FDA WARNING_LETTER - Supersmart USA, LLC - October 01, 2025

The U.S. Food and Drug Administration (FDA) issued a warning letter to Supersmart USA, LLC on January 21, 2026, following a review of the company’s website conducted in October 2025. The investigation revealed that several of the company"s dietary supplements—including Berberine, Glucofit, Super DHA, and Celadrin—were marketed with unauthorized health claims. These claims suggested the products could treat, prevent, or mitigate serious medical conditions such as diabetes, cardiovascular disease, depression, and chronic inflammation. Under the Federal Food, Drug, and Cosmetic Act, such claims classify the products as unapproved new drugs because they lack established safety and effectiveness for these specific uses. Additionally, the FDA identified misbranding violations, noting that the products failed to provide adequate directions for use. Specifically, for products like Super DHA, which are marketed for conditions requiring professional medical supervision, it is impossible for a layperson to use the product safely based only on label instructions. The FDA has mandated that Supersmart USA, LLC investigate and correct these violations immediately. The company must provide a written response within 15 working days detailing the specific steps taken to bring their products into compliance and the measures implemented to prevent future recurrences. Failure to address these concerns may result in legal enforcement, such as product seizure or court injunctions.