FDA WARNING_LETTER - Hopewell Essential Oils - April 23, 2020

The FDA and FTC issued a Warning Letter to Hopewell Oils after reviewing their website, hopewelloils.com, on April 13 and 23, 2020. The agencies observed that Hopewell Oils offers essential oils and herbal products for sale in the U.S. with claims to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. These claims establish the products as unapproved new drugs, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)). Furthermore, the products are deemed 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) (21 U.S.C. § 331(a) and (d)). The letter also states that advertising such products as preventing or treating human disease without competent and reliable scientific evidence is unlawful under the FTC Act (15 U.S.C. 41 et seq.). Hopewell Oils was directed to immediately cease selling these unapproved products and to email both FDA and FTC within 48 hours describing corrective actions taken, including documentation. Failure to comply could result in legal action, including seizure, injunction, being added to FDA's public list of non-compliant firms, and potentially requiring repayment to consumers. Products may also be subject to detention and refusal of admission if imported.