FDA WARNING_LETTER - Glow Medispa, LLC dba Mint Med - May 01, 2026
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The U.S. Food and Drug Administration (FDA) issued a warning letter to Glow Medispa, LLC, operating as Mint Med, following a website review conducted in May 2026. The agency found that the Cincinnati-based company is marketing compounded drugs, specifically semaglutide and tirzepatide, using false and misleading information. The primary issue centers on the company’s website, which displays product labels suggesting Mint Med is the actual manufacturer or compounder of these drugs. In reality, Mint Med does not produce these medications. Under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, specifically sections 502 and 301, products are considered mislabeled if their advertising is inaccurate. By implying a false source of production, the company has introduced mislabeled drugs into the marketplace, violating federal laws intended to protect the public from unsafe or ineffective products. To resolve these issues, the FDA requires Mint Med to submit a written response within 15 business days. This response must outline the root causes of the violations and the specific steps taken to correct them. Required actions include identifying the actual producers of the compounded drugs, providing representative samples of corrected labeling, and removing any deceptive claims from the website. The FDA warned that failure to promptly address these concerns could result in legal consequences, such as the seizure of products or a court-ordered injunction to stop operations.
ID · 4c79d077-8408-4fb1-a671-9cbab102eaaa
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