Medical journalist report of innovative biologics: friends in the US Senate need our support to strengthen the influence of DSHEA within the FDA

Townsend Letter for Doctors and Patients,  Jan, 2004  by Morton Walker,  Randall Walker

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Readers encouraged to speak out in support of US Senate Bill S.1538.IS

The year 1994 stands as a milestone on the rocky road for advancement of Complementary and Alternative Medicine (CAM) in the United States. Just nine years ago, the 103rd Congress led our country in a positive direction by enacting the Dietary Supplement and Health Education Act of 1994, now known as DSHEA, officially making it Public Law 103-417. Under DSHEA, the FDA was instructed to create a classification called "dietary supplements" governing natural health products. This legislation allows the FDA to forego the pre-market notification process and rigorous testing required of pharmaceutical drugs. As a result, fledgling companies have introduced a wide variety of innovative nutritional supplements without being subjected to excessive government regulation that would have overwhelmed their limited financial resources. Proliferation of new nutriceuticals has fueled the development of Complementary and Alternative Medicine (CAM) treatment protocols for patients suffering from chronic diseases. Such proliferation has persisted despite the best effort of conventional medical doctors, so-called quackbusters, health insurance companies, and other obstructors. The variety of new products available to CAM providers has also fostered growth of the new science of anti-aging medicine that has become increasingly important to a growing population of older Americans.

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Senators Orrin Hatch and Tom Harkin Are Staunch Friends of CAM Medicine

Whether or not you share his conservative political point-of-view, every health-conscious American owes US Senator Orrin Hatch (R-UT) a debt of gratitude for serving as an unwavering and skillfull champion of DSHEA since its inception. In recent testimony before the Senate Commerce Committee, Senator Hatch explained, "Enactment of DSHEA followed literally decades of Food and Drug Administration [FDA] animosity toward dietary supplement products. This animosity and the lack of a clear regulatory structure for supplements were clearly demonstrated prior to passage of DSHEA. That is why two-thirds of the Senate cosponsored our bill. That is why a majority of the House cosponsored the bill. And that is why it passed so overwhelmingly." (1)

Our gratitude is also bestowed on DSHEA co-author Senator Tom Harkin (D-IA). The influence and involvement of Senator Harkin continues to be crucial to the present day success of DSHEA. As Chairman of the Labor, Health and Human Services, and Education Appropriations Subcommittee, the group of Senators responsible for recommending how much of the federal government's budget should be allocated to health-related agencies, Senator Harkin is a key promoter for DSHEA. His voting record shows that he consistently supports the advancement of medical science in the war against disease on all fronts.

Representative Waxman Joins Anti-DSHEA Forces Afoot in Congress

Support for DSHEA back in 1994 by Rep. Henry Waxman (D-CA) among his colleagues in the US House of Representatives, was also crucial to getting the law approved. Today, however, we observe with dismay that Rep. Waxman has jumped on the "anti-ephedra/anti-nutriceutical" political bandwagon and can no longer be considered a friend of DSHEA. He is co-sponsor of proposed legislation in the U.S. House of Representatives that would encourage the FDA to closely scrutinize companies marketing products containing any type of plant extract. His bill, H.R. 3377, ominously named the "Dietary Supplement Access and Awareness Act," would enact an onerous reporting system that unnecessarily duplicates the FDA's own Adverse Event Report (AER) system. As with some of his colleagues, Rep. Waxman relies on the hysteria surrounding ephedra to defend his legislative attack on DSHEA.

Referring to AERs received by the FDA, Rep. Waxman states, "The FDA must have the authority to investigate manufacturers and take action against them when necessary to protect consumers' health. It is shocking that a dietary supplement company withheld information for years about illnesses and deaths that may have been due to its product while it continued to make millions of dollars a year selling that product. This bill will give FDA the authority to prevent a similar occurrence in the future." (2)

Informed citizens and legal experts could dispute Waxman's grasp of the facts and argue that the FDA already has the regulatory authority he describes. H.R. 3377 is another example of the recent trend in Congress of enacting redundant legislation to reinforce the legality of government agencies by listing duties which they are already empowered to perform under existing laws.

Rep. Waxman may have been induced to reverse himself and attack DSHEA because of his political aspirations. His co-sponsor on the H.R. 3377 bill, Rep. John Dingell (D-MI), is the ranking Democratic member of the Committee on Energy and Commerce who is considered very powerful because of his seniority and acumen. (3) Whatever his reason for doing so, Rep. Waxman has succumbed to the basest from of politics--fear-mongering.