Beauty & Spa Concepts, DBA Beenefits – FDA Warning Letter, May 5, 2021
On May 24, 2021, the FDA and FTC issued a Warning Letter to Beenefits regarding the sale of "Brazilian Propolis Extract" on www.beenefits.com and www.instagram.com/beenefits/. The agencies reviewed the websites on January 8, 2021, and May 5, 2021.
The product is deemed an unapproved new drug under Section 505(a) of the FD&C Act (21 U.S.C. § 355(a)) and a misbranded drug under Section 502 (21 U.S.C. § 352) because it is marketed with claims to mitigate, prevent, treat, diagnose, or cure COVID-19. Examples of claims include customer testimonials stating it's a "coronavirus cure" or "kept me safe from the coronavirus," and website links labeled "COVID-19" near product information, directing users to articles suggesting propolis use for COVID-19.
The FDA requires immediate cessation of sales for unapproved COVID-19 products. Beenefits must email COVID-19-Task-Force-CFSAN@fda.hhs.gov within 48 hours, detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to comply may result in legal action, including seizure and injunction. The company will be added
ID · 45d51d2d-6bb4-4520-bf57-3a6ea9f63f3c
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