FDA Sued for Failing to Confirm Product’s Medical Food Status

By Riëtte van Laack –

Last week, Health Science Funding, LLC filed what might be the first medical food lawsuit against FDA.  (A copy of the Complaint is available here, and a copy of the Motion for a Preliminary Injunction is available here.)  Plaintiff markets what it claims to be a medical food for women with lupus, Prastera® DHEA.

The concept of a “medical food” is a legal category recognized by Congress in 1988 in the Orphan Drug Amendments, and later incorporated into the Federal Food, Drug, and Cosmetic Act ("FDC Act").  A medical food is:

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.

Medical foods may be marketed without prior approval or notice to FDA. In fact, no law or regulation on its face gives FDA the authority to approve medical food labels.  Nevertheless, Plaintiff submitted the label for Prastera® DHEA to FDA and asked that FDA confirm that the product is a medical food under the law.  Plaintiff claims that, rather than confirming that the product is a medical food, FDA raised two concerns:  1.)  Dietary supplements are not “automatically” Medical Foods; and 2.) FDA is not aware of any “distinct nutritional requirements” for DHEA in female lupus patients.  In addition, FDA allegedly “verbally threaten[ed] Plaintiff with enforcement action.”

Plaintiff claims that FDA’s concerns are irrelevant to the question of whether the product is a medical food.  Notably, although Plaintiff asked FDA to confirm that the product is a medical food, it claims that FDA is not qualified to determine whether lupus patients have distinctive nutritional requirement for DHEA (an essential element of the medical food definition).  Plaintiff claims that FDA’s knowledge of such nutritional requirements is irrelevant.  Unsatisfied with FDA’s response, Plaintiff now turns to the Court and asks that the Court confirm that Prastera® DHEA is a medical food.  In addition, it asks that the Court enjoin FDA from taking enforcement action against Plaintiff until the Court rules. 

Plaintiff claims that the case involved a “straightforward issue of statutory construction.”  However, FDA history regarding medical foods suggests that Plaintiff’s interpretation of the medical food definition is not that simple.  For numerous legal reasons we anticipate that the Court will not seize what Plaintiff identifies as a rare “opportunity to create a legacy” and “help save four women’s lives today, and another four tomorrow, and another four every tomorrow for years into the future.”