OCLO LLC/OCLO Nanotechnology Science – FDA Warning Letter, Apr 15, 2021
On April 15, 2021, the FDA and FTC reviewed the website https://dioxidodecloro.us, social media at https://facebook.com/Hallandale.Beach.2018/, and eCrater storefront (OCLO) operated by 220 SW 9th Ave, #506 Hallandale, FL 33009. The firm was found to be selling chlorine dioxide products, including "OCLO 3000," with claims to mitigate, prevent, treat, diagnose, or cure COVID-19.
These products are deemed 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 "This solution can be used to combat a large number of viral infections including COVID-19" and "The chlorine dioxide is effective for the COVID19 treatment."
The FDA requires immediate cessation of sales of these unapproved and unauthorized COVID-19 related products. The firm must email
ID · c4616695-53b3-49a5-be9b-a75ab6b5b50a
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