FDA Warning Letter on unapproved and misbranded Drugs

On February 7, 2024, the FDA issued a Warning Letter to a company based in the United States, US Chem Labs. The letter addresses the marketing and distribution of three new drugs: "Semaglutide," "Tirzepatide," and "Thymalin," without FDA approval, and with misbranding issues. These drugs have been marketed with labels stating "research chemicals only" and "not for human consumption," yet they are intended to prevent, treat, or cure diseases or affect the body's structure or function.

Semaglutide and Tirzepatide, originally intended for type 2 diabetes treatment, are increasingly sought after for weight loss. Thymalin stimulates the thymus gland to produce peptides regulating the immune and endocrine systems.

The FDA deems these products "unapproved new drugs" as they lack FDA-approved applications and adequate directions for use. Particularly concerning is the marketing of Thymalin for use in children, posing risks due to their vulnerability to drug effects. The FDA's Warning Letter to US Chem Labs provides further details.