FDA Issues Revised Draft Guidance on "Medical Foods"

On August 13, the Food and Drug Administration (FDA) announced the availability of a draft guidance entitled “Frequently Asked Questions About Medical Foods; Second Edition.”[1]   The draft guidance updates and expands a previous draft issued in May 2007 regarding the definition, labeling, and availability of medical foods.  To allow FDA to consider comments before it begins work on the final version, comments on the draft guidance should be submitted by October 15, 2013.

The regulatory requirements for medical foods have not changed.  However, the revised draft document should be helpful to the food industry because it provides greater clarity about the types of products that do not qualify as medical foods.  FDA has answered a number of specific questions that should address areas of past confusion about how medical foods may be positioned in the market and the types of conditions for which they may be recommended.

The major changes from the 2007 guidance are discussed below.

Definition of Medical Foods

The 2007 guidance stated that not all foods fed to sick patients are medical foods.  The updated guidance expands on this statement, noting that 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.”

In the previous guidance, medical foods were described as foods that are specially formulated and processed for a patient who is seriously ill or who requires the use of the product as a major treatment modality. The revised guidance replaces the phrase “treatment modality” with “component of a disease or condition’s specific dietary management”, eliminating the technical term and emphasizing that the medical food must be designed for dietary management of a disease or condition, rather than generalized ‘treatment.’

Registration of Medical Foods

In response to frequently asked questions regarding registration of medical foods, the guidance has been updated to reflect that any facility that manufactures, processes, packs or holds medical foods for consumption in the United States must register with FDA just as any other food facility. 

Medical Foods Distinguished from Drug Products

Medical foods must be formulated to be consumed or administered enterally under the supervision of a physician.  The revised guidance clarifies that FDA does not interpret this requirement to mean that medical foods must only be made available by prescription.  Instead, FDA interprets this requirement to mean that a medical food must be intended only for a patient under 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.  This at least raises a question of whether FDA thinks it is appropriate for medical foods to be sold directly to the public (e.g., in grocery stores) or whether they should be distributed more directly through healthcare providers.  Affected manufacturers may wish to submit comments to FDA about the availability issue.

Importantly, FDA would not consider foods that are merely recommended 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 labeling of medical foods may not bear the symbol “Rx only.”  However, FDA would not object to the use of language to communicate that the food must be consumed or administered enterally under the supervision of a physician (e.g., “must be used under the supervision of a physician”).

The labeling of medical foods should not include National Drug Code (NDC) numbers.

Ingredients in Medical Foods

An ingredient that is added to a medical food must be safe and suitable and comply with all applicable provisions of the Food, Drug, and Cosmetic Act (FD&C Act) and FDA’s regulations. Any ingredient added to a medical food should be:

(1)   a food additive used in accordance with FDA’s food additive regulations (see 21 CFR Part 172);

(2)   a color additive used in accordance with the color additive regulations (see 21 CFR Parts 73 and 74);

(3)   a substance that is generally recognized, by qualified experts, to be safe under the conditions of its intended use (GRAS) (see 21 CFR 170.30 and 21 U.S.C. 321(s)); or

(4)   a substance that is authorized by a prior sanction issued by FDA (see 21 CFR 170.3(l)).

Specific Diseases or Medical Conditions

• Inborn Errors of Metabolism (IEMs): FDA generally considers IEMs, which include 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.  Therefore, if a product meets the definition of a medical food, it could be used in the management of IEMs that cannot be managed with diet modification alone.
• Where a disease or medical condition has specific nutrient requirements, but can typically be managed through dietary modification alone (e.g., pregnancy, diabetes, scurvy or other diseases related to essential nutrient deficiencies), FDA generally would not consider the disease or condition to be one for which a medical food could be marketed.

Conventional Foods

Conventional foods that do not ordinarily contain protein or are ordinarily low in protein (e.g., fruits) would not meet the regulatory criteria for medical foods, because they are not specially formulated or processed.

Overall, the revised draft document appears to provide more specific guidance on FDA’s view of the appropriate role of medical foods and how these products may be positioned.  Manufacturers that disagree with FDA should consider submitting comments before the October 15, 2013 deadline.

For more information about FDA’s regulation of medical foods (or other products), please contact Mel Drozen (drozen@khlaw.com; 202-434-4222) or Frederick Stearns (stearns@khlaw.com; 202-434-4288).