Timothy Morck, PhD, founder and president of the consultancy Spectrum Nutrition, said that a workshop the Council for Responsible Nutrition is holding in Washington, DC on Thursday, Nov. 16 will delve into the questions that continue to beset the category. The workshop is aimed at companies already actively involved in the category as well as those interested in entering it. Morck, who will speak at the gathering, said it will look at the state of regulation and whether FDA’s stance can be broadened to include more products that can have beneficial effects in the nutritional management of various diseases.
Continuing state of limbo
The medical foods category has been in something of a limbo since the Food and Drug Administration put out a guidance on the subject in 2013 that was reinforced by another publication in May 2016. The 2016 Q&A includes the following language, which has been proven to be contentious: FDA contends that a medical food is intended only for those conditions that have “special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone.”
That wording goes beyond the original statute that defined medical foods in the opinion of CRN. In July CRN announced its intent to explore whether it made sense to expand its membership parameters to include companies specializing in medical foods in an effort to help lead the charge to properly delineate this category.
“FDA’s concern generally is about safety, and secondly that consumers not be misled,” Morck told NutraIngredients-USA. “By making a very narrow definition of what they feel is a medical food they have control of that process. They have a very small staff and medical foods is a low priority.”
Expanding beyond inborn errors of metabolism
The tight definition that FDA put out in its most recent communications on the subject make it difficult to fit a number of supplement categories into teh medical food definition. One of the original indications for which the category was created—inborn errors of metabolism—requires specially formulated foods that are devoid of the substances that these children cannot metabolize, such as phenylalanine in the case of phenylketonuria, or PKU. But even with that tight definition, many companies are still knocking on the door, Morck said. Among the health indications that have been the subject of medical food development are ADHD and hyperlipidemia and digestive issues.
“On the other hand, medical foods are of great interest to companies that would like to publicize the research that shows that when we administer foods or supplements with certain bioactive components they can have great benefit to patients with diseases,” Morck said.
One of the parameters of a medical food according to the regulation is that these products are supposed to be used under the supervision of a health care professional. Morck said that stricture doesn’t fit well with the modern market landscape. Many brands that are interested in bringing medical foods to market want to do so via direct to consumer, online sales. Where is the medical professional in that loop?
“A lot of these companies that are looking at this space are trying to go direct to consumer with it and it was never the intention that consumers would be making their own decisions about these products. If you have a brand that sells through practitioners like Metagenics, that would give support to the notion that medical supervision would be applied in those cases,” Morck said.
For more information on the workshop, click here.