February 2003

FDA task force to regulate supplements

FDA Commissioner Mark B. McClellan, M.D., is forming an internal FDA task force that will develop scientific guidelines that will establish standards for qualified health claims in foods. The FDA Task Force on Consumer Health Information for Better Nutrition will make available to consumers more and better information about the health benefits of food and dietary supplements.

The task force will be chaired by FDA Deputy Commissioner Lester M. Crawford and vice chaired by Joseph A. Levitt, director of the Center for Food Safety and Applied Nutrition (CFSAN).

In addition, the task force will rely on expertise from other government agencies, consulting with experts in the fields of health information and nutrition, as appropriate.

"The work of the Consumer Information Task Force is a critical step toward getting better nutrition and health information to the American people as quickly as possible," said McClellan. "The task force includes senior FDA managers and the agency's top experts in this field. Their work will be instrumental in providing industry and the public a clear understanding of the types of new health information that will be available regarding foods and dietary supplements."

The task force’s goals for the next six months include:

• Reporting on how the agency should apply the "weight of the evidence" standard established under the consumer health information initiative for qualified health claims on conventional foods;

• Developing a framework of regulations that will give these principles the force and the effect of law;

• Identifying procedures for implementing the initiative, as well as determining the organizational staffing needs necessary for the timely review of health claim petitions; and

• Developing a consumer studies research agenda designed to best present scientifically based information to consumers in a truthful and non-misleading way, and to identify the kinds of information known to be misleading to consumers

The task force will hold monthly meetings starting in February 2003, and will identify mechanisms to obtain additional public input.

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