The United States Food and Drug Administration (FDA) regulates medical foods. Medical foods are a special category that must meet the statutory definition in section 5(b) of the Orphan Drug Act (21 U.S.C. § 360ee(b)(3)) and comply with the agency’s regulations at 21 C.F.R. § 101.9(j)(8). Medical foods are exempt from the labeling requirements for nutrient content claims and health claims. Many other food labeling and regulations do apply to medical foods, including Current Good Manufacturing Practices, Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), Registration of Food Facilities requirements, and if applicable, the Low Acid Canned Food regulations and Emergency Permit Control regulations.
Fuerst Ittleman has experience assisting businesses with all aspects of the medical food regulations and relevant food regulations. We have assisted clients with the basic determination of whether their products fit within the statutory and regulatory definition for a medical food. We regularly conduct ingredient reviews to determine if the ingredients are approved food additives, Generally Recognized as Safe (GRAS), or if the ingredients are subject to an exemption for investigational use. We also have comprehensive experience conducting label reviews for compliance with FDA regulations. All of this experience allows us to assist your business in understanding medical food regulations and, more importantly, helping your business become compliant and profitable.
For more information, please contact us at contact@fuerstlaw.com or (305) 350-5690.
