FDA is re-evaluating its regulation of "medical foods" and is seeking comments on the criteria used to determine if a product meets the definition of a medical food, appropriate safety standards, claim substantiation, labeling, quality control procedures and postmarketing surveillance requirements.
By definition medical foods are those formulated to be eaten by sick people under a doctor's supervision to treat a disease or condition that scientists have determined have distinctive nutritional requirements. Medical foods were exempted from a number of labeling and claim requirements of the Nutrition Labeling and Education Act. Ironically that means food intended for the sick is subject to much less scrutiny than virtually all other foods. FDA is concerned over the explosion of products being marketed as medical foods potential safety problems in their manufacture and control and the potential for fraudulent claims on packages. Comments are due to FDA by February 27 1997.