About Mineral

Warning LetterOpen

Hyun Eun Lee About Mineral 3063 W. Chapman Ave., #6301 Orange , CA 92868 United States contact@aboutmineral.comIssued Apr 7, 2021Center for Drug Evaluation and Research

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Letter Details

Firm: About Mineral
Location: Hyun Eun Lee About Mineral 3063 W. Chapman Ave., #6301 Orange , CA 92868 United States contact@aboutmineral.com
FEI Number: N/A
Country: United States
Issue Date: April 07, 2021
Issuing Office: Center for Drug Evaluation and Research
Product Type: Drugs
Status: Open

Summary

About Mineral was warned for selling unapproved topical skin products (Puriton) that were marketed to mitigate, prevent, treat, diagnose, or cure COVID-19, in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act. The products were also found to be misbranded drugs under section 502 of the FD&C Act and were unlawfully introduced into interstate commerce through the company's website and social media channels (Facebook and Instagram). The FDA and FTC jointly conducted their review during the COVID-19 public health emergency, heightening the agency's enforcement priority against unauthorized products making coronavirus-related claims.