NS Products, Inc. – FDA Warning Letter, May 26, 2021

The FDA issued a Warning Letter to Wolfe Vaughn and Craig Sheralyn regarding their product “NaturaCure,” sold on www.naturacure.net, following a March 2021 website review. The FDA determined that claims made on the website establish “NaturaCure” as an unapproved new drug under sections 201(g)(1)(B) and 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act), as it is intended for the cure, mitigation, treatment, or prevention of diseases like ovarian cysts, uterine fibroids, endometriosis, and various infertility disorders. Examples of violative claims include statements about avoiding surgery, replacing fertility treatments, and high success rates for specific conditions, supported by testimonials. Introducing or delivering this product into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act. Furthermore, “NaturaCure” is misbranded under section 502(f)(1) of the Act because it lacks adequate directions for use, as its intended purposes are not amenable to self-diagnosis or treatment by a layperson, violating section 301(a). The firm must respond within 15 working days with specific corrective actions and documentation to prevent recurrence of violations. Failure to comply may result in legal action, including seizure and injunction.