FDA WARNING_LETTER - Aesthetic Essentials Limited - November 01, 2025

The FDA issued a Warning Letter to Aesthetic Essentials Limited on November 3, 2025, following a review of their website, www.aesthetic-essentials.com. The company is primarily in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by introducing unapproved new drugs and misbranded drugs into U.S. interstate commerce. Specifically, the FDA identified injectable botulinum toxin products, such as "Rentox 200U," which lack required FDA approval for safety and effectiveness for their marketed indications. These products are also deemed misbranded because, as prescription drugs requiring professional oversight, they fail to bear adequate directions for safe use by a layperson. The FDA emphasizes the inherent risks to consumers from such unapproved and misbranded drugs, including potential contamination and serious adverse health effects from injectables. Aesthetic Essentials Limited is required to immediately cease offering these unapproved and misbranded drugs for sale to U.S. consumers. The company must submit a written response within 15 working days detailing specific steps taken to address these violations and prevent recurrence, supported by documentation. Failure to comply may result in further legal action.