FDA WARNING_LETTER - Elle Pharm - November 01, 2025

On November 3, 2025, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Elle Pharm, following a review of their website, www.ellepharm.com. The FDA found that Elle Pharm is introducing unapproved and misbranded new drugs into interstate commerce, specifically citing injectable botulinum toxin products such as "Hutox 100ui" and "Hutox 100." These actions violate multiple sections of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including provisions related to new drug approval and misbranding.

The main violations stem from the sale of unapproved drugs that lack FDA clearance for safety and effectiveness, and are therefore not recognized as safe and effective for their labeled uses. The FDA emphasizes the inherent risks to consumers, including potential contamination, counterfeiting, or incorrect active ingredients, especially for injectable products which bypass natural defenses. Furthermore, the products are considered misbranded because, as prescription drugs, they lack adequate directions for safe use by a layperson and require supervision by a licensed practitioner.

Elle Pharm is required to immediately stop offering these unapproved and misbranded drugs to U.S. consumers. The company must provide a written response to the FDA within 15 working days, detailing the specific steps taken to correct the violations and prevent their recurrence, including supporting documentation. Failure to comply may result in further legal actions, such as product seizure or injunctions.