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TEN YEARS AFTER DSHEA - IMPLEMENTATION OF THE DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT
By Lee Bechtel National NHF Advocate
May 05, 2004

This year is the tenth anniversary of the Dietary Supplement Health and Education Act (DSHEA). The Subcommittee on Human Rights and Wellness of the US House of Representatives’ Government Reform Committee, held a hearing at the end of March on the 1994 DSHEA law, and the status of dietary supplements in the United States. The hearing centered on what the FDA has and has not done to implement the law, and the ongoing debate over the safety of supplements and Congressional legislation to change or repeal the DSHEA law.

DSHEA was intended to facilitate consumer access to vitamins, minerals, and other dietary supplements, increased scientific research, the safety of supplements, and increased public education and consumer protections through the Food and Drug Administration (FDA). Witnesses included representatives from industry and consumer groups, the Food and Drug Administration (FDA), and testimony from Senators Orrin Hatch (R-UT), an original sponsor of DSHEA, and Dick Durbin (D-IL), the sponsor of Senate bill S. 722. The hearing was held at the direction of Subcommittee Chairman, Representative Dan Burton (R-IN), a long time supporter of DSHEA and legislation to grant Americans more freedom to exercise their individual choice in health care treatment decisions.

Characteristically, Senator Hatch took the position that the FDA has the authority to effectively regulate supplements but has been “extremely slow” to implement the DSHEA law. On the other side, Senator Durbin, in explaining his reasons for S. 722, took the position that the DSHEA had not protected consumers and needed to be changed. He disputed claims made by critics of his bill that it attempted to impose FDA drug like approval processes on dietary supplements. In addition, Congresswoman Susan Davis (D-53-CA), who, along with Congressman Henry Waxman (D-30-CA), and eight others, are sponsoring H.R. 3377, disputed the testimony of industry and consumer group representatives that their bill would, in effect, repeal, part of the DSHEA law and impose FDA drug like approval processes on two-thirds of the supplement products currently on the market.

The Congresswomen maintained that dietary supplement supporters were misinterpreting the intent of H.R. 3377. To be clear and fair, the Congresswomen is either being misadvised by staff or does not understand the DSHEA law or how the FDA DSHEA regulatory process works. While this sounds harsh, it is not new that elected representatives do not understand public policy, the intent of Congress in enacting laws, nor the full scope of the impact on average Americans when they introduce legislation, or vote on bills. Following the hearing, Congresswoman Davis wrote an op-ed that appeared in The Hill, a Congressional newspaper, defending H.R. 3377 and why DSHEA needs reformed. She said, "When Health and Human Services Secretary Tommy Thompson recently announced the Food and Drug Administration’s (FDA) decision to ban ephedra, ardent supporters of the Dietary Supplement Health and Education Act (DSHEA) claimed that the law worked. I cannot believe the intention of DSHEA was for it to take eight years, 155 deaths and a countless number of heart attack and stroke victims before a dangerous dietary supplement was taken off the shelf." This opinion piece is just one more reason why NHF members need to be diligent in defending health rights. DSHEA does work. Why it continues to take the blame for the FDA's failure to act in a prompt and efficient way is verging on the ridiculous.

Any NHF members in the Congresswomen’s Congressional District need to contact her to send a letter to inform her on what is at stake for her constituents. A sample letter is available, click on bill number H. R. 3377. What is at stake ? Among other things, less access to dietary supplements, higher costs for supplements, and increased health care costs because Americans will have less choice to take supplements which have proven therapeutic benefits that will keep them healthier and out of the hospital. According to public survey data, the majority of the 158 million Americans who take supplements believe them to be either reasonably or completely safe. Surveys have also shown that people take supplements for purposes such as treating colds or alleviating depression, even though there are health claims restrictions on product therapeutic benefits.

Against this backdrop, the FDA’s new Director of the Center for Food Safety and Applied Nutrition (CFSAN), Dr. Robert Brackett, testified that the FDA did not support ANY changes in the DSHEA law. In other words, the Bush Administration and the FDA do not support the Durbin legislation, S. 722, and do not support H.R. 3377. The agency’s “current” position is that the DSHEA law is adequate and that the agency has impeded the effective implementation of the 1994 law. Aside from the normal regulatory participation avenues, groups supporting DSHEA and the freedom to have access to dietary supplements and alternative medical treatments have been compelled to go the route of federal judicial action, starting with Pearson v. Shalala, 64 F.3d 650 (D.C. Cir. 1999). The NHF was actively involved in the Pearson case, which successfully reversed the FDA’s position on what constituted a dietary supplement health claim.

In a related development, in April the Institute of Medicine (IOM) released a report, “Dietary Supplements: A Framework for Evaluating Safety”. The IOM has recommended, among other changes, that the FDA doesn't need direct evidence of human harm before banning the sale of dietary supplements. The report also concluded that the 1994 Dietary Supplement Health Education (DSHEA) law should be amended to mandate that supplement manufacturers report adverse side effects, just like prescription drug makers must now do. According to Dr. Susan Walker, the FDA's dietary supplement chief, the IOM report, "appears to be consistent" with the ephedra supplement approach. DSHEA requires the FDA to demonstrate “unreasonable risk” from a supplement, something the IOM panel insisted can be done with less strict evidence. The report says that data from animals, test-tube studies, or similar products could justify the removal of a supplement from the market. I am not a scientist. I am familiar with the current clinical research and post-market evaluation requirements the FDA has for prescription drugs. How do “test-tube studies” justify the human biological response? The FDA has never recalled an approved prescription drug based on test-tube studies. The IOM study was funded by the FDA and recommends several of the same changes to the DSHEA law included in the Durbin and Davis/Waxman legislation. As has usually been the case with the FDA, there is a conflict in their position on whether DSHEA should or should not be changed.

At the DSHEA hearing, existing scientific data and the FDA’s own Adverse Event Reporting (AER) data was presented on the public safety of dietary supplements compared to other FDA regulated products. The FDA’s own data on adverse medical events, in the same year, for supplements was 1,214 cases compared to 300,000 for prescription drug adverse events. Illnesses from tainted foods, which the FDA also regulates, kill 5,000 Americans each year. A 2002 survey of a national pharmacy database found a total of 429,827 medication errors from 1,081 hospitals. And, in 2001, 7.5 million Americans received unnecessary surgeries that resulted in 37,136 unnecessary deaths. Unless you are a federal bureaucrat, or someone with a direct financial stake, like a pharmaceutical company, the average person, looking at the data, has to ask themselves, which of the categories of FDA regulated products/services, or health care treatment options, really poses a more significant risk to public health?

What does this mean to NHF members and average Americans? It perhaps means nothing? Or, depending on the Congressional elections this fall, it could mean a lot. I am not referring to the Bush vs Kerry Presidential campaign. Its outcome could play a role. If the Democratic party wins control of the House of Representatives, Henry Waxman would assume the chairmanship of the key FDA authorizing committee, and H.R. 3377 could become a key “dietary supplement reform” issue. With a Democrat elected as President and the House in control of Democrats, the political and legislative process is much easier. If Republicans maintain control of the Congress, then the prospects for passage of H.R. 3377 would more likely remain slim. Only time will tell.