CFSAN Announces FY04 Priorities

WASHINGTON--The Food and Drug Administration's (FDA) Center for Food Safety and Applied Nutrition (CFSAN) has published its program priorities for the 2004 fiscal year (FY), which ends Sept. 30. Among the "A" list priorities are concentrations on food safety and defense, and an emphasis on consumer safety and nutrition.

CFSAN divided the list into four sections: Assuring Food Safety and Security, Improving Nutrition and Dietary Supplement Safety, Assuring Food and Cosmetic Safety, and Assuring Food Safety: Crosscutting Areas. The nutrition area contains several top priorities of interest to the dietary supplement industry, including publishing a proposed rule to regulate qualified health claims, publishing a final rule for supplement GMPs (good manufacturing practices), publishing guidance on substantiation of structure/function claims, and developing guidance on submissions of 75-day prenotifications for new dietary ingredients. It also plans increased physical inspections of imported food (and supplement) products with the goal of inspecting more than 60,000 shipments.

Enforcement also is a priority, with CFSAN planning to increase enforcement against supplements with unsubstantiated or misleading claims--particularly singling out weight loss products--and identify dietary supplements/ingredients with safety problems and take enforcement action. In addition, FDA plans to increase enforcement against use of dietary supplement ingredients in conventional foods if the ingredients are neither GRAS (generally recognized as safe) nor an approved food additive.

Among the positive nutrition priorities were FDA's plan to continue its cooperative research agreement with the University of Mississippi's National Natural Products Research Center, and its plan to survey consumers about their understanding of the relationship between heart disease risk and consumption of trans, saturated and omega-3 fatty acids.

"We're really aiming to put the nutrition back in the CFSAN name," said Robert Brackett, Ph.D., director of CFSAN (www.cfsan.fda.gov). "Obviously, one of our highest priorities is to get out a final rule on GMPs. We're also looking at enforcement on how to protect the public from unsafe products while allowing the industry to manufacture in as open a way as possible." Brackett said the goal is to release the GMP final rule by the end of the calendar year.