FDA WARNING_LETTER - Pharmaganics LLC - September 09, 2021

The FDA issued a Warning Letter to Diabetes Doctor following an August 2021 review of their website (www.diabetesdoctor.com), social media (Facebook, Instagram), and product listings on Walmart and Amazon. The FDA determined that the "Diabetes Doctor Pre-Diabetes" and "Diabetes Doctor Blood Sugar 24 Hour" products are unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act.

The products are deemed drugs because claims made on various platforms indicate their intent for use in the cure, mitigation, treatment, or prevention of disease, such as "Fights Insulin Resistance," "Maintain healthy function of vital diabetes organs," "Lower fasting blood sugars," and "Lower HbA1C." Since these products are not generally recognized as safe and effective for these uses, they are considered "new drugs" requiring prior FDA approval, which they lack. Furthermore, they are misbranded because they are intended for conditions not amenable to self-diagnosis or treatment, making it impossible to provide adequate directions for layperson use.

The FDA requires a written response within 15 working days detailing corrective actions and steps to prevent recurrence. Failure to comply may result in legal action, including seizure and injunction.

Concurrently, the Federal Trade Commission (FTC) issued a cease and desist demand, stating 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.