FDA Updates the Medical Foods Guidance
(Thursday, March 23, 2023) This week FDA updated its Medical Foods guidance to clarify and expand on its previous guidance from 2016. The main update is regarding the requirement for allergen warning on medical food labels but there are several other pointers in the guidance about medical foods to answer common questions from consumers and industry alike. Medical foods are defined as specially formulated food intended to address distinctive nutritional requirements of a disease or condition based on medically established scientific principles. Medical foods are frequently confused by the consumer with prescription products, and by the manufacturers as food or dietary supplements. The guidance answers common questions such as do you need a prescription for medical foods, or do you need an Rx label on these products; the answer is No for both. It also clarifies that nutritional content labels are not needed for medical food products, neither do these products need health claims. FDA does not approve or list medical foods but requires that the manufacturing facilities register as food manufacturing facilities. “Supervision by physician” is loosely defined in the regulations and FDA clarifies that it does not mean that constant consultation with a physician is required, rather “recurring meetings with the physician” are sufficient. Medical foods do not get National Drug Code (NDC) numbers. FDA also lists specific diseases or conditions that cannot be treated with medical foods. Diabetes, scurvy, pellagra, and pregnancy are specifically listed as diseases or conditions that cannot be treated with medical foods. The updated guidance does not give any surprising information but is very useful to clarify commonly help misperceptions about medical foods. AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: mkumar@fdamap.com Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
|