September 28, 2022

Warning Letter to FluxxLab For Unapproved COVID Treatments

The FDA has sent a warning letter to FluxxLab LLC because th company is allegedly selling COVID-19 treatments that have no proof of efficacy. The letter states, “The FDA has observed that your website offers the Covid-19 Immune Support Tincture and the CBDA+CBD Oil Tincture products for sale in the United States and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. Based on our review, these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a).

“Furthermore, these products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. § 352. The introduction or delivery for introduction of these products into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d).”

Warning Letter to FluxxLab For Unapproved COVID Treatments

FDA has been taking measures to protect consumers from products sold in the wake of the coronavirus pandemic that, without approval or authorization by the FDA, claim to treat, prevent, diagnose, or cure COVID-19 in people. The FDA is requesting that the company cease the sale of any approved and unauthorized products.

Claims on the FluxxLab LLC company’s website establish the intended use of these products and misleadingly represent them as safe and effective. Some of the statements say that the products provide immune support and that CBDs “can prevent the virus from infecting cells and causing infection.”

The company must send an email describing specific steps taken to address these violations. In addition, it is unlawful under the FTC act to advertise that a product can prevent, treat, or cure human diseases unless there is competent and reliable scientific evidence, including well-controlled human clinical studies, that substantiate that the claims are true when they are made. No such study is currently known to exist for the products in question.

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