Amcyte Pharma, Inc. – FDA Warning Letter, Dec 20, 2021

On January 3, 2022, the FDA issued a Warning Letter to the operator of https://nasitrol.com/ following a December 20, 2021, website review. The FDA found that Nasitrol was offered for sale in the U.S. with claims to mitigate, prevent, treat, diagnose, or cure COVID-19. This renders Nasitrol an unapproved new drug, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and a misbranded drug under section 502 (21 U.S.C. § 352).

The introduction of this product into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act (21 U.S.C. § 331(a) and (d)). The FDA emphasized its urgent measures to protect consumers from unapproved products claiming to address COVID-19, given the public health and national emergencies declared for the pandemic.

The letter demands immediate action to cease the sale of all unapproved and unauthorized COVID-19-related products. The recipient must email COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours, detailing specific corrective steps, including documentation, to prevent recurrence. Failure to comply