Lysulin, Inc. – FDA Warning Letter, Sep 9, 2021

The FDA issued a Warning Letter to Lysulin, Inc. after reviewing their website (lysulin.com), social media (Instagram, Facebook), and Amazon storefront in August 2021. The FDA determined that Lysulin's "Lysulin Weight Loss Shake," "Lysulin Diabetes and Prediabetes Chewables," "Lysulin Diabetes and Prediabetes Liquid," "Lysulin Diabetes and Prediabetes Capsules," and "Lysulin Diabetes and Prediabetes Powder" products are marketed with claims that establish them as unapproved new drugs under the Federal Food, Drug, and Cosmetic Act (the Act).

Violations include claims of curing, mitigating, treating, or preventing diseases like diabetes and prediabetes, such as "maintain healthy A1c blood sugar levels in diabetics and prediabetics" and "reduce blood glucose." These claims, found on their website, social media, and Amazon, along with personal testimonials, classify the products as drugs. Since these products are not generally recognized as safe and effective for their intended uses, they are considered "new drugs" requiring prior FDA approval, which they lack. Furthermore, the products are deemed misbranded under section 502(f)(1) of the Act because they lack adequate directions for use by a layperson, as they are intended for conditions requiring professional supervision.

The FDA requires a written response within 15 working days detailing corrective actions and prevention measures. Failure to comply may result in legal action,