FDA WARNING_LETTER - Lime Essentials - April 01, 2026

The U.S. Food and Drug Administration (FDA) issued a warning letter to Lus Essentials LLC on May 14, 2026, following a review of the company’s website in April 2026. The FDA identified significant safety and regulatory violations concerning skin treatment products, including the "Dr. Yanhee Acne Treatment Set" and "Dr. Yanhee Cream Set." Laboratory testing revealed these products contain high levels of mercury, a toxic substance capable of causing permanent kidney and neurological damage. Under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, the FDA categorized these items as unapproved new drugs because they are marketed with claims to treat medical conditions—such as acne and melasma—without the agency"s evaluation for safety and efficacy. Furthermore, the products are deemed misbranded because the labels fail to disclose the presence of mercury, potentially misleading consumers about their safety. To address these violations, Lus Essentials LLC must identify the root causes of these issues and implement corrective measures to ensure legal compliance. The company is required to provide a formal written response to the FDA within fifteen business days, detailing the specific actions taken to resolve the violations and prevent them from recurring. Failure to comply promptly may result in legal consequences, such as product seizures or court-ordered injunctions.