FDA/CFSAN - Qualified Health Claims: Letter of Enforcement Discretion - Nuts and Coronary Heart Disease (Docket No 02P-0505)
FDA Logo U.S. Food and Drug AdministrationCenter for Food Safety and Applied Nutrition
U.S. Department of Health and Human Services
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Office of Nutritional Products, Labeling and Dietary Supplements
July 14, 2003

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Qualified Health Claims: Letter of Enforcement Discretion -
Nuts and Coronary Heart Disease

(Docket No 02P-0505)


Mr. D. J. Soetaert
President
International Tree Nut Council
Nutrition Research and Education Foundation
2413 Anza Avenue
Davis, CA 95616

RE: Health Claim Petition - Nuts and Coronary Heart Disease
(Docket No. 02P-0505)

Dear Mr. Soetaert:

This letter is to notify you of our decision with regard to the health claim petition you submitted on August 28, 2002, on behalf of the International Tree Nut Council Nutrition Research and Education Foundation. This petition requests that the Food and Drug Administration (FDA) authorize a health claim about the relationship between the consumption of nuts and reduced risk of coronary heart disease (CHD) on the label or in the labeling of whole or chopped nuts and certain nut-containing products. Your petition identifies peanuts and nine tree nuts (i.e., almonds, Brazil nuts, cashew nuts, hazelnuts, macadamia nuts, pecans, pine nuts, pistachio nuts, and walnuts) as appropriate for your requested health claim. Specifically, your petition requests that FDA authorize the following two model health claims for these nuts and certain nut-containing products:

  1. "Diets containing one ounce of