FDA WARNING_LETTER - Quinessence Aromatherapy LTD - March 06, 2020

The FDA and FTC issued a Warning Letter to Quinessence Aromatherapy Ltd following a February 2020 review of their website, www.quinessence.com, and Twitter page. The agencies determined that Quinessence was offering essential oil products for sale in the United States with claims to mitigate, prevent, treat, cure, or diagnose Coronavirus Disease 2019 (COVID-19).

These products are deemed unapproved new drugs, violating section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). Furthermore, they are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. 352, and their introduction into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d). Examples of violative claims included "Essential Oils to Protect Against Coronavirus" and lists of "most powerful anti-virus essential oils."

The FTC also cited violations of the FTC Act, 15 U.S.C. 41 et seq., for advertising products to prevent, treat, or cure human disease without competent and reliable scientific evidence. The letter emphasizes that no approved products exist to treat or cure COVID-19, rendering the claims unsubstantiated.

Quinessence is required to immediately cease the sale of these unapproved products and correct all violations. Within 48 hours, the company must email both the FDA and FTC, detailing specific corrective actions, steps to prevent recurrence, and supporting documentation. Failure to comply may result in legal action, including seizure, injunction, and being added to FDA's public list of non-compliant firms. FTC violations could lead to orders requiring consumer refunds.