Aidance Scientific, Inc. – FDA Warning Letter, Jul 1, 2026

On October 1, 2026, the U.S. Food and Drug Administration (FDA) issued a warning letter to Aidance Scientific, Inc. regarding its product, "Terragen HG Formula." This letter followed a July 2026 review of the company’s website and Amazon storefront. The FDA determined that the product is being marketed as an unapproved new drug, specifically for the treatment and relief of symptoms associated with sexually transmitted infections (STIs), such as genital herpes. The agency expressed significant concern regarding these claims, noting that STIs require professional medical diagnosis and treatment. Marketing over-the-counter products for these conditions can lead consumers to forgo necessary medical care, potentially resulting in severe health complications like infertility or life-threatening infections. Under the Federal Food, Drug, and Cosmetic Act, any product intended to treat or prevent disease is classified as a drug and must undergo an FDA approval process to ensure it is safe and effective. The FDA clarified that even products labeled as homeopathic are not exempt from these legal requirements. Aidance Scientific, Inc. is required to respond within 15 business days, outlining the specific steps taken to correct the violations and prevent them from happening again. The company must provide documentation of these changes and is responsible for ensuring all its products comply with federal law. Failure to address these issues promptly could lead to legal actions, including product seizures or court-ordered injunctions.