Regulatory Focus™ > News Articles > FDA Releases Updated Draft Guidance on Medical Foods

FDA Releases Updated Draft Guidance on Medical Foods

Posted 14 August 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) regulates many products, among them healthcare products, food and tobacco. And while it is no stranger to combination products, particularly drug/device combinations, less common is a classification of products known as medical foods. Now FDA is out with a newly revised draft guidance document intended to answer some of industry's most common questions on how FDA intends to regulate medical foods.


Medical foods straddle a complicated regulatory line. On one hand, they are intended to be food products, and are consumed much as any other food product would be. However, because they are associated with specific medical claims (i.e. the treatment, prevention or cure of a condition or disease), they are regulated somewhat more similarly to-but not the same as-drugs, all while maintaining many requirements common to general food products.

Under the Orphan Drug Act of 1984, medical foods are defined 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."

Key in that definition are three points:

  • The food must be consumed orally.
  • It must be specifically formulated (as opposed to a naturally occurring product).
  • The food must be used under medical supervision.
  • The food must be intended to manage/treat a specific disease or condition.

Medical foods are not products intended to be consumed as part of an overall diet intended to reduce the risk of disease, such as eating a diet high in vegetables and fruits to help reduce the risk or effects of diabetes or obesity.

FDA's guidance also adds a fifth component, one elaborating on the definition of "medical supervision": a medical food is "intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food."

Labeling Standards

Because these medical foods aren't regulated as traditional foods, different labeling standards apply. For example, the terms of the Nutrition Labeling and Education Act of 1990, which established nutrient content claim standards, do not apply.

However, most other food regulations still apply, including those requiring:

  • a statement of identity
  • the net quantity of contents
  • the identity and location of the food manufacturer
  • a list of ingredients, sorted by order of predominance
  • Unless the food is distributed primarily in Puerto Rico, the language on the label must be in English.
  • principal display panel (PDP) requirements under 21 CFR 101.2
  • misbranding requirements under 21 CFR 101.18
  • allergen labeling requirements under the Food Allergen Labeling and Consumer Protection Act of 2004

In addition, FDA's guidance notes that medical foods must meet current good manufacturing practice (CGMP) standards under 21 CFT 110.

Prescription Status and NDCs: Not Required or Advised

Notably, FDA's guidance also clarifies that unlike normal prescription drug or device products, medical foods do not have to be prescribed. Rather, the statute only required that they be used under the supervision of a medical practitioner (i.e. physician).

"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," it explains in the guidance. The guidance does not explain what the agency feels a "recurring basis" is with respect to proper supervision, however.

As a result, medical foods may not have an "Rx only" symbol to denote a requirement to restrict the product. Doing so will render it misbranded under Section 403(a)(1) of the Federal Food, Drug and Cosmetic Act, FDA writes in the guidance. Similarly, medical foods should not include National Drug Code (NDC) numbers (as all drug products are required to have).

Comments on the draft guidance are due to FDA by 15 October 2013.

Draft Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition

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