Medical foods/foods for special dietary uses definitions to be clarified in upcoming regs.
This article was originally published in The Tan Sheet
Executive Summary
MEDICAL FOODS/FOODS FOR SPECIAL DIETARY USE CATEGORIES TO BE CLARIFIED BY FDA under a future "regulatory regime" for "the broad group of heterogeneous products that are marketed as medical foods," the agency said in an Advance Notice of Proposed Rulemaking published in the Nov. 29 Federal Register. Although "some ambiguity exists in the distinction between these two types of foods, the statutory language provides several bases on which to distinguish medical foods from foods for special dietary use," the ANPR maintains.