Plaintiff’s Allegations Do Not Establish That Its Product Is a Medical Food as a Matter of Law Although FDA has not formally considered whether lupus may have distinctive nutritional requirements, it has serious reservations about plaintiff’s assertion that there are such requirements for purposes of the medical food statute. Even if plaintiff were correct that lupus patients may benefit from DHEA, plaintiff has not shown that lupus results in a “distinctive nutritional requirement” for DHEA, as required by 21 U.S.C. § 360ee(b)(3).20 Whether the 20 The studies plaintiff cites do not qualify its product as a medical food as a matter of law. Plaintiff cites a 1987 study showing decreased levels of different androgens in women with lupus, including DHEA, but such low levels do not necessarily mean the low levels (of DHEA) would qualify as a “distinctive nutritional requirement,” or that lupus is subject to dietary management with DHEA.

Under the statute, a medical food “is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on Case 2:13-cv-03663-CCC-MF Document 15 Filed 08/12/13 Page 11 of 16 PageID: 347 10 recognized scientific principles, are established by medical evaluation.” 21 U.S.C. § 360ee(b)(3). In particular, whether a disease or condition requires “specific dietary management,” or has “distinctive nutritional requirements” is a general question about the disease or condition that FDA is in the best position to answer after reviewing available evidence such as clinical trial data or literature reports.