FDA WARNING_LETTER - Glowface - November 01, 2025

On November 3, 2025, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Glowface following a review of its website, www.glowface.store. The FDA identified significant violations related to the sale of unapproved new drugs and misbranded drugs in interstate commerce.

The main issues involve Glowface’s offering of injectable botulinum toxin drug products, specifically "Botulax 200U set" and "Botulax 200U." These products are considered unapproved new drugs because they lack the necessary FDA approval for safety and effectiveness before being introduced to the U.S. market. Additionally, they are deemed misbranded as they are prescription-only products that cannot be safely used by a layperson without professional supervision, and their labeling fails to provide adequate directions for use. These actions violate sections of the Federal Food, Drug, and Cosmetic Act (FD&C Act) pertaining to drug approval and labeling requirements.

The FDA highlighted the inherent risks to consumers, including potential contamination, counterfeiting, and varying active ingredient amounts, which can lead to serious health consequences, particularly with injectable products. Glowface is required to immediately cease offering all unapproved and misbranded drugs for sale to U.S. consumers. The company must also conduct a thorough review of its website, product labels, and promotional materials to ensure full compliance. A written response detailing specific corrective actions taken and preventative measures, with supporting documentation, must be submitted to the FDA within 15 working days. Failure to comply may result in further legal action.