Medical Foods Under the Orphan Drug Act

MEDICAL FOODS UNDER THE ORPHAN DRUG ACT
Physicians’ Use of Dietary Supplements and Nutrients as Therapy that May Benefit 
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 Medical Foods do not treat disease; rather, they support optimal clinical outcomes by nourishing normal structure and function. A “Medical Food” under the 2005 Orphan Drug Act is any food or dietary supplement that is recommended by a physician for the dietary management of a medical condition. When recommended by a physician, the nutrient can be considered as Medical Food protected under the Act.

Here is how the Orphan Drug Act defines a Medical Food:

"…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)) 

The FDA, in commenting on the Congressional enactment, tells us, 

"Medical foods are distinguished from the broader category of foods for special dietary use and from foods that make health claims by the requirement that medical foods 
          a. be intended to meet distinctive nutritional requirements of a disease or condition, 
           b. used under medical supervision and
          c. intended for the specific dietary management of a disease or condition."

The FDA FAQs further inform us, 

"The term "medical foods" does not pertain to all foods fed to sick patients. Medical foods are foods that are specially formulated and processed (as opposed to a naturally occurring foodstuff used in a natural state) for the patient who is seriously ill or who requires the product as a major treatment modality."

And the Agency concludes: 

"In general, to be considered a medical food, a product must, at a minimum, meet the following criteria: 
          a. the product must be a food for oral or tube feeding; 
          b. the product must be labeled for the dietary management of a specific medical disorder, disease, or condition for which there are distinctive nutritional requirements; and 
          c. the product must be intended to be used under medical supervision..."

http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/MedicalFoods/default.htm

We therefore conclude from this exposition by the FDA several points of note: 

(1) the Orphan Drug Act pre-empts state regulation of Medical Foods*; 
  
(2) products protected under DSHEA can be considered Medical Foods, and 
  
(3) it is appropriate for health care providers to recommend dietary management of various nutritional and metabolic syndromes that are being identified by advanced health care practitioners.

* Many physicians are concerned about how they can integrate dietary supplements into their medical practices, since various state medical boards still have some restrictions on the inclusion of nutrition in the standard practice of medicine. Congress intended the Orphan Drug Act as remedial legislation, to address the question of the use of foods in medical practice. The Act in general is intended to exempt certain remedies from previous legal restrictions, including Medical Foods. Congress has legally pre-empted state medical regulations with regard to the “dietary management” of medical conditions. This permits physicians to recommend dietary supplements in ways that, before the Act, might have been restricted by state regulations.

Many of the fatalities or other harms people experience during standard medical treatment are not from the disease itself, but from the toll the surrounding circumstances takes on the immune system, causing malnourishment and further sickness. 

This is where nutrients step in to fight side-by-side with the patient and physician, by promoting overall wellness, enhancing immunity and supporting metabolism.  Simply put, healthier, stronger patients do better when fighting their disease compared to patients whose health has been physically compromised by, for example, cancer and the treatment for cancer. 

The type of medical conditions for which dietary management is indicated include many conditions and syndromes, including Wasting Syndrome, associated with serious diseases such as cancer or various immune system disorders.

The standard applied to the use of Medical Food is not the same standard as applies to the use of drugs and invasive modalities, such as radiation and surgery. The standard for those medical treatments is “significant scientific agreement” as mediated by FDA approval of such standard treatments.

Congress, in determining to create the separate regulatory category of Medical Food, instructed that a different standard apply. That standard is:

     “distinctive nutritional requirements, based on recognized scientific principles… established by medical evaluation…”

Thus, recognized scientific principles, as developed by nutritional science, provide the reliable and competent substantiation for the use of high-potency nutrition as Medical Food for the dietary management of medical conditions associated with disease.

As a society and medical community we are not currently at the point where we have a guaranteed "cure" to cancer or other "noncommunicable diseases of under nutrition" (as identified by WHO in 2002)… however there is always hope. Year after year, millions of patients do survive cancer and other debilitating disease.  By providing nutritional, wellness, and metabolic support, Medical Foods help patients as a complement to their prescribed medical treatment. As the physician's therapy partner and ally, the Medical Food providers will stand with physicians and patients, side-by-side. 

The Medical Foods are labeled as is usual for a food or dietary supplement, with an added label providing the requirements to meet the Medical Foods standards: a place for the physician’s name; the patient’s name; the statement, 

            “For the Dietary Management of ___________.” and “To be used under medical supervision.”

The Practice of Medicine is both an art and a science. Modern medicine has at its disposal an entire arsenal of treatment and therapy modalities. Licensed physicians are authorized by both state and federal law to bring that arsenal to bear upon proper diagnosis. State medical boards help define the standard of care. The federal FDA helps determine what drugs and devices may be used for what treatments. 

Congress, in the Orphan Drug Act, placed special emphasis on the use of nutrients, including dietary supplements, for the dietary management of medical conditions. This management is, itself, not a “treatment of disease” but is, rather, a “therapy that may benefit” permitted under AMA Ethics Code Opinion 3.04. 

In the case of Medical Foods this distinction is critical. Medical Foods, as therapy that may benefit, can be recommended by a physician and offered under medical supervision, to manage medical conditions associated with various disease conditiosn, to assure optimal clinical outcomes.

The Vitamin Lawyer Consultancy offers the Medical Community incisive CME training, “Medical Foods and Dietary Supplements In Medical Practice.” My webinar course provides an overview of Medical Foods in Medical Practice. Access is available upon request: ralph.fucetola@usa.net (with Medical Foods" in the subject line).

© 2013

Ralph Fucetola JD
The Vitamin Lawyer.com Consultancy
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