FDA WARNING_LETTER - StayWell Copper Products - May 26, 2020

On May 28, 2020, the FDA and FTC issued a Warning Letter to the company operating www.staywellcopper.com, www.facebook.com/StayWellCopperProducts/, www.instagram.com/staywellcopper/, and www.twitter.com/StaywellCU. The letter states that the company's copper "Germ Stopper" products are being sold 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, and are misbranded drugs under section 502. The introduction of these products into interstate commerce is prohibited by sections 301(a) and (d). The letter emphasizes the public health emergency declared for COVID-19 and the FDA's urgent measures to protect consumers from unapproved products.

The company is required to immediately cease selling these unapproved and unauthorized products for COVID-19 related uses. Within 48 hours, an email must be sent to 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 seizure and injunction, and the firm will be added to FDA's public list of non-compliant companies.

The FTC also stated that advertising a product can prevent