The FDA defines a medical food as:
“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.”1
The FDA goes on to say “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.”1
A medical food therefore, must be given under the supervision of a medial provider for a specific disease process.
Medical foods are not drugs and are not under the same guidelines as a pharmaceutical. They are treated more like a dietary supplement.
There are strict label requirements including:
Name of product
Net contents
Complete List of ingredients in descending order of predominance
Name and location of business
Label requirements met for a medical food including: Name, Net Contents, Complete list of ingredients, and location of business.,Medical foods also must comply with all the manufacturing guideline of any foods in the United States. This includes an FDA registered facility, current good manufacturing practices, and proper packaging.
What about a prescription?
This is an excellent question that comes up a lot especially for our products UreaAide™ packets and UreaAide™ unflavored. As these are medical foods and not drugs, a prescriptions is not necessary to purchase. We sell direct to consumers which actually saves money by cutting out the middle man (pharmacies). Having said that this also means getting medical foods covered by insurance can be difficult. Often, if covered, this would be under the medical benefit and not the pharmaceutical benefit.
Are medical foods a qualified Medical expense? Will my HSA/FSA/MSA cover it?
Medical foods are a tax deductible qualified medical expense with any tax differed health account. This is discussed in the publication 502 by the IRS.2
Herein they state the following criteria to meet coverage:
1. The food doesn’t satisfy normal nutritional needs
2. The food alleviates, or treats an illness
3. The need for a food is substantiated by a physician
This is by definition a medical food such as UreaAide™ for the management of Hyponatremia (low sodium).
What about a National Drug Code number (NDC)?
This is interesting, the FDA actually states medical foods should NOT have a NDC number as this could be considered misleading to consumers, as they are not drugs.1
They go on to say:
“The presence of an NDC number on a food product that is not a drug misbrands the product under section 403(a)(1) of the FD&C Act. In addition, any representation that creates an impression of official FDA approval through the use of an NDC number in labeling constitutes misbranding.1
In closing medical foods are non-prescription supplements that can be purchased directly. They should be taken only under the supervision of a medical provider but must have certain labeling and manufacturing requirements. Medical foods are qualified medical expenses and any health saving account may be used to purchase. Medical foods may be covered by insurance companies but not typically. If they are covered it would usually be under the medical benefit and not the pharmaceutical benefit.
References:
1. FAQ about medical foods second edition. FDA.
https://www.fda.gov/media/97726/download
2. Publication 502. IRS. Qualified Medical Expenses
https://www.irs.gov/pub/irs-pdf/p502.pdf