Sal Nature LLC/FertilHerb – FDA Warning Letter, May 26, 2021

The FDA issued a Warning Letter to FertilHerb following a March 2021 review of its website, www.fertilherb.com, concerning the product “FertilHerb for Women.” The FDA determined that website claims, such as treating PCOS, endometriosis, amenorrhea, irregular menstruation, luteal phase defect, and reducing miscarriage risk, establish the product as a drug intended for the cure, mitigation, treatment, or prevention of disease under section 201(g)(1)(B) of the FD&C Act. Consequently, the product is an unapproved new drug under section 201(p) because it is not generally recognized as safe and effective for these uses. Introducing such a product into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act. Furthermore, “FertilHerb for Women” is misbranded under section 502(f)(1) of the Act as it lacks adequate directions for use, given its intended purposes are not amenable to self-diagnosis or treatment by a layperson. The introduction of misbranded drugs into interstate commerce violates section 301(a) of the Act. FertilHerb must respond in writing within 15 working days, detailing corrective actions and preventive measures. Failure to comply may lead to legal action, including seizure and injunction. The Federal Trade Commission (FTC) also expressed concerns regarding unsubstantiated efficacy claims, warning of potential legal action, civil penalties, and consumer refunds.