The guidance, which was issued in August 2013, sought to clarify the definition of a medical food and the conditions under which it can be sold and under which it should be used. It is an updated version of a draft guidance the agency issued in 2007. Of course, languishing in draft form is a fate that befalls many guidances issued by the agency.
First to the definition of what a medical food is supposed to be. Medical foods, defined first in the Orphan Drug Act, are specially formulated products meant for oral intake as opposed to naturally occurring foodstuffs. They are meant to be aimed at patients who because of a medical condition have problems ingesting, absorbing or metabolizing certain nutrients or who have “other special medically determined nutrient requirements.” A medical food should provide specific nutritional support for dietary needs arising out of specific disease or condition, and they are intended to be used under medical supervision. And the consumer is supposed to be receiving active and ongoing medical supervision.
Specific exclusion for diabetes
The updated guidance also included two new sections on products formulated for diabetes. As diabetes is the most prevalent metabolic condition, and involves a disordered metabolism of carbohydrates resulting in dangerous fluctuations of sufferers’ blood sugar levels, on the surface it seemed as if product designed specifically to help consumers better manage these levels would be a good fit as a medical food. A physician could take into account the consumption of these specific products when designing a treatment strategy for an individual patient, or so the thinking went.
Not so fast, FDA said. The agency admitted that diabetes sufferers do have specific nutritional requirements: “Patients with type 1 DM (type 1 Diabetes Mellitus) should use carbohydrate counting or the carbohydrate exchange system to match insulin dose to carbohydrate intake and facilitate physiologic insulin replacement. Patients with type 2 DM should restrict calories, eat regularly, increase fiber intake, and limit intake of refined carbohydrates and saturated fats.”
But the guidance goes on to say that in the agency’s opinion, these interventions can be achieved by changes in the diet and do not require a specific medical food-type product. “Diet therapy is the mainstay of diabetes management. A regular diet can be modified to meet the needs of an individual affected by either type of DM (along with appropriate drug therapy if necessary). . . Therefore, FDA generally would not consider a product labeled and marketed for DM to meet the regulatory criteria for a medical food,” the agency wrote.
There was a flurry of regulatory action surrounding the issuance of this latest draft guidance. FDA sent out warning letters to a number of companies marketing medical foods in late 2013 and early 2014 but since then has been quiet on the subject.
“FDA has done nothing with it. There has been no regulatory action in the last year in this area,” Marc Ullman, an attorney in the firm Ullman, Shapiro and Ullman, told NutraIngredients-USA.
Richard Eichholz, PhD, a principal in the consulting firm bioStrategies, said the companies he has worked with in the medical foods space have welcomed a stricter regulatory climate that might restrain the activities of some more uninhibited marketers. Over the years a number of products have entered the market under the designation of a medical food, some of which seemed at first glance to have stretched the definition. There was a feeling that some marketers were using the term “medical food” to mean a super category of dietary supplements that claimed more targeted benefits.
“Most people I’ve talked to in medical foods area like the fact that FDA is getting more involved in trying to regulate the category,” Eichholz said.
Uneven playing field
But Eichholz said there was widespread consternation that FDA had taken such a hard line on diabetes, and some companies have forged ahead with diabetes aimed products even so.
“Certainly there have been a lot of complaints about it and there are companies hoping or betting that it will be removed,” he said. “We still see several companies with medical foods out there that either specifically mention diabetes or are talking about glycemic control or hypoglycemia. As far as we can tell there are a couple of companies still developing medical foods for diabetes.
“Well over half of the medical foods category is metabolic related but now there is no way to have a product in this category for the paradigm metabolic disease, which is diabetes,” Eichholz said.
Ullman said the way FDA issued the draft guidance on medical foods is a good example of regulatory overreach and the problems that it can cause in the market.
“This is an example of what we call regulation by guidance. All federal agencies do it. They issue a guidance which can’t be challenged in court like a formal regulation could. You can only challenge it as part of an enforcement action,” Ullman said.
The Council for Responsible Nutrition asked FDA to remove what president and president Steve Mister called “extra statutory language” in the guidance. 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 something that is found in anything that Congress wrote, he said. According 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.
Ullman said the current situation creates an uneven playing field in which some companies forge ahead, waiting for FDA to come after them specifically (or not). “And then you have some more conservative companies who say, here are companies that have products on the market that we discontinued because of the guidance,” he said.