The recent warning letter from the FDA to the manufacturer of Axona® highlights a frequently misunderstood aspect of medical food regulation. Namely, that food substances with medical benefits are not candidates to be medical foods unless the disease they are intended to treat is recognized to have a distinctive nutritional requirement or need for that food substance. Although it may seem logical that a nutritional need for a substance must exist in a disease state if the administration of a food substance provides benefits to patients with that disease, the FDA does not agree. The FDA requires a broader recognition by the scientific and medical communities that a specific nutrient requirement (e.g., a nutrient deficit or the need to avoid a specific nutrient) exists. For example, the FDA often cites the widely recognized increased metabolic rate in burn patients and their need for enhanced caloric intake as an example of a recognized nutritional need. Meeting this standard of medical and scientific acceptance is especially problematic for manufacturers of products for which emerging science supports the clinical benefits of nutrient therapy.
The Weinberg Group has decades of experience in working with clients on medical food issues. Clients with questions are encouraged to call us to assist.
Posted by Carrie Rabe, Ph.D., Senior Consultant. For more information, please contact Carrie at firstname.lastname@example.org.