FDA WARNING_LETTER - Glam Derma - November 01, 2025

The FDA issued a Warning Letter to Glam Derma on November 3, 2025, after reviewing its website, www.glamderma.com. The letter identifies significant violations related to introducing unapproved and misbranded injectable botulinum toxin drug products, such as “NABOTA 100 Type A” and “Nabota 100,” into U.S. interstate commerce.

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), these products are considered unapproved new drugs because they lack required FDA approval for safety and effectiveness (sections 301(d) and 505(a)). They are also misbranded (sections 301(a) and 502(f)(1)) as they are prescription drugs that cannot be safely used by laypersons without professional supervision, thus lacking adequate directions for use. The FDA emphasizes the serious health risks associated with unapproved injectable drugs, including potential contamination, counterfeiting, inconsistent active ingredients, and life-threatening complications like sepsis or systemic toxin spread.

Glam Derma is required to immediately cease selling all unapproved and misbranded drugs to U.S. consumers. The company must respond in writing within 15 working days, detailing the specific corrective actions taken to address the violations and prevent their recurrence. Failure to comply may lead to further legal action, including product seizure or injunction.