Medical food category continues to develop with Fiber Choice acquisition
Fiber Choice is a line of supplements owned by Swedish company Moberg Pharma AB. The core ingredient of the line is inulin, a purified dietary fiber usually derived from chicory root that has demonstrated prebiotic properties.
Medical food focus
Caret Pharma is a subsidiary Caret Group, which also owns IM Health Science, which will market the Fiber Choice line. The new acquisition fits in with IM Health Science’s strategic direction, to find dietary interventions that can help sufferers of various intestinal conditions such as Irritable Bowel Syndrome and Functional Dyspepsia deal with their symptoms. The company lists two products on its website aimed at these conditions that are billed as medical foods.
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 the Council for Responsible Nutrition. CRN is considering an expansion of its membership parameters to include companies operating in the medical foods space in an effort to help lead the charge to properly delineate this category.
Does an intestinal condition imply a nutritional component?
In the case of the medical foods marketed by IM Health Sciences, the issue is not entirely clear. An irritable bowel and episodes of dyspepsia would both seem to be related to diet. And the marketers of medical foods related to these conditions could make the case that making changes to the diet alone has been insufficient to help many sufferers achieve relief. But does the delivery a specific dietary ingredient, such as an encapsulated, targeted-release peppermint oil as is the case with IBgard, IM Health Sciences’ intestinal bowel syndrome product, really address a specific nutrient issue related to the condition?
For its part, IM Health Sciences believes the key differentiation between medical foods and supplements is that the former is directed at patients suffering from a disease or diagnosed condition. Supplements, on the other hand, are meant to be taken by healthy people.
“Medical foods are different than dietary supplements primarily because they are intended for people with medical conditions, rather than healthy people. Medical foods are required to be used under medical supervision. Medical foods do not require a prescription and are customarily more accessible and affordable to patients as non-prescription products,” the company said.
That concept of what a medical food ought to be seems to have been accepted by retailers, at least. The company says its products are for sale nationwide in CVS, Walgreens and Rite Aid pharmacies.
