U.S. Talc: No Testing Rule, More Lawsuits

What is the signal?

Reports in early October said L'Oreal has engaged restructuring advisers to deal with rising U.S. legal liabilities. According to those reports, its U.S. unit is working with restructuring counsel Weil, Gotshal & Manges and investment bank Ducera Partners on lawsuits brought by individuals alleging that talc products caused illness. The structure under review would move tort liabilities into a separate corporate entity and unload them through a sale to an outside investor, separating the exposure from the operating businesses; as an option outside Chapter 11, advisers are said to be exploring a sale similar to Honeywell's divestiture last year of certain asbestos liabilities to the corporate liability acquisition platform Delticus.

The case count shows the direction. In its latest half-year report L'Oreal said about 760 U.S. proceedings over the alleged presence of asbestos particles in some talc-containing cosmetic products were pending as of 30 June, up from about 620 at the end of 2025.

The regulatory side is empty in the other direction. Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), FDA must establish regulations for standardized methods of detecting and identifying asbestos in talc-containing cosmetic products. It published a proposed rule in the Federal Register on 27 December 2024 requiring manufacturers to test a representative sample of each batch or lot of a talc-containing cosmetic product by two methods: Polarized Light Microscopy (PLM), and Transmission Electron Microscopy with Energy Dispersive Spectroscopy and Selected Area Electron Diffraction (TEM/EDS/SAED). On 28 November 2025 FDA withdrew that proposal, citing comments received during the comment period that warrant further consideration and assessment before final regulations are issued.

Withdrawal is not the same as losing interest. The MoCRA requirement to set standardized testing methods remains in law, and separately FDA has collected marketed talc-containing cosmetic products and tested them for asbestos, releasing data from its 2023 testing.

The limits of what this shows. The L'Oreal structure is a reported option under review, not a completed transaction. The 760 figure is one company's pending U.S. count as of 30 June, so later movement is not reflected, and pending claims are allegations rather than findings that talc is unsafe or that asbestos was present. The methods in the withdrawn proposal are not a current legal obligation, and talc requirements in Korea, the EU and other markets have to be checked separately. Even so, the development questions are clear: do you use talc, and if you do, with what testing and what records will you account for it?

1. An empty regulation does not mean less work

When a rule is withdrawn the usual reading is that the burden has eased. Talc is hard to read that way. When a standardized test method is written into a regulation, "we tested by that method and kept the record" becomes a baseline defence. Without the regulation that baseline is gone, and you have to account for what you tested, how, and why the method was adequate.

That is why the withdrawn proposal still has value as a reference even though it is not binding. The combination the regulator considered adequate was two microscopy methods used together, and the test unit was a representative sample of each batch or lot. Hold the certificates you currently receive from suppliers against that benchmark and the gaps become visible.

Timing is worth weighing too. The statutory obligation has not disappeared, so a new proposal can appear. Bringing your certificates up to that combination now reduces the work of re-persuading suppliers and re-running tests if a rule returns. Take "not yet required" as the standard instead, and once a rule exists there is no way to create records retroactively for lots already produced.

• Whether you have checked which test method is named on the talc certificate
• Whether the test unit is the lot, or a single representative sample per year
• Whether the detection limit is stated on the certificate
• Whether a number links the certificate's sample lot to your finished-goods lot

2. Removing talc redesigns the feel first

In powder-led formats such as pressed powders and eyeshadows, talc has long been used for spread and pay-off, lubrication between particles, pressability, and bulk. Decide to remove it and that role has to be redistributed across a combination such as mica, sericite, silica and starch-based powders.

What changes does not stop at one line of the formula. A different powder base means re-checking colour pay-off, adhesion on skin, the pressed cake's strength, drop and transit testing, and the fit with the compact. So "talc-free" is a redesign of the formula before it is a line on the label, and changing the formula of a product already on sale shifts what the customer feels, which reaches repurchase.

Pulling the decision earlier costs less. The powder base is tied to the mould, the pack and the filling and pressing conditions, so removing talc after the formula is close to final means reversing a pack and a pressing condition you already approved. Put "talc, in or out" on the same line of the brief as the format decision and the decisions that follow fall into place at once.

• Whether talc in or out was decided before the format and pack
• Whether there is a list of tests to repeat for a replacement base (pay-off, cake strength, drop)
• How a change of feel will be verified if you are reformulating an existing product
• Whether talc requirements in export markets outside the U.S. were checked separately

3. The unit of control is the supplier and the lot, not the ingredient name

Talc is not a synthetic material; it is a mineral that is mined and refined. The claim in the litigation is not "talc was used" but that asbestos particles were allegedly present in some talc-containing products, and the same reason is why FDA has collected marketed products and tested them for asbestos. So the unit of control becomes the supplier, the origin and the lot rather than the name printed in the ingredient list.

One line appears on the label, but the conditions behind that line can differ lot by lot. What matters on a certificate is not only the word "not detected" but which method was used, how low the detection limit goes, and which lot the sample came from. A certificate missing those three cannot be used years later when that lot has to be explained.

There is one more place where a change passes quietly: switching suppliers, or the same supplier changing origin or refining route. The formula sheet and the ingredient name stay the same, so it may never reach a change-control procedure. For a talc-containing product it is safer to treat a change of supplier or origin with the same weight as a formula change, and to agree in advance that a new certificate is issued when it happens.

4. "Talc-free" and "no asbestos detected" are proved by different routes

The two phrases sound alike but rest on different paperwork. "Talc-free" is a fact about the formula, so it is supported by the formula sheet, the raw material list, and the production conditions that prevent cross-contamination. "No asbestos detected" is a test result, so it only means something alongside the sample, the method, the detection limit and the lot.

The phrase "not detected" is worth unpacking as well. It means below the detection limit of the method used, not proof of absence under any condition. So when it goes on a label or into marketing copy, the record has to show by which method and to what level it was checked. Use a certificate with no stated detection limit to support an absolute claim and there is nothing to explain it with later.

Removing talc does not close the question either. If the replacement base uses other mineral powders, where those were mined and refined and what testing they went through remains an item to check in the same way. Going talc-free is not by itself an answer for mineral materials as a whole.

• Whether the claim you intend to print is proved by the formula or by a test
• Whether the certificate states the sample lot, the method and the detection limit
• Whether talc-free claims are backed by written cross-contamination controls
• Whether the supply route of replacement mineral powders is held to the same standard

5. Look at where the liability stays

The core of the structure L'Oreal is reported to be reviewing is separating liability from the operating businesses. That a company of that size has engaged specialist advisers to look at such a route can be read as a signal that this kind of liability is long and heavy. A small brand has no such route.

Customers and retailers look at the brand name on the product. Even with manufacturing outsourced, the question comes back in the name of whoever sold it. So what makes the real difference in contract manufacturing is whether the brand receives and keeps copies of raw material certificates and test records, or whether they sit only with the manufacturer. Years later, the party asked for those records is likely to be the brand.

Retention has to be decided with it. L'Oreal's pending U.S. count rising from about 620 at the end of 2025 to about 760 as of 30 June shows how this kind of claim arrives over a long period after launch. Lot-level records have to be findable after production has ended and the account has been closed, which means writing down the retention period and who holds the records before production starts.

The first question for the brief

Instead of writing "a powder product", narrow it to one sentence. Put "do we use talc, and if so which test method is named on the certificate we receive for each lot" on the same line as the format decision, and the pack, the pressing conditions and the label copy follow from it.

The second thing to write is a single page on the supply route: supplier, origin, lot number, the method and detection limit of the certificate you will receive, and the condition that triggers a new certificate when the supplier or origin changes. Without that page only the one line in the ingredient list survives, and nobody can trace the conditions behind it.

The last is where the records live. Before production starts, settle how many years certificates and test records are kept, whether the brand or the manufacturer holds them, and whether a number links the raw material lot to the finished-goods lot. In an interval where the regulation is empty, the record is all that is left.