Earth Angel Oils – FDA Warning Letter, Mar 25, 2020
On April 14, 2020, the FDA issued a Warning Letter to Earth Angel Oils after reviewing their website, www.earthangeloils.com, on March 25, 2020. The FDA observed that the company was offering essential oil products for sale in the U.S. with claims to mitigate, prevent, treat, diagnose, or cure COVID-19.
These products were deemed unapproved new drugs, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and misbranded drugs under section 502 of the FD&C Act (21 U.S.C. § 352). The introduction of these products into interstate commerce violated sections 301(a) and (d) of the FD&C Act (21 U.S.C. § 331(a) and (d)). The letter noted that the problematic claims appeared to have been removed from the website as of the letter's date.
Earth Angel Oils was required to email COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours, detailing steps taken to prevent future violations. The company will be added to the FDA's public list of firms receiving warning letters for COVID-19-related product violations, with a notation that the
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