that the agency’s relaxed regulation has manifested itself in three ways:
•	1) “Sometimes the agency has not enforced the authority that it possesses.” 
•	2) “Sometimes the agency has asserted that certain requirements exist but then has not followed up to enforce.”
•	3) “Sometimes the agency has expended substantial resources unsuccessfully on inappropriate targets.” 
However, the arguments about the FDA’s lack of responsiveness and concern are in error, rather Congress has stifled many of the FDA’s efforts at additional regulation.  As a result, part of what new FDA regulation has to address is how to ensure that when a consumer brings a complaint concerning a dangerous sports product that the FDA can overcome roadblocks put in their way by Congress. Implicitly, this requires an examination of the undue influence that manufacturers and retailers have over Congress and how to give the FDA real authority in the face of such pressures.
VI. Regulation from Other Directions
	Due to the existing safety threats of sports products and the absence of a strong presence from the FDA, part of the solution to the problem of sports products and dietary supplement regulation is for other organizations to regulate themselves.  Therefore, this section details the efforts coming from five different avenues, both inside and outside of the sports industry, to address this deficiency.  The specifics groups discussed below are as follows: the Federal Trade Commission, the National Collegiate Athletic Association, the professional athletic associations, the International Olympic Committee, and the World Anti-Doping Agency.	
A. The Federal Trade Commission
While the FDA possesses most of the direct government authority over dietary supplements, the Federal Trade Commission (“FTC”) has also applied its general authority to monitor “unfair or deceptive” trade practices to assist with regulation of this industry.  In particular, the FTC supervises advertising of dietary supplements by ensuring the truthfulness of the health claims made by supplement manufacturers and retailers.  The standard that the FTC imposes on advertisers is that there must be a “reasonable basis” for their claims before they can make them public.  Since the FTC’s concern is with only one aspect of dietary supplements, specifically the deceptive nature of industry advertisements, they are able to monitor the manufacturers and retailers in this specific area more effectively than the FDA. 
Regarding health claims, the FTC considers various factors in their determination about the accuracy of the claim.  The FTC places particular emphasis on experts in the field and to what extent these experts would agree that scientific evidence adequately supports the manufacturer’s assertions. Specifically, when the FTC does challenge the deceptiveness of a specific advertisement, they require proof from the company that their product representations rely on “competent and reliable scientific evidence.”  In these cases, the company must come forward with proof, such as objective scientific studies conducted by experts, to demonstrate the reliability and accuracy of the company’s claims.  If the FTC decides that the product claims are either explicitly or implicitly without any reasonable substantiation, then the FTC will declare the claim to be an unfair or deceptive trade practice, which results in the issuance of a cease and desist order to the manufacturer or retailer. 
Due to their more focused approach, the FTC has succeeded in forcing some manufacturers to comply with advertising requirements established by the Federal Trade Commission Act (“FTCA”).  For example, in Federal Trade Commission v. Pharmtech Research, Inc., the D.C. District Court enjoined the manufacturer of a dietary supplement called “Daily Greens” from advertising its product as a “cancer resisting agent.”  The DC District Court asserted that because there was no reasonable scientific basis for making this claim, the marketing campaign was false and misleading under the FTCA.  Pharmtech based their product claims on a study indicating that a correlation existed between specific compounds found in certain foods and lower human cancer rates; these compounds were the main ingredients in “Daily Greens.”  Despite statements in the study that the consumer would obtain these benefits only from eating the specific foods and not from consumption of those specific dietary supplements, Pharmtech relied on the study findings as conclusive proof their product’s efficacy. 
While courts are often hesitant to grant injunctions, the DC District Court found that an injunction was proper because of the substantial likelihood that the FTC would prevail on its claim that Pharmtech violated Section 12 of the FTCA.  The court relied on “undisputed” evidence that Pharmtech wrongly alleged that using their supplement was associated with lower cancer rates, and Pharmtech eliminated essential details that would have proven the falsity of their claims.  In addition to Section 12 of the FTCA, the court found that Pharmtech violated Section 45 because their advertising played on consumer fears about cancer to make their product more marketable.  Pharmtech protested the injunction arguing that the costs of changing their marketing strategy and the negative reaction of retailers to the litigation affected their business in violation of their rights under the First Amendment of the Constitution.  Nevertheless, the court reasoned that since the First Amendment did not prohibit regulation of false or misleading advertising, that any additional costs that Pharmtech would bear did not outweigh the public’s interests in ensuring truthful advertising. 
The importance of this decision was that it marked an instance in which the federal court supported the FTC’s authority to assert that the use of advertising for dietary supplements that was false or misleading would result in enforcement actions against the manufacturer.  Outside of the courts, the FTC has also brought several enforcement actions through administrative orders against numerous manufacturers, retailers, and advertisers who publicized unsubstantiated health claims.  In fact, the FTC reached a $2.4 million settlement with General Nutrition Centers (“GNC”), whereby GNC would pay this amount as a penalty for violating a previously issued FTC order for untruthful claims made regarding a dietary supplement.  Thus, the FTC has not limited their actions to manufacturers, but has also challenged advertisers that played a part in making unsubstantiated health claims.  Nevertheless, most of the FTC’s enforcement actions have occurred against dietary supplement manufacturers who claimed that consumers who used their products would receive health benefits when no evidence existed about the effectiveness of the supplement.  Therefore, the most common FTC enforcement relates to manufacturer statements that their supplement increases weight loss, improve muscle development, or boost metabolism.
B. The National Collegiate Athletic Association
As of August 13, 2002, the National Collegiate Athletic Association (“NCAA”) had compiled a list of over eighty banned substances, including both ephedra and androstenedione.  Part of the reason for the NCAA’s stringent regulation was that an NCAA study released in August of 2001 revealed that 42 percent of college athletes were taking some form of nutritional supplement, and out of those athletes, 58.7 percent bought their supplements at a retail store.  Moreover, despite media reports of possible health risks, NCAA coaches feared that collegiate athletes are ignoring the warnings and the NCAA’s attempts to educate them.  Colorado football coach, Gary Barnett, expressed his worries saying, “I think that most of them aren’t paying attention to things that are being said to them . . . all of us are concerned about that . . . It’s like drugs.  It’s like alcohol.  It’s like gambling.  All you can do is lay it out for them, and it usually takes something like this [study] for them to start waking up.”  Therefore, in addition to the prohibitions, the NCAA instituted very strict penalties, where athletes lost one year of playing eligibility for testing positive for banned substances. 
Another huge impetus to this regulation was that the NCAA has encountered too many incidents in recent years, where college athletes died who were taking performance enhancing sports products, most often containing ephedra.  For example, just within collegiate football, two players died in 2001 while using supplements containing ephedra.  Rashidi Wheeler, a Northwestern football player, died on August 3, 2001 following a strenuous workout.  Similarly, a Florida State player named Devaughn Darling collapsed and died during conditioning drills.  Because of these deaths, coaches and school administrators have accepted a lot of responsibility for educating athletes about the dangers of supplements. 
“Before the first [Colorado University] CU football practice every year, trainer Steve Willard meets with the players to go over the list of banned substances and talk about supplements.  He encourages players to come to him if they are unsure about a supplement.  The NCAA also maintains a hotline for coaches, trainers and athletes to call if they have questions about whether a product is banned.” 
Since the NCAA has more of an obligation than professional athletic associations to safeguard the well-being of its athletes, they have been more aggressive in their efforts to educate college athletes and impose bans.  Regrettably, the NCAA will have to wait to see whether their recent educational and regulatory efforts succeed.
C. Professional Athletic Associations
The athletic associations governing professional athletes have taken varied approaches to address the issue of sports products and dietary supplements.  Many of the bans for professional athletes have resulted because if any of them consume dietary supplements, such as androstenedione, they cannot compete on the international level.  Therefore, all North American professional leagues, with the exception of Major League Baseball, have barred the use of androstenedione and ephedra.  Instead, Major League Baseball purports to be conducting a long-term study to determine the health and safety risks of supplements.   This regulatory inconsistency among professional athletics has created a controversy between different athletic leagues, which have begun to criticize each other for their relaxed standards toward the use of dietary supplements.
The National Football League (“NFL”) has the most publicized and strictest substance policy, due mostly to the deaths of Korey Stringer and other football players at every level.  On September 27, 2001, less than two months after Korey’s death, the NFL strengthened the league’s prohibition on the use of anabolic steroids and related substances; the most rigorous rules concerned sports supplements containing ephedra and other high-risk stimulants.  The three most important provisions of the new policy were as follows:
•	1) “The use or distribution of products containing the following high-risk stimulants is prohibited: Ephedrine alkaloids, including ephedra and ephedrine (also known as Ma Huang, Bishop's Tea, and Chi Powder), methylephedrine, norephedrine (also known as phenylpropanolamine), pseudoephedrine, and norpseudoephedrine.”
•	2) “NFL clubs and players are prohibited from participation in any unauthorized endorsement arrangements with supplement manufacturers or distributors.  Approval will not be granted for an endorsement involving any company that produces or markets a product containing a substance that is on the NFL's banned list.”
•	3) “All clubs must communicate these policies and procedures to all club employees and representatives, including players.”
These newly stated rules demonstrate a marked interest by the NFL not only to safeguard the lives of their players, but also to protect the lives of other Americans.  In particular, the NFL’s regulations show a realization that kids idolize and mimic the behavior of professional athletes; therefore, prohibiting athletes’ endorsement of these products made a statement to children that they not use performance enhancers.
The NFL also implicitly recognized the deficiencies in the FDA’s current regulations through the passage of their new regulations.  In a press release, the NFL recognized that these dietary supplements present major health risks for athletes and others engaged in strenuous physical activity.  The NFL Commissioner, Paul Tagliabue, particularly noted the downside to the significant increase in the availability of sports products that enhance performance.  Specifically, Tagliabue emphasized that because these dietary supplements enter the market without any prior governmental approval, there is no way to ensure the safety or effectiveness of the supplements or even that the ingredients listed are what the product actually contains.  Commissioner Tagliabue also indicted a particular concern with ephedra-based products, stating that, “[l]ast December, players and clubs were alerted to the risks of ephedrine in a notice from Dr. John Lombardo, NFL Advisor on Anabolic Steroids.  He advised that, particularly with regard to athletes, there is growing evidence linking ephedrine to fatal heart rhythm difficulties, strokes, thermo-regulatory problems, seizures and other serious conditions.”  Thus, it is clear that the NFL has acknowledged the possible health risks and has erred on the side of more encompassing protection.
D. The International Olympic Committee
The International Olympic Committee (“IOC”) has a strong commitment to the prevention of doping; therefore, the IOC has placed both ephedra and androstenedione on their list of banned substances.  At the international level, the IOC has instituted strong prohibitions for athletes attempting to compete in the Olympics because some countries do not test athletes at all while others only test haphazardly.  Moreover, in their diligence, the IOC also has constantly updated their regulations, due to claims that many athletes have found ways to evade the system and avoid detection.  However, conflicting evidence exists as to the extent that athletes are taking banned substances.  Therefore, a survey released by the US Anti-Doping Agency (“USADA”) said that 40 percent of athletes feared a positive drug test, even though 84 percent of the same athletes confirmed that they do not use performance enhancers and another 91 percent stated that they would not take performance enhancers even if they knew another competitor was doing so.
Regardless of the conflicting data, one truth that has emerged is that some recorded positive drug tests resulted from athletes’ use of supplements and sports products.  Since many of these positive tests occurred among a number of athletes from the same country or involved well-known athletes that should have known better, the IOC has made sport product supplements their personal mission in the last few years.  The problem that the IOC is now facing is that some athletes have claimed that their use of a banned substance contained in a supplement was inadvertent.  Athletes have cited a number of situations in which such innocent doping might occur:  
•	1) “The supplement contains a banned substance as a stated ingredient, but the athlete is not aware that the substance is banned or that it acts to cause a positive doping test.”
•	2) “The supplement contains a banned substance within stated ingredients, but the athlete is unaware of the relationship between the products.”
•	3) “The supplement contains banned substances that are not declared as a stated ingredient.  These ingredients may be added deliberately and not declared, or added inadvertently as by-products of other ingredients or contaminants of the production process.”
However, the IOC’s global standards are necessary because athletes can now obtain supplements and banned substances from overseas through mail order, Internet sales, or personal importation.  Therefore, even though athletes in one country may not have the sports product in their own country, once they find out that it is giving other athletes an edge they will seek to get it.  Consequently, the IOC regulations cause all athletes to attain a global understanding about what it is they can and cannot take, and the IOC equalizes the balance for countries where there is less regulation of the production and marketing of supplements.  
Due to the IOC’s diligence, many athletes and coaches have criticized them for being overly restrictive.  The most boisterous criticisms came on the last day of the 2002 Winter Olympic Games in Salt Lake City, when the IOC disqualified three cross-country skiers, “Larissa Lazutina and Olga Danilova of Russia and Johann Muehlegg of Spain,” for positive drug tests.  The controversy arose because the substance for which the IOC banned the skiers was darbepoetin, a drug that was not included on the list of banned substances handed down by the IOC.  Therefore, this contentious decision resulted is criticisms that what really concerned the IOC was their public image and not the positive drug tests; “For the IOC to publish drug-testing and then change them in the middle of the Olympics is like moving the finish line after a race is started.”  However, the Chairman of the IOC’s medical commission, Arne Ljungvist, defended the ejections by claiming that only because the substance was so new was it not already banned.  While critics can dispute the IOC’s tough application of its policies, the IOC has applied the rules uniformly, meaning that if anyone tests positive for whatever reason, the IOC bars them from competing.
Although the IOC’s regulations can lead to some unfortunate results, the message is clear that education is key.  After the fact, claims that the positive drug test resulted from a sports product or cold medicine are impossible to prove.  Thus, the IOC has effectively made it is the responsibility of each athlete to know what they are ingesting and to make their own informed choice.  As a result, if the athlete subsequently tests positive and they as well as their coaches and medical staff were aware that the use of any sports product might result in a positive drug test, then they have only themselves to blame.  However, the IOC has made the athletes’ choice easier because athletes know that the risk of taking a performance enhancer is receiving a positive drug test, which would result in not only the loss of an Olympic medal and a prohibition from competing, but also the potential loss of earnings and deterioration in the respect of others. 
E. The World Anti-Doping Agency
Like the IOC, the World-Anti Doping Agency (“WADA”) also has a strong commitment to the international prevention of doping.  WADA’s effectiveness in the US is due in large part to connections between the agency and the former Clinton administrations.  On August 9, 2000, President Clinton signed Executive Order No. 13165, which created the White House Task Force on Drug Use in Sports under the authority of the Office of National Drug Control Policy (“ONDCP”).  The executive order stated that the policy reason behind this change was as follows: 
“The use of drugs in sports has reached a level that endangers not just the legitimacy of athletic competition but also the lives and health of athletes—from the elite ranks to youth leagues.  The Monitoring the Future Study issued in 1999 found that in just 1 year’s time the rate of steroid use among young people rose roughly 50 percent among both sexes and across all age groups.”
Although ONDCP initiated several independent efforts that served to inform the public about the dangers of athletic drug use, the greatest impact of Clinton’s Executive Order was that it placed the Director of the ONDCP on the WADA.  Since Clinton’s administration played a key role in the development of WADA, it was important that the US have representation within the agency. 
On November 10, 1999, WADA was established in Lausanne, Switzerland because of a general dissatisfaction on the international level with the lack of IOC involvement outside of the actual Olympic games to combat athletic doping.  Therefore, the international athletic community created WADA for the purpose of “promoting and coordinating the fight against doping in sport in all its forms at the international level.”  The US was even instrumental in the creation of WADA’s charter; specifically, ONDCP wrote the 1998 U.S. Government Position Paper Recommendations, which they submitted to the IOC committee concerned with fighting the use of performance-enhancing substances in sports.  This recommendation paper contained several specific suggestions that WADA incorporated into its charter, including:
•	The establishment of a random testing system for athletes in every Olympic discipline both out-of-competition and in-competition.
•	The support of a robust research agenda that would advance capabilities to detect doping. 
•	The building of anti-doping capabilities in different regions of the world.
•	The goal to combat both performance-enhancing substances and other chemical substances recognized by the international community as illegal (e.g. ecstasy, LSD, THC, and opiates). 
The US Government reiterated these proposals in an October 1999 letter to Mr. Juan Antonio Samaranch, the former-IOC President.  The ONDCP letter stated, “our sole purpose is to develop an effective, independent and transparent international anti-doping regime that provides the world's athletes a level playing field upon which victory is a product of dedication, good coaching and natural talent.” 
The United States was not the only nation to take a strong interest in the international use by competitive athletes of performance-enhancing substances and the establishment of WADA.  For example, in November of 1999, an International Drugs in Sport Summit took place in Sydney, Australia.  This summit brought together the officials of 25 nations and called for the creation of the World Anti-Doping Agency to:
•	“Promote and coordinate the fight against doping.”
•	“Reinforce the ethical basis for anti-doping and protect the health of athletes.”
•	“Establish and maintain a list of prohibited substances.”
•	“Coordinate no notice, out-of-competition testing.”
•	“Develop analytical standards.”
•	“Promote harmonized sanctions.”
•	“Develop education programs.”
•	“Promote and coordinate peer-reviewed research.” 
Another proposal adopted by WADA that came out of this summit was that the participating governments agreed to establish the International Intergovernmental Consultative Group on Anti-Doping (“IICGAD”).  The IICGAD was to combine different international efforts by organizing regular meetings in different countries consisting of an all-inclusive group of nations representing every continental region.  Moreover, the IICGAD was designed to preserve the structure, mission, and independence of WADA to promote high-quality international anti-doping policies and programs. 
WADA achieved widespread international support and success by incorporating the views of all participating countries.  As mentioned above, the WADA charter incorporated the recommendations from the US government and the rest of the international community.  Moreover, in its early years, WADA reached agreements with 34 international sports federations governing Olympic summer and winter sports, and generated an Executive Board comprised of an equal number of representatives from the Olympic Movement and public authorities.  In addition, WADA gained stability from sharing its finances on a fifty/fifty basis with the IOC and national governments.  This sharing was import because the financing comes from many different nations and sources; thus, it helps to maintain WADA’s independence from the IOC.  Therefore, unlike with the FDA’s battle with Congress, WADA avoided many of the outside pressures and influences to remain a truly independent agency. 
To date, WADA’s greatest benefit is that it has taken active measures to prevent athletes that take performance-enhancing substances from competing at the international level.  For instance, before the 2002 Winter Olympic Games held in Salt Lake City, WADA officials forced more than 3,5000 athletes to take out-of-competition drug tests.  Furthermore, in response to demands by cross-country skiers and coaches, WADA usurped the testing responsibilities of the Federation Internationale de Ski to ensure that nearly every skier underwent a drug test before the opening ceremonies.  Lastly, at the Winter Games, WADA introduced the Athlete’s Anti-Doping Passport Program, which provided athletes with educational materials, a record of their drug testing history, and a web-accessible database of these records.  Although these efforts might seem minimal, they helped to level the playing field across all nations and ensure that countries, like the US, with more ineffectual regulation of performance enhancing sports products would not receive an unfair advantage.
VII. Solutions To The Current System
A. Concerns about the FDA’s Unwillingness to Act
Although some members of Congress, such as Senator Orrin Hatch, have contended that the FDA has sufficient authority that they are unwilling to wield, there is significant evidence to the contrary that demonstrates that Congress and the courts are the actual barrier to FDA regulation.  As previously discussed, the FDA on numerous occasions has proposed stricter regulations on dietary supplements.  Most recently, in 1998, an FDA proposal sought to pass regulations that would provide clear guidance on the types of statements that were permissible structure-function claims and those statements that were impermissible drug claims.  In part, the proposed changes would have altered the definition of disease in the DSHEA to prohibit manufacturers from making more unsubstantiated claims about their sports products.  However, the mere suggestion of a definitional change created great controversy that divided along two lines.  On one side of this controversy were the consumer groups that believed the proposed FDA rule over the structure-function claims was necessary because claims implying that dietary supplements prevented or cured disease were harmful and misleading.  On the other side, were the supplement manufacturers and Congressional representatives, who asserted that most structure-function claims were helpful and made in good faith.  Therefore, these people believed that the manufacturers had no responsibility to protect customers who wrongly inferred a disease-related claim from the product label.  The disputed types of claims included statements, such as “supports the immune system,” “reduces stress and frustration,” “helps maintain cardiovascular function,” “improves absent-mindedness,” “promotes relaxation,” and “helps maintain regularity.”  Consequently, the FDA’s impossible task was to generate a rule that would satisfy both sides of the debate. 
However, added to the FDA’s already tenuous position was opposition from the courts.  The DC Circuit Court reached a landmark decision in 1999 when they adjudicated the case of Pearson v. Shalala. Specifically, the court upheld a challenge by the American Preventive Medical Association and struck down the FDA’s attempts to restrict further health claims on foods and dietary supplements under the more stringent NLEA requirements.  The court found that the First Amendment required the FDA to pay particular attention to restrictions on manufacturers’ ability to make supportable health statements on their product labels.  The NLEA regulations permit a manufacturer to make a health claim for either a sports food or a dietary supplement only if, “based on the totality of publicly available scientific evidence,” the FDA determines that there exists “significant scientific agreement” among experts that the claim has factual support.  Although the FDA had rejected the petitioner’s claim based on a finding that the scientific evidence was inconclusive, the court decision reversed the FDA’s judgment. 
The effect of the Pearson court’s decision was to overturn not only the FDA’s substantive findings, but also to invalidate all of the FDA’s standards and reasoning.  First, the court declared that the FDA impermissibly restricted the petitioners First Amendment rights because the FDA did not articulate a sufficient government interest to justify regulating the petitioner’s speech.  Instead, the court felt that a sufficient restriction that would resolve the FDA’s interests would be to include a disclaimer underneath the claim stating, “the evidence is inconclusive.”  Moreover, the court rebuffed the FDA’s “significant scientific agreement” standard as insufficient because it breached the FDA’s duty not to engage in “arbitrary and capricious” action. 
Similarly, when the FDA expressed its dismay with the Pearson ruling and its implications, members of Congress discouraged further litigation of the case.  A group of House republicans communicated this discouragement to the FDA Commissioner by requesting, “that the FDA spare the taxpayers the cost of further legal proceedings” and simply approve the use of Pearson’s claims.  However, in another attempt to assert their authority, the FDA rejected this advice and sought a rehearing of the case; however, the DC Circuit Court refused to grant the rehearing.  Thus, this case is clear evidence of the FDA recognizing a violation of the regulations governing dietary supplement and having obstacles purposefully placed in their way.
Despite this opposition, the FDA has acted in a manner that will best resolve the issue of who has the final authority over dietary supplement regulation.  Specifically, the FDA has taken affirmative steps to maintain its ability to regulate supplement manufacturers’ health claims.  For example, the FDA circumvented congress power in the Pearson case by persuading the Department of Justice (“DOJ”) to seek a rehearing of the Pearson case.  In an effort to support the FDA, the DOJ requested that either the original three-judge panel, or an en banc panel, rehear the case.  The DOJ based their request on the argument that the ruling relied on “a misreading of Supreme Court commercial speech disclaimer precedents, none of which involved claims bearing on public health.”  Furthermore, the DOJ confirmed the FDA’s supreme authority and asserted that the effect of the court’s decision was to deprive the FDA of their rightful power to “define and apply regulatory provisions on a case-by-case basis.”  Therefore, it is apparent that the FDA is most assuredly seeking to regulate dietary supplements and if the power play with the DOJ succeeds, it may open up a new avenue whereby the FDA can further restrict sports products without such restrictive opposition.
While the FDA waits to discover whether again the DC Circuit will reconsider the Pearson decision and the FDA’s position on dietary supplement health claims under NLEA, the FDA is not remaining idle but is drafting comments on new rules for structure-function claims for dietary supplements.  Commissioner Henney is considering whether to establish a separate panel or committee within the FDA to review labeling claims concerning dietary supplement because the FDA is planning to study consumer understanding of structure-function claims.  Henney specifically wants to target structure-function claims to discern whether consumers can distinguish these claims from drug claims as well as examine whether consumers are aware of the attenuated risks that can result from dietary supplement use.  All the FDA’s efforts have received further support from outside organizations that have encouraged Congress to allocate additional funds for studies on the long-term side effects dietary supplements.  Thus, although the battle over dietary supplements regulations continue, the minimal effect of the current DSHEA regulations indicates that the FDA needs more stringent limitations to apply to dangerous sports products and supplements.
B. Extending Food, Drug and Cosmetic Act to Sports Products
To understand the power that the FDA wields outside of DSHEA, some analysis is necessary about the regulations that the FDA uses to restrict other ingested substances under the FDCA.  As mentioned earlier, the FDA’s level of regulatory control depends of whether they define the substance as a conventional food, a food additive, or a drug.  Therefore, this section will explore the viability of placing dietary supplements under a different regulatory category, either as conventional foods, food additives, or drugs.   
1. Foods – The FDCA defines a food as, “(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.”  While the FDCA does not require that foods have pre-market approval, the FDA can remove foods from the market if they find them to be adulterated or misbranded.  Adulteration under the FDCA includes any food that, “bears or contains any poisonous or deleterious substance which may render it injurious to health,” or any food where, “any valuable constituent has been in whole or in part omitted or abstracted therefrom.”  In contrast, the FDA’s ability to declare a food misbranded turns on whether the labeling of the product is misleading.  It is apparent from these FDCA’s regulations on conventional foods that these products face almost identical restrictions to those for dietary supplements.  Therefore, just as the DSHEA regulations are too weak, consumers would not benefit much by having dietary supplements placed within the realm of conventional foods under the FDCA.
2. Food Additives – The FDCA defines food additives as, “any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food.”  Similar to foods, the FDCA presumes the safety of food additives, unless the FDA has not authorized their use according to the standard, “generally regarded as safe (“GRAS”).”  This GRAS standard creates more exacting restraints than that of conventional foods because if the FDA decides that a product is “generally not regarded as safe,” then the FDA has the ability to prevent the food additive from ever entering the market.  Although it is not certain whether the GRAS standard allows the FDA to remove current products from the market, the restrictions for adulterated or misbranded food additives would still apply.  The problem with defining any dietary supplement as a food additive is that DSHEA provides an explicit exemption that prevents such classification for dietary supplements. 
Despite this exemption, on multiple occasions the FDA has attempted to regulate dietary supplements as food additives, but with limited success.  The FDA has had one positive result in United States v. Nature’s Plus, where the District Court for the Eastern District of New York created a precedent for the FDA to classify a product as a food additive rather than a dietary supplement.  More specifically, the court decided that when more than one component combines to create a dietary supplement, the FDA could apply the more stringent regulations for food additives.  The substances at issue were CoQ10 and Geranium, both of which were two of several ingredients in the supplement; thus, the FDA could properly classify each of the substances as a food additive. 
Although the manufacturer claimed that the FDCA already categorized the separate substances and thus the FDA could not re-categorize them as food additives, the court rejected this argument in favor of the FDA.  The court found that the language of the FDCA was clear and unambiguous enough to hold that the FDA could fit the substances under the “component” requirement in the FDCA. In addition, the court referred to congressional intent to assert that Congress meant the FDA to have the ability to classify some dietary supplements as food additives, especially if they were potentially toxic.  Consequently, the message handed down by this court was that, in some instances, the FDA already had the authority to regulate a supplement as a food additive require further proof of the safety of the product. 
However, two subsequent decisions undercut the FDA’s authority to reclassify dietary supplements as the Eastern District of New York allowed in the Nature’s Plus case.  First, in the United States v. Black Currant Oil, the FDA initiated an in rem proceeding to have two drums of black currant oil defined as adulterated food additives.  The manufacturer had combined black current oil with gelatin to make a consumable capsule, and then, marketed the capsule as a dietary supplement.  Therefore, the Seventh Circuit Court of Appeals held that the FDA could not classify it as a food additive under the FDCA, since adding the oil to the capsule did not alter the food’s character.  In reaching their decision, the court claimed that because the capsule was simply a container for the oil and because without the capsule, the oil itself would still be a dietary supplement, the FDA’s classification of the oil as a food additive was a distorted application of the FDCA.  Moreover, the court asserted that that method of marketing should not determine whether a substance is a food additive; thus, the FDA could only remove the black currant oil from the market if they could prove that the product was unsafe under the DSHEA standards for dietary supplements. 
In a follow-up case, black currant oil and its classification as a dietary supplement once again was at issue.  In the case of the United States v. 29 Cartons of . . . an Article of Food, the First Circuit Court of Appeals refused to permit the FDA to remove substances from the market that the FDA believed were something other than dietary supplements because the court deemed this decision as a manipulation of the language of the FDCA.  Like the Seventh Circuit, the First Circuit Court of Appeals held that when the manufacturer added black currant oil to another “inert” substance, such as a gelatin capsule, the FDA could not consider the product to be a food additive under the FDCA.  As a result, the could held that the FDA must prove that the product was unsafe and posed health risks before they could define the capsule as a dietary supplement and remove it from the market.  
The 29 Cartons court also referred to congressional intent by stating that it would not be rational to conclude that Congress meant to define a product as a food additive when no substance had been added to another food.  Therefore, the manufacturer’s subjective intent to combine two substances did not create an inference that the manufacturer produced a food additive in this instance.  Even though the FDA insisted that the court should defer to its interpretation, the court refused to do so because they believed that the FDA’s interpretation lacked persuasiveness given the attendant circumstances.  Therefore, these two cases served to reverse the earlier Eastern District of New York case and to demonstrate a clear unwillingness to allow the FDA to bend the language of the FDCA to classify products as food additives when the marketing and substance of the product would permit it to be defined under the more relaxed category of dietary supplement. 
However, there still exists the possibility that the courts will allow the FDA to reclassify current dietary supplements as food additives.  One way to distinguish the different courts’ positions is that the product at issue in the Nature’s Plus case combined more than two substances, whereas the subsequent two cases combined one substance and a capsule.  The other way to characterize these cases is that in one instance, the product was toxic; while in the two subsequent cases, the court believed that the products were safe.  As a result, this group of rulings is not necessarily inconsistent and may permit the FDA to classify as food additives dietary supplement products that contain many dangerous substances, such as ephedra.  Therefore, to succeed the FDA must convince the current courts that the specific dietary products consist of a number of substances added to one base, that the products are in fact unsafe, and that congressional intent favors granting the FDA this authority. 
3. Drugs – The FDA’s broadest and most stringent regulatory powers concern the restrictions imposed by the FDCA on drugs.  The FDCA defines a drug as: 
“(A) articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and  (D) articles intended for use as a component of any article specified in clauses (A), (B), (C) of this paragraph.” 
Without going into the details of everything that this definition include, it should be noted that the FDA employs the very strict FDCA drug guidelines regarding pre-market safety approval for any substance defined or marketed as a drug.  The FDCA’s pre-market tests are restrictive in that the FDA will only approve drugs for general use if the manufacturer satisfies the requirements for pre-clinical and clinical studies, which demonstrate the safety and effectiveness of the drug.  In addition, drug manufacturers must register annually with the FDA all products they if they engage in the, “manufacture, preparation, propagation, compounding, or processing of a drug or drugs.”  
Further, even when the products are in the market, the FDA maintains powers, similar to conventional foods and food additives, to remove products for several reasons, such as misbranding or adulteration.  In addition, the FDA will require that consumers can only obtain certain drugs through a prescription, if the FDA considers the drugs dangerous or habit-forming in the absence of supervision.  Compliance with the rules is crucial, because if the FDA decides that a drug is adulterated, then the manufacturer will possibly be subject to government enforcement actions, including criminal sanctions depending on the circumstances.  The FDA will declare a drug to be adulterated if, (1) a drug contains unsanitary or poisonous ingredients, (2) the strength, quality, or purity of the drug differs from the official compendium, or (3) the manufacturer fails to follow the requirements for proper manufacture, packing, storage, or installation.
	In regards to labeling and health claims, the FDCA incorporates more stern requirements than for conventional foods or food additives.  The FDCA mandates that drug manufacturers must provide information to ensure the safety of their products on the labels.  As a result, like with adulteration, the misbranding of drugs subjects the manufacturer to government enforcement actions.  Under the FDCA, a finding that a product is misbranded is an indication that the drug contains a false and misleading label or that the label does not conform to the FDCA specifications, such as not providing the directions for use of the product or warnings about potential health dangers.  As for health claims, the FDA considers health claims to be analogous to a label.  Therefore, a manufacturer must support any published claim with “substantial evidence” pursuant to well-researched expert studies, or the manufacturer might face government enforcement action.  Obviously, the FDA standards and penalties for drugs compared to those for dietary supplements are more severe in that the standards of safety are higher and the required scientific evidence to show product safety is significantly greater, thus, the consumer receives better protection. 
Due to the FDA’s recognition of their increased power over drugs and that the claims of many dietary supplements are analogous to those of drugs, the FDA in some instances has sought to regulate dietary supplements as drugs.  In United States v. Ener-B Vitamin B-12, the court held that the FDA improperly classified a vitamin B-12 supplement that was in gel form as a new drug.  The manufacturer, Nature’s Bounty, intended for the consumer to apply the gel to the inside of the nose, thus, allowing the body to absorb the gel into the bloodstream through the nasal mucosal membranes.  Although Nature's Bounty contended that the FDA’s prior categorization of the gel as a dietary supplement prevented the FDA from re-classifying it as a drug, the court rejected this argument.
 The Second Circuit Court of Appeals referred to the language of the FDCA and found that its exemption preventing the classification of dietary supplements as drugs only held as long as “the label or the labeling contains certain truthful and not misleading statements.”  Moreover, the court pointed to persuasive language in the legislative history indicating that Congress had expressly rejected using any wording that would have exempted the FDA from defining substances as drugs solely because the FDCA had previously classified the same substances as dietary supplements.  As a result, the court refused to approve the meaning that Nature’s Bounty gave to the provision and chose to advocate the FDA's position, which past congressional intent supported. 
However, in a more recent case, the FDA’s effort to re-classify a dietary supplement as a drug failed.  In Pharmanex v. Shalala, the District Court of Utah held that the FDA could not redefine the classification of the supplement Cholestin based simply on the fact that the red yeast used in the supplement had an active ingredient that was indistinguishable from a similar synthesized substance.  Pharmanex, the manufacturer of Cholestin, marketed the product as a dietary supplement and claimed that the product would help the consumer maintain a healthy cholesterol level.  However, the FDA believed that they should redefine Cholestin as a drug because Merck & Co. manufactured a prescription drug named Mevacor that consumers used to control cholesterol.  Furthermore, the main ingredient in Mevacor was Lovastatin, a synthesized substance identical to the ingredient in Cholestin. 
The Utah court rejected this reasoning because they found that the FDA had not approved Lovastatin or Cholestin as a finished drug product.  In the absence of this FDA approval, the court held that Cholestin retained its status as a dietary supplement.  Furthermore, the court found it unlikely that the FDA would ever define either Cholestin or Lovastatin as drugs because they were merely active ingredients and the FDA could only classify finished products as drugs under the FDCA.  While the FDA contended that Congress’s use of the word “article” in the FDCA definition of “new drugs” conclusively included main ingredients, the court was unwilling to accept this construction. 
Fortunately, the Tenth Circuit Court of Appeals overturned the Pharmanex decision of the District Court of Utah in 2000.  The Tenth Circuit also discussed the meaning of the word “article” as used in 21 U.S.C. § 321(ff)(3)(A) and (B), but rejected Pharmanex’s previously accepted interpretation because that definition would not clarify the scope of the provision.  The court recognized that the provisions served as the limiting principle to the DSHEA’s ability to “assuage the regulatory burdens on the dietary supplement industry.”  Moreover, the court found that the legislative history did not help to resolve the ambiguities because the Senate Reports did not indicate ho to apply these provisions.  Therefore, the court held that given the overall statutory context and the surrounding language, 21 U.S.C.S. § 321(ff)(3)(B) had sufficient ambiguity to merit deference to the FDA’s interpretation. In conclusion, the Tenth Circuit affirmed that the FDA interpretation that the lower court struck down was not “arbitrary, capricious, or manifestly contrary to the statute.”
Therefore, unlike with food additives, these cases affirm the FDA’s ability to classify dietary supplements as drugs.  Because the Tenth Circuit overturned the one negative decision decisions that could inhibit this power, it seems likely that another court will hold valid such FDA reclassifications of dietary supplements as drugs.  In addition, the fact that there exists increased public attention to dietary supplement manufacturer’s use of drug-like health claims provides the FDA with an additional weapon.  As stated previously, the DSHEA already permits the FDA to regulate dietary supplements in order to subject the supplement to greater regulations if the manufacturer makes claims of disease prevention or cure.  Consequently, given the prevalence of such borderline health and nutritional claims for supplements and the court’s willingness to recognize FDA reclassifications, manufacturers will be less likely to challenge FDA’s determinations regarding reclassifications of dietary supplements as drugs when the product includes curative.  In conclusion, superior precedent exists on the FDA’s side to reclassify dietary supplements under the stricter drug regulations, thus, while there is some ambiguity as to how much Congress and the courts are willing to let the FDA proceed, it is still an extremely viable option.
C. Proposal for New Regulations
	This section is based on the assumption that the current FDCA regulations can in no way be extended to dietary supplements, thus, further regulation sports products would be necessary.  If the prohibitions and exceptions that Congress placed in the DSHEA proved to be the downfall for the FDCA’s application to dietary supplements, then the only remaining solution is to create and seek Congressional approval for a new regulation to replace the DSHEA.  Given the clear congressional divide over the need for greater for FDA regulation, such an effort would be a Herculean task.  However, to make new legislation carry any weight, it should augment the penalties for violating the rules and strengthen the requirements for the four considerations that factor into the FDA’s determination of how substances are classified: product definition, product safety, nutritional claims, and labeling.
1. Product Definition – This paper outlined the basic definitional problems of sports products above.  To reiterate quickly, sports products could be classified as conventional foods; however, that is the category that the DSHEA currently uses and it is not sufficiently restrictive.  Further, the FDA could seek to regulate sports products under the definition for food additives.  However, the problems are that the ingredients for some products necessitate a higher standard than GRAS standard, that the DSHEA has an explicit statutory exemption, and that past courts have divided on the circumstances in which the FDA can change the classification of a dietary supplement.  Finally, even though some sports products, such as powders and pills, can satisfy the definition of a dietary supplement, their function or nutritional claims might allow the FDA to regulate them as drugs.  Unfortunately, three problems result from the FDA attempting this extension: 1) certain members of Congress have shown a reluctance to approve this extension, 2) some sports products would not qualify as drugs creating a definitional split, and 3) some previous court decisions rejected FDA attempts to re-classify these products.   
Therefore, one of the first steps to clarifying product definition would be to ascertain from Congress or generate from congressional legislative history a clear statement of congressional intent and interpretation.  On the one hand, the Senate Report leading to the DSHEA contained a statement by the Committee on Labor and Human Resources expressing the intention to have the FDA regulate dietary supplements as foods and not as drugs.  One the other hand, the Second Circuit in the Ener-B Vitamin B-12 case noted that Congress explicitly rejected a proposed provision that excluded dietary supplements from the drug definition.  Therefore, congressional intent is unclear and is part of what is resulting in conflicting court decisions, thus, the FDA should seek clarification about whether Congress intended to give both the FDA and the courts the discretion to classify dietary supplements as drugs. 
Regardless of the clarification of congressional intent, Congress should not permit some sports products to be regulated as dietary supplements because their purpose it not to “supplement the diet.” For example, some manufacturers market sports pills and powders with nutritional claims indicating that their purpose is to physiologically affect the body.  Unfortunately, the definition of dietary supplement refers to many ingredients included in sports products, such as vitamins, minerals, amino acids, and herbs.  Clearly, there exists a conflict of interpretation between Congress, the FDA, and the courts concerning the proper definition of sports products within the current regulatory regime.  Therefore, trying to classify all sports products underneath within one existing category is impossible. 
Therefore, the best available solution for new regulation would be to eliminate the “dietary supplement” classification.  This classification seeks to align products that embody different, structures, form, levels of synthetic ingredients, and beneficial claims.  Instead, the FDA should evaluate each product on an individual basis and place it in the category of conventional food, food additive, or drug.  To make the process more fair, the FDA could allow the sports product manufacturers to include evidence that there product more properly belonged in a certain category based on a number of factors, such as the manufacturer’s ability to analogize their product to another product classified in a particular category.  The purpose of this new standard is to resolve the tug of war between Congress, the FDA, and the courts.  Moreover, it invalidates a classification that seems to create more problems than it solves.  Finally, even if an entirely new regulation never came to fruition, this change alone might post a significant improvement by allowing the various sports products to fall within the confines of the FDCA.  
2. Product Safety – New FDA regulations relating to the safety of sports products must ensure that the products are safe to use and that performance claims have substantial scientific evidence to prove their truthfulness.  Due to current definitional problems, regulating sports products under FDCA drug provisions would subject some products to more strict regulation than others.  Therefore, any product safety suggestions contained herein would work best after resolving the definitional problems.  However, because the FDA cannot quickly resolve the problems of defining different sports products, these suggestions without any further change still have the potential to be an improvement over the current system. 
Dietary supplements, unlike drugs, do not endure pre-market approval, but only have to comply with labeling and adulteration standards.  Thus, the DSHEA allows manufacturers to market a dietary supplement, if the ingredients have been used previously in a food supply or if there is evidence of the product’s safety under typical use.  Without prior use of the supplement, the manufacturer must state that evidence exists of its safety and provide such evidence to the FDA.  Furthermore, since dietary supplements are a subset of conventional foods, they are subject to many of the safety requirements applicable to conventional foods. 
When instituting new regulations, the FDA and Congress should seriously consider requiring pre-market approval similar to what is already required for drugs.  Since safety concerns about sports products vary depending on the form of the product and the amount of time it has been on the market, one fair solution would be to permit different standards depending on the length of time the ingredients have been on the market.  Therefore, minimal or no pre-market approval would be permissible for new products containing existing ingredients in quantities similar to products that had been on the market for a long time.  For example, the FDA could subject sports product with common ingredients to regulations similar to food additives, while permitting exemptions for ingredients that meet the GRAS standard.  Since a lot of debate exists on whether sports products are safe, the FDA should possess some minimal, unrestricted power to assess independently the hazards of a particular sports product to determine whether to subject it to the regulations for drugs.
Lastly, as an alternative suggestion or a supplement to the above suggestion, new regulations should place some threshold on consumer complaints or reports of health maladies.  Therefore, the FDA would have a duty to investigate a sports product if it received more than a certain number of complaints during a specified period, more than a certain number of complaints ever, or any complaints pertaining to life threatening illness or death.  By giving exact numerical baselines, it would prevent any allegations of biased FDA intervention.  Moreover, it would decrease the potential for manufacturers to unduly pressure the FDA because the threshold would be mandatory and not subject to discretion.  Most importantly, it would create a level of oversight that would require the manufacturers to exercise constant vigilance over the safety of their products by paying attention to consumer reports.
3. Nutritional Support Claims – Although sports products are not supposed to make traditional preventative or curative health claims, the distinction between claims made about drugs and those made about dietary supplements is now almost nonexistent.  However, theoretically, sports product claims are strictly nutritional support claims relating either to the effects of the product, or to the basic structure or function of the body.  As evidenced in previous sections, the nutritional claims that a product can make differ greatly depending on whether the FDA classifies it as a dietary supplement, a conventional food, a food additive, or a drug.  As a result, dietary supplements require little evidentiary support for nutritional claims because they enter the market without prior approval and are subject to removal by the FDA in limited circumstances.  For conventional foods, the regulations are not substantially greater in that the manufacturer must provide sufficient information about the value of the product for its intended use.  Lastly, drug manufacturers must seek pre-market approval, which requires them to have substantial scientific evidence to establish the safety of the product and truthfulness of the claims. 
Since dietary supplements have a wide range of bodily effects, meaning some products are potentially deadly while others have no demonstrable effect, their health or nutritional claims need further examination than they currently receive under the DSHEA.  Therefore, a single regulatory system for claims might be insufficient necessitating the implementation of a dual standard.  For those products that seek to make claims that they can prevent illness or improve bodily features, such as blood pressure or cholesterol, the FDA should be able to force those products to comply with the more stringent drug standards of scientific proof.  In contrast, for sports products that make claims about taste or content, the FDA should have the discretion to hold them to the lower dietary supplement standard.  Examples of such claims would be that PowerAde tastes better than AllSport, that PowerBars contain many carbohydrates, or that Gatorade is full of electrolytes.  This two-level approach would improve on the current system by creating a high evidentiary standard for the types of claims most likely to mislead or confuse the consumer, while allowing more freedom for comparatively harmless claims.  Since nutritional support claims are common with dietary supplements, regulating all claims using a drug standard might prove too expensive.  Therefore, instituting a dual standard that creates a compromise between two existing regulatory standards gives manufacturers the opportunity to decide what kinds of claims they are willing to pay for to be able to make. 
4. Labeling – As discussed previously, abundant problems exist with the labeling on sports products.  Often, the labeling is insufficient and does not give the consumer enough information to make informed decisions; sometimes the labeling is incomplete making it unclear what the supplement's ingredients are; and frequently the labeling is inaccurate and makes claims or includes nutritional information that is incorrect.  Therefore, new regulations must require that the labels on sports products provide sufficient and accurate information for consumers, so that consumers can make informed choices about whether to use a product.  The labeling requirements for drugs would be most appropriate, since many sports products, especially powder or pills, make nutritional claims equivalent to claims of drug manufacturers.  However, given the hesitation by some members of Congress over the possibility of additional regulation, they might refuse to adopt such a strict standard.
Therefore, at a minimum, the label on any sports product should include a list of all the ingredients and the ingredient quantities because this information is often dispositive as to whether a consumer purchases a product.  For instance, if a consumer knows that they have kidney problems, reliable information that the sports product contains creatine could result in the avoidance of disaster.  While on their face, the FDA’s requirements seem like they should be sufficient, labeling is one of the primary concerns addressed by advocates for greater regulation.  Moreover, unlike most conventional foods, consumers are not as knowledgeable about sports products and their ingredients; therefore, stern labeling requirements are the best way to assist a consumer in making an informed choice. 
In addition, particular and strict regulations pertaining to nutritional support claims are necessary because nutritional claims often are also included on product labels.  While ideally the FDA would prohibit unapproved supplements from including nutritional support claims, there are regulatory steps that the FDA could use to improve the current situation.  Labeling regulations for nutritional support claims should make specific criteria concerning the content of the claim, the display method for the claim, the particular type of label necessary to display the claim, and the studies or evidence that supports the claim.  To combat the use of nutritional support claims, the FDA should mandate that manufacturers of sports product provide warnings on possible health risks from recommended use of the product (such as using a product in conjunction with strenuous exercise) as well as warnings about abuse or misuse of the product.  These warnings are essential because many sports products, especially the powders, are available in bulk sizes and do not require a prescription, which makes it more likely that a consumer will not realize that their regular dose exceeds the recommended dosage.  
5. Penalties – Regardless of the specific regulatory provisions included in any new regulation, there is a demonstrable need for harsher penalties.  As discussed in the Metabolife case and elsewhere, the current system is already rife with abuse.  Many manufacturers are misbranding their sports products resulting in greater use and positive drug tests by athletes unaware that a banned substance is an ingredient.  In addition, some manufacturers are concealing consumer complaints and reports of serious adverse effects from use of their products.  While the courts are able to impose serious penalties through civil or criminal litigation, the FDA needs a strong enforcement mechanism.  Therefore, the baseline for any intentional rules violation should be severe and the baseline for any unintentional violation should be stricter to make manufacturers more wary of violating the law.  
Moreover, given that most products are not subject to pre-market approval, when concerns regarding the safety or health claims of a product arise, the burden of proof should rest on the manufacturer and not the FDA.  The current DSHEA regulations force the FDA to wield the initial burden to prove their accusations.  However, given the acknowledged inconclusive evidence on some products, like ephedra, this burden is almost automatically dispositive in favor of the manufacturer.  While such a defendant-friendly standard would be sufficient if the system were functioning properly and people were not dying, when there are clear indications that an unapproved substance may be killing people, the manufacturer should have to show that they have scientifically verified the safety of their product. 
VIII. Conclusion
Since the definition that the FDA applies to sports products is determinative of which regulatory regime is applicable, the greatest concerns relate to the restrictions regarding product safety, nutritional support claims, and labeling.  The current regulatory scheme could address these concerns by not being rigid and insisting upon the use of existing classifications or standards that have proven to be deficient.  Instead, the FDA should be permitted to use its granted authority to re-classify existing dietary supplements if they are more appropriately regulated under a different heading.  This re-classification will in many instances necessitate that certain sports products be regulated as drugs, but if this classification is proper and the product is dangerous and on the market, it is better to require the evidentiary support, then to wait for more children to die.  Under the current system, ephedra, androstenedione, and creatine are not in any danger of removal from the market, but instead are a source of bluster by Congress about the need for investigations and studies. 
Otherwise, in the absence of such change, the only other solution is to generate a completely new regulation to replace the DSHEA to reduce the proliferation of athlete’s deaths and to curtail problems of manufacturer abuse that remain unresolved under the current system.  While the congressional approval process for new regulation would be lengthy and would generate concerns regarding sufficient FDA resources, it is clearly a better solution than to allow the system to go unchecked while waiting for a clear congressional mandate or consistency in court decisions.  Furthermore, sales of these dangerous sports products are not abating and the increased attention to their use by successful professional athletes, is just leading more kids to take them seeking personal performance enhancement.  Since these products are not definitely safe, whatever the disagreements are about the use of ephedra-containing products for adults, no one wants them in the hands of kids.  Tragically, without some further restrictions on how consumers obtain these products or whether these products ever reach the market, many more children are doomed to become statistics.