Regulatory Focus™ > News Articles > US Regulators Offer More Time to Comment on Medical Foods Guidance

US Regulators Offer More Time to Comment on Medical Foods Guidance

Posted 13 November 2013 | By Alexander Gaffney, RAC

US regulators are giving industry more time to weigh in on a new guidance document intended to clarify the process by which medical foods are regulated.


In August 2013, the US Food and Drug Administration (FDA) released the second edition of its Draft Guidance for Industry: Frequently Asked Questions About Medical Foods.

As its name implies, the guidance focused on medical foods-a category of products that straddles a complicated regulatory line between medicine and food.

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 four 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.

The Guidance

FDA's draft guidance clarifies several gray areas around that definition as well, adding that a fifth component, medical supervision, is a key differentiator between regular foods and medical foods.

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," the guidance states.

In addition, FDA's guidance clarifies that unlike normal prescription drug or device products, medical foods do not have to be prescribed. Accordingly, 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).

Additional portions of the guidance focus on the types of diseases and conditions that medical foods may be marketed as managing.

Comment Extension

Originally, the guidance had a respond-by date for comments of 15 October 2013, and two trade groups, the Council for Responsible Nutrition (CRN) and the Healthcare Nutrition Council (HNC) sent in comments in mid-September.

However, in a 13 November 2013 Federal Register notice, FDA said it would be extending the comment period by an additional 30 days (until 14 December 2013) to accommodate "requests for an extension."

"Following publication of the August 13, 2013, notice of availability, we received requests for a 60-day extension of the comment period," FDA explained. "The requesters explained that they needed more time to review the guidance, develop comments, and assemble data."

FDA said that 60 days was unwarranted, as much of the guidance was similar in substance to its last revision in 2007. It said 30 days would allow for "adequate time for interested persons to submit comments without significantly delaying further FDA action on this draft guidance."

The agency added that it had originally intended to extend the period in October 2013, but due to the government shutdown had been unable to issue that notice.

Federal Register Notice

Medical Foods Guidance

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