FDA WARNING_LETTER - Accera, Inc. - December 31, 2013

The FDA issued a Warning Letter to Accera, Inc. regarding their Axona product, marketed as a "medical food" for mild to moderate Alzheimer's disease. The FDA reviewed the product label and websites (accerapharma.com, about-axona.com) in December 2013.

The FDA determined Axona is misbranded under 21 U.S.C. § 343(a)(1) because it does not meet the statutory definition of a medical food (21 U.S.C. § 360ee(b)(3)) or the criteria in 21 C.F.R. 101.9(j)(8). Specifically, there are no distinctive nutritional requirements or unique nutrient needs established for mild to moderate Alzheimer's disease.

Furthermore, the therapeutic claims on the label and websites, such as "Axona may enhance memory and cognition in mild to moderate Alzheimer's" and "helps patients with mild to moderate Alzheimer's disease by addressing diminished cerebral glucose metabolism," establish Axona as an unapproved new drug under 21 U.S.C. § 321(g)(1)(B). As a new drug, it lacks FDA approval for safety and effectiveness (21 U.S.C. § 355(a)). It is also misbranded under 21 U.S.C. § 3