FDA WARNING_LETTER - Thomas Brunner Hygiene GmbH - August 12, 2025

The FDA issued a Warning Letter to Thomas Brunner Hygiene GmbH on July 24, 2026, following a records review initiated in August 2025 and a website audit in April 2026. The agency determined that the firm’s over-the-counter (OTC) antiperspirant products are manufactured in violation of Current Good Manufacturing Practice (CGMP) and the Federal Food, Drug, and Cosmetic Act. Key violations include failing to test finished products for active ingredient strength and identity before distribution. The company also failed to test high-risk ingredients, such as glycerin, for dangerous contaminants like diethylene glycol (DEG) and ethylene glycol (EG). Furthermore, the FDA noted a lack of validated manufacturing and cleaning processes, inadequate water system monitoring, and insufficient stability testing to support product expiration dates. Several "syNeo" brand products were classified as unapproved new drugs and misbranded because they use combinations of active ingredients not permitted by the federal OTC antiperspirant monograph. To address these issues, the FDA requires the company to engage an independent quality consultant and submit a comprehensive corrective action plan within 15 business days. This plan must include a risk assessment for products currently on the market, updated testing protocols for raw materials and finished goods, and evidence of validated manufacturing processes. Failure to correct these deficiencies may lead to the FDA detaining or refusing the company’s products at the U.S. border.