The medical foods category has an uncertain bill of health
With unclear guidance, the sector is difficult for manufacturers and consumers
After years of experimentation, Robin Gentry McGee created a medical food for use in feeding tubes.
The founder and CEO of Functional Formularies came up with something that was thin enough with no particulate matter to stop movement through the tube. It retained nutrients, calories, protein and fat. It could sit on a shelf for two years. The products, Liquid Hope (for adults) and Nourish (for children), contain 16 organic whole foods and a vitamin premix. Neither has any dairy or meat products.
Gentry McGee developed the product after her father had a traumatic brain injury and was placed on a ventilator and a feeding tube. The ingredients in the feeding tube pouch contained corn syrup and a lot of vitamins, but no real food.
“This was not what we should be giving him to try and heal his body,” Gentry McGee told Food Dive.
Her biggest challenge was the lack of information available to create medical foods for feeding tubes.
“Early on, this was a foreign concept to registered dietitians,” Gentry McGee said.
Today, dietitians and doctors all over the world recommend the company’s formulas for use in feeding tubes. But it was a long road to get there. The company works with three food manufacturers that originally rejected working on the medical food because they were unable to see the viability of the product.
“I have seen the market change tremendously in the 10 years I have been doing this,” Gentry McGee said.
Functional Formularies isn’t required to receive FDA approval for its medical food products. However, the company’s suppliers are registered with the FDA and have USDA inspectors on site.
The FDA’s role (or lack thereof) in regulating medical foods
The role of the FDA—or rather the lack of oversight the agency has when it comes to medical foods—is a major hurdle to expanding the category. Right now, the FDA can only provide non-legally binding guidance on use of the term “medical foods.”
In fact, it will take an act of Congress to give the FDA the oversight to review or prove medical foods or specific indications.
The FDA’s guidance to define a medical food is very narrow, applying to foods used to treat metabolic diseases like phenylketonuria. The foods are specially formulated and processed for diseases or conditions that can’t be managed by altering a patient’s diet. And those foods must be part of ongoing care, Entera Health Inc. Vice President of Compliance, Regulatory & Medical Affairs Bruce Burnett told Food Dive.
The FDA is willing to review evidence that demonstrates distinctive nutritional requirements (DNRs) for other diseases or conditions, American Society for Nutrition senior director of advocacy and science policy Sarah Ohlhorst told Food Dive. She said food companies have a long road ahead of them because of the lack of clarity around DNRs.
“One big challenge is that the terminology ‘DNR’ is a requirement for a medical food, and it is not something that the FDA has put bounds around,” Ohlhorst said.
How to develop a medical food product
Developing a medical food that does something other than treat metabolic defects could be challenging. But that doesn’t mean companies haven’t tried to claim their products fit into the category.
The most common warning letters sent out by the FDA since 2006 use the words no “distinctive nutritional requirement” for the disease or condition, according to a presentation by attorney Jessica O’Connell. She was part of a panel presentation discussing the category at the IFT expo earlier this month.
Since 2009, many warnings deal with the interpretation that an item is still not considered a medical food if there is no evidence that requirement cannot be met through dietary modification alone, O’Connell shared.
In the last decade, warning letters addressing the failure to show DNRs have dealt with claims to treat Alzheimer’s, fibromyalgia, chronic fatigue syndrome, leaky gut syndrome and eczema. Those addressing dietary modification alone dealt with claims regarding pregnancy, diabetes and bariatric surgery recovery.
Other things that remain mysteries when defining medical foods are situations where patients may require tube feeding. This is sometimes considered a medical food — but not always, Ohlhorst said. A patient with throat cancer may require a feeding tube because he is unable to eat using his mouths or throats, not because of a disease or condition that can’t be met through a normal diet.
Approach with caution
Insurance coverage poses another challenge in the medical foods category. There are six drug listing agencies that tell insurance companies which products are considered prescription items that can be covered by insurance, versus those considered over-the-counter. Those agencies can change how entire categories of foods are considered. In May, one of these companies made this kind of change, abruptly ending medical coverage for food.
Until the FDA expands the medical foods category, the focus metabolic defects puts a damper on experimenting with other molecules that could meet DNRs, as well as ingredients or nutritional substances such as flavonoids and carotenes, Burnett said.
Medical foods are serious therapeutics that are not to be used as regular food, he said.
“They have to have clinical substantiation,” Burnett said, “and they have to be generally recognized as safe.”