Natural Foods Merchandiser

Supplements' fate under new FDA chief uncertain

Dr. Andrew von Eschenbach, who was appointed acting commissioner of the U.S. Food and Drug Administration Sept. 23 after Commissioner Lester Crawford abruptly resigned, may never take over the job permanently.

?That sounds correct to me,? said an FDA spokesperson, addressing rumors that von Eschenbach is a placeholder until the Bush administration can find a permanent commissioner nominee. The spokesperson cautioned, however, that the Department of Health and Human Services oversees the nomination process and would know better than the FDA who is likely to permanently replace Crawford. HHS spokespeople didn?t return a phone call seeking comment.

At this point, supplements industry leaders are only guessing whether von Eschenbach?s appointment will help or hinder pending supplements legislation and decisions.

?I have no vibe yet on Dr. von Eschenbach. He?s truly an unknown quantity as far as our industry is concerned,? said Loren Israelsen, executive director of the Utah Natural Product Alliance.

?Dr. von Eschenbach is a physician who comes from a research and science background. The rough and tumble world of dealing with regulatory politics is a very different thing,? Israelsen said. ?With Crawford it was different. He had a deep institutional knowledge and knew everybody.?

Von Eschenbach is the former head of the M.D. Anderson Cancer Center at the University of Texas and director of the National Cancer Institute. In response to criticism that overseeing both the FDA and NCI would be a conflict of interest, von Eschenbach announced Monday he would temporarily step down from day-to-day leadership of the cancer institute.

Israelsen believes that ?without a permanent captain, the FDA will be far less responsive, simply because there?s no one there to call the plays.? Steve Mister, president and chief executive of the Council for Responsible Nutrition, added, ?You don?t see bold, new initiatives with an acting commissioner like you see with a full commissioner.?

Mister said von Eschenbach?s appointment won?t change CRN?s lobbying strategy with FDA on supplements issues.

?In recent history, we?ve had more acting commissioners than we?ve had commissioners,? he noted. He said CRN would continue to monitor FDA?s actions on good manufacturing practices for supplements, petitions for qualified health claims, guidance on new dietary ingredient submissions, and mandatory adverse-event reporting for supplements.

The FDA spokesperson said the agency is still on track to announce supplement GMPs before the end of this year, but ?is not preparing to address [mandatory] adverse event reporting at this time.? He also said FDA received more than 50,000 comments last year on NDI submissions, so the agency is still determining whether that process would be included in its 2006 program priorities.

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