FDA WARNING_LETTER - About Mineral - March 30, 2021

On April 7, 2021, the FDA and FTC issued a Warning Letter to the company operating aboutmineral.com, about Puriton topical skin products. The agencies reviewed the company's website and social media on March 25 and 30, 2021. The FDA found that Puriton products were offered for sale in the U.S. with claims to mitigate, prevent, treat, diagnose, or cure COVID-19.

These products are deemed unapproved new drugs under section 505(a) and misbranded drugs under section 502 of the FD&C Act, violating sections 301(a) and (d). The letter emphasizes the ongoing COVID-19 public health emergency and the FDA's urgent measures against unapproved COVID-19 products. The company is ordered to immediately cease selling these unapproved and unauthorized products.

The company must email COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours, detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to comply may result in legal action, including seizure and injunction. The company will be added to the FDA's public list of firms receiving COVID-19 related warning letters. The FTC also cited violations of the FTC Act for unsubstantiated claims, subject to civil penalties up to $43,792 per violation, and requires