FDA WARNING_LETTER - FluxxLab LLC - August 04, 2022

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/