California Barred from Enforcing Prop 65 DEA Warning After First Amendment Challenge

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On June 24, 2026, the U.S. District Court for the Eastern District of California entered a final judgment and permanent injunction barring the Attorney General from enforcing Proposition 65’s cancer-warning requirement for diethanolamine (DEA) in cosmetics.  The judgment adopts a stipulation that the Personal Care Products Council (PCPC) and Attorney General Rob Bonta filed the day before, resolving PCPC’s First Amendment challenge to the DEA warning.

First Amendment Arguments

As discussed in a previous post, DEA was automatically added to the Prop 65 list after the International Agency for Research on Cancer (IARC) concluded that the substance is “possibly carcinogenic to humans.”  However, in its complaint, PCPC argued that IARC did not identify any studies establishing a link between DEA and cancer in humans, relying instead on a study of “questionable relevance” in a highly susceptible strain of mice.  As a result, PCPC contended, applying the DEA Prop 65 cancer warning “in cosmetic and personal products is false, misleading, and factually controversial,” in violation of the First Amendment.

What the Parties Agreed

The Attorney General did not concede the constitutional question.  He continues to dispute that the DEA warning violates the First Amendment, but agreed to resolve the case in light of, as the stipulation puts it, “the current state of the relevant science” and three recent decisions rejecting compelled Prop 65 cancer warnings: a Ninth Circuit ruling on glyphosate, and two district court rulings on acrylamide and titanium dioxide. Under the stipulation, the Attorney General reserves the right to move to dissolve the injunction under Federal Rule of Civil Procedure 60(b) if the facts or law change.

What the Order Provides

The order declares that, based on the current state of the science, the DEA cancer warning cannot be constitutionally enforced.  It permanently enjoins the Attorney General, his officers, employees, and agents, and “all those acting in privity or concert with” them from filing or prosecuting new lawsuits to enforce the DEA warning requirement for cosmetic and personal care products.  For companies that make or sell DEA-containing cosmetics—shampoos, liquid soaps, and body washes—the order removes the Attorney General as a source of new DEA warning suits.

Because the judgment was entered on the parties’ stipulation rather than after a merits ruling, no court weighed the DEA science or held the warning unconstitutional in adversarial litigation.  Its declaratory language is tied to the current state of the science, and the Rule 60(b) reservation leaves room to revisit the injunction if that science or the law changes.

The case is The Personal Care Products Council v. Bonta, No. 2:26-cv-00682 (E.D. Cal.), complaint filed March 2, 2026.

Latest Prop 65 Challenge Targets DEA After Series of Industry Wins

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A cosmetics industry trade group is asking the Eastern District of California to enjoin a Proposition 65 warning for diethanolamine (DEA), arguing that the label disclosure violates the First Amendment.

The suit was filed March 2, 2026, by the Personal Care Products Council (PCPC).  It follows a string of court victories challenging other Prop 65 warning requirements for chemicals including glyphosate, acrylamide, and titanium dioxide, the last of which was also brought by PCPC.

DEA was automatically added to the Prop 65 list after the International Agency for Research on Cancer (IARC) concluded that the substance is “possibly carcinogenic to humans.”  However, PCPC argues that IARC was unable to find a single study establishing a link between DEA and cancer in humans, instead basing the determination on a study of “questionable relevance” in a highly susceptible strain of mice.  Other regulatory bodies, like FDA and EPA, have not reached the same conclusion, and some have “expressed skepticism” about the mouse study, PCPC argues.

“Indeed, no California agency has made any scientific determination as to whether DEA causes cancer in humans.  Nor has any federal agency done so,” the complaint states.

According to PCPC, laws regulating commercial speech are typically subject to intermediate scrutiny, with a more lenient standard for purely factual and noncontroversial disclosures.  However, because the “cancer warning requirement as applied to DEA in cosmetic and personal products is false, misleading, and factually controversial, it cannot survive any level of constitutional scrutiny” and therefore violates the First Amendment, the complaint alleges.

PCPC argues that the warning requirement effectively forces companies to choose between “conveying the unsubstantiated message that DEA in cosmetic products increases cancer risk in humans” or facing “a significant and imminent risk of an enforcement action.”  Although an exception exists for products that do not present significant risk, the complaint notes that companies must be able to prove that defense in court if challenged, a costly and uncertain process that leads many to “acquiesce and provide a warning” even if they believe it is inaccurate.

PCPC also claims that, since the warning requirement took effect in 2013, hundreds of companies manufacturing or selling personal care products have paid over $7 million in settlements with private enforcers.

The trade association seeks a declaration that the warning is unconstitutional as applied to personal care products and a permanent injunction barring enforcement by California or private parties.

The case is The Personal Care Products Council v. Bonta, No. 26-cv-682 (E.D. Cal.), filed 3/2/26.

FDA Withdraws Asbestos Testing Proposal for Talc Cosmetics

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On November 28, 2025, in response to adverse comments, FDA published a notice announcing its withdrawal a December 2024 proposed rule that would have required manufacturers of talc-containing cosmetic products to test for asbestos.

The rulemaking is required by section 3505 of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which directs FDA to “promulgate proposed regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products.”  FDA’s notice makes clear that the agency plans to issue a new proposed rule in the future.

FDA cites “Make America Healthy Again (MAHA) priorities to ensure safe additives in the American food and drug supply, the highly scientific and technical issues addressed in public comments the Agency has received, and the complexity of asbestos testing and legal considerations under the Administrative Procedure Act” as good cause for the withdrawal.

The concern underlying the rulemaking stems from the geological relationship between asbestos and talc.  According to FDA, asbestos is found in the same rock types that host talc deposits, which sometimes results in the presence of asbestos in talc cosmetics.

Although the testing requirements will not take effect, the Federal Food, Drug, and Cosmetic Act (FFDCA) continues to prohibit the sale of adulterated cosmetics, including those that contain “any poisonous or deleterious substance which may render [the product] injurious to users.”  FDA has previously taken action in this area: testing in 2019 led to recalls of talc cosmetics potentially containing asbestos, while testing in 2023 did not detect asbestos in any of fifty sampled products.

December 2024 Proposal

The December 2024 proposed rule would have required manufacturers to test talc-containing cosmetic products—or the talc ingredient before use—and maintain records demonstrating compliance. Manufacturers would have needed to test a representative sample of each batch or lot using both:

  1. Polarized Light Microscopy (PLM) (with dispersion staining).
  2. Transmission Electron Microscopy (TEM)/Energy Dispersive Spectroscopy (EDS)/Selected Area Electron Diffraction (SAED).

Noncompliance would have rendered a cosmetic adulterated.  A talc cosmetic product would also have been deemed adulterated if any asbestos was present—even if only a single fiber was detected.

Issues Raised by Commenters

In the withdrawal notice, FDA notes several provisions of the proposed rule that were contested by commenters, including:

  • The proposed definition of “asbestos,” which differed from definitions used by OSHA, the Mine Safety and Health Administration (MSHA), and EPA.
  • Whether FDA has statutory authority to add a specific adulteration provision relating to talc testing or to deem any detectable asbestos as adulterating a cosmetic.
  • FDA’s inclusion of cosmetic products that are also drugs within the scope of the rule.

In addition, commenters raised concerns about the proposed test methods, although FDA did not address these in the withdrawal notice.  For example, the United States Pharmacopeia (USP) questioned whether TEM was superior to other test methods, arguing that it might yield more false positives.  USP also asserted that a single-fiber threshold for positive samples diverges from generally accepted TEM fiber counting procedures and would pose challenges for reproducibility.

More information on talc and asbestos can be found on FDA’s website.

FDA Issues Draft Guidance for MoCRA Facility Registration and Product Listing

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The U.S. Food and Drug Administration (FDA) has released draft guidance, Draft Guidance for Industry: Registration and Listing of Product Facilities and Products, on the new regulatory requirements established in the Modernization of Cosmetics Regulation Act (MoCRA).  Among other provisions, MoCRA added section 607 to the Federal Food, Drug, and Cosmetics Act (FFDCA), requiring cosmetic product facility registration and cosmetic product listing.  The draft document details key registration and product listing requirements, including who must submit, what information is required, when registration and listings must be submitted, and how the FDA intends to accept registration and listing information.

All persons who own or operate a facility engaged in the manufacture or processing of a cosmetic product for distribution in the U.S. must register their facility.  Under MoCRA, a cosmetic product “means a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.”  FFDCA section 607(a)(1) provides two exceptions regarding who must register.  The first exception is for small businesses that have average gross annual sales of less than $1 million in the previous three years, unless they manufacture or process cosmetics that regularly come in contact with the mucus membrane of the eye, are injected, are intended for internal use, or are intended to alter appearance for more than 24 hours (and are not meant to be removed by the customer).  The second exemption is for facilities subject to the drugs and devices requirements under chapter V of the FFDCA, unless they also manufacture cosmetics that are not subject to the drug and device requirements.  The same exemptions apply for submission of product listing information.

Facility registration requirements are outlined in sections 607(a) and (b) of the FFDCA.  The requirements for facility registration include all brand names under which the cosmetic products manufactured or processed in the facility are sold and the product categories for each cosmetic product manufactured or processed in the facility.  Registrations must be submitted by December 29, 2023, for facilities that were manufacturing or processing cosmetic products on December 29, 2022.  Facilities that began manufacturing or processing after December 29, 2022, must register within 60 days of first engaging in that activity or by February 27, 2024, whichever date is later.  Registrations must be updated within 60 days of any changes to the registration information and must be renewed biennially.

Product listing requirements are outlined in FFDCA section 607(c) and include the facility registration number for each facility where the cosmetic product is manufactured or processed, its applicable cosmetic category or categories, and a list of product ingredients (including fragrances, flavors, or colors).  Listings must be submitted by December 29, 2023, for products that were marketed on December 29, 2022.  Products that were first marketed after December 29, 2022, must be listed within 120 days of marketing the product, or within 120 days of December 29, 2023, whichever date is later.  Any updates to the listing must be made annually.

Importantly, FDA clarified that any prior registrations through the Agency’s voluntary cosmetics registration programs will not be transferred to the new system; submitters will have to re-submit this information.

According to FDA, an electronic submission portal should be open for submissions beginning in October 2023, although a paper submission form is also available.

EU, U.S. TTIP negotiators discuss reducing chemical costs, regulating cosmetics.

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Last week, U.S. and European Union (EU) negotiators held a second round of Transatlantic Trade and Investment Partnership (TTIP) discussions. During the week-long talks, negotiators examined how to reduce regulatory and industry costs for chemicals.

According to U.S. TTIP chief negotiator Dan Mullaney, a range of tools are available to reduce costs for chemicals and other sectors.  Ignacio Garcia Bercero, the EU’s chief negotiator, said specific ideas for cost reduction include harmonization of labeling requirements and better cooperation between the EPA and ECHA in performing risk assessment and exchanging data to avoid unnecessary testing. Bercero said the European and U.S. negotiating teams also discussed regulatory compatibility for cosmetics. Negotiators considered the feasibility of achieving “greater convergence” between the positive and negative lists of cosmetic ingredients in the EU and the U.S., which may be difficult since the U.S. allows certain cosmetic ingredients that are prohibited in the EU, said Bercero.

Meanwhile, NGOs have continued to express concerns over the lack of transparency in TTIP negotiations. Spokespeople from the European Consumer Organization (BEUC) and Friends of the Earth Europe said that open negotiations are necessary to ensure that the trade deal does not undermine or eliminate existing consumer legislation in the EU, as well as U.S. states like California with stricter chemical legislation. Both groups want access to the negotiating texts and regular consultations before and after each negotiating round. In response to NGO concerns, both Mullaney and Bercero said that talks on regulatory convergence in the chemical sector will not affect the level of protection or legislation under REACH or TSCA. The EPA has also stated that it does not believe TTIP negotiations will influence the agency’s “risk-based approach to chemicals management.”

The next round of TTIP negotiations will take place in Washington, D.C., between December 16 and 20.

New EU Cosmetics Regulation To Take Effect in July 2013.

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On July 11, 2013, the new European Union (EU) cosmetics Regulation (EC 1223/2009) will fully replace the existing cosmetics Directive (76/768/EEC) that has applied since July 27, 1976.  Unlike the previous EU cosmetics Directive, the self-executing Regulation unifies the cosmetics requirements of the European Economic Area (EEA) into a single law and eliminates ambiguities that may occur among EU member states during the enforcement process. The new Regulation, which applies to all EU cosmetics companies, is intended to ensure that consumers’ health is protected and that they are well informed by monitoring the composition and labeling of cosmetic products.

The Regulation is focused on simplifying procedures, streamlining terminology, and strengthening certain elements of the regulatory framework for cosmetics. The main changes it introduces include:

  • creating a new, electronic, centralized system that will replace the current national competent authority notification process
  • clarifying the format and content of the product information file (PIF) to be used in conducting a product safety assessment; particularly, the PIF must include data to support any claims made about a product
  • narrowing the “exceptional cases” when substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMRs) can be used
  • requiring the presence of nanomaterials in cosmetic ingredients be clearly indicated by the word “nano” in brackets
  • requiring cosmetics companies to designate a legal or natural person within the EU—known as a “responsible person”—whose role will be to ensure certain safety requirements for each cosmetics product introduced on the market

The Regulation also continues the previously established ban on animal testing, which came into full force through the Cosmetics Directive on March 11, 2013. Although the inclusion of the ban has been applauded by many consumers and animal welfare groups, it has also raised some concerns in the cosmetics industry about the potential negative impact on innovation due to the inability to fully test new ingredients as well as potential conflicts arising from the testing requirements imposed by other regulations. The European Commission has posted an impact assessment [PDF] online that discusses the various effects of the ban.

Notable milestone reached by the Regulation en route to becoming applicable, exclusively, to cosmetics placed on the EU market include: prohibiting use of CMR 1A/1B/2 substances in cosmetics, although certain CMR 2 substances may be exempted by the EU Scientific Committee of Consumer Safety (SCCS) after assessment; submission of all cosmetics through the new centralized notification system; commencing the  notification process  for nanomaterials already on the market.  All cosmetics are expected to be fully compliant with the new Regulation by July 11, 2013.