Warning Letter — Glow Medispa, LLC dba Mint Med
The FDA issued a warning letter to Glow Medispa, LLC (dba Mint Med) following an inspection that identified the distribution of unapproved and misbranded drug products. The agency cited the company for making therapeutic claims that classify products as drugs without required FDA approvals.
The action affects Glow Medispa, LLC (dba Mint Med), as well as medical spa management, regulatory compliance officers, and entities involved in the retail sale of aesthetic medical treatments.
This enforcement action signals CDER’s continued oversight of the medical spa industry, specifically targeting the sale of products without valid New Drug Applications (NDAs). Regulatory teams should note that marketing language describing the treatment or prevention of disease can trigger drug classification, necessitating a rigorous review of promotional claims to avoid misbranding.
Review all marketing materials and digital assets to ensure product claims do not inadvertently classify unapproved items as drugs. Verify that all distributed drug products are appropriately listed with the FDA and sourced from compliant manufacturers. Ensure therapeutic claims are supported by an approved New Drug Application.
FDA Warning Letter issued to: Glow Medispa, LLC dba Mint Med. 06/08/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/glow-medispa-llc-dba-mint-med-730390-06082026
Open in openFDA / FDA.gov