Regulatory Focus™ > News Articles > Warning Letter to Medical Food Distributor Shows Fault Lines Between Food, Drug Claims

Warning Letter to Medical Food Distributor Shows Fault Lines Between Food, Drug Claims

Posted 10 September 2013 | By Alexander Gaffney, RAC

A new Warning Letter sent by the US Food and Drug Administration (FDA) to an online retailer of medical foods claims the company misbranded its products by failing to meet the statutory definition of medical food, providing an early glimpse into FDA's new enforcement approach toward the sector.


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.

On August 2013, FDA released a new draft guidance document, Frequently Asked Questions About Medical Foods, Second Edition-the same day it sent a Warning Letter to Metagenics, an online retailer of medical foods.

FDA's guidance also adds a fifth definitional 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."

Notably, medical foods are also not prescribed. Per FDA, and "Rx Only" statement would cause the food to be misbranded under Section 403(a)(1) of the Federal Food, Drug and Cosmetic Act (FD&C Act).

The Metagenics Letter

FDA's Warning Letter to Metagenics claims the company's labeling for various products causes them to be misbranded because they do not meet the statutory definition of medical food as established in 21 CFR 101.9(j).

"A medical food must be intended for the dietary management of a disease or condition for which there are distinctive nutritional requirements," FDA explains to Metagenics in the letter. "Further, pursuant to 21 CFR 101.9(j)(8)(ii), 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."

However, nine products offered for sale by Metagenics did not meet the statutory definition under 21 CFR 101.9(j) in FDA's estimation, and are thus misbranded as medical foods.

The foods offered for sale cover a wide range of conditions, including chronic fatigue syndrome (CFS), fibromyalgia, leaky gut syndrome, metabolic syndrome, cardiovascular disease, inflammatory bowel conditions, Type 2 diabetes, eczema, rhinitis, allergy-responsive asthma, bariatric surgery patients and peripheral artery disease.

In all cases, FDA said it was "not aware" of evidence that these products would stand to help patients with the noted conditions, particularly as many (i.e. CFS) express a normal capacity to ingest, digest, absorb and metabolize nutrients. In other cases, FDA said "dietary modification alone" was likely sufficient to help patients, such as those with metabolic syndrome, Type 2 diabetes or cardiovascular disease.

"Because these products are intended to support diseases or conditions that do not have distinct requirements for certain nutrients, these products do not meet the statutory definition or regulatory criterion for medical foods set forth in 21 CFR 101.9(j)(8)(ii)," FDA wrote.

Qualifying Statement to the Contrary, Still Unapproved

FDA also cited a number of other related claims that it said caused the drug to be marketed as a new drug product under section 201(g)(1)(B) of the FD&C Act. "The therapeutic claims on your website establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease," FDA wrote. Medical foods, meanwhile, are only for dietary management-not disease management.

The distinction resulted in 13 of Metagenics' products being found to be unapproved, requiring their removal from the market. The finding is perhaps especially ironic given a prominent disclaimer at the bottom of Metagenics' website: "These statements have been not evaluated by FDA. This product is not intended to diagnose, treat, cure or prevent any disease."

FDA would appear to disagree strongly with that statement.

FDA Warning Letter to Metagenics

FDA Guidance on Medical Foods

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