By Scott Bass and Deepti Kulkarni
Despite growing scientific evidence demonstrating the role of nutrition in managing disease and other health conditions, the Food and Drug Administration (FDA) has failed to embrace the regulatory category delineated for “medical foods.” In our view, FDA’s unwillingness is primarily driven by the unfounded fear that, if left unchecked, the marketing of ineffective medical foods would run rampant, resulting in adverse impacts. Consequently, the agency has narrowly construed the definition of medical foods and thereby prohibited the marketing of numerous nutritionally beneficial food products as “medical foods”.
While FDA’s intentions might be good, its current approach leaves consumers without access to beneficial products and discourages promising research and development in products that have the potential to significantly improve public health and reduce healthcare costs.
FDA publicly recognized the concept of medical foods in the early 1970s when it determined that Lofenalac—a powdered formula for infants with phenylketonuria, an inherited metabolic disorder—should be classified as a food for special dietary use rather than as a drug. Subsequently, the agency implemented changes to its labeling regulations, further recognizing and encouraging the development of such foods. But, it wasn’t until 1988 that an official definition for “medical foods” was established. Specifically, Congress defined a “medical food” as “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” Less than a year later, FDA outlined the types of food that would fit within the definitional scope, which included formulas for inherited metabolic disorders, nutritionally complete and incomplete formulas, and oral rehydration products.
Congress acknowledged the benefits of medical foods again in 1990, when it passed the Nutrition Labeling and Education Act (NLEA), and exempted medical foods from requirements for health and nutrient content claims, among other things. This exemption further clarified that such claims could be made for medical foods. In 1993, FDA issued regulations implementing the NLEA exemption that further defined medical foods, and set the stage for the agency’s current narrow construction. In particular, FDA defined medical foods intended for special dietary management to only include the management of conditions that “cannot be achieved through the modification of the normal diet alone.”
Recognizing that further clarity was needed, in 1996, the agency published an Advance Notice of Proposed Rulemaking (ANPR) outlining certain key issues. Even though significant comments were filed in response, FDA withdrew the ANPR, and issued a brief guidance in its place in 2007. That guidance has been revised twice, most recently by a Final Guidance released in May 2016.
Current State and Path Forward
In the Final Guidance, FDA reiterates its view that medical foods intended to help patients manage special medical nutrient needs are limited to conditions that cannot be managed through regular diet modification alone. The agency further constricts the definitional scope by reasoning that most conditions can be managed by regular diet modification, regardless of how unrealistic this might be for some patients. This narrow interpretation suggests that the only permissible categories of medical foods, in FDA’s estimation, are those the agency identified almost twenty years ago, after Congress established the medical foods definition.
This reading is not supported by the statute, and it overlooks the advancements that have taken place since FDA first recognized the medical foods category. Indeed, the “regular diet modification” proviso is not a component of the statutory medical foods definition, and FDA’s continued reliance on it has been met with significant opposition and concern. For instance, while FDA maintains that medical foods are inappropriate for diabetes – on the basis that the disease can be managed through regular diet modification alone – many experts contend that individuals with diabetes benefit significantly from medical foods, as demonstrated by research. The agency’s exclusion of diabetes and other conditions from those that may be treated with medical foods has detrimental repercussions, particularly as the number of patients with chronic conditions, as well as the aging population, continues to grow.
Although FDA has been unwilling to recognize advances in the area of medical foods, it has suggested reforms in other sectors based on scientific and legal developments. Notably, in May 2016, FDA announced that it will reevaluate its definition of “healthy” under its food labeling regulations based on evolving nutrition research. In addition, after a slew of successful legal challenges against FDA regarding its policies prohibiting the promotion of medical products for unapproved uses, the agency has been compelled to rethink its regulation of truthful and non-misleading commercial speech. These reforms have the potential to transcend into other areas, including the regulation of medical foods. Moreover, as scientific research continues to reveal the impacts of nutrition on disease, FDA will have to re-think its corresponding policies. Proponents would be well-advised to pay close attention to these developments, and take strategic and concerted steps to further demonstrate the value of medical foods, as well as the detrimental effects of FDA’s current policies.
Scott Bass is a partner at Sidley Austin LLP and heads the firm’s Global Life Sciences team.
Deepti Kulkarni is an associate in Sidley’s Food, Drug and Medical Device Regulatory practice.
Sidley partner Diane McEnroe and counsel Emily Marden also contributed to this article.
This article has been prepared for informational purposes only and does not constitute legal advice. This information is not intended to create, and the receipt of it does not constitute, a lawyer-client relationship. Readers should not act upon this without seeking advice from professional advisers. The content therein does not reflect the views of the firm.
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