A company that makes a “medical food” for women with lupus has filed a complaint against the Food and Drug Administration (FDA) in a New Jersey federal court seeking a declaratory judgment that its label complies with federal law. Health Sci. Funding, LLC v. FDA, No. 13-3663 (U.S. Dist. Ct., N.J., filed June 13, 2013). The product at issue, Prastera® brand DHEA, apparently restores DHEA to normal levels in female lupus patients and purportedly minimizes certain risks of the disease.
The company claims that it sought FDA approval of its product label, and the agency responded that it had “serious questions and concerns” about the labeling. While FDA allegedly acknowledged that DHEA helps lupus patients, it said “efficacy alone does not qualify a product to be marketed as a medical food” and noted that products freely available to consumers—such as DHEA dietary supplements—are not “automatically” medical foods under the statute. According to the complaint, “While this statement may be correct, . . . it is not relevant. The question at hand is not whether all dietary supplements in the abstract ‘automatically’ meet the statutory definition of Medical Food, but whether Plaintiff’s particular labeling in fact does so.”
The complaint also asserts that “FDA advised that it is ‘not aware of any distinctive nutritional requirements’ for lupus. FDA’s ignorance of lupus patients’ requirement for DHEA, however, is not relevant as a matter of law. This is because the statute requires that the ‘distinctive nutritional requirement’ be established not by FDA, but by ‘medical evaluation’—i.e., by the patient’s physician.” According to the plaintiff, “FDA ignorance of those medical evaluations . . . is not legally relevant under the statute.”
The plaintiff claims that on further discussions with FDA representatives, the agency “threatened enforcement action” while continuing to press its legally irrelevant concerns. The company also claims that the agency “demanded ‘immediate remedial action,’ but failed to say what remedial action would possibly be needed.” In light of these alleged threats and FDA’s purported pattern of enforcement against other medical food manufacturers, the plaintiff requests a declaratory judgment “confirming that Plaintiff’s product label conforms to the statutory definition of Medical Food articulated in 21 U.S.C. § 360ee(b)(3).” It also seeks an injunction to stop FDA from taking enforcement action.