The non-profit organization used the release of its Strategic Roadmap and Action Plan to advocate for changes to the Food and Drug Administration (FDA)’s regulations that limit access to medical foods. Specifically, ANH takes issue with the restriction of medical foods to the treatment of rare diseases under the Orphan Drug Act.
Alongside this specific issue, the report noted that the FDA allows for the use of medical foods only with physician supervision, with ANH stating that most doctors receive little to no training in nutrition, and that it does not allow qualified nutrition professionals to be a part of the process.
The term medical foods refers to specially designed food items that meet the specific nutritional needs of individuals with particular illnesses or critical health conditions, and are regulated by the FDA. Robert Verkerk, scientific director at ANH, told NutraIngredients that the medical food market is estimated to be worth $6.2bn.
ANH outlines that limiting medical foods to rare diseases neglects other areas with high need, such as people living with a chronic disease. To address this, the organization is calling for statutory language that would allow medical foods to address other illnesses, clarify their prescription status, and enable reimbursement through Medicare and private insurers, among other pathways.
The managing directors of Dutch Medical Food, Guru Ramanathan and Rolf Smeets, told NutraIngredients that they agreed there is more scope to use medical foods to aid public health.
“We believe the potential of medical foods in healthcare remains underutilized. As chronic diseases continue to rise, for example, with certain cancers increasingly managed as chronic conditions, medical nutrition plays an increasingly vital and cost-effective role in improving health outcomes,” they said.
Revising the regulatory framework
According to Verkerk, medical foods were originally included in the Orphan Drug Act, passed in 1988, as it was recognized that certain nutrients could play a crucial role in specific rare diseases. This allowed nutritional formulas to be regulated as medical foods rather than conventional drugs, but also tied medical foods to rare conditions.
“Nearly 40 years on, we have a very different situation with very few drugs providing comprehensive solutions to a rash of chronic conditions, and a very substantial body of evidence that points to the role of nutrients as an invaluable, adjunct layer in integrative protocols,” said Verkerk.
In its roadmap, the organization suggests five major reforms to allow wider access to medical foods and improve affordability: modernize the definition; expand access and supervision; clarify prescription status and enable reimbursement; replace regulatory intimidation with guidance; and educate healthcare professionals.
“Clinical research, education, and awareness are essential to fully realize [medical food] benefits,” Ramanathan and Smeets said, in terms of action required to harness the potential of medical foods. “A clear and adaptive regulatory framework, supported by updated reimbursement policies, will foster innovation and ensure patient access.”
Chronic diseases: A natural target
ANH states that the main area where medical foods can provide solutions is in chronic diseases. An estimated 129 million people in the US are living with at least one major chronic disease. The ANH roadmap highlights osteoarthritis as a condition where substantial benefits could be delivered by medical foods.
Verkerk explained that osteoarthritis, and many other chronic conditions, are linked to persistent, low-grade inflammation, oxidative stress, and immune dysregulation, among other factors, which can be targeted by medical foods. In terms of what specific medical foods and nutrients could be beneficial for osteoarthritis, he mentioned curcuminoids, boswellia serrata, polyphenols, ginger, avocado-soyabean unsaponifiables, type II collagen, hyaluronic acid, and omega-3 fatty acids.
“It no longer makes sense in a society where the majority of adults over 50 have one or more chronic conditions to prevent nutrients from being used for people with these conditions,” he concluded.
