FDA WARNING_LETTER - Quten Research Institute, LLC - November 17, 2020

The FDA issued a Warning Letter to Qunol following a November 2020 review of their website, qunol.com. The agency determined that claims made for Qunol Ultra CoQ10 and Qunol Extra Strength Turmeric establish them as unapproved new drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), as they are intended for disease treatment, cure, mitigation, or prevention. These products are not generally recognized as safe and effective, classifying them as "new drugs" under section 201(p) of the Act, which require prior FDA approval per sections 301(d) and 505(a) before interstate commerce introduction. Furthermore, the products are misbranded under section 502(f)(1) of the Act because they lack adequate directions for use, as their intended uses address conditions not amenable to self-diagnosis or treatment by a layperson. The introduction of these unapproved and misbranded drugs into interstate commerce violates sections 301(d), 505(a), and 301(a) of the Act. Qunol is required to take prompt corrective action and respond in writing within fifteen working days, detailing steps taken to address the violations and prevent recurrence, or provide justification if they believe their products are not in violation. Failure to comply may result in legal action, including seizure and injunction.