“Medical foods have long existed as a category. FDA is taking a closer look at that category,” Jim Lassiter, president of Laguna Beach, CA-based consultancy Ingredient Identity told NutraIngredients-USA.
Warning letter from website review
The warning letter, dated Aug. 13, 2013, resulted from a review of the company’s website. Such website reviews and warning letters do not result from the same inspection‑483-warning letter protocol as a GMP inspection; when FDA finds noncompliant website language it can and does issue warning letters immediately.
Medical foods are a lesser known subcategory of dietary supplements. To use the definition in the guidance (which itself parrots the language in the defining regulation), a medical food is “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.”
Additionally, a medical food must be a product formulated specifically to address a medical condition that gives rise to a specific nutritional deficiency or to address the needs of patients who have specific difficulties in absorbing certain nutrients or ingesting certain foods as a result of a specific disease. For example, if a given condition gave rise to a potassium deficiency, a banana marketer could not brand his products as medical foods.
14 products cited
FDA took issue with 14 products that Metagenics was selling as medical foods. The products are branded to address the needs of patients suffering from chronic fatigue syndrome, fibromyalgia, leaky gut syndrome, metabolic syndrome, cardiovascular disease, inflammatory bowel disease, type 2 diabetes, atopic disorders such as eczema, rhinitis, and allergy-responsive asthma, bariatric patients both before and after stomach reduction surgery and periphereal artery disease.
In the warning letter, FDA said it believes that the medical foods regulation and guidance to “narrowly constrain the types of products that fit within this category. In addition to other criteria, medical foods must be for the dietary management of a specific disorder, disease, or condition for which there are distinctive nutritional requirements and must be intended to be used under medical supervision.”
In the test of the warning letter, FDA cited for every one of the products the following bit of boilerplate: “FDA is not aware of any distinctive nutritional requirement for patients with (disease name), nor is FDA aware of any evidence that patients with (disease name) have a limited or impaired capacity to ingest, digest, absorb, or metabolize any specific nutrients.”
Also included in the list of Metagenics’s products were two meant for patients suffering from Type 2 diabetes. In the draft guidance, FDA specifically excluded Type 1 and Type 2 diabetes as conditions for which a medical food can be marketed and sold.
FDA concludes that “these products are misbranded within the meaning of Section 403(a)(1) of the Act because their labeling is false or misleading in that the products are labeled as a medical food but do not meet the definition of a medical food.”
Double whammy
Once the Metagenic’s products have been disallowed as medical foods, they fall into the category of unapproved new drugs, as far as FDA is concerned. The claims which might have function in the medical food realm become unallowed disease claims if the products are intented as supplements. An example would be a product that Metagenics says provides “specialized nutritional support to address…liver detoxification function in patients with chronic fatigue syndrome.”
FDA concludes the discussion on disease claims with this: “Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are ‘new drugs.’ ”
Metagenics response
In a statement in response to the warning letter the Californian company said: "As an industry leader in the development of medical foods, we have great confidence in the unsurpassed quality and safety of our products as supported by well-designed clinical studies and nutrition research.
"Metagenics recently received a Warning Letter from the FDA related to the categorization of the company’s products as medical foods. The letter was received concurrent with the issuance of new guidance for medical foods from the FDA, which includes potential changes to current practice. The letter from the FDA only addressed the positioning of Metagenics’ line of products as medical foods, but raised no concerns regarding the quality, manufacturing or safety of our products."
Renewed scrutiny
So is this an example of FDA using a draft guidance as a basis for enforcement? Has the category become somewhat overbroad during its long market history? Does it now include products that don’t perfectly match the regulatory definitions?
“I do think that they [FDA] are sending that message,” Lassiter said. “I think their target selection (Metagenics) was part of that message.
“The timing of the release of the warning letter and the timing of the release of the updated draft guidance was not a coincidence. FDA is saying, here’s our point and here’s how we are making it.”