FDA Proposes New Regulations on Talc-Containing Cosmetics to Enhance Consumer Safety

The FDA proposes new regulations for talc in cosmetics, mandating strict asbestos testing and record-keeping to protect consumers from contamination risks.

Two years after the launch of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the U.S. Food and Drug Administration (FDA) has finally revealed its long-awaited proposed rule addressing cosmetic products containing talc.

This marks a significant pivot in regulatory focus since MoCRA’s enactment on December 29, 2022, which initially emphasized updates on registration and listing protocols.

Focus on Talc Safety

While MoCRA introduced a broad range of guidelines, the current spotlight is on one critically important issue—talc and its potential asbestos content in cosmetics.

A key directive in MoCRA instructed the FDA to develop standardized testing methods aimed at detecting asbestos in talc-based products.

On December 26, the FDA released the proposed regulations that would fulfill this requirement.

Talc, a naturally occurring hydrous magnesium silicate, is widely recognized as a common ingredient in various cosmetic products, particularly baby powder.

In the realm of cosmetics, it plays essential roles such as moisture absorption, shine control, and ensuring products do not clump together.

However, a major concern lies in its association with asbestos, a known carcinogen, which can sometimes be found in the same geological formations.

As a result, talc mined in certain areas may carry trace amounts of asbestos, posing a potential risk to consumers.

The newly proposed regulations aim to protect users by minimizing this risk in talc-containing cosmetics.

Comprehensive Testing Requirements

The proposed rule introduces a comprehensive framework covering several aspects, including testing protocols, record-keeping obligations, and enforcement measures.

It also clarifies key terminology, defining terms like “representative sample” and “asbestos” for better understanding and compliance.

Manufacturers of all cosmetics containing talc will need to adhere to these new testing protocols.

This requirement extends even to those cosmetic products that are categorized as drugs.

According to the FDA’s proposal, companies must screen for potential asbestos contamination using robust methodologies like Polarized Light Microscopy, Transmission Electron Microscopy, Energy Dispersive Spectroscopy, and Selected Area Electron Diffraction.

To provide some leeway, the FDA allows manufacturers the option to either perform their own tests or rely on certificates of analysis from talc suppliers.

However, if they choose the latter route, it is crucial that these manufacturers verify the accuracy of the supplier’s testing by confirming the reliability of their results.

At a minimum, every single batch or lot of talc-containing cosmetic products or ingredients must undergo testing of a representative sample for asbestos contamination.

Record-Keeping and Enforcement Measures

The proposed regulations require meticulous record-keeping.

Manufacturers must document their asbestos testing procedures rigorously, preserving raw data along with detailed methodologies for sampling.

If they opt to use a supplier’s analysis, they need to retain records proving the supplier’s analysis has been validated through reliable asbestos test results.

Moreover, these records should be readily available for review by FDA representatives within one business day upon request and must be maintained for at least three years following their creation.

The proposed guidelines clarify the situations in which a cosmetic product or its talc content may be considered adulterated under the federal Food, Drug, and Cosmetic Act (FDCA).

These conditions include situations where manufacturers fail to conduct necessary asbestos tests for talc-containing products, do not keep accurate testing records, detect asbestos presence in cosmetic products, or find asbestos in talc intended for use in cosmetics.

The FDA has opened the floor for comments on this proposed rule, seeking public input until March 27, 2025, before finalizing the regulations.

It is important to note that the FDA expects the finalized rule to take effect 30 days after its official publication.

Such regulations are a crucial step toward ensuring consumer safety in the cosmetics industry by addressing the potentially harmful implications of talc use.

Source: Natlawreview