FDA WARNING_LETTER - Herbal Dermals LLC FZ dba Gotucream - April 01, 2026

Herbal Dermals LLC FZ, doing business as Gotucream, received an FDA warning letter on June 17, 2026, following a review of the company’s website conducted in April 2026. The FDA identified that the product "Gotucream" is being marketed as an unapproved new drug, which violates the Federal Food, Drug, and Cosmetic Act. The main issue involves promotional claims on the company’s website asserting that the cream can treat, mitigate, or cure specific medical conditions, such as Balanitis, and its associated symptoms like inflammation, pain, and sores. Under the current regulatory framework, any product intended for use in the diagnosis or treatment of a disease is classified as a drug and must undergo an FDA approval process to ensure it is safe and effective for its intended use. Since Gotucream lacks an approved application and is not generally recognized as safe and effective by experts, its sale and distribution are prohibited. To resolve these violations, the FDA requires Herbal Dermals LLC FZ to investigate the root causes of these compliance failures and implement permanent corrective actions. The company must provide a written response within 15 business days detailing the steps taken to address the issues and prevent their recurrence. Failure to rectify these violations promptly may result in legal enforcement actions, including product seizures or injunctions.