In a nine-page commentary sent to FDA, CRN first recaps how medical foods were defined at their inception and examines how FDA has dealt with the category since then. And much of what has been done CRN agrees with. The latter portion of the commentary points out the ways in which the organzation believes FDA has overstepped the statutory bounds.
“That’s just how we want them to read it,” Steve Mister, president of CRN, told NutraIngredinets-USA. “We want them in the first couple of pages to be nodding their heads and get them to agree with us. And then we want point out that as they developed the regulations around medical foods, they added some added extra-statutory language for the purposes of that regulation that just wasn’t there in the statute."
Development of regulations
In the latter part of the comments, CRN lays out its criticisms of the way in which the guidance was recently expanded. The first part of the commentary gives CRN’s view of how medical foods have been delineated in the Orphan Drug Act in 1988, the piece of legislation that created the category. In that legislation, Congress defined medical foods as a product to be taken enterally, under the supervision of a physician, that 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.”
FDA put its own parameters around medical foods in a subsequent regulator, parameters which CRN reiterates and agrees with in the comments. This means to be a medical food, the product must in fact be a food, and use only GRAS ingredients. These products must be formulated to meet specific nutritional requirements for the management of specific disease states. CRN agrees with the proposition that if distinctive nutrition requirements for a given disease state have not been established, then a medical food for that condition may not be marketed. And the agency also supports the idea that medical foods must be administered under the supervision of a physician.
Sticking point
Where the organization differs with FDA is in the following phrase, which Mister said FDA promulgated in the course of writing regulations. It’s not some thing that is found in anything that Congress wrote, he said. Accoridng to CRN, “as reflected in the Draft Guidance, FDA has concluded that medical foods may be marketed only for diseases and conditions ‘the dietary management of which cannot be achieved by modification of the normal diet alone.’ ”
“Those words are not in the statute. They added that language when they wrote the regulations,” Mister said.
That extra qualifier greatly restricts what can and can’t be called a medical food, Mister said. For example, in the updated draft guidance FDA specifically eliminated Type 1 and Type 2 diabetes as conditions for which medical foods can be marketed, even though there is strong evidence that products specifically formulated to address the nutritional needs of these conditions have scientific evidence backing their efficacy, Mister said. Such a product might include specific combinations of slow-digesting, complex carbohydrates to limit post-prandial blood sugar spikes.
“But we do want FDA ot enforce the category What you have now are products that are dietary supplements being called medical foods so that they can put a disease claim on them. We just think that you should meet the definitions that Congress put on the category,” Mister said.
"There is a lot of interest in the category, and for many years there was very little enforcement," he said.