http://www.thenhf.com/press_releases/pr_05_oct_2009.html
ALERT FROM THE NATIONAL HEALTH FEDERATION
DHEA REGULATION AND DEFENDS DSHEA
By Lee Bechtel, NHF Lobbyist
October 5, 2009
On September 29, 2009, the Subcommittee on Crime and Drugs, of the Senate Judiciary Committee held a hearing entitled "Body Building Products and Hidden Steroids: Enforcement Barriers."
The subcommittee Chairman, Arlen Specter (D-PA), and Senator Orrin Hatch (R-UT) were the only Senators at the hearing. Testifying were Michael Levy, Division Director, Office of Compliance, Food and Drug Administration (FDA), Joseph Rannazzi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration (DEA), Travis Tygart, US Anti-Doping Agency (USADA), Daniel Fabricant, Interim Executive Director and CEO, Natural Products Association (NPA), and Richard Kingham, Covington and Burling.
The public-policy and federal-regulation issue at the center of the hearing was, and is, the attempt to regulate Dehydroepiandrosterone (DHEA) as a controlled substance, i.e., an anabolic steroid, when used as a common ingredient in dietary supplements. DHEA is an endogenous hormone made in the human body, and serves as a precursor to male and female androgens and estrogens in the body. DHEA levels in the body decrease after age 30, and are reported to be low in some people with anorexia, end-stage kidney disease, non-insulin dependent diabetes, AIDS, adrenal insufficiency, and in critically-ill persons. People can abuse DHEA, similar to the use of anabolic steroids, to build body mass and muscles. Used correctly, millions of Americans benefit from the normal use of supplement products that contain small amounts of DHEA as an ingredient.
The "andro" and DHEA issue has been the subject of federal legislation and regulations going back to the mid 1990s with the passage of the DSHEA and Anabolic Steroids/Controlled Substances laws. DHEA when used as an ingredient in common forms of supplement products, under current laws, is not covered under DSHEA and is not a controlled substance. DHEA can be classified as an illegal steroid if the DEA can present evidence that it meets all of the eight (8) existing law requirements for being an anabolic steroid under the Anabolic Steroids/Controlled Substances law. Legislation has been introduced to add DHEA to the DEA's controlled list of anabolic steroids, even though the DEA already has this authority.
There are body-building dietary supplement products that contain anabolic steroids masked as DHEA being sold by a small group of manufacturers. These manufacturers do not have to comply with the DSHEA requirement for new ingredient registration. Having DHEA in legal supplement products classified as an anabolic steroid would result in hundreds of – if not more – supplement products being removed from the legal dietary supplement marketplace due to the “newly illegal” sale of supplements containing hidden steroid ingredients.
At the hearing, Senator Orrin Hatch (R-UT), the principal sponsor of the 1994 DSHEA law, along with Senator Tom Harkin (D-IA), defended the DSHEA law. He also entered into the hearing record a letter he sent to the DEA on its evidence and its interpretation of how DHEA containing supplements could be added to the DEA list of controlled substances. The DEA letter to the Senator said that it did not have to prove that DHEA met all of the eight current law requirements to classify DHEA as a controlled substance, and that it had no evidence to date of substantial public health-safety risk. No studies on the long-term effects of DHEA have been conducted. DHEA can cause higher than normal levels of androgens and estrogens in the body, and theoretically may increase the risk of prostate, breast, ovarian, and other hormone-sensitive cancers.
Senator Hatch's position was that the DEA's interpretation of current law is incorrect, and that if the DEA had evidence supporting all eight requirements of current law they should move forward with adding DHEA to the controlled list of illegal anabolic steroids. Otherwise, they should enforce current law or drop the matter. Hatch also said that the lack of FDA resources, i.e., funding and personnel, were hindering the FDA from performing its DSHEA functions. He also indicated that the FDA has been grossly negligent in carrying out aspects of the DSHEA law, like dietary-supplement health claims.
Senator Specter, on the other side of the issue, indicated that the FDA did need more taxpayer money and more bureaucrats for effective enforcement of the DSHEA law, and that the FDA pre-clearance process for supplements with new ingredients should be reviewed. Under DSHEA, a company submits a pre-clearance registration to the FDA and the FDA has 75 days to review and disapprove. Michael Levy, Division Director, Office of Compliance, Food and Drug Administration (FDA) testified that 78 new registrations were filed this year; but he did not know how many decisions had been made on these supplements. Senator Specter did not directly suggest that a drug-like pre-clearance process be put in place, but he did keep the door open for more Congressional action leading to more FDA regulatory control over dietary supplements.
More information on the hearing is available at http://www.judiciary.senate.gov/hearings/. The NHF also strongly suggests that all NHF members and readers of this press release contact both Senators in order to let Senator Hatch know that you appreciate and support his stand in favor of DEA and to let Senator Specter know that you strongly disagree with his position, urging him to support DEA and Hatch. They can be reached at:
Arlen Specter (R - PA)
711 Hart Office Building
Washington, DC 20510
(202) 224-4254 phone
(202) 228-1229 faxWeb Form: specter.senate.gov/public/index.cfm?FuseAction=Contact.Co...
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Orrin G. Hatch (R - UT)
104 Hart Office Building
Washington, DC 20510
(202) 224-5251 phone
(202) 224-6331 faxWeb Form: hatch.senate.gov/public/index.cfm?FuseAction=Offices.Cont...
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