FDA WARNING_LETTER - NeuroScience, Inc. - August 15, 2011

On August 9, 11, and 15, 2011, the FDA inspected NeuroScience, Inc.'s facility in Osceola, Wisconsin, and reviewed product labeling and websites (neuroscienceinc.com, neurorelief.com). The inspection revealed several violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, Zymenta and Cerelist products were found to be misbranded under section 403(a)(1) of the Act, 21 U.S.C. § 343(a)(1). They were labeled and marketed as medical foods but did not meet the statutory definition in the Orphan Drug Act, 21 U.S.C. § 360ee(b)(3), or the criteria in 21 CFR 101.9(j)(8). The FDA stated there's no evidence patients with Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI) have distinct nutritional requirements for the ingredients or that these needs cannot be met by modifying a normal diet.

Furthermore, Avipaxin, Calm-PRT, Cerelist, DL-phenylalanine, GI Reset™, NorLox, Recolonize-1: Th1 Inhibitor™, Taurine, and Zymenta products were promoted with therapeutic claims, classifying them as unapproved new drugs under section 201(g)(1)(B