FDA WARNING_LETTER - North Isle Wellness Center - June 17, 2020

The FDA and FTC issued a Warning Letter to theblublock.com following website reviews on May 28 and June 17, 2020. The letter addresses the sale of Methylene Blue products marketed to mitigate, prevent, treat, diagnose, or cure COVID-19. Given the ongoing public health emergency, the FDA is taking urgent measures against such unapproved products. The FDA determined these products are unapproved new drugs, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and misbranded drugs under section 502 (21 U.S.C. § 352). Their introduction into interstate commerce is prohibited by sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)). The FTC also found that the firm's coronavirus-related prevention or treatment claims lack competent and reliable scientific evidence, violating the FTC Act (15 U.S.C. 41 et seq.). The firm must immediately cease selling these unapproved products and making unsubstantiated claims. Within 48 hours, the company must email both the FDA and FTC detailing specific corrective actions taken, including steps to prevent recurrence and supporting documentation. Failure to comply may result in legal action, including seizure and injunction, addition to FDA's public warning list, and potential consumer restitution for FTC violations.