FDA WARNING_LETTER - Aceva, LLC - September 09, 2021

The FDA and FTC issued a Warning Letter to Aceva regarding their "Sugar Balance" product, sold via aceva.com and promoted on social media (Twitter, Facebook). An August 2021 review of their websites found claims establishing the product as an unapproved new drug under section 201(g)(1)(B) of the FD&C Act, intended for disease diagnosis, cure, mitigation, treatment, or prevention. Specific claims included improving insulin sensitivity, enhancing blood sugar control, regulating blood sugar, and decreasing the body's need for insulin, targeting conditions like diabetes. As an unapproved new drug (section 201(p)), its introduction into interstate commerce violates sections 301(d) and 505(a) of the Act. Furthermore, the product is misbranded under section 502(f)(1) because it lacks adequate directions for use, as its intended purposes are not amenable to self-diagnosis or treatment by a layperson, thus violating section 301(a). The FTC also determined that advertising claims about preventing, treating, or curing human disease without competent and reliable scientific evidence, including well-controlled human clinical studies, violates the FTC Act. Aceva was instructed to cease and desist from such unsubstantiated claims. The firm must respond to the FDA within 15 working days with corrective actions and to the FTC within 15 working days regarding their advertising claims, or face potential legal action, including seizure, injunction, and civil penalties up to $43,792 per violation from the FTC.