U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Nutritional Products, Labeling, and Dietary Supplements
October 10, 2000

Letter Regarding Health Claims that Were
the Subject of the Pearson Court Decision

(Docket Nos. 91N-0098, 91N-100H, 91N-0101 and 91N-0103)

Jonathan W. Emord, Esq.
Emord & Associates, P.C.
1050 17th Street, N.W.
Suite 600
Washington, D.C. 20036

Dear Mr. Emord:

By separate letters, you have been notified of the Food and Drug Administration's (FDA) decisions regarding health claims for folic acid with respect to neural tube defects (Docket No. 91N-100H), and for fiber with respect to colorectal cancer (Docket No. 91N-0098). As you know, the agency intended, by October 10, 2000, to finalize its decisions for all four health claims that the court decision in Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999), directed the agency to reconsider. Although the Center for Food Safety and Applied Nutrition has been working diligently on all of these issues, FDA has not yet completed its decisions regarding the claims for anti-oxidants with respect to cancer (Docket No. 91N-0101), and for omega-3 fatty acids with respect to coronary heart disease (Docket No. 91N-0103). FDA will complete those decisions no later than October 24, 2000. I apologize for this delay.

Letter Regarding Dietary Supplement Health Claim for Folic Acid with Respect to Neural Tube Defects (Docket No. 91N-100H)

Letter Regarding Dietary Supplement Health Claim for Fiber with Respect to Colorectal Cancer (Docket No. 91N-0098)

Hypertext updated by dms/kwg 2000-NOV-27