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Medical foods guidance

This article was originally published in The Tan Sheet

Executive Summary

FDA's "Guidance for Industry: Frequently Asked Questions about Medical Foods" provides a definition of the category, and notes medical foods must comply with cGMPs and the Food Allergen Labeling and Consumer Protection Act of 2004. However, medical foods do not require pre-market review or approval and are exempted from the labeling requirements for health claims and nutrient content claims under the Nutrition Labeling and Education Act of 1990. The agency notes it does have a compliance program specifically for medical foods. In a November 2004 Federal Register 1notice, FDA withdrew an advance notice of proposed rulemaking on medical foods, stating its existing compliance program was a sufficient framework. The agency recently sent a warning letter to Ganeden Biotech for products labeled as medical foods that did not meet the FDA definition; however, the letter was later withdrawn (2"The Tan Sheet" March 5, 2007, In Brief)...

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