FDA WARNING_LETTER - Bespoke Apothecary LLC - September 26, 2022

The FDA and FTC issued a Warning Letter to Bespoke Apothecary after reviewing their website and social media in September 2022. The firm was found to be selling "COVID kit" and "Post Virus Recovery Herbal Tea" products, which were 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, and misbranded drugs under section 502. Their introduction into interstate commerce is prohibited by sections 301(a) and (d). The FTC cited the firm for making unsubstantiated claims, which is unlawful under the FTC Act, 15 U.S.C. § 41 et seq., as no competent and reliable scientific evidence supports their COVID-19 related prevention or treatment claims. Bespoke Apothecary must immediately cease selling these unapproved products and making unsubstantiated claims. Both agencies require an email response within 48 hours detailing corrective actions and prevention measures. Failure to comply may result in legal action, including seizure, injunction, civil penalties up to $46,517 per FTC violation, consumer refunds, and inclusion on FDA's public list of fraudulent COVID-19 product sellers.