# FDA WARNING_LETTER - FluxxLab LLC - August 04, 2022

Source: https://www.keypedia.com/records/warning_letter/fluxxlab-llc/103ef140-381a-48cd-a9ff-b82a862afe53

> FDA WARNING_LETTER for FluxxLab LLC on August 04, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: FluxxLab LLC
- Inspection Date: 2022-08-04
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On August 4, 2022, the FDA and FTC issued a Warning Letter to FluxxLab LLC and Arendis, LLC, specifically addressing Arend John Kuijvenhoven, regarding the sale of unapproved and misbranded products related to COVID-19. The FDA reviewed the website fluxxlab.com on July 12, 2022, and August 1, 2022, identifying "Covid-19 Immune Support Tincture" and "CBDA+CBD Oil Tincture" products.

These products are marketed with claims to mitigate, prevent, treat, diagnose, or cure COVID-19, rendering them unapproved new drugs under 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). The introduction of these products into interstate commerce is prohibited by sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)).

Examples of violative claims include statements about CBDA binding to SARS-CoV-2 spike proteins to prevent infection, found on product pages like "https://fluxxlab.com/product-category/cbda/" and "https://fluxxlab.com/product/

## Related Officers

- [Associate Director](https://www.keypedia.com/people/serena-viswanathan/7d1b292d-1f22-42ff-8452-0bc9673b8326)
- [Carolyn E. Becker](https://www.keypedia.com/people/carolyn-e-becker/ad2daae5-dda1-4b9c-a69a-775997e7b60b)

Company: https://www.keypedia.com/companies/fluxxlab-llc/6c803223-3ec5-41d3-b7cd-b85e78ea8e45

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c