Creatine: Legal consequences

Last modified: Thursday, 26. March 2009 - 5:18 am

As previously stated, creatine is not a controlled substance and is available for over-the-counter retail purchase in the United States.

Legal history

As of early 2002, creatine supplementation was not on the list of banned or prohibited supplements of the International Olympic Committee, the United States Olympic Committee, or the NCAA. However, since nutritional supplements are not closely regulated by the FDA, the United States Anti-Doping Agency (the USADA, which oversees drug testing for the USOC) warns that ingestion of any nutritional supplement is at the athlete’s own risk.
A number of prominent international sports and sports medicine organizations — including the International Olympic Committee, the Federation Internationale de Nation Amateur (FINA, the world governing body of swimming), the Sport Nutrition Advisory Committee of the Coaching Association of Canada, the U.S. Anti-Doping Agency, and the UK Sports Council — also maintain a “take at your own risk” policy for the use of creatine and other nutritional supplements by athletes. Some associations such as the Irish Sports Council have taken a stronger stance, advising athletes against creatine and performance supplement use of any kind. The French Rugby Federation (FFR) has an outright ban on creatine. In addition, France has classified creatine as a performance-enhancing drug, and its sale is banned in that country.
There have been cases of Olympic athletes taking adulterated supplement products they assumed were pure and later testing positive for steroids and other banned substances not listed on the product label. American bobsledder Pavle Jovanovic and Norweigan Greco-Roman wrestler Fritz Aanes are just two of the dozens of Olympic athletes banned in recent years for positive steroid drug tests. Both Jovanovic and Aanes claimed they took the banned substance unintentionally when they ingested contaminated dietary supplements. Subsequent testing of Aanes’s dietary supplement did indeed find the banned steroid precursor nandrolone. However, even if steroid ingestion is unintentional, the athlete is still assumed to be responsible for its use, and Jovanovic and Aanes were banned from competition for two years as a result.
In 2001 the International Olympic Committee announced that 15-20% of the approximately 600 nutritional supplements the agency tested were adulterated with substances that could lead to positive doping tests. The IOC and the World Anti-Doping Agency (WADA), called upon the U.S. government for stricter regulation and labeling of supplements.

Federal guidelines, regulations, and penalties

Creatine is classified as a nutritional or dietary supplement, and as such it is regulated by the United States Food and Drug Administration (FDA) as a dietary supplement. Dietary supplements do not have to meet the same stringent manufacturing and clinical testing and approval requirements that are required of drugs before reaching the U.S. consumer market. Federal legislation known as the Dietary Supplement Health and Education Act (DSHEA) was passed in 1994 in an effort to standardize the manufacture, labeling, composition, and safety of botanicals, herbs, and nutritional supplements. In January 2000, the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) announced a 10-year plan for establishing and fully implementing these regulations by the year 2010.
But DSHEA is very different then the standard approval process for drugs and medical devices, and emphasizes the regulatory enforcement of label claims and advertising and marketing issues rather than the efficacy and quality of the supplements themselves. Unlike new drug and medical device applications, controlled clinical trials aren’t part of the supplement review process, nor is any FDA inspection of a company’s manufacturing facilities or quality control systems.
Under the act, a dietary supplement manufacturer is required to make certain submissions or notifications to the FDA only when specific health claims are made for the product. And the primary responsibility for the safety of the supplement rests with the product manufacturer; any required regulatory submissions can be made up to 30 days after the supplements are already available for sale to the general public. There are also no regulatory restrictions on the serving size a manufacturer chooses for the supplement, nor on the amount of included active ingredients. As such, the potency and dosage of creatine supplements may vary widely from manufacturer to manufacturer.
Anyone deciding to take creatine monohydrate should obtain the supplement from a reputable manufacturer that observes stringent quality control procedures and industry-accepted good manufacturing practices (GMPs). A good way to determine the quality of a supplement is to look for the designations “USP” or “USP Verified” on the product label. This designation indicates that the supplement meets the guidelines of the U.S. Pharmacopeia dietary supplement verification program (DSVP). Dietary supplements prepared under USP guidelines meet nationally recognized strength, quality, purity, packaging, and labeling standards as recommended by the FDA. The USP seal also tells the consumer that the supplement manufacturer is in compliance with FDA-prescribed GMPs.

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