U.S. Government Seeks to Outlaw Nutritional Supplements
Issued by The Medical Committee for Aging Research and Education (MCARE)
An Educational Outreach Project of The American Academy of Anti-Aging Medicine (A4M)
April 21, 2003 / Austrian psychotherapist and Nazi concentration camp survivor Victor Frankl (1905-) wrote that, “The last of the human freedoms is to choose one’s attitudes.” Today in the United States, a campaign on Capitol Hill attempts to revise the American public’s perspective on nutritional medicine supplements, thereby profoundly alter basic healthcare freedoms that each of us enjoys.
The United States of America was founded on the tenets of a government of, for, and by the people. After years of bloodshed and personal sacrifice, in 1776 our forefathers assigned every American inalienable rights of life, liberty, and the pursuit of happiness. On July 4, 2003, America will celebrate the 227th year in which her citizens have enjoyed the inalienable rights of freedom of thought, action, and speech. These freedoms include the fundamental right of the individual to make choices concerning his or her healthcare.
In 1994, the United States Congress enacted the Dietary Supplements Health and Education Act (DSHEA), which was hailed for its unprecedented legislative validation of the sanctity of personal healthcare freedoms. DSHEA strikes a delicate balance between the freedoms of consumers of nutritional products and the authority of governmental bodies such as the Food and Drug Administration (FDA). One of the most commendable facets of DSHEA is the law’s protection of safe, legitimate, effective nutritional products from governmental and special-interest forces that would otherwise seek to unfairly remove such products from market, restrict their availability, or categorize them to require prescriptions to obtain.
DSHEA’s protection of the rights of individuals who have presumed their freedom of access to nutritional products is now being challenged on several fronts. The sudden attention of Congress and government agencies on over-the-counter nutritionals was prompted by a rising number of recent deaths and serious injuries among American athletes who use supplements containing ephedra or ephedrine alkaloids. Secretary Tommy Thompson of the Department of Health and Human Services opened a period of rapid public comment to seek evidence and medical literature to determine the risk that ephedra and ephedra-containing products pose, design a new product warning label, and initiate controls over unsubstantiated advertising claims for ephedra-containing products. The FDA opened a public comment period for the reintroduction of a proposed ruling on ephedra-containing products. Riding on the momentum of the ephedra re-evaluation, Senator Richard Durbin (D-IL) has reopened the comment period on the DSHEA legislation, opening the door to restrictive amendments or the outright repeal of DSHEA.
It is important to be aware that ephedra is completely different from over-the-counter hormones: they share no similarities in chemical composition, therapeutic intent, or safety profiles. Regrettably however, it would appear that those on Capitol Hill and in government agencies have utilized much of the momentum of the efforts to restrict ephedra to fuel a broader campaign that targets over-the-counter hormones. Presently, the 108th Congress is considering House Resolution (H.R.) 207. H.R. 207’s sponsors, Representatives Sweeney (R-New York) and Osborne (R-Nebraska), seek to grant sweeping power to the Attorney General to amend the Controlled Substances Act to convert a wide variety of over-the-counter nutritional supplements into this by-prescription-only drug category that implies dangerous abuse potential. Specifically, the definition of “immediate precursor” of an anabolic steroid would be broadened to include any substance that promotes muscle growth.
While it is commendable that Representative Sweeney and the bill’s cosponsors propose this legislation to protect adolescents from the harmful effects of steroids, such a law would severely curtail adult access to a broad range of muscle-building nutritional products. Today’s widely-available, over-the-counter nutritionals such as DHEA, 7-keto DHEA, and pregnenolone would become tomorrow’s highly restricted drugs. The fact that these nutritionals have enjoyed a 20-year long proven record of no or low adverse effect profile has no bearing on this proposed legislation. The fact that a conversion of an over-the-counter nutritional to the status of a prescription drug, thereby inflating its costs to the consumer by 10-, 20-. 30-fold or more has been ignored. For prescribing and utilizing over-the-counter muscle-building nutritionals, anti-aging physicians, health practitioners, and consumers would face arrest and criminal prosecution. Their assets would be subject to forfeiture to the government.
Despite H.R. 207’s predecessor, H.R. 5564, becoming stalled during the previous Congressional session, a sister bill is being introduced to the Senate. Sponsored by Senator Biden (D-Delaware), the Senate’s version strives to strike the wording of “muscle growth” from the Anabolic Steroid Control Act. In effect, this would control and criminalize any supplement or hormone with a chemical structure similar to testosterone. Under the Senate bill, prohormones – namely DHEA, pregnenelone, and progesterone – would be considered anabolic steroids and no longer be considered to be nutritional supplements.
Additionally, Representative Susan Davis (D- California) introduced H.R. 724, named the Dietary Supplementation Information Act. This bill seeks to amend the Federal Food, Drug, and Cosmetic Act to require that supplement manufacturers register with the FDA and report adverse experiences by manufacturers of nutritional supplements. Much like the Adverse Events Reporting Service (AERS) for prescription medications, the DSIA will create an important registry from which safety information can be retrieved and disseminated. This registry will not only protect the public from unsafe supplements, but also may very well serve to validate the safety of hundreds of supplements. Through their absence from the registry, many anti-aging medical therapeutics will have their safety profiles reaffirmed.
American author Baldwin Evans (1904-78) wrote that “Freedom of speech and freedom of action are meaningless without freedom to think.” Don’t let reactive censorship overtake the healthcare freedoms that you, your loved ones, and your patients enjoy. Write your Congressional representatives today to voice your opinion on this critical issue before it’s too late. To locate the mailing addresses for your Congressional representative and Senators, visit http://thomas.loc.gov/ and click on “House Directory” or “Senate Directory.”
