FDA WARNING_LETTER - Hyaluron Pen Store, LLC dba Glow Nest Beauty - November 01, 2025

The FDA issued a Warning Letter to Glow Nest Beauty on November 3, 2025, following a review of the company"s website, www.glownestbeauty.com. The primary issues identified involve the introduction of unapproved and misbranded injectable botulinum toxin drug products, specifically "Rentox 200U," into interstate commerce. These products violate the Federal Food, Drug, and Cosmetic Act.

Key violations include marketing products as unapproved new drugs, as they lack the necessary FDA approval for safety and effectiveness. Additionally, the products are deemed misbranded because they are prescription-only drugs sold without adequate directions for use by a layperson and without requiring a prescription from a licensed healthcare practitioner. The FDA emphasizes the inherent risks to consumers, noting that unapproved drugs may be contaminated, counterfeit, or contain incorrect ingredients, potentially leading to serious health conditions like sepsis.

To address these concerns, the FDA mandates that Glow Nest Beauty immediately stop selling all unapproved and misbranded drugs to U.S. consumers. The company is also required to promptly correct all identified violations and thoroughly review its website, product labels, and promotional materials to ensure full compliance with federal drug regulations and safeguard public health.