EU Natural Inc. – FDA Warning Letter, May 26, 2021

The FDA issued a Warning Letter to Eu Natural following a March 2021 review of their website (www.store.eunatural.com) and social media, identifying violations related to their “CONCEPTION Female Fertility Prenatal” and “CONCEPTION MEN Male Fertility” products. The FDA determined that claims on the websites establish these products as unapproved new drugs under sections 201(g)(1)(B) and 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act), as they are intended for disease treatment and are not generally recognized as safe and effective. Introducing these unapproved new drugs into interstate commerce violates sections 301(d) and 505(a). Additionally, the products are misbranded under section 502(f)(1) because they lack adequate directions for use, addressing conditions not amenable to self-diagnosis or treatment, violating section 301(a). The firm must respond in writing within 15 working days, detailing corrective actions and preventing recurrence, or provide justification. Failure to comply may result in legal action, including seizure and injunction. The Federal Trade Commission (FTC) also noted that unsubstantiated efficacy claims violate the FTC Act, potentially leading to injunctions, civil penalties up to $43,792 per violation, and consumer refunds. The firm must also notify the FTC within 15 working days regarding actions taken to address their concerns.