FDA WARNING_LETTER - CBD Online Store - April 06, 2020

On April 7, 2020, the FDA and FTC issued a Warning Letter to CBD-Online-Store regarding unapproved and misbranded CBD products marketed for COVID-19. Reviews of the company's website (https://cbd-online-store.com/) and Facebook page on March 30 and April 6, 2020, revealed products claiming to mitigate, prevent, treat, diagnose, or cure COVID-19. 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)). Additionally, the FTC found the advertising unlawful under the FTC Act (15 U.S.C. 41 et seq.) as claims of preventing or treating human disease lacked competent and reliable scientific evidence, specifically for COVID-19. The company must immediately cease selling these unapproved products. Within 48 hours, they must email both FDA and FTC detailing corrective actions, including steps to prevent recurrence and supporting documentation. Failure to comply may lead to legal action, including seizure, injunction, being added to FDA's public fraud list, and potential consumer refunds for FTC violations.