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

Source: https://www.keypedia.com/records/warning_letter/copper-touch-llc/4d41e25d-3794-4c7b-b43f-df01871026a9

> FDA WARNING_LETTER for Copper Touch, LLC on April 17, 2020. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Copper Touch, LLC
- Inspection Date: 2020-04-17
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

## Related Officers

- [Director](https://www.keypedia.com/people/donald-d-ashley/060f0dda-e6e8-4f9c-97e7-f540d523d902)
- [Richard A. Quaresima](https://www.keypedia.com/people/richard-a-quaresima/d0be06fa-21e5-46d0-879d-95af9663066c)

Company: https://www.keypedia.com/companies/copper-touch-llc/80d5f604-3ebc-456d-a63b-34573cc3d220

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