FDA WARNING_LETTER - Cureganics - March 10, 2022

The FDA and FTC issued a Warning Letter on March 28, 2022, to Cureganics.com following website reviews on February 15 and March 10, 2022. The letter addresses the sale of cannabidiol (CBD) products marketed with unproven claims 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, and misbranded drugs under section 502. Their introduction into interstate commerce is prohibited by sections 301(a) and (d). The FTC also found the firm in violation of the FTC Act (15 U.S.C. § 41 et seq.) for making unsubstantiated claims regarding COVID-19 prevention or treatment, lacking competent and reliable scientific evidence. Cureganics is required to immediately cease the sale of these unapproved products and stop making unsubstantiated claims. The firm must email both agencies within 48 hours detailing corrective actions. Failure to comply could lead to legal action, including seizure, injunctions, addition to FDA's public warning list, civil penalties up to $46,517 per violation under the COVID-19 Consumer Protection Act, and consumer refunds.