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Companies Receive Warning From FDA
Concerns Surround Dietary Supplements
By Amy Shipley
Washington Post Staff Writer
Friday, March 17, 2006; E05
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.
© 2006 The Washington Post Company
Concerns Surround Dietary Supplements
By Amy Shipley
Washington Post Staff Writer
Friday, March 17, 2006; E05
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.
© 2006 The Washington Post Company
