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www.fdanews.com/articles/213314-nj-manufacturer-gets-warning-letter-for-nasal-spray-claimed-to-prevent-covid-19

NJ Manufacturer Gets Warning Letter for Nasal Spray Claimed to Prevent COVID-19

February 28, 2024

The FDA sent a warning letter to Salvacion USA of Englewood Cliffs, N.J., on Feb. 13 for its online sales of Covixyl Nasal Spray, which the company’s website says “helps block airborne viruses, keeping you from getting sick.”

The agency also pointed to a claim on the company’s website that “Laboratory testing and clinical trials have proven the power of Covixyl to block airborne viruses before they gain entry into the body, for up to 6 hours.”

The warning letter asks for corrective action within 15 days, including requesting that if the company believes its products are not in violation of the FD&C Act, it should include its “reasoning and any supporting information for our consideration.” As of this publication date, the company’s website, www.covixyl.com, appears operational and is continuing to sell its product.

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