CFSAN Reports FY04 Accomplishments

WASHINGTON--The Center for Food Safety and Applied Nutrition (CFSAN) reported for fiscal 2004 (FY04), which ended Sept. 30, it met its goal of completing at least 90 percent of its "A" list goals. CFSAN completed 151, or 93 percent, of its "A" list goals--including taking steps to implement the Bioterrorism Act, banning dietary supplements containing ephedra, exploring consumer understanding of qualified health claims and releasing plans to minimize outbreaks of foodborne illness.

"These results reflect a continued commitment to the management strategy of focusing our resources on where we provide the most benefit to American consumers and the continued dedication of the CFSAN workforce," said Robert Brackett, Ph.D., director of CFSAN (www.cfsan.fda.gov).

Among the accomplishments in the area of dietary supplements were:

* responding to 47 notifications for new dietary ingredients, 31 of which had deficiencies or safety concerns;

* taking enforcement actions (often in conjunction with the Federal Trade Commission) against misleading and unsubstantiated label claims;

* developing guidance on qualified health claims and nutrient content claims;

* publishing draft guidance on substantiation for dietary supplement claims;

* releasing the final rule declaring dietary supplements containing ephedrine alkaloids misbranded; and

* taking action against companies selling products with androstenedione, which had not been approved as a new dietary ingredient.

However, the priority of most interest to the dietary supplement industry--the release of the final dietary supplement GMPs (good manufacturing practices)--was pushed onto the FY05 list. During a press briefing on Jan. 18, Brackett told HSR there are people working "frantically" to finalize the GMPs. However, he added the resignation of Tommy Thompson as secretary of Health and Human Services (HHS) and the probable appointment of Michael Leavitt to that position will likely delay the release. "It is likely Secretary Leavitt and his staff will want to take a look over the document and become fully familiar before the GMPs move forward," he said.