FDA WARNING_LETTER - LyfeUnit / www.lyfeunit.com - June 01, 2026

On June 23, 2026, the FDA issued a warning letter to LyfeUnit (www.lyfeunit.com) following an inspection of its website conducted on February 27, 2026. The agency identified significant violations of the Federal Food, Drug, and Cosmetic Act involving the sale of unapproved and misbranded drug products, specifically injectable ketamine. The FDA noted that LyfeUnit marketed these products for mental health treatments and surgical procedures without obtaining the necessary regulatory approvals for safety and effectiveness. The letter emphasizes that ketamine is a controlled substance that carries serious risks, including sedation and respiratory depression. While certain versions of ketamine are FDA-approved, they are subject to strict medical supervision and safety programs known as Risk Evaluation and Mitigation Strategies (REMS). LyfeUnit’s products bypass these safeguards and are sold without requiring a prescription from a licensed practitioner. Furthermore, the drugs are considered misbranded because their labeling fails to provide adequate directions for safe use by a layperson. The FDA has directed LyfeUnit to immediately cease the sale of these unapproved drugs to U.S. consumers. The company must submit a written response within 15 business days outlining the specific steps taken to correct the violations and the measures implemented to prevent their recurrence. Failure to comply may result in legal action, such as product seizure or injunctions.