Does FDA Consider Your Product to be a “Medical Food?” If so – What Regulations Apply?
If doctors often recommend that you choose certain types of food product to manage the symptoms or reduce the risk of a disease, does that make it a medical food, subject to those regulations? How do you know if the dietary-use food you produce is actually a “medical food”? Is there a statutory definition? What labeling requirements apply to these foods?
FDA addresses frequently asked medical food questions such as these, updating its 2007 guidance and finalizing the August 2013 draft guidance, in the May 12 publication of its final guidance “Frequently Asked Questions About Medical Foods: Second Edition.” This second edition updates the draft responses and provides additional information on the definition and labeling of medical foods, types of diseases and conditions that a medical food could be used to manage.
We often get asked questions at TAG about what is or is not a medical food and this information is helpful in trying to figure all that out. Following are answers to the questions we asked above, along with other selected key questions from the final guidance:
What is a medical food?
Medical foods are defined in the Orphan Drug Act, in general, as those that are to be used under medical supervision and intended for the specific dietary management and nutritional requirements of a disease or condition. Thus, even if your food is regularly recommended by a doctor for dietary or disease management, it is not necessarily a medical food.
Specific FDA regulatory criteria (21 CFR 101.9(j)(8)) as:
specially formulated and processed for the feeding of a patient through oral intake or enteral tubal feeding directly into the stomach or small intestine;
intended for the dietary management of a patient who has medically limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foods or certain nutrients, or other special medically determined nutrient requirements, which cannot be achieved by simply modifying the diet;
provides nutritional support specifically modified to manage nutrient needs of a specific disease or condition, as determined by medical evaluation; and
intended to be used only under medical supervision for the patient requiring recurring medical care.
If your food meets all these criteria, it is considered to be a medical food and is exempt from the nutrition labeling requirements of 21 CFR 101.9 Additionally, manufacturers of medical foods must comply with all applicable FDA requirements for foods.
2. What is FDA’s meaning of “under the supervision of a physician”?
This means that the patient is receiving “active and ongoing medical supervision (e.g., in a health care facility or as an outpatient) by a physician who has determined that the medical food is necessary to the patient’s overall medical care.” Additionally, the patient should generally see the physician on a recurring basis for, among other things, instructions on the use of the medical food as part of the dietary management of a given disease or condition.
3. Are medical foods subject to drug or nutrient content claim labeling?
Neither. Medical foods are not considered to be drugs, so are not subject to drug-specific regulations. Nor do they need to follow labeling requirements for health claims. Rather medical food labels must follow all other applicable food labeling requirements, containing:
A statement of identity.
Net quantity of contents.
Name and place of business of the manufacturer, packer, or distributor.
A complete list of ingredients, listed by their common or usual name and in descending order of predominance.
All other label information required of foods, with the information in English unless distributed solely in the Puerto Rico or a territory where the predominant language is not English, the predominant language may be substituted for English. Additionally, if the label includes any foreign language(s), then all mandatory label information must be repeated in each.
4. Should the medical food be labeled as a prescription (Rx)?
The labeling of medical foods may not bear the symbol “Rx only.” Medical foods are not required by federal law to be dispensed by prescription, so labeling it as “Rx only” would misbrand a medical food under FD&C, because it would be a false and misleading statement. However, because medical foods are required to be formulated to be consumed or administered enterally under the supervision of a physician, phrasing such as “must be used under the supervision of a physician” is allowed.
5. Does FDA generally consider inborn errors of metabolism (IEMs) to be diseases or conditions that a medical food could be used to manage?
FDA generally considers IEMs – inherited biochemical disorders in which a specific enzyme defect interferes with the normal metabolism of protein, fat, or carbohydrate – to be diseases or conditions that a medical food could be used to manage. Because some of these require a medical food, in addition to a specific dietary modification, to obtain adequate levels of essential nutrients, the medical foods become indispensable for individuals with these IEMs. Some examples of specific IEMs that medical foods could be used to manage involve amino acid/protein, organic acid, or fatty acid metabolism.
6. Does FDA consider pregnancy to be a condition for which a medical food could be labeled and marketed?
No. 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. It is generally practicable for women who are pregnant to follow the IOM and FDA recommendations for nutrient intake within a normal diet, so FDA generally would not consider a product labeled and marketed for pregnancy to meet the regulatory criteria for a medical food.
7. Does FDA consider diabetes mellitus (DM) or diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) to be a those for which a medical food could be labeled and marketed?
No. Diet therapy is the mainstay of diabetes management, and a regular diet can be modified to meet the needs of an individual affected by DM (along with appropriate drug therapy if necessary). Diseases resulting from essential nutrient deficiencies (e.g., deficiencies of vitamin C, niacin) are primarily caused by inadequate intake (e.g., famine, significant calorie restriction, eating disorders, alcoholism, diet practices/fad diets). These diseases can typically be managed through consumption of a healthy, well-balanced diet.
8. Would conventional foods be considered to be medical foods if, in their natural state, they do not contain, or are low in, protein?
No. Conventional foods such as fruits, certain vegetables, fats, and sugars generally are not specially formulated to be significantly low in protein or to contain no protein, rather they are low in protein in their natural state. Because a medical food must be a specially formulated and processed product (as opposed to a naturally occurring foodstuff used in its natural state), conventional foods that do not ordinarily contain protein or are ordinarily low in protein would not be considered to be medical foods.
Interestingly, while obesity and labeling for gluten-free, low-sodium, etc., are issues of importance to food companies, there is no mention of any of these in the FAQ guidance. Overall, however, our view is that this is helpful and important guidance and is, in fact, pretty focused on key areas. Nevertheless it is important to understand if those areas apply to the type of food you are making and marketing.
About The Acheson Group (TAG)
Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG's team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com