Everything Health LLC – FDA Warning Letter, Jun 8, 2021
On May 24, 2021, the FDA and FTC issued a Warning Letter to the company operating https://ssnaturalhealing.com, including associated social media. The agencies reviewed the website on February 23, 2021, and May 11, 2021, finding the product "CoronaBox" offered for sale, intended to mitigate, prevent, treat, diagnose, or cure COVID-19.
The FDA determined CoronaBox is an unapproved new drug, violating 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). Its introduction into interstate commerce is prohibited by sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)). The letter cites numerous claims from the website and social media, such as "The Corona box is all you need to kick that nasty virus!" and testimonials, as evidence of intended use and misleading representations.
The company was ordered to immediately cease selling unapproved and unauthorized COVID-19 products. Within 48 hours, an email to COVID-19-Task-Force-CFSAN@fda.hhs.gov was required, detailing corrective actions, recurrence
ID · 2884f83b-7fd2-4d4e-ad06-a5c428eb965e
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