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Rob McCaleb Testifies about Proposed FDA Supplement Labeling Rules.

On March 25, HRF President Rob McCaleb testified at a congressional hearing called to examine the role of the FDA in implementing the Dietary Supplement Health and Education Act (DSHEA). The hearing, entitled "DSHEA: Is the FDA Trying to Change the Intent of Congress?" is the first of a planned series on this topic. McCaleb's testimony at the hearing summarized HRF's objections to FDA's proposed supplement labeling rules (Docket #98N-0044). These proposed rules recommend sweeping changes to the way in which dietary supplements are regulated and include a redefinition of the term "disease."

The FDA's proposed redefinition of disease would classify any deviation from a state of "normal" as a disease, even if that deviation is universal or a normal part of aging, such as onset of menses or menopause. Under the proposed new definition of disease, any dietary supplement with virtually any effect on the body could be classified as a drug.

According to McCaleb, the proposed FDA rules run counter to the letter, spirit, and intent of DSHEA. By reversing the major provisions of DSHEA, the rules could prevent the use of most statements of nutritional support on supplement labels, with an end result of negating the public's right to access truthful information about the known effects of supplements. McCaleb also objected to FDA's proposal that labeling should be regulated according to what is implied in a label statement, rather than what is actually stated.

"DSHEA is producing exactly the kinds of changes that we envisioned in supplement research, development, and use of dietary supplements. A better-informed public is using the best-researched supplement ingredients to produce real gains in public health. It is time for the FDA to abandon its continuing battle against dietary supplements and against the right of the public to access truthful information about the known effects of supplements," McCaleb stated in his opening remarks.

At the hearing, McCaleb was a member of a panel that also included Dr. Edward Croom, Research Associate Professor and Associate Professor of Pharmacognosy at University of Mississippi; Dr. Margaret Gilhooley, Professor of Law at Seton Hall University; James L. Turner, representative for Citizens for Health; and attornies Scott Bass and David Kracov. The panel was questioned by Congressmen Dan Burton (R-Indiana) and Stephen Horn (R-California). FDA Director Dr. Jane Henney also testified.

McCaleb was one of several panelists who discussed regulation of alternative medicine in general, and specifically the availability of treatments or practices that do not yet have government approval. Asked about research prioritization, McCaleb responded that "a rational strategy for botanical research in the United States would begin with a look at the best-researched European phytomedicines."

The next hearing in the series was tentatively scheduled for May 27 or June 8. For a transcript of the March 25 hearing or more information about upcoming hearing dates, contact Beth.Clay@mail.house.gov or www.house.gov/reform. -

Christine Meadows, HRF

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