FDA WARNING_LETTER - Functional Remedies, LLC D/B/A Synchronicity Hemp Oil - March 01, 2022

The FDA and FTC issued a Warning Letter to Synchronicity Hemp Oil after reviewing their website on February 16 and March 1, 2022. The agencies observed the sale of Full-Spectrum Hemp Oil and CBD products marketed with 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 (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 advertising such claims without competent and reliable scientific evidence, particularly for COVID-19, violates the FTC Act (15 U.S.C. § 41 et seq.). The company is required to immediately cease selling these unapproved and unauthorized COVID-19 related products and to review all promotional materials. Within 48 hours, the firm must email both the FDA and FTC detailing corrective actions taken and plans to prevent recurrence. Failure to comply could lead to legal action, including seizure, injunction, civil penalties up to $46,517 per violation under the COVID-19 Consumer Protection Act, and inclusion on FDA's public warning list.