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Assault on Dietary Supplements Continues
By Lee Bechtel National NHF Advocate
June 10, 2004

On June 8, 2004, Senator Dick Durbin (D-IL), the ranking member of the Government Management Subcommittee, of the Senate Government Affairs Committee, held the first of what is expected to be several legislative hearings this year and next on his Dietary Supplement Health and Education Act (DSHEA) repeal bill, S. 722, the so called Dietary Supplement Safety Act.

The Durbin bill would amend the Dietary Supplement Health and Education Act of 1994 (DSHEA) so that supplements are regulated the same way as are prescription and over-the-counter drugs.

When introduced in 2003, Senator Durbin cited the deaths of several people who had used supplements with ephedra ingredients as examples for why S. 722 was needed. Since then, the FDA issued its ephera rule banning the sale of ANY supplements “containing a source of ephedrine alkaloids”, not just individual supplements with ephedra as an ingredient. The Senator also introduced Senate Resolution 260, expressing the sense of the Senate that the Food and Drug Administration should take action to remove dietary supplements containing ephedrine alkaloids from the market.

With this aspect of dietary supplement safety off the table, it was clear from the Senator’s opening statements and questions that he has changed his position. Now, the Senator believes that more supplements, not just supplements with stimulant ingredients, need to be regulated like drugs with regard to FDA approval and post approval monitoring. Prior to this hearing, in the press and other communications, Durbin criticized opponents of S.722 for their view that the intent of his legislation was to impose drug like requirements on dietary supplements.

Equally as important as the Senator’s modification of position is the support he is receiving from the American Medical Association (AMA), from the Center for Science in the Public Interest (CSPI), a liberal public interest group, and from the Consumers Union, another group which has a long record of support for more federal government control and regulation. In addition, a witness representing the Institute of Medicine (IOM), also testified on its recent report, “Dietary Supplement: A Framework for Evaluating Safety”. The FDA funded the IOM report.

Testifying for the FDA, the Director for the Center for Food Safety and Applied Nutrition (CFSAN), Robert Brackett, presented and defended the agency’s view that no changes were needed in the DSHEA law. Instead, the FDA continues to take the position that it just needs more money to enforce the DSHEA law, regulations, and enforcement activities. Senators Durbin and Voinovich (R-OH) both questioned Brackett and industry representatives on why the FDA had been so slow in issuing regulations and taking enforcement actions under DSHEA. Brackett cited the lack of financial resources. Industry representatives from the Council for Responsible Nutrition (CRN) and the American Herbal Products Association (AHPA) countered that industry, consumer, and affiliated medical groups had, in fact, proactively worked with the agency to implement DSHEA.

Senator Durbin made clear his position that the industry and other pro-DSHEA groups had actively engaged in efforts to prevent the full implementation of the law.

Both Senators asked about using dietary supplement User Fees, which are already in place for biologics, drugs, and medical devices, to finance CFSAN DSHEA regulatory activities. Industry representatives pointed out that dietary supplements are regulated as foods, and that food manufacturers and suppliers do not pay such product approval fees to the FDA. It was also pointed out that with regard to supplement safety, illnesses from tainted foods kill 5,000 Americans each year, according to FDA data, compared to the much lower number that might be attributed to the consumption of supplements.

During his cross examination of hearing witnesses, Senator Durbin disputed the current legal interpretation and regulation applying to dietary supplements as foods. In his prepared remarks and in comments, he repeatedly referred to the need for mandatory Adverse Event Reporting (AER) requirements. Citing that thousands of adverse events were probably not being reported each year, and recent FDA data on 1,200 dietary supplement AERs in a given year, the Senator stated that the safety of consumers was gravely at risk. Brushed aside was the comparable FDA data showing that dietary supplement AERs represented less that half-of-one percent of AERs filed for FDA approved drugs. And, that prescription drugs are estimated to be one of the top five leading causes of death in the US each year, at more than 106,000 Americans each year.

Senator Durbin indicated that the federal regulatory framework created under DSHEA had, in his opinion, created loopholes that were not protecting the public from unsafe supplements, from dishonest product advertising, and in the labeling of products. Some time was spent explaining the history of the structure and function labeling issue with the FDA. This was an issue in which the National Health Federation (NHF) was one of the leading groups in correcting the FDA’s position on allowable health claims on labels. This was the landmark Pearson Vs Shalala case in 1999.

Senator Durbin said that there would be more hearings in the future, and that the information presented at the hearing would help in galvanizing more Senate support for his legislation. He also made a point of recognizing that Congressman Henry Waxman, and others, had introduced a similar bill, H.R. 3377, in the House of Representatives. The House bill has more bipartisan support than does S.722. However, Senator Durbin said that he is fully committed to the issue and his legislation. He went out of his way to express his personal commitment to continue to press for its passage by the Senate in the future.

Durbin was reelected in 2002, and his term does not end until 2008. So, the Senator has four more years to accomplish his mission to repeal major parts of the DSHEA law, even if not successful this year. Regardless of the Presidential election outcome, if the Democratic Party takes control of the US Senate then the prospects for S.722 will increase greatly unless continued opposition advocacy is maintained by all of the parties involved.

People wishing to write their Congressman and Senator in opposition to S.722 can do so via the NHF Webpage, in the Government Affairs Section. Likewise, opposition to the Waxman bill can also be registered.