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Holistic Healer & Wellness Center, Inc. was cited for marketing Diabalance Diabetes Supplement as an unapproved new drug through claims that it treats, mitigates, and prevents diabetes and related conditions such as high blood sugar and insulin resistance. The company's website contained multiple therapeutic claims—including statements that the product "helps balance blood sugar levels for people with diabetes" and "works great to lower high blood sugar"—that established the product as a drug under federal law rather than a dietary supplement. Since the product lacked FDA approval and was not generally recognized as safe and effective for these uses, its marketing and sale violated the Federal Food, Drug, and Cosmetic Act. The FDA coordinated with the Federal Trade Commission in identifying these violations during their August 2021 website review.