

You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. 1061, Rockville, MD 20852.įor questions regarding this document, contact the Infant Formula Medical Foods Staff at the Center for Food Safety and Applied Nutrition (CFSAN) at 24. Submit comments to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. Center for Food Safety and Applied NutritionĬomments and suggestions regarding this document may be submitted at any time.
