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[Definitie:] "An ergogenic aid is any substance or phenomenon that enhances performance."
(Wilmore and Costill) 
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1 0 - 0 3 - 2 0 0 6 FDA issues warning letters on dietary supplements
AP WASHINGTON — The government has told companies that make and sell two dietary supplements with synthetic steroids that their products are classified as unapproved drugs and cannot be sold legally.
The products, promoted for building muscle and increasing strength, may cause serious long-term health problems, the Food and Drug Administration said Thursday. The agency said that anyone who has bought the products to stop taking them and return them to their place of purchase. The agency issued warning letters for: • Anabolic Xtreme Superdrol, manufactured for Anabolic Resources LLC of Gilbert, Ariz., and distributed by Supplements To Go of Cincinnati. • Methyl-1-P, manufactured for Legal Gear of Brighton, Mich., and distributed by Affordable Supplements of Wichita Among the problems the FDA said are associated with anabolic steroids are liver toxicity; testicular atrophy and male infertility; masculinization of women; breast enlargement in males; short stature in children; harmful cholesterol levels; and potentially higher risks of heart attack and stroke. A man who answered the phone at Affordable Supplements and declined to give his name said he could not comment. Legal Gear had no telephone listing. Messages left with Anabolic Resources and Supplements To Go were not immediately returned. The action came on the same day that a consumer expert told the House Government Reform Committee that dietary supplements should undergo safety testing before being allowed on the market. The 1994 law that allows supplements to be sold without government approval "created serious regulatory loopholes that have opened the floodgates to thousands of untested dietary supplement products," Janell Mayo Duncan of Consumers Union said. Examples of dietary supplements include vitamins, minerals, amino acids, herbs and botanical products. Supplements have grown to a $20 billion market in the United States, C. Lee Peeler of the Federal Trade Commission told the committee. While many supplements are safe and useful, Duncan said the absence of FDA supervision has resulted in a growing number of questionable products that would not be allowed on the market if they had been subject to safety testing. Duncan urged that supplement makers be required to advise the FDA if they become aware of serious problems associated with their products. Peeler noted that the FTC has filed more than 100 actions over the past decade challenging false of unsubstantiated claims for supplements. 1 0 - 0 3 - 2 0 0 6 Affordable Supplements, Warning Letter
Food and Drug Administration Dear Sir/Madam: This letter relates to your firm's marketing of the product Legal Gear Methyl 1-P, containing the synthetic steroids 6-alpha-methyl-etiocholene-3,17-dione and 17ahydroxyprogesterone. The product label and your Internet website at http://www.affordablesupplements.com list 6-alpha-methyl-etiocholene-3,17-dione as an ingredient, and analysis of this product revealed that it also contains another steroid not declared as an ingredient, 17a-hydroxyprogesterone. The product label and your website state that this product contains an "anabolic agent." Further, your website includes statements about this product such as the following: "[C]apable of building huge muscle and without any side effects . . . ." "[S]olid gains in mass with limited side effects." [T]he only legal choice for people wanting to build serious mass and gain massive strength." The product label and your website, from which this product may be ordered, represent this product as a dietary supplement. However, the product cannot be a dietary supplement because the active ingredients used in the product, 6-alpha-methyl-etiocholene-3,17-dione and 17a-hydroxyprogesterone, are not vitamins, minerals, amino acids, herbs or other botanicals,or dietary substances for uses by man to supplement the diet by increasing the total dietary intake, nor are they concentrates, metabolites, constituents, extracts, or combinations of any dietary ingredient described above. Rather, both of these ingredients are synthetic steroids. Consequently, 6-alpha-methyl-etiocholene-3,17-dione and 17a-hydroxyprogesterone are not "dietary ingredients" as defined in Section 201 (ff)(1) of the Federal Food, Drug and Cosmetic Act (the Act) [21 USC 321(ff)(1), and your product is not a dietary supplement because it does not contain a dietary ingredient. 1 7 - 0 3 - 2 0 0 6 Companies Receive Warning From FDA
Concerns Surround Dietary Supplements
By Amy Shipley Four companies distributing steroids in over-the-counter dietary supplements face possible criminal charges and regulatory action if they do not take steps to correct the violations by late next week, the Food and Drug Administration said in letters sent to the companies last Thursday. The warning letters represented the FDA's first public action in its investigation into steroids in dietary supplements, which was prompted by a story in The Washington Post last October that uncovered five designer steroids in five readily available dietary supplements marketed by four companies. A later story revealed another such steroid in a different product by a fifth company. The fact that the FDA letters mentioned only two of the steroids and one of the five companies raises the possibility of more letters or further action, but an agency spokesman said Wednesday it was the FDA's policy not to comment on pending investigations. Most of the companies cited in The Post piece announced around the time the story ran that they were discontinuing steroid products. The letters come at a time of heightened scrutiny on the dietary supplement industry and renewed interest in steroids in sports with the recent publication of a book that alleges that San Francisco Giants slugger Barry Bonds used of steroids and other drugs. Also last week, Rep. Thomas M. Davis III (R-Va.) chaired a full hearing of the Government Reform Committee on the regulation of dietary supplements that was spurred in part by The Post story as well as the committee's yearlong investigation into steroids in Major League Baseball and professional sports. Meanwhile, in late February, a prominent consultant and writer in the dietary supplement industry, Bruce Kneller, was arrested in Canton, Mass., and charged with possession and intent to distribute anabolic steroids. Kneller, a consultant to Gaspari Nutrition, one of the companies mentioned in The Post's investigation, pleaded not guilty. And Patrick Arnold, whom federal investigators allege made the steroids at the center of the Bay Area Laboratory Co-Operative (BALCO) scandal that ensnared Bonds and dozens of other well-known athletes, operates the Illinois-based dietary supplement company Proviant Technologies. The FDA letters charged two companies -- Anabolic Resources of Gilbert, Ariz., and Supplements To Go of Cincinnati -- with distributing Anabolic Xtreme's Superdrol. Legal Gear of Brighton, Mich., and Affordable Supplements of Wichita, Kan., were charged with distributing Legal Gear's Methyl 1-P. Don Catlin of the UCLA Olympic Analytical Laboratory analyzed Superdrol, Methyl 1-P and four other products for The Post last summer and declared that all contained anabolic steroids. The Post reimbursed Catlin for the cost of the testing. Catlin later turned over information about the substances to the FDA at the agency's request. The FDA letters cast doubt on the legitimacy of at least some claims by companies that they were pulling their steroid products from the market. In its letter to Anabolic Resources, the FDA noted that the company's Web site stated that Superdrol was "discontinued" even while it remained commercially available. Three sources with ties to the industry said some dietary supplements containing steroids continued to circulate before last week's letters went out -- some openly -- but that many companies abandoned the production and distribution of such products last fall to avoid possible criminal sanction. One company official also described the FDA warning letters as a relative slap on the wrist given the major action -- such as federal indictments -- some feared would result from the agency's investigation. The letters, authored by Joseph R. Baca, compliance director at the FDA's Center for Food Safety and Applied Nutrition, charged the four companies with distributing drugs rather than dietary supplements and stated that they had 15 days in which to notify the FDA of specific corrective action taken. The FDA, which noted that anabolic steroids may cause some long-term adverse health effects, in 2004 sent warning letters to 23 manufacturers and distributors of the now-illegal steroid androstenedione, which was used by Mark McGwire when he broke baseball's home run record. |
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