On December 26, 2024, the US Food and Drug Administration (FDA) proposed an important proposal requiring cosmetics manufacturers to conduct mandatory asbestos testing on talc containing products in accordance with the provisions of the 2022 Cosmetic Regulatory Modernization Act (MoCRA). This proposal will have a profound impact on the cosmetics industry, especially on the cosmetic grade talcum powder market.
The FDA’s proposed detection methods mainly include two types: polarized light microscopy (PLM): this method can analyze a large number of samples and identify asbestos by observing optical crystallographic properties (such as color, multi-color, refractive index, birefringence, etc.) and particle morphology. Transmission Electron Microscopy/Energy Dispersive Spectroscopy/Selective Electron Diffraction (TEM/EDS/SAED): This method can detect smaller fibers and identify asbestos by analyzing elemental composition, crystal structure, and particle morphology.
The FDA stated that combining these two methods can maximize the detection of asbestos. Although PLM has a lower magnification, it can analyze a larger number of samples; And TEM/EDS/SAED can detect smaller fibers. The two methods complement each other, improving the accuracy and comprehensiveness of detection.
The proposal of international standard consistency aligns with international standards. The European Union, Canada, and Japan have established similar strict regulations to ensure that talc products do not contain asbestos pollution. Microscopic techniques such as PLM and TEM are widely used worldwide to accurately detect asbestos. This unified standard not only helps protect consumer health, but also promotes international trade and increases consumer confidence in the safety of global talc products.
The FDA’s proposal clearly states that if asbestos is detected in cosmetics or talc used in cosmetics, the product will be considered adulterated and violate the Federal Food, Drug, and Cosmetic Act. This regulation provides a clear legal basis for law enforcement.
The main purpose of this proposal is to reduce the risk of consumer exposure to asbestos and prevent related diseases. At the same time, it will also help manufacturers reduce the frequency of product recalls and mitigate operational risks.
In addition, this proposal fills some gaps in the MoCRA guidelines, particularly regarding the insufficient understanding of cosmetic safety testing standards by small and medium-sized enterprises. The FDA has now clearly defined the testing methods for asbestos in talc, providing clearer guidance for the industry.
The FDA has opened a public review period for public participation and subsequent steps, with a deadline of March 27, 2025. This provides an opportunity for the industry and the public to participate in the regulatory process. If ultimately passed, this new regulation will greatly improve the safety of talc containing cosmetics and provide stronger protection for consumer health.
The FDA’s proposal reflects the regulatory authorities’ high emphasis on cosmetic safety, particularly in the detection of asbestos, a known carcinogen. Given the FDA’s new proposal, Bureau Veritas recommends that cosmetic manufacturers begin evaluating and updating their quality control processes early, particularly for products containing talc. Relevant enterprises should seek timely assistance from third-party testing agencies, train relevant personnel, and establish a sound supply chain management system to ensure compliance with new regulatory requirements, maintain brand reputation, and consumer trust.
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Post time: Jan-03-2025
