FDA WARNING_LETTER - North Coast Biologics - April 28, 2020

On May 21, 2020, the FDA and FTC issued a Warning Letter to North Coast Biologics regarding the sale of an "nCoV19 spike protein vaccine" advertised on their websites and social media. The product was offered for sale to mitigate, prevent, treat, diagnose, or cure COVID-19.

The FDA determined the product is an unapproved new drug under section 505 of the FD&C Act (21 U.S.C. § 355) and a misbranded drug under section 502 (21 U.S.C. § 352). Furthermore, it is an unlicensed biological product under section 351 of the PHS Act (42 U.S.C. § 262), lacking a valid biologics license application (BLA) or an investigational new drug (IND) application. The introduction of this product into interstate commerce is prohibited under sections 301(a), (d), and (k) of the FD&C Act.

The letter cited specific claims from March and April 2020 on Facebook and LinkedIn, establishing the product's intended use and misleadingly representing it as safe and effective for COVID-19 prevention. Despite an April 28, 2020, update stating the product was no longer available, some claims remained online.

North Coast Biologics