FDA WARNING_LETTER - Native Roots Hemp - April 02, 2020

The FDA and FTC issued a Warning Letter to Farm2Pharmacy.com on April 6, 2020, following reviews of their website and social media on March 25 and April 2, 2020. The letter addresses the sale of cannabidiol (CBD) products, marketed with unproven claims to mitigate, prevent, treat, diagnose, or cure Coronavirus Disease 2019 (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)). The FTC also cited violations of the FTC Act (15 U.S.C. 41 et seq.) for advertising disease prevention/treatment claims without competent and reliable scientific evidence. The company is required to immediately cease selling these unapproved and unauthorized COVID-19 related products. Within 48 hours, Farm2Pharmacy must email both FDA and FTC, detailing corrective actions taken, steps to prevent recurrence, and supporting documentation. Failure to comply may lead to legal action, including seizure, injunction, consumer restitution, and inclusion on FDA's public list of firms selling fraudulent COVID-19 products.