March 25, 2003 The Honorable Mark
McClellan, M.D., Ph.D. Dear Commissioner McClellan: Recent press reports concerning the proliferation of “pro-steroid” and “precursor steroid” products in the marketplace, as well as the discovery of “new” steroids, such as norbolethone, raise questions about whether additional Federal action should be taken in order to address the safety issues and regulation of these dietary supplements. As you know, the Committee on Energy and Commerce has jurisdiction over matters relating to the regulation of food and drugs, advertising and marketing practices and consumer protection, generally. The Committee has reviewed this matter and is seeking information about the Food and Drug Administration’s (“FDA”) efforts, to date, to address the safety and regulatory concerns surrounding the development and marketing of “pro-steroids” and “precursor steroids.” We are concerned that current law may not be sufficient to empower agencies, such as FDA and DEA, to regulate or, where appropriate, ban these substances. It is the Committee’s understanding that substances known as “pro-steroids” and “precursor steroids” may not be subject to pre-market regulation by any government agency because they are not encompassed within the parameters set forth in the 1990 Controlled Substances Act nor are they classified as anabolic steroids under the Anabolic Steroid Control Act of 1990 (“the Act”). Under the Act, Congress banned all known anabolic steroids; however, the Act did not contemplate banning “pro-steroids,” such as 1-testoterone and 4-hydroxy-testosterone, which have only recently been discovered by scientists. Similarly, “precursor steroids” are not covered by the Act because they are metabolically formed before testosterone, the steroid that provided the benchmark for regulation under the Act. However, it appears that once ingested, “precursor steroids” combine with naturally occurring substances in the body (such as enzymes) to form an illegal steroid. Thus, some dietary supplement manufacturers appear to have exploited loopholes in the Act and develop steroids that may, in fact, be more powerful than the ones Congress banned in 1990. A recent article in the Washington Post on March 8, 2003, raises the specter concerning the proliferation of designer drugs, especially in the sports industry, that provide athletes with undetectable performance-enhancing steroids. Due to the recent emergence of several issues relating to safety of dietary supplements, we are seeking to learn about the FDA’s efforts, to date, to address the proliferation of “pro-steroids” and “precursor steroids” in the marketplace, and related issues concerning potential loopholes in the 1990 Act. Accordingly, pursuant to Rules X and XI of the U.S. House of Representatives, we request that FDA provide the Committee with the following information by Monday, April 7, 2003: 1. Is FDA aware of instances wherein “pro-steroids” or “precursor steroids” are marketed as drugs, i.e. marketed to diagnose, cure, mitigate, treat or prevent disease in man or other animals? Is FDA aware of instances wherein “pro-steroids” or “precursor steroids” are marketed in a false or misleading fashion? Is FDA aware of instances wherein products marketed as dietary supplements actually contain testosterone or synthetic derivatives thereof? 2. If FDA is aware that “pro-steroids” and “precursor steroids” are marketed as drugs, does FDA have the authority to regulate such products as drugs? In the past five years has FDA taken enforcement action against “pro-steroids” or “precursor steroids” marketed as drugs, marketed in a false or misleading fashion, or containing testosterone or synthetic derivatives thereof? If so, please specify in detail what enforcement actions were taken. 3. Has FDA conducted or commissioned any studies concerning the use of “pro-steroids” or “precursor steroids” among children. If so, provide a copy of each study. 4. Is FDA aware of any legitimate medical uses for “pro-steroids” or “precursor steroids” that are being studied or being pursued as an investigational new drug? If so, provide a copy of each study, or for each new drug, if any, provide information on its indication(s), sponsor(s), name, and status. Additionally, we request a non-public briefing on these matters no later than Wednesday, April 2, 2003. We would appreciate a prompt reply to this letter. Please contact Kelli Andrews, Majority Counsel, at (202) 226-2424, or David Nelson, Minority Investigator, at (202) 226-3400, in order to set up this briefing and for any questions you may have regarding these matters. Sincerely,
John
D. Dingell James
C. Greenwood, Chairman Peter
Deutsch, Ranking Member | |
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