Regulatory Corner

Date: January 2, 2003
To: AAF Contacts
From: Clark Rector, Jr., vice president-state government affairs
Jeff Perlman, executive vice president-government affairs
Re: FDA Health Claims Initiative

Shortly before Christmas, the Food and Drug Administration announced the Consumer Health Information for Better Nutrition initiative. The initiative’s goals are to encourage accurate, science based-claims about the health benefits of conventional foods and dietary supplements, and to eliminate deceptive and misleading dietary supplement claims.

The most significant aspect of the announcement to AAF members is the allowance of health claims for conventional foods. Previously, the FDA has contended that the law allowed substantiated, scientifically based qualified health claims to be made for dietary supplements, but not conventional foods. Under this new scheme, health claims must be preapproved by FDA and meet a scientific “weight of the evidence” standard. The FDA will use the same “reasonable consumer” standard as the Federal Trade Commission when considering whether food claims are misleading.

The FDA also announced it will strengthen enforcement of dietary supplement rules and will establish an FDA Task Force on Consumer Health Information for Better Nutrition. The task force will “develop a framework to help consumers obtain accurate, up-to-date, and science-based information about conventional food and dietary supplements.”

The complete FDA press release announcing the initiative can be found on the Internet at www.fda.gov/bbs/topics/NEWS/2002/NEW00859.html. Guidance for Industry: Qualified Health Claims in the Labeling of Conventional Foods and Dietary Supplements is at www.cfsan.fda.gov/~dms/hclmgui2.html. The FDA has also released a White Paper giving an overview of the initiative. That document can be found at www.fda.gov/oc/nutritioninitiative/whitepaper.html.

If you have any questions, or have trouble accessing the documents on the FDA Web site, please give either of us a call at (202) 898-0089.