In May of last year the Food and Drug Administration put out a final guidance on the subject of medical foods. The category was founded to give companies a way to address certain difficult to treat inborn errors of metabolism, such as phenylketonuria, an inherited disorder in which sufferers must eat a special diet that limits their exposure to the amino acid phenylalanine.
FDA therefore had from the inception of the category a very narrow view of what kinds of products fit the definiton. The diseases these products are meant to address need to have a specific dietary component and one that cannot be dealt with by basic modifications to food intake. In the case of phenylketonuria, for example, products must be specially formulated with proteins in which the amino acid has been removed.
Door shut on metabolic disorders
But over the years the category has been pulled and stretched by companies that would like to apply it to issues that have a dietary association, but not a specific dietary component. Chief among these are the whole slew of metabolic disorders, starting with metabolic syndrome and working all the way up to full blown diabetes itself. FDA has viewed this development with a jaundiced eye, and with the final guidance it put its foot down.
On the question of whether diabetes mellitus (DM) has a dietary component, FDA had this to say:“There are no distinctive nutritional requirements associated with the management of DM. Essential nutrient requirements for individuals affected by DM are no different than those for unaffected (generally healthy) persons.”
And on whether a medical food could be formulated to address the needs of DM patients, FDA said this: “No. Diet therapy is the mainstay of diabetes management. A regular diet can be modified to meet the needs of an individual affected by DM (along with appropriate drug therapy if necessary).”
Duffy MacKay, senior vice president of scientific and regulatory affairs for the Council for Responsible Nutrition, said there has been little development on the issue since the issuance of the final guidance.
“Overall there haven’t been any major additions to that story,” MacKay told NutraIngredients-USA.
Still, the pull of a medical food positioning remains strong. Medical foods, which can be packaged in a way similar to a dietary supplement, are supposed to be used under the supervision of a physician. In return for the limited markets they were originally supposed to address, the products can make drug-like claims.
“We know that many companies are trying to jam products into the medical foods space,” said Marc Ullman, a New York-based attorney who is of counsel with the firm Rivkin Radler. “They see those drug-type words which is why they want to do it.”
Critics of FDA’s position on medical foods to address diabetes and other metabolic conditions have the following rejoinder to FDA’s blanket order. If diet alone can address these conditions, why are so few people successful in that? Why do some many patients, when first diagnoses with pre diabetes, then eventually end up with full blown diabetes and must remain on drug therapy for the rest of their lives?
“It appears that the industry largely disagrees with FDA’s interpretation. In the case of metabolic disorders the body has a limited capacity to digest sugars. We think it’s a perfect fit for a medical food and a missed opportunity for FDA to take this position,” McKay said.
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