Recent regulatory updates show a clear global trend: increased technical rigor, greater transparency, and higher expectations for control throughout the entire product lifecycle. One clear example is FDA cosmetics recalls, which are gaining new regulatory weight in the United States.
In this article, we highlight recent regulatory developments involving the FDA, the European Union, and China. Also, explain how this evolving landscape may impact companies operating in highly regulated markets.
FDA issues draft guidance on mandatory cosmetics recalls
The Food and Drug Administration has published a draft guidance titled “Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry.” The document aims to clarify how the agency intends to exercise its legal authority to mandate recalls, as established under MoCRA.
The guidance defines criteria, procedures, and regulatory expectations when adulterated or misbranded cosmetics pose serious consumer health risks.
In practice, it signals a shift in FDA cosmetics recall management, no longer relying solely on voluntary manufacturer actions.
Although the guidance is still in draft form, it reflects the FDA’s current interpretation of its legal authority. This reflects higher expectations for post-market system maturity, complaint handling, traceability, and rapid response to adverse events.
For companies manufacturing, exporting, or marketing cosmetics in the U.S., this reinforces reviewing internal processes, contingency plans, and technical documentation. FDA cosmetics recalls are no longer exceptional events but an integral part of ongoing regulatory planning, directly impacting risk management and brand protection.
European Union considers simplifying MDR requirements
Beyond FDA cosmetics recalls, the European regulatory environment is also evolving. The European Commission has proposed simplifying certain requirements of the Medical Device Regulation (MDR), aiming to reduce regulatory burden without compromising product safety.
The initiative may affect assessment timelines, post-market obligations, and the role of Notified Bodies.
While focused on medical devices and IVDs, it reflects a broader regulatory trend also seen in cosmetics: addressing efficiency while maintaining strong oversight.
MDCG reinforces post-market surveillance expectations
Further supporting this trend, the Medical Device Coordination Group (MDCG) published updated guidance on post-market surveillance in Europe.
The document emphasizes systematic data collection, continuous risk analysis, and alignment between PMS activities, PMCF, and risk management.
The message is clear: authorities increasingly expect structured, proactive post-market approaches across regulated industries.
China reviews requirements for new cosmetic ingredients
While FDA cosmetics recalls are reshaping expectations in the U.S., regulatory updates are also emerging in Asia. China’s National Medical Products Administration (NMPA) has opened a public consultation to revise dossier requirements for New Cosmetic Ingredients (NCI).
The proposed changes may affect data requirements, evaluation timelines, and market entry strategies in China.
For brands considering international expansion, this signals ongoing regulatory adjustment aimed at balancing innovation, predictability, and safety oversight.
A global shift toward greater regulatory accountability
Taken together, these updates highlight a global regulatory shift toward stricter technical standards, clearer post-market expectations, and stronger enforcement tools. In the U.S., this translates into a more structured and less reactive approach to FDA cosmetics recalls, requiring companies to be prepared well in advance.
Closely monitoring these developments and integrating them into regulatory planning is essential for compliance strategies. Maintaining up-to-date processes, consistent documentation, and well-supported regulatory decisions helps reduce risk, prevent delays, and strengthen the long-term regulatory sustainability of products on the market.
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