FDA WARNING_LETTER - Lattice Biologics, Ltd. - September 01, 2020

The FDA and FTC issued a Warning Letter to Lattice Biologics regarding their amniotic fluid product, AmnioBoost, marketed for mitigating, preventing, treating, diagnosing, or curing SARS or ARDS related to COVID-19. The agencies reviewed the company's website and social media in August 2020.

The product is deemed 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). It is also classified as a biological product under section 351 of the PHS Act (42 U.S.C. § 262). Lawful marketing of such a product requires a valid biologics license application (BLA) or an investigational new drug (IND) application for clinical use, neither of which is in effect for AmnioBoost.

The letter cites claims on the company's website and social media as evidence of the product's intended use for COVID-19 related conditions, misleadingly representing it as safe and effective.

Lattice Biologics is required to take immediate action to cease marketing these unlicensed, unapproved, and unauthorized products for COVID-19 related uses. Within 48 hours, the company must email COVID-19-Task-Force-CBER@