FDA WARNING_LETTER - Copper Touch, LLC - April 17, 2020

On April 21, 2020, the FDA and FTC issued a Warning Letter to the company operating coppertouch.com after reviewing their website on April 15 and 17, 2020. The letter addresses the sale of "Sani-Bar GK95" and "Sani-Disc GK95D" products, which are marketed with claims to mitigate, prevent, treat, diagnose, or cure COVID-19.

The FDA determined these products are unapproved new drugs, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and are 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)). The letter highlights the public health emergency declared for COVID-19.

The company is required to immediately cease selling these unapproved and unauthorized products for COVID-19 related uses. Within 48 hours, the company must email COVID-19-Task-Force-CDER@fda.hhs.gov detailing corrective actions, including steps to prevent recurrence and supporting documentation. Failure to comply may result in legal action, including