Kayla Cristales and Luke Nguyen • Haynes Boone

The relationship between talc and asbestos begins at the mining process. Talc is a naturally occurring mineral composed of magnesium, silicon, oxygen and hydrogen. It is a common ingredient in certain cosmetic products, such as baby powder, blush and eyeshadow.

Asbestos is also a naturally occurring mineral and is often found near talc. As a result, in the past 10-15 years, in particular, there have been reports of asbestos contamination in cosmetics containing talc. These reports lead to high-profile class action lawsuits, FDA-commissioned testing, recalls, and, ultimately, the Congressional mandate within the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) directing FDA to issue regulations to establish standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products. The agency issued the proposed “Talc Rule” on December 27, 2024, which, per MoCRA, is set to become final as of June 25, 2025.[1]

Testing Requirements and Compliance Options

If finalized, the rule will require cosmetic manufacturers to conduct asbestos testing on either a “representative sample” of each batch or lot of finished products containing talc or on all batches or lots of the talc ingredient prior to using it in the production of any finished products. Alternatively, finished product manufacturers may opt to rely on testing performed by their talc suppliers, as evidenced by a certificate of analysis (COA) for each batch or lot supplied, provided that the COA contains the minimum required information and the manufacturer establishes and maintains the reliability of the talc supplier and the testing reflected in the COA.

Additional Details:

• “Representative Sample”: The rule defines representative sample as “a sample that consists of a number of units that are drawn based on rational criteria, such as random sampling, and intended to ensure that the sample accurately portrays the material being sampled.”
• Analytical Methodology: Regardless of which of the above options a manufacturer decides to utilize to comply with the rule, the required testing must be performed using both Polarized Light Microscopy (PLM) (with dispersion staining) and Transmission Electron Microscopy (TEM)/Energy Dispersive Spectroscopy (EDS)/Selected Area Electron Diffraction (SAED).
• Minimum Information Required in COAs: Each COA must state that (a) the supplier used an analytical approach that includes both PLM and TEM/EDS/SAED and (b) the COA is specific to the talc purchased by the manufacturer, including identification of a lot or batch number for the talc being tested, the date or date range when the test(s) were performed and the results of each test.
• Establishing and Maintaining Talc Supplier/COA Reliability: Manufacturers may only rely on COAs provided by talc suppliers if they verify the reliability of such COAs by conducting or procuring (from an independent lab) confirmatory asbestos testing using both PLM and TEM/EDS/SAED at least (a) upon receipt of the initial COA from a given supplier and (b) annually thereafter.

Record-keeping

Manufacturers subject to the rule (if enacted as proposed) must maintain records of asbestos testing for talc-containing products that describe: (a) the testing procedures used on the sample and (b) the testing results, including raw data. If a manufacturer relies on a talc supplier’s COA, the manufacturer must maintain records of (i) each COA and (ii) documentation showing how the manufacturer established and maintained the supplier’s reliability through verification of the test results reflected in the COA upon initial receipt and annually thereafter.

The required records must be maintained for three years. The proposed rule also specifies that if FDA requests the records for inspection—a power granted under the new proposal—the manufacturer must produce the records within one business day.

Enforcement

The FDA proposes actions authorized under commonly used provisions of the federal Food, Drug, and Cosmetic Act (FDCA) to enforce the rule. A talc-containing product will be deemed adulterated under the FDCA if:

• the manufacturer fails to test for asbestos or verify a supplier’s COA in accordance with the rule’s respective requirements for such approach;
• the manufacturer fails to maintain the required documents related to the testing of talc-containing products for the requisite timeframe; or
• the talc-containing products are found to contain any amount of asbestos.

Thus, if finalized, a cosmetic manufacturer who introduces talc-containing cosmetic products into interstate commerce without complying in full with the rule, or whose compliance with the rule was not sufficient to prevent asbestos contamination, will be subject to enforcement action, ranging from Warning Letters, to mandatory recalls (per FDA’s new authority granted by MoCRA), product seizures, import restrictions and others.

Litigation Risks

Talc-containing products—and asbestos contamination—have been prolific targets for class action lawsuits in recent years. Many stakeholders hoped that the Talc Rule would provide a safe harbor or, otherwise, limit cosmetic companies’ litigation risks by precluding private causes of action (under preemption principles) in cases where the company complied in-full with the applicable FDA regulations, as we have seen in other contexts. However, by stipulating that a product will be adulterated and, thus, unlawful under the rule not only if the applicable company failed to comply with the rule, but also if any product tests positive for any amount of asbestos, notwithstanding the company’s full compliance, the rule may increase litigation risks in certain instances.

For example, though it is well established that there is no private right of action to enforce the provisions of the FDCA, there is an equally well established history of plaintiffs bringing class action claims under state consumer-protection laws based largely upon FDCA violations. More specifically, plaintiffs have often alleged that (among other things) simply by placing the relevant cosmetic product on the market, the defendant impliedly (and, in some cases, explicitly) represented that the product is safe for the intended use(s) when the product was, in fact, adulterated under the FDCA because of the defendant’s failure to comply with the applicable FDA regulation(s), and, as a result, the defendant’s marketing or labeling of the applicable product(s) was deceptive and/or misleading in violation of state consumer protection/false advertising laws. This same construct could potentially be used by plaintiffs’ attorneys to weaponize the Talc Rule in situations where either the defendant failed to comply with the Talc Rule (regardless of whether the product was ultimately contaminated) or the product was contaminated and, thus, adulterated (regardless of whether the defendant complied with the testing requirements under the Talc Rule).

Recommendations for Cosmetic Brands

The proposed rule focuses on manufacturers of talc-containing cosmetics. But it is important to understand that cosmetic brands utilizing contract manufacturers are just as susceptible to FDA enforcement or class action litigation as parties engaged in manufacturing, directly. To protect against risks of FDA enforcement and/or consumer litigation if the rule is finalized, cosmetic companies must take steps to ensure that all applicable products will be produced in full compliance with the rule and maintain robust documentation to that effect. But, as already indicated, reducing enforcement and litigation risk to the maximum extent possible not only requires that you comply with the rule, but also warrants careful consideration as to how you comply with the rule.

In our view, it is critically important that cosmetic manufacturers and brands do not seek to comply with the rule via the “representative sample” approach to compliance (i.e., testing a sufficient sampling of finished products containing talc for asbestos contamination). This leaves room for the possibility that all required testing is performed in accordance with the rule, but one or more products, nonetheless, are found to contain even an infinitesimal amount of asbestos.

Instead, we recommend that those subject to the rule opt to comply by either performing or procuring asbestos testing (via the required methods) on every single batch or lot of the talc that will be used in the finished product prior to such use or requiring that such testing be performed by the supplier that provides such talc (in accordance with the rule), provided that the company complies with its obligation to verify such supplier’s reliability as required by the rule. To the extent a brand owner relies entirely on third-party manufacturing (without engaging in any type of activity within the scope of “manufacturing”) and is, thus, not directly subject to the testing requirements under the rule, it should ensure that its contract manufacturer(s) adheres to the above guidance and provides documentation to that effect. In addition to this principal recommendation, the following should be considered for further risk reduction and/or support: 

1. Contract Manufacturer Due Diligence: Priorto engaging any new contract manufacturer to produce a talc-containing cosmetic, cosmetic brands should conduct due diligence to ensure that any prospective manufacturers have adequate, documented procedures in place that demonstrate complete compliance with the rule via one of the approaches outlined above that involves asbestos testing (and confirmed negative results) for any and all talc that may be used in any finished good.
2. Written Agreements: Cosmetic companies with talc products should take steps to execute well drafted written agreements with any third parties that are involved in any aspect of manufacturing and/or supplying a talc-containing product or the talc to be used therein. Such agreements should clearly allocate the parties’ respective regulatory responsibilities in as much detail as possible regarding testing and documentation, and there should be indemnification obligations tied directly to all such obligations.   
3. Internal Policies: Develop or update internal recordkeeping procedures as needed, preferably written Standard Operating Procedures or other similar documented policies, specifically outlining how the company will comply with the rule and mandating record retention for at least three years from the date of manufacture. It may be worthwhile to have a written policy that similarly outlines contracting requirements in connection with the use of any supplier or contract manufacturer.
4. Above and Beyond: Companies should consider the extent to which it may be feasible to conduct or procure additional testing to ensure that its approach to compliance is effective and/or periodic checks, internal audits and other similar mechanisms to support their compliance efforts. All such efforts should be clearly documented and maintained, as they may be useful in defending against any future proceeding in relation to the Talc Rule.

It remains to be seen whether, or to what extent, the new administration will prioritize publication of a final Talc Rule in accordance with the timeline set forth in MoCRA or if any updates or additional initiatives may be implemented. For now, we recommend taking active steps to comply with the rule as proposed to ensure that you are adequately prepared if and when the rule is finalized.

References

[1] See, e.g., FDA’s TalcWebpage, https://www.fda.gov/cosmetics/cosmetic-ingredients/talc; see also 89 Fed. Reg. 105490 (Dec. 27, 2024).

About the Authors

Kayla Cristales is an associate in Haynes Boone’s FDA Regulatory and Compliance Group. Her practice focuses on transactional and regulatory matters for FDA-regulated clients, particularly in the beauty/wellness and life sciences spaces. For example, Kayla regularly counsels cosmetic and OTC drug and device brand owners, retailers, and distributors in connection with packaging and label compliance and claim-related risk assessments; substantiation reviews; product classification analyses; manufacturing, development, commercialization, and/or supply agreement negotiation; and advertising, marketing, and other promotional communications, among many other areas involving the wide range of often complex and overlapping federal and state laws and regulations governing cosmetics, drugs (including biologics), and medical devices, respectively.

Luke Nguyen is an associate in the FDA Regulatory Practice Group in Haynes Boone’s Dallas office. His practice focuses on assessing and solving FDA regulatory compliance issues for companies developing, manufacturing, or marketing FDA regulated products.