Back in May, 2013 when I wrote about Medical Foods on the Vitamin Lawyer Health Freedom Blog, http://vitaminlawyerhealthfreedom.blogspot.com/2013/05/medical-foods-under-orphan-drug-act.html - I had little material to work from. The term "Medical Food" was mentioned as early as the late 1990s in FDA guidances, and more formally defined in the 2005 Orphan Drug Act; that definition remains basic:
"…a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation....” Section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3))
Starting later last year, FDA began reviewing the statute and the short, just several paragraphs, FAQs the FDA had issue on the topic the year after the Statute, although the comment period has been extended, as often happens with a controversial regulation offered under the Administrative Procedures Act.
The new regulations both broaden the class of health care givers who can recommend Medical Foods (by clarifying that Medical Foods are not subject to "prescription") and tighten-up what constitutes a Medical Food. There is clearly no requirement that only physicians provide the evaluation and recommendation for the use of Medical Foods.
Federal law continues to preempt state regulations of the use of Medical Food for the dietary management of medical conditions. This preemption is made more complete by the establishment of these further regulations, thereby further nullifying restrictions by state medical boards and legislation. For example there was a Medical Board regulation in New Jersey that forbid NJ licensed physicians from earning more than a ten-percent return from selling his patients dietary supplements, if the vitamins were "intended to treat disease..." But if intended for the dietary management of medical condition, the use of Medical Food is taken out of the category of "intended to treat disease" and the limits thereupon.
The Draft Guidance is located here:
The purpose of which is:
This guidance is intended to provide industry with a convenient place to find answers to frequently asked questions (FAQs) about medical foods. The responses to these FAQs address common questions about the definition of and regulations for medical foods.
Some of the significant points made in the Guidance relate, for example, to the question whether formal medical prescriptions are required. FDA answered that question with a direct "No."
The Guidance documents further define the use of Medical Foods:
...a medical food must be intended for a patient who has a limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone.
Elsewhere FDA reminds us:
Medical foods do not have to undergo premarket approval by FDA. But medical food firms must comply with other requirements, such as good manufacturing practices and registration of food facilities. Medical foods do not have to include nutrition information on their labels, and any claims in their labeling must be truthful and non-misleading.
Further restricting the category, we find the following language in the Guidance:
Medical foods are not those simply recommended by a physician as part of an overall diet to manage the symptoms or reduce the risk of a disease or condition, and all foods fed to sick patients are not medical foods. Instead, medical foods are foods that are specially formulated and processed (as opposed to a naturally occurring foodstuff used in a natural state) for a patient who is seriously ill or who requires use of the product as a major component of a disease or condition’s specific dietary management.
FDA does not interpret either the Orphan Drug Act or FDA’s implementing regulations at 21 CFR 101.9(j)(8) to require that medical foods be made available by prescription. Instead, the statute requires that a medical food be consumed or administered enterally under the supervision of a physician. FDA considers this requirement to mean that the intended use of a medical food is for the dietary management of a patient receiving active and ongoing medical supervision (e.g., in a health care facility or as an outpatient) of a physician who has determined that the medical food is necessary to the patient's overall medical care. The patient should generally see the physician on a recurring basis for, among other things, instructions on the use of the medical food. FDA does not consider foods that are simply recommended by a physician or other health care professional as part of an overall diet designed to reduce the risk of a disease or medical condition or as weight loss products to be medical foods.
The new Guidance does not materially change the provisions for recommending Medical Foods by health care providers; the actual provision of Medical Foods must still be under the "supervision" of a physician (as that word is defined in State law).
However, other Federal standards apply to the actual labeling an marketing of Medical Foods. And those issues will be addressed in a later blog entry.