Why Microbiological Contaminations are the Largest Cause of Cosmetic Recalls, and How to Avoid One.

According to FDA figures, the single largest reason for recalls of Cosmetics, Drugs and Dietary Supplements is microbiological contamination. The development of new more “natural” formulations, loss of robust preservatives and legacy manufacturing and processing are key drivers of this trend. Hygienic manufacturing requires the coordination of formula development, preservation, process design, scale-up, facility and equipment design, operations, training, quality assurance and testing, as well as leadership at all levels, to minimize risk.

Hear how this has been addressed by a task force from industry, sharing knowledge and best practices, the role of associations, similar to AIChE, academia and individual companies. Congress passed the Modernization of Cosmetics Regulations Act at the end of 2022. According to this regulation, the FDA must publish draft guidance for industry on Good Manufacturing Practices during 2024 and finalize them in 2025. The Act greatly increases the level of scrutiny of the cosmetics industry, including the ability to control microbiological risk.