Can Food Be Treated as Medicine and Prescribed by Doctors?
(Thursday, May 12, 2022)
Traditionally, a medicine is something intended to treat a specific disease while food is consumed for nutrition. But with increasing evidence linking the food we consume to our diseases and health, can doctors prescribe food to prevent, treat and/or manage diseases just like they would prescribe a drug for similar purposes? What would be the regulatory and medical consequences? Can food companies claim to treat diseases? An interesting commentary on the food-as-medicine concept on WedMD discusses a growing trend of “lifestyle medicine” doctors prescribing specific food components to manage chronic diseases. Food management has been linked to cancer, diabetes, longevity, and other health conditions. For a long time, dietary management was the forte of nutritionists who would plan a person’s diet for general health and wellness goals. However, having a physician make not just suggestions but prescriptions for food components and diet management is a new concept. Doctors are free to make any suggestions, recommendations, prescriptions, or any other medical decisions about their patients. So, in principle, physicians asking their patients to consume certain food ingredients and diets is feasible, and patients will likely comply at a higher rate if their physicians are the ones explaining the rationale for such diet management. But there is one major practical challenge to such prescriptions: there are no prescription food products. Companies making food products for specific medicinal benefits, find a hard push-back from FDA. While FDA cannot regulate medical practice, it does regulate the claims for any food products. In the past, even claims of simpler medicinal benefits by food manufacturers, led to FDA Warning Letters. The regulations that require clinical evidence for safety and effectiveness for any medical claims apply to manufacturers of such products. So, food manufacturers would need to conduct clinical trials for the “prescription food products”. Not only that, creating food product formulations that can be reviewed as pharmaceuticals would require significant product design and formulation, which may not be easy to create for food manufacturers. With the absence of specific prescription products, physicians would end up acting as nutritionists, which may not be very appealing to them. This in turn would lead to consumers and patients not getting access to this medical information from their physicians. It may seem like a circular logic, but it is factual due to the nature of the regulations for prescription products and food. For the food-as-medicine concept to be practical, there needs to be major shift in the principles of medical and health management. Are we ready for that? Hard to say.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC