CRN workshop to define issues surrounding medical foods –

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.”


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