Fertility Nutraceuticals LLC – FDA Warning Letter, May 26, 2021

The FDA issued a Warning Letter to Mr. Norbert Gleicher after reviewing the websites www.fertilitynutraceuticals.com and www.fertilitysupplementstore.com in March 2021. The letter addresses the products “CONFLAM- Forte™,” “FERTINATAL® DHEA”, and “OVOENERGEN™ CoenzymeQ10”. The FDA determined that claims on the websites and product literature establish these products as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) due to their intended use in disease treatment, cure, mitigation, or prevention. As these products are not generally recognized as safe and effective for their intended uses, they are considered "new drugs" under section 201(p) of the Act. Introducing these unapproved new drugs into interstate commerce violates sections 301(d) and 505(a) of the Act. Additionally, the "CONFLAM Forte™" product is deemed misbranded under section 502(f)(1) of the Act because it lacks adequate directions for its intended uses, which are not suitable for self-diagnosis or treatment by a layperson. Introducing this misbranded drug violates section 301(a) of the Act. The firm must notify FDA within 15 working days of specific corrective actions taken. The Federal Trade Commission (FTC) also reviewed the websites, expressing concern that efficacy claims may lack competent and reliable scientific evidence, violating the FTC Act. The FTC urges a review of all claims and warns of potential legal action, including injunctions, civil penalties up to $43,792 per violation, and consumer refunds. A separate response to the FTC is required within 15 working days.