FDA WARNING_LETTER - Time Challenger Labs International Inc. - December 19, 2024

The FDA issued a Warning Letter to Time Challenger Labs International, Inc. following an inspection on December 18-19, 2024, and a subsequent website review in May 2025. The agency identified significant violations of the Federal Food, Drug, and Cosmetic Act. Firstly, the company is marketing several products, including "Adrenal Boost," "Chaga," and "UTI," with claims on its website that establish them as unapproved new drugs. These claims suggest the products treat diseases or affect bodily functions, but they lack the necessary FDA approval and are not generally recognized as safe and effective for such uses. This marketing constitutes a violation of drug regulations.

Secondly, the facility was found to have serious deficiencies in its Current Good Manufacturing Practice (CGMP) for dietary supplements, rendering its products adulterated. Specific CGMP violations include failing to establish product specifications for identity, purity, and composition of finished dietary supplements, and failing to establish specifications for raw material components. The company also lacked essential master manufacturing records for its product formulations and batch production records for manufactured dietary supplement batches. Notably, some of these CGMP violations were repeat observations from a previous inspection.

Time Challenger Labs International, Inc. is required to cease marketing its products as unapproved drugs and must implement comprehensive corrective actions to address all identified CGMP violations. This includes establishing and following all required specifications and documentation for dietary supplement manufacturing. The FDA expects a detailed response outlining these corrective steps.