# FDA WARNING_LETTER - Beauty & Spa Concepts, DBA Beenefits - May 05, 2021

Source: https://www.keypedia.com/records/warning_letter/beauty-spa-concepts-dba-beenefits/45d51d2d-6bb4-4520-bf57-3a6ea9f63f3c

> FDA WARNING_LETTER for Beauty & Spa Concepts, DBA Beenefits on May 05, 2021. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Beauty & Spa Concepts, DBA Beenefits
- Inspection Date: 2021-05-05
- Product Type: Food
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: 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

## Related Officers

- [Program Division Director](https://www.keypedia.com/people/michael-w-roosevelt/136906d6-8e93-4080-acf9-5d48d4509a80)
- [Associate Director](https://www.keypedia.com/people/serena-viswanathan/7d1b292d-1f22-42ff-8452-0bc9673b8326)

Company: https://www.keypedia.com/companies/beauty-spa-concepts-dba-beenefits/135bd56a-034e-4bdf-8134-36cf80efce35

Office: https://www.keypedia.com/offices/center-for-food-safety-and-applied-nutrition/e04dc4e5-ee4f-4b0d-be8c-1139531ddab2