# FDA WARNING_LETTER - Curativa Bay Corporation - June 22, 2020

Source: https://www.keypedia.com/records/warning_letter/curativa-bay-corporation/bf3e5b6b-97bb-471e-a648-761bd5a1bc3d

> FDA WARNING_LETTER for Curativa Bay Corporation on June 22, 2020. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Curativa Bay Corporation
- Inspection Date: 2020-06-22
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On June 25, 2020, the FDA and FTC issued a Warning Letter to Curativa Bay regarding their "Advanced Hypochlorous Skin Spray" product. The agencies reviewed the company's websites, https://www.curativabay.com and www.facebook.com/curativabay, on June 16 and June 22, 2020, respectively.

The FDA determined that the product is 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). The product is marketed with claims to mitigate, prevent, treat, diagnose, or cure COVID-19, which are unsubstantiated. The introduction of such products into interstate commerce is prohibited by sections 301(a) and (d) of the FD&C Act (21 U.S.C. § 331(a) and (d)).

The FTC stated that advertising a product to prevent, treat, or cure human disease requires competent and reliable scientific evidence, including well-controlled human clinical studies, which are not known to exist for this product regarding COVID-19.

Curativa Bay must immediately cease the sale of these unapproved and unauthorized products. Within 4

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Company: https://www.keypedia.com/companies/curativa-bay-corporation/dd4bad7e-6c0d-4e0c-af1d-226dcb9425a2

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