Chobani “Zero Sugar” Lawsuit Dismissed Due to Federal Preemption
On Thursday, May 29, 2025, Judge John J. Tharp, Jr. at the U.S. District Court for the Northern District of Illinois filed an order granting Chobani’s motion to dismiss a class action lawsuit that alleged “Chobani Zero Sugar” yogurt was misbranded. Chobani’s yogurt contained allulose, a naturally occurring monosaccharide found in figs and raisins, which the plaintiffs argued made any “zero sugar” or “no sugar” claims misleading and deceptive.
In its defense, Chobani cited to the Temporary Marketing Permit (TMP) granted by FDA authorizing to the sale of its “Zero Sugar” yogurt that contained “nonnutritive sweeteners.” The Company also referenced FDA Guidance in which FDA stated the agency is exercising enforcement discretion by excluding allulose from the amount of “Total Sugars” on product labels.
FDA based its decision on data that showed allulose does not promote cavities, produces a negligible increase in glycemic and insulinemic responses, and substantially reduces the number of total calories in products in which it replaces added sugars.
The Court agreed with Chobani that though the guidance is nonbinding, it still represents FDA’s interpretation of how allulose is regulated under 21 C.F.R. § 101.9(c)(6)(ii). This view of the regulation is controlling if it is not “plainly erroneous” or inconsistent with the regulation itself. Because of this, the Court concluded the plaintiff’s claims are expressly preempted by federal law since allulose is not a sugar under the allulose guidance.
Keller and Heckman will continue to monitor litigation trends related to product labeling and marketing claims.
The Swiss Federal Supreme Court Bans References to Animals in Plant-based Foods
On May 2, 2025, the Swiss Federal Supreme Court ruled that designations referring to animal species are not allowed to label plant-based meat substitutes (here is the official press release, in French, 2C_26/2023). The full judgment is not yet available, so we cannot provide a more in-depth analysis of the arguments of Switzerland’s supreme judges, and the information below is based solely on the press release.
In 2021, the Zurich Cantonal Laboratory banned a company from labelling its pea protein meat substitutes with names referring to animal species; the company appealed this ban, and the Administrative Court of the Canton of Zurich decided in its favor in 2022, allowing the use of references to animal meat in its products. However, in its judgment of May 2, 2025, the Federal Supreme Court upheld the appeal filed by the Federal Department of Home Affairs, annulling the first instance decision of the Zurich Administrative Court and thus ruling against the company.
According to the press release, food products destined for consumers made exclusively with vegetable proteins (i.e., those usually defined as ‘plant-based meat’) cannot be designated by names of animal species, even if these are accompanied by an indication specifying the vegetable origin of the product, such as ‘planted chicken,’ ‘chicken-like,’ ‘pork-like,’ ‘vegan pork,’ or ‘vegan chicken.’ In fact, the term ‘chicken’ refers to poultry; therefore, it cannot be used for products that do not contain a meat component, as it would be misleading for consumers. In other words, plant-based products alternative to meat must be labelled in such a way as to enable the consumer to recognize the type of foodstuff and to differentiate it from products that they aim to substitute.
TSCA Section 21 Petition Seeks Reconsideration of 2024 Rule Regarding Procedures for Chemical Risk Evaluation
On May 15, 2025, the Center for Environmental Accountability (CEA) filed a petition under Section 21 of the Toxic Substances Control Act (TSCA) requesting that the U.S. Environmental Protection Agency (EPA) reconsider the 2024 final rule regarding procedures for chemical risk evaluation under TSCA and initiate a rulemaking to amend certain provisions in 40 C.F.R. Part 702, subpart B. According to CEA, the current process “has led to overly conservative risk conclusions and, in turn, unnecessary risk management rules that force industry to abandon well-studied chemistries that provide beneficial uses in our daily lives.” The petition states that EPA’s risk evaluation procedural regulations should:
Provide additional definitions for key terms, offering increased transparency and clarity regarding methods and goals of the risk evaluation process;
Bolster intra- and interagency collaboration throughout the risk evaluation process, including requirements that EPA document the outcome of those efforts;
Confirm EPA’s authority to determine which conditions of use (COU) fall within the scope of a risk evaluation;
Explain the criteria EPA may use in determining the COUs it expects to consider;
Provide for a de minimis level below which EPA may exclude COUs from the scope of the risk evaluation;
Explicitly require consideration of existing regulations administered by EPA and other agencies when determining exposure estimates for each COU for a chemical substance;
Require that any assumptions, uncertainty factors, models, and/or screening approaches used in the risk evaluation reasonably reflect the COUs of the chemical substance in practice;
Require EPA to make an unreasonable risk determination for each COU of a chemical substance assessed in a risk evaluation;
Clarify when determinations regarding unreasonable risk or no unreasonable risk are considered final agency actions;
Explicitly require peer review for all risk evaluations;
Create a clear regulatory pathway for the development and submission of draft risk evaluations by requesting manufacturers and other interested persons; and
Extend applicable comment periods and include opportunities for further extensions.
Under TSCA Section 21, EPA has 90 days from the date of receipt to grant or deny the petition. More information on EPA’s 2024 procedural framework rule for conducting TSCA risk evaluations is available in our May 14, 2024, memorandum.
Minnesota Extends Public Comment Period on Proposed PFAS Reporting Rule as Entities Voice Concerns about Compliance with Deadlines and Due Diligence Standards
On May 22, 2025, the Minnesota Pollution Control Agency (MPCA) held a public hearing on its “Proposed Permanent Rules Relating to PFAS in Products; Reporting and Fees” (proposed rule). Administrative Law Judge (ALJ) Jim Mortenson facilitated the hearing, which had more than 100 participants in attendance. MPCA has made available online the PowerPoint document used for the hearing presentation, the hearing exhibits, and a transcript of the hearing.
Procedural Background
The pre-hearing public comment period for the proposed rule closed on May 21, 2025. Under Minnesota administrative procedure, comments must be accepted for five days following a hearing on a proposed rule, and the overseeing ALJ may extend the comment period by no more than 20 days. Following the close of comments and a brief rebuttal period, the presiding ALJ will issue a report on the proposed rule within 30 days, unless an extension is granted.
The post-hearing comment period for the proposed rule has been extended until 4:30 p.m. (CDT) on June 23, 2025. A rebuttal period of five business days, lasting from the close of the public comment period until 4:30 p.m. (CDT) on June 30, 2025, will follow. Persons may respond to public comments during this rebuttal period, but they may not submit new comments. Any person who wishes to comment on the rule or provide rebuttal may do so via e-comments, mail, or fax. MPCA will not accept comments submitted via e-mail. Comments must be received by MPCA by the end of the respective periods, so persons planning to submit comments or rebuttals via mail should ensure comments are sent with enough time to reach MPCA by the cutoff.
To allow a proposed rule to move forward, the presiding ALJ must answer in the affirmative the following three questions: (1) Does the agency have legal authority to adopt the rule? (2) Has the agency fulfilled all relevant legal and procedural requirements to promulgate the rules? and (3) Has the agency demonstrated the need and reasonableness of each portion of the proposed rule? ALJ Mortenson will consider the comments provided both during the hearing and in writing as he evaluates the proposed rule following the close of the record. More information on the proposed rule is available in our April 22, 2025, memorandum.
Comments on the Proposed Rule
While the comments provided at the hearing covered a wide range of topics and industry concerns, two topics were the focus of many of the comments. First, commenting parties raised concerns about the statutory deadline for initial reporting of January 1, 2026. Second, commenters questioned whether the proposed due diligence standard, which requires reporting parties to search for information until all required information is known, is attainable. Supply chain and product complexity were cited as factors impacting the regulated community’s ability to meet the reporting deadline and to comply with the due diligence standard. Representatives of the following parties commented during the hearing (with links to written comments, if available):
The RV Industry Association spoke about the implications of reporting for complex products with potentially thousands of components and international supply chains and stated that the proposed due diligence standard is impractical.
The Complex Products Manufacturers Coalition (CPMCoalition) discussed the reporting deadline, stating that reporting by January 1, 2026, is infeasible for manufacturers of complex products because the manufacturers are the downstream users of many component parts. The CPMCoalition also commented on the due diligence standard, stating that “until all required information is known” is unachievable and asking MPCA to adopt the U.S. Environmental Protection Agency’s (EPA) “not known or reasonably ascertainable” (NKRA) standard instead.
The Alliance for Automotive Innovation (Auto Innovators) cited the challenges that component-level reporting places on products with potentially thousands of parts, such as vehicles. Auto Innovators also mentioned the proposed due diligence standard and the reporting timeline and noted that compliance with these would be burdensome to the regulated community.
Sustainable PFAS Action Network (SPAN) asked that the first reporting deadline be extended to allow affected entities to fulfill the regulatory obligations. SPAN also noted that additional exemptions should be offered for fluoropolymers and that greater confidential business information (CBI) protections should be available.
The Air-Conditioning, Heating, and Refrigeration Institute (AHRI) reviewed the reporting deadline and noted that six months would not be enough time to fulfill the proposed regulatory obligations. AHRI asked that MPCA release a list of compounds meeting the definition of PFAS under the law and sought clarification on definitions and the scope of the regulations. Finally, AHRI asked that MPCA adopt EPA’s NKRA due diligence standard.
SEMI and the Semiconductor Industry Association (SIA) brought up the importance of PFAS in the semiconductor industry and noted that there are no viable alternatives for certain PFAS used in critical components of semiconductors.
The Association of Equipment Manufacturers (AEM) commented that the Toxic Substances Control Act’s (TSCA) Section 8(a)(7) NKRA due diligence standard should be adopted and noted that compliance is not feasible for industrial entities under the proposed due diligence standard and reporting deadline. AEM also noted that testing infrastructure and laboratory capacity to meet the reporting standard, as proposed, may not exist.
Perlick Corporation commented on the compliance implications with a fast-approaching deadline and primarily discussed issues related to accountability. Perlick noted that manufacturers may sell to distributors, which may then sell to contractors in various locations, and therefore a manufacturer may have no hand in a product entering Minnesota’s market. The corporation stated that requiring manufacturers to track where products end up is a problematic standard.
Daikin Applied Americas Inc. (DAA) mentioned the complexity of certain heating, ventilation, and air conditioning (HVAC) products and the burden that requiring information about each specific component would place on the manufacturer under the existing reporting deadline. DAA noted that it has about a 40 percent response rate from its top suppliers on information about PFAS in components, which does not include local businesses and smaller suppliers.
The American Coatings Association (ACA) noted that the existing reporting deadline is not viable. ACA also cited the testing requirements in the proposed rule and stated both that fluorine measurements are not a good approximation for PFAS and that estimates should be allowed, as they are more reliable than testing for certain products.
Environmental Law and Science PLLC noted that the proposed reporting deadline is not realistic, given how complex many supply chains are.
Sixty-six written comments were filed during the pre-hearing comment period. The majority of these comments echo points raised during the public hearing. In responding to comments, MPCA will need either to justify how the statutory reporting deadline and proposed due diligence standard can be met or issue reporting extensions and modify the due diligence standard in response to comments. MPCA will also likely address questions about scope, testing infrastructure and methodology, language clarifications, applicability of exemptions, and more.
Commentary
Manufacturers and other entities impacted by the proposed rule and upcoming reporting requirements that have not participated in these public comment opportunities should review the submitted comments and determine whether their respective interests and concerns have been adequately addressed. Entities should consider submitting comments about areas of concern or uncertainty, even if other comments have raised similar or identical issues. Reviewing existing comments may help entities better understand the potential legal and business impacts of the proposed rule. Comments are due by June 23, 2025, at 4:30 p.m. (CDT).
Catherina D. Narigon contributed to this article
Massachusetts Appeals Court Affirms Treble Damages for Knowing Chapter 93A Violation
In Wicked-Lite Supply, Inc. v. Woodforest Lighting, Inc., the Massachusetts Appeals Court examined whether a seller’s conduct in a commercial lighting transaction violated Chapter 93A, Sections 2 and 11, and if the conduct was knowing or willful enough to warrant multiple damages. The plaintiff, having experienced repeated failures with purchased lights, received only blame-shifting and inadequate remedies from the seller. Despite knowledge of defects, the seller insisted there was no problem and provided knowingly incompatible replacement lights. Discovery revealed the seller was aware of the faulty lights. Despite additional discussions about resolving the matter, the seller did not fix the problem and made the buyer feel like “a hamster on a wheel.” The trial judge found a Chapter 93A violation and awarded treble damages due to the defendant’s willing and knowing misconduct.
Appeals Court Analysis
On appeal, the defendant argued the conduct amounted to a simple breach of contract (which the jury had found), not a Chapter 93A violation, especially since the jury found no breach of the implied warranty of merchantability. Thus, the defendant contended, the jury necessarily rejected the premise that the defendant knowingly sold a product that it knew or should have known was defective. The Appeals Court disagreed, explaining that whether conduct violates Chapter 93A is based on “the totality of the circumstances.” The court reaffirmed that conduct need not attain “the antiheroic proportions of immoral, unethical, oppressive, or unscrupulous conduct, but need only be within any recognized or established common law or statutory concept of unfairness” to violate Chapter 93A. The trial judge had found the Chapter 93A violation was distinct from any breach of contract or related warranty issues, based on the defendant’s knowledge of defects and persistent, unfounded assurances that nothing was wrong, which were in essence, misrepresentations.
Willfulness, Knowledge, and Multiple Damages
The Appeals Court upheld the award of treble damages, noting that multiple damages under Chapter 93A were warranted based on the egregiousness of the conduct. The Appeals Court was bound by the trial judge’s findings of fact, which were supported by the evidence and all reasonable inferences drawn from that evidence. Here, the evidence was sufficient to prove willfulness and knowledge to support multiple damages.
The Appeals Court contrasted this case with VMark Software, Inc. v. EMC Corp., where the defendant “acted in good faith in its dealings with the plaintiff” and fully expected the product would function as represented. The defendant in that case also was “persistently ready and willing, though ultimately unable, to correct” the issue. Thus, in VMark Software, multiple damages were not appropriate.
Key Takeaways
This decision underscores that Chapter 93A findings are highly fact-specific. Courts will assess both the unfairness of the conduct and the willfulness of the violation under the totality of the circumstances when determining liability and damages. Also, in the context of dealings with customers, the decision underscores the importance of attempting to resolve problems in good faith and not giving customers the “runaround.”
EPA Delays PFAS Reporting Deadlines, Again: Implications for Manufacturers and Importers
On May 12, 2025, the U.S. Environmental Protection Agency (EPA) announced an amendment delaying the data submission period for the Toxic Substances Control Act (TSCA) PFAS reporting rule, which will now begin on April 13, 2026, and end on October 13, 2026. Small manufacturers who report solely as article importers will have until April 13, 2027, to complete their submissions. The EPA stated that this delay is necessary to allow additional time for the development of the reporting software. While no other changes are currently planned, the agency is considering reopening certain aspects of the rule for public comment to accommodate potential modifications before the new deadlines.
The interim final rule, published in the Federal Register on May 13, 2025, became effective immediately but remains open for public comment for 30 days. This is the second delay in the reporting timeline. The original requirement was established in September 2023, mandating manufacturers and importers of PFAS from 2011 to 2022 to submit reports. Initially, the reporting period was scheduled to begin on July 11, 2025, but was postponed to accommodate ongoing preparations.
The initial rule aimed to impose reporting and recordkeeping requirements on entities involved in the manufacture or import of PFAS, including those in “articles,” as that term is defined by TSCA, for the years between 2011 and 2022. The EPA explained that delays are primarily due to the need for more time to develop necessary data collection tools and that the agency is considering future rule modifications influenced by efforts to deregulate, such as Executive Order 14219. The agency is also responding to petitions from chemical companies seeking to narrow the scope of the current rule and obtain exemptions consistent with standard TSCA 8(a) reporting provisions.
Reese’s Law: The Evolving Regulatory and Enforcement Landscape for Consumer Products Containing Button Cell or Coin Batteries
Over the past year, manufacturers, importers, distributors, and retailers of consumer products containing button cell and coin batteries (or products intended to contain them) have continued to adapt to the requirements of Reese’s Law and the Consumer Product Safety Commission’s (CPSC) corresponding enforcement efforts.[1]
Passed by Congress in August 2022, Reese’s Law is intended to protect children and other consumers against the hazard of ingesting button cell or coin batteries.[2] Reese’s Law applies to “consumer products,” as defined by the Consumer Product Safety Act (CPSA),[3] manufactured or imported on or after March 19, 2024, that contain, or are designed to use, a button cell or coin battery.[4] The requirements of Reese’s Law largely fall into two categories: (1) labeling requirements for the products themselves and packaging; as well as (2) “performance requirements” related to how the product itself secures its battery.[5] A discussion of Reese’s Law can be found here with some common FAQs found here.
As detailed below, a few recurrent themes have emerged over the past year with respect to Reese’s Law. Businesses that manufacture, import, distribute, or sell consumer products utilizing button cell and coin batteries should take immediate action to ensure those products are compliant.
Reese’s Law Noncompliance Has Already Been the Source of CPSC Reports and Recalls
Compliance with Reese’s Law is a top priority for the CPSC. Instead of pulling back on enforcement (as seen in other areas of the federal government in recent months), the CPSC has shown that it remains committed to ensuring compliance with Reese’s Law.[6]
To date, noncompliance with Reese’s Law has resulted in several recalls, affecting a wide variety of products, including infant swings, firearm accessories, “smart” patio doors, and submersible RGB LED lights. The violations prompting these recalls run the gamut, including for example, failing to adequately contain the batteries making them accessible to children, and/or failing to include the required labels on the products themselves or their packaging. Many such recalls address both performance and labeling violations.
Businesses should immediately report to the CPSC when they become aware of a potential violation or instance of noncompliance with Reese’s Law. Reporting any potential violations is consistent with the duty that all manufacturers, distributors, importers, and retailers have under Section 15(b) of the CPSA—i.e., the duty to report when a consumer product fails to comply with applicable consumer product safety requirement, such as Reese’s Law.[7]
Compliance May Be Difficult in Certain Circumstances
Reese’s Law provides stringent labeling and performance requirements for consumer products that contain button cell or coin batteries (regardless of whether the batteries are included or sold separately).[8] These requirements can necessitate significant investments of time, money, and other resources to ensure proper compliance.
1. Labeling Requirements
As to labeling, Reese’s Law requires precise labeling on both a covered product’s packaging and the product itself (with some limited exceptions).[9] Compliance may require significant revamping of a covered product’s packaging to include required warning labels and even retooling the manufacture of a covered product itself to include on-product warnings. Even stricter requirements apply to a covered product sold with button cell or coin batteries themselves (i.e., batteries included), rather than by itself, without batteries included.[10]
The CPSC’s recent activity with respect to Apple’s AirTags for noncompliance with the labeling requirements of Reese’s Law are a prime example of labeling enforcement.[11] In its press release announcing an agreement with Apple, the CPSC wrote that Apple had modified both the product itself and the product’s packaging to display the required warnings, and that Apple had taken further action to remediate noncompliant units already sold to consumers.[12] The CPSC concluded its press release with a reminder that manufacturers, importers, distributors, and retailers must report noncompliant products to the CPSC immediately.[13]
2. Performance Requirements
Reese’s Law also includes several “performance requirements” including that consumer products containing button cell or coin batteries must secure the battery inside the battery compartment in such a way that the battery is not exposed or released during reasonably foreseeable use or misuse to minimize the risk of ingestion.[14] For example, a covered product must be able to endure a certain amount of force or tension applied directly to the product, and also be able to withstand drops from certain heights, all without the battery breaking free of the battery compartment.[15] Best compliance practices often include working with a third party testing laboratory to confirm product compliance. Should such testing reveal noncompliance with Reese’s Law for a covered product already in the stream of commerce, it could trigger an obligation under the CPSA to report to the CPSC.[16]
What Does This Mean for My Business?
Complying with Reese’s Law should be top-of-mind for all manufacturers, importers, distributors, and retailers of consumer products containing button cell or coin batteries. Businesses that manufacturer, importer, distribute, or sell covered products should take immediate action to ensure their products comply with the requirements, including consulting with experienced counsel as appropriate and acting on their duty to report any noncompliant products to the CPSC. Additionally, ensuring compliance will require such businesses to coordinate with their suppliers and incorporate these requirements into their annual compliance reviews or audits to identify and correct any compliance gaps.
[1] Safety Standard for Button Cell or Coin Batteries and Consumer Products Containing Such Batteries, 16 C.F.R. § 1263 (2023).
[2] Reese’s Law, 15 U.S.C. § 2056e.
[3] See Consumer Product Safety Act, 15 U.S.C. § 2052(a)(5), which defines a “consumer product” as “any article, or component part thereof, produced or distributed (i) for sale to a consumer for use in or around a permanent or temporary household or residence, a school, in recreation, or otherwise, or (ii) for the personal use, consumption or enjoyment of a consumer in or around a permanent or temporary household or residence, a school, in recreation, or otherwise” with limited exemptions.
[4] See Notes to Reese’s Law, 15 U.S.C. § 2056e (A product is covered by Reese’s Law if it is “[1] a consumer product [2] containing or designed to use one or more button cell or coin batteries, regardless of whether such batteries are intended to be replaced by the consumer or are included with the product or sold separately.”); see also 16 C.F.R. 1263.2.
[5] See Button Cell and Coin Battery Business Guidance, Consumer Product Safety Commission, https://www.cpsc.gov/Business–Manufacturing/Business-Education/Business-Guidance/Button-Cell-and-Coin-Battery.
[6] See Recalls & Product Safety Warnings, Consumer Product Safety Commission, https://www.cpsc.gov/Recalls.
[7] Consumer Product Safety Act, 15 U.S.C. § 2064(b)(2).
[8] Notes to Reese’s Law, 15 U.S.C. § 2056e; see also 16 C.F.R. 1263.2.
[9] See 16 C.F.R. §§ 1263.3, 1263.4 (2023).
[10] Section 3 of Reese’s Law imposes further requirements on the sale of button cell or coin batteries themselves—specifically that the packaging in which such batteries are sold must comply with the Poison Prevention Packaging Act (PPPA). See Button Cell and Coin Battery Business Guidance, Consumer Product Safety Commission, https://www.cpsc.gov/Business–Manufacturing/Business-Education/Business-Guidance/Button-Cell-and-Coin-Battery; see also 16 C.F.R. 1700.15 (regulation implementing the Poison Prevention Packaging Act).
[11] CPSC Secures Agreement with Apple for Enhanced Warnings to Protect Children from Hazards of Battery Ingestion; Apple Takes Action to Address Labeling Violations on AirTags, Consumer Product Safety Commission, https://www.cpsc.gov/Newsroom/News-Releases/2025/CPSC-Secures-Agreement-with-Apple-for-Enhanced-Warnings-to-Protect-Children-from-Hazards-of-Battery-Ingestion-Apple-Takes-Action-to-Address-Labeling-Violations-on-AirTags.
[12] Id.
[13] Id.
[14] 16 C.F.R. §§ 1263.1(a), 1263.3 (2023).
[15] See id.
[16] Consumer Product Safety Act, 15 U.S.C. § 2064(b)(2).
EAB Issues Consent Agreement and Final Order for TSCA Section 5 Violations
On May 5, 2025, the U.S. Environmental Protection Agency (EPA) Environmental Appeals Board (EAB) issued a consent agreement and final order between EPA and Cytonix, LLC (Cytonix). According to the consent agreement, in 2022, EPA inspectors discovered Cytonix’s potential noncompliance with requirements under Section 5 of the Toxic Substances Control Act (TSCA) for a manufactured chemical substance consisting of short-chain polyfluorinated materials (Chemical A) that was developed as a replacement for a chemical substance containing long-chain (C8) perfluorinated alkyl groups. In 2024, EPA identified potential TSCA Section 5 violations for manufacturing Chemical A prior to submitting a premanufacture notice (PMN) or a low volume exemption (LVE) application. According to Cytonix, it mistakenly believed Chemical A was included on the TSCA Inventory at the time of manufacture. As soon as Cytonix learned of the illegal manufacture, it immediately ceased manufacture and quarantined all of its existing stocks of Chemical A. Cytonix does not intend to process or use the quarantined existing stocks of Chemical A but seeks only to dispose of them under the terms of the consent agreement. Cytonix neither admitted nor denied the specific factual allegations. Cytonix agreed to pay a civil penalty of $190,525 for the alleged violations. The terms of settlement state that:
As a condition of the consent agreement, Cytonix shall consult the Interim Guidance on the Destruction and Disposal of Perfluoroalkyl and Polyfluoroalkyl Substances and Materials Containing Perfluoroalkyl and Polyfluoroalkyl Substances-Version 2 (2024) for analyzing disposal options of quarantined existing stocks of Chemical A that minimize potential environmental releases;
If Cytonix chooses to dispose of the existing quarantined stocks of Chemical A, Cytonix shall dispose of any unused portion of its existing stocks in accordance with applicable federal and state requirements. Cytonix should coordinate with the applicable state(s) where disposal may occur to determine if additional requirements or a preferred approach (e.g., incineration) should be considered before disposing of Chemical A; and
Cytonix shall submit documentation showing compliance with these terms of settlement within 30 days of disposal of all existing quarantined stocks of Chemical A containing PFAS and specify the disposal method used.
Texas Launches Another Investigation into Healthy Claims in Cereals
Yesterday Texas Attorney General Ken Paxton announced that it had sent General Mills a Civil Investigative Demand as part of a new investigation regarding the company’s marketing of its cereal products as “healthy” and a “good source” of vitamins and minerals despite containing what Texas calls “petroleum-based food colorings.”
The announcement alleges, without pointing to evidence, that a host of negative health outcomes can be attributed to these synthetic food colorings and voices support for the Trump administration’s battle against such colorings.
This move follows the Trump administration’s announcement of its planned phase-out of the use of synthetic dyes last month as well as a similar investigation against Kellogg by Texas, which was announced last month.
FDA Releases 2023 CORE Annual Report
Yesterday FDA’s Coordinated Outbreak Response & Evaluation (CORE) Network announced the release its 2023 annual report summarizing food-borne outbreak and adverse events in FDA-regulated foods.
In 2023, the CORE Signals and Surveillance Team, which evaluates emerging outbreaks and disease surveillance trends in collaboration with CDC, FDA field offices, and state agencies, evaluated 69 incidents, of which 25 were passed for follow up to an FDA Response Team, and 10 resulted in public health advisories. Of the responses with identified products linked to illness, fruit produce made up the greatest share at 31% (4 cases), followed by other produce at 23% (3 cases).
The report notes FDA’s continued partnership with Mexican food safety regulators including exchange of outbreak information through the Binational Outbreak Notification Protocol which was initiated for four CORE responses. FDA also conducted two accompanied, but unannounced inspections of Mexican food facilities.
Notable outbreaks identified in the report were the lead-contaminated cinnamon apple sauce pouches traced to a cinnamon supplier in Ecuador, adverse reactions (including death) linked to Morel mushrooms served at a Montana restaurant, and an outbreak of Listeria monocytogenes linked to soft serve ice cream in Brooklyn.
The Report predates FDA’s October 2024 reorganization into the Human Foods Program. Since the reorganization, CORE has reorganized into the Office of Coordinated Outbreak Response, Evaluation, & Emergency Preparedness (CORE+EP).
FDA Extends Comment Period for Front-of-Package Nutrition Labeling Rule
On May 8, 2025, the U.S. Food and Drug Administration (FDA) extended the public comment period for its proposed rule on front-of-package (FOP) nutrition labeling by 60 days. Stakeholders now have until July 15, 2025, to submit feedback.
The extension comes in response to requests for more time to review and comment on the proposal. The proposed rule, announced January 16, 2025, would require most packaged foods to display a simplified “Nutrition Info” box on the front of the package. The box would highlight the level of three nutrients of public concern: saturated fat, sodium, and added sugars, using descriptive terms such as “low,” “med,” or “high.”
The rule is part of a broader initiative at the agency to reduce diet-related chronic diseases and is intended to provide consumers with a quick and easy way to understand nutrition information related to packaged food products.
Comments can be submitted via Regulations.gov under docket number FDA-2024-N-2910. Keller and Heckman can assist in drafting or submitting comments on behalf of interested parties.
Toy Story: Insurance Lessons from Mattel Defect Case
A Delaware court recently held in Mattel, Inc. and Fisher Price, Inc. v. XL Insurance America, Inc., et al., that a series of product liability claims dating back to 2013 constituted a single “occurrence” under the toy manufacturer’s and distributor’s commercial general liability (CGL) policies.
The case stemmed from Mattel’s request for defense and indemnity coverage in response to claims that certain toys caused bodily injuries to infants. The CGL coverage tower, which included policies issued by multiple primary, excess, and umbrella insurers, spanned from 2011 to 2020.
The primary policies defined “occurrence” as “an accident, including continuous or repeated exposure to substantially the same general harmful conditions.” They also included a Lot or Batch Clause Endorsement with a “Deemer Clause,” which deemed all injuries arising from a single “lot” of products as occurring whenever the injury in the first filed claim occurred. Under the endorsement, a “lot” was defined as “two or more discrete units of the same or substantially similar good or product” that shared a common harmful condition, defect, error or suspected deficiency.
The umbrella policies used a similar definition of “occurrence” and included an Occurrence Amendatory Endorsement. This endorsement aggregated distinct claims arising from the same alleged defect or hazard in substantially similar products into a single “occurrence.” However, unlike the Lot or Batch Clause Endorsement, the Occurrence Amendatory Endorsement did not include a “Deemer Clause.”
The toy manufacturer, along with one of its primary insurers, contended that the product liability claims should all be treated as a single “occurrence.” In contrast, another insurer in the coverage tower argued that the issue was premature, asserting that the court first needed to determine the proximate causation of the alleged injuries before addressing the number of “occurrences.”
The Delaware court ultimately held that the claims constituted a single “occurrence” under the applicable policies. It permitted allocation of the claims based on the year in which the injuries occurred. The court found that the claims arose from “the same or substantially the same ‘hazard’: the defective design of the [manufacturer’s] products, including the incline angle, posed a hazard to the health of infants.” It emphasized that the products were part of the same product line and shared common hazards, satisfying the policy’s definition of a single “occurrence.”
With respect to allocation, the court held that coverage under the excess and umbrella policies could only be triggered by a bodily injury that actually occurred during a particular policy’s year. Significantly, the Occurrence Amendatory Endorsement in the excess and umbrella policies did not contain a “Deemer Clause”—unlike the Lot or Batch Clause Endorsement in the primary policies—which would have treated all injuries arising from a single “lot” of products as occurring at the time of the first claimed injury. As a result, the court concluded that the claims must be allocated to the policy in effect at the time each individual bodily injury occurred, rather than being grouped under a single policy year.
This decision underscores the critical importance of carefully reviewing the definition of “occurrence” in liability policies, including any endorsements that modify or clarify its application. Given that the number and timing of occurrences often plays a central role in the availability and extent of coverage, policyholders should consult experienced coverage counsel to help interpret policy language and ensure they maximize potential recovery under all applicable layers of insurance.