HHS Sees Andro as Controlled Substance

WASHINGTON--The Department of Health and Human Services (HHS) announced March 11 it was urging Congress to enact legislation to classify androstenedione-containing products as controlled substances. The Anabolic Steroid Control Act is pending in the Senate (SB 1780) and the House (HR 3866), and are sponsored by Sens. Orrin Hatch (R-Utah) and Joe Biden (D-Del.) and Reps. James Sensenbrenner (R-Wis.), John Sweeney (R-N.Y.) and John Conyers (D-Mich.), respectively. In a pre-emptive action, HHS sent letters to 23 companies asking them to cease distribution of products sold as dietary supplements that contain andro and warning them they could face enforcement actions if they do not take appropriate actions for these pending controlled substances.

According to the Food and Drug Administration (FDA), andro is produced naturally in humans during the production of testosterone and estrogen--it is considered an anabolic steroid precursor because it can be converted in the body to testosterone. "While andro products may seem to have short-term benefits, the science shows that these same properties create real and significant health risks," said FDA Commissioner Mark B. McClellan, Ph.D., M.D., in a press release. "Anyone who takes these products in sufficient quantities to build muscle or improve performance is putting himself or herself at risk for serious long-term and potentially irreversible health consequences. [W]e will do all we can to protect Americans against companies that seek to profit by trying to convince consumers otherwise."

With andro, it appears it was not on the market as an [approved] dietary ingredient prior to 1994, Susan Walker, M.D., from FDA, told INSIDER. Therefore, andro companies would be required to submit a new dietary ingredient notification and, until they do--with information that establishes that their dietary ingredient is reasonably expected to be safe--the law automatically puts them in an adulterated category. So, companies that have not notified FDA are marketing adulterated products. Walker added that there have never been any new dietary ingredient notifications submitted for andro-containing products.

Even though there is a list of almost 200 ingredients that immediately defaulted into the approved ingredient list after passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994, andro was not one of them. In fact, in 2001, Sens. Hatch and Tom Harkin (D-Iowa) sent FDA a letter asking about the status of andro as a dietary supplement. Today, they got their answer.

HHS Secretary Tommy Thompson also encouraged Congress to pass legislation that would enable the U.S. Drug Enforcement Agency (DEA) to regulate andro products as anabolic steroids under the Controlled Substances Act. HHS and DEA reported they will be providing technical assistance to the legislature as they mull over this legislation.

Letters went out electronically to companies such as AST Sports Science, Golden, Colo.; ISS Research, Charlotte, N.C.; MD Labs, Phoenix; Prolab Nutrition, Chatsworth, Calif.; and Twinlab, Hauppauge, N.Y. Natrol, the parent company of Prolab, reported it hasnt sold andro products for more than a year. The FDAs records were out of date, the company told INSIDER.

Twinlab Corp. issued a statement March 12 stating it respectfully disagreed with FDAs warning letter. When IdeaSphere Inc. acquired Twinlab assets in December 2003, the company received pre-existing inventory of Twinlab's Andro Fuel product, but it is considered residual inventory that is being phased out of the market.

Twinlab reported it is currently manufacturing another performance product, Andro Nitrate 4 Fuel, which it will begin selling in April 2004. This product contains no androstenedione, the company said. Andro is a long-standing Twinlab brand name drawing its identity from the Greek root meaning male or masculine, and will be retained for that reason.

For more information and to see copies of FDAs warning letters, visit www.cfsan.fda.gov/~dms/andrlist.html.

The Council for Responsible Nutrition (CRN) and the National Nutritional Foods Association (NNFA) both supported the actions taken against andro products. If companies have not complied with the law and are therefore not legitimately marketing these products as dietary supplements, FDA's strong regulatory actions are justified, said Annette Dickinson, Ph.D., CRN president. NNFAs executive director, David Seckman, added, I would like to make clear that dietary supplements are not steroids. While some companies may have chosen to break the law by masquerading steroids as a dietary supplement, it does not change that indisputable fact.

HHS and FDAs announcement follows a March 10 hearing entitled "Steroid Use in Professional and Amateur Sports" held by the U.S. Senate Committee on Commerce, Science & Transportation, headed by Sens. John McCain (R-Ariz.) and Biden. At the hearing, Balco's woes were revisited, and the topic of andro was addressed by Major League Baseball (MLB)--the sport most linked with andro after it came to light that Mark McGuire had used it during his record-breaking season. It was at that hearing McCain told MLB representatives that the league's lax regulations have motivated the committee's need to look for "legislative remedies" to address the steroid problem. For more on the hearing, visit http://commerce.senate.gov/hearings/witnesslist.cfm?id=1100.