FDA WARNING_LETTER - Life Technologies - December 31, 2025

On February 20, 2026, the FDA issued a Warning Letter to MaxLife Technologies Inc. dba Maxlife, following a December 2025 review of its website. The FDA observed significant violations related to the marketing of compounded semaglutide and tirzepatide drug products. Maxlife is cited for misbranding its products under sections 502(a) and 502(bb), and engaging in prohibited acts under section 301(a) of the Federal Food, Drug, and Cosmetic Act (FDCA).

The main issues involve false and misleading claims. Maxlife’s website falsely implied that it was the compounder of these drugs, despite not being so. Furthermore, the company made unsubstantiated assertions of FDA approval and clinical testing for its compounded semaglutide and tirzepatide products. Compounded drugs are not FDA-approved, rendering claims such as "FDA Approved" or stating products are "clinically tested and FDA-approved" inherently misleading.

Maxlife is required to take immediate action. Within fifteen working days, the company must provide a written response to the FDA’s Office of Compounding Quality and Compliance. This response must detail specific corrective steps, including identifying the actual entities compounding the products, submitting representative labeling, and modifying or removing all false or misleading claims from its website. Failure to adequately address these violations may result in further legal action, such as seizure and injunction.