NeuroScience Solutions, Inc. – FDA Warning Letter, Apr 16, 2019

The FDA issued a Warning Letter to NeuroScience regarding their product Kavinace, labeled and sold as a dietary supplement. The letter, dated April 10, 2019, addresses the inclusion of 4-amino-3-phenylbutyric acid HCl (phenibut) as a dietary ingredient in Kavinace's labeling.

The FDA asserts that phenibut does not fit any of the dietary ingredient categories defined under section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(ff)(1)]. Therefore, declaring phenibut as a dietary ingredient causes Kavinace to be misbranded under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)], as its labeling is false or misleading.

NeuroScience is required to investigate and determine the causes of this violation and prevent its recurrence. The firm must ensure compliance with all federal laws and FDA regulations. Prompt corrective action is mandated, as failure to comply may result in legal action, including seizure and/or injunction.

NeuroScience must notify the FDA in writing within fifteen working days of receipt of the letter, detailing the specific steps taken to correct the violation and prevent recurrence, along with supporting documentation. If corrective action cannot be completed within this timeframe, a reason for the delay and an estimated