CRN’s board voted unanimously at its June meeting to extend representation to this category of products as an exploratory move. CRN president and executive director Steve Mister told NutraIngredients-USA that the move had been under consideration for several years but was delayed by the NYAG affair.
“We’ve looked at this a couple of times over the past few years. We had some serious conversations about this at our December 2014 board meeting, and then the NYAG decided to take up all of our time. We decided we needed to be 100% devoted that year to defending the industry against DNA testing. Since then we think we’ve pretty much put the DNA issue to bed,” Mister told NutraIngredients-USA.
Medical foods is a regulatory category that was initially put into place to allow for the formulation of products that addressed specific nutritional needs for patients suffering from rare diseases. An early example is phenylketonuria, an inborn error of metabolism in which sufferers lack the ability to adequately metabolize the amino acid phenylalanine. They require special foods formulated with almost none of this amino acid in them so that they can still get adequate protein in their diets. With this intervention, sufferers of this genetic disorder can have a normal lifespan.
The Food and Drug Administration put out an updated draft guidance on medical foods in 2013. According to the guidance, a medical food was defined in the Orphan Drug Act in 1988 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.”
So in this sense, medical foods are adjuncts of drug or other therapies, and are specifically aimed at addressing dietary issues resulting from the underlying disease itself or arising from those treatment interventions.
And that word “formulated” is important; if a given condition or treatment resulted in a potassium deficiency, for example, a marketer of bananas couldn’t trump up his wares as a medical food for this purpose. Similarly, in cases such as liver disease where patients would need a low protein diet, foods that are normally low in protein would not meet the specification of a medical food.
In the guidance FDA also focused on labeling queries, formulation issues, marketing of medical foods and questions around specific conditions, including a surprising rejection of the notion that products that help diabetes sufferers manage their blood glucose levels could be marketed as medical foods.
CRN had objected to what it call’s FDA’s ‘extra statutory’ limitations on the category that were part of the 2013 guidance. The agency said medical foods were only meant for conditions “the dietary management of which cannot be achieved by modification of the normal diet alone.” That wasn’t part of the original statute, Mister said. FDA updated the guidance via a Q&A posted in 2016, but many of these bones of contention remain.
“We’ve pushed back on that notion,”Mister said. “We believe the category can have enormous potential over the next decade.”
Helping to chart a course for category
Mister said added medical food marketers to the membership can help CRN have more of a voice in more precisely delineating the category. In the years since the category has been put into place, regulatory fuzziness has allowed some companies to try to apply a medical food positioning to many different kinds of products. Mister said while CRN does not want FDA to overly restrict the category, his group doesn’t want to see a free for all where companies are making disease-type claims, either.
“If the collective industry doesn’t try to manage the category and chart a course you will have companies come in that just want to make claims. Responsible companies need to come together to help define what medical foods should be,”Mister said. “We don’t have all the answers yet, which is why we announced this exploratory stage. We will plan a workshop on this for some time in the fall, and we’d like to have people from FDA there.”