Biotech, Food, Drug – Page 3

Deli’s Party Platters Found Subject to Sales Tax Despite Customer Assembly Required

In the world of sales tax, the devil is often in the details. A recent decision from the New York State Tax Appeals Tribunal (“Tribunal”) serves as an example of how seemingly insignificant details can determine whether a sale is subject to tax. In the Matter of Todd A. Neupert, DTA No. 830368 (Feb. 13, 2025).
The Facts: Petitioner is the owner of a deli that sells a variety of prepared foods, as well as deli meat and other non-prepared items. The New York Division of Taxation audited the deli and determined that Petitioner improperly failed to charge sales tax on “party platters” sold by the deli resulting in a notice of determination for $12,579.62 in sales tax due. The party platters include pre-sliced meats and cheeses served on a deli tray with condiments and other accoutrements, such as lettuce, tomatoes, and banana peppers. Rolls are provided separately in a bag that accompanies the platters, and the customer is charged one price for all the items. Petitioner argued that the platters were not “prepared food” because the platters required assembly by the customer, i.e., making sandwiches.
At the administrative law judge (“ALJ”) level, the ALJ determined that the party platters were prepared foods subject to tax, relying on a Tax Bulletin issued by the Department of Taxation & Finance (“Department”) (TB-ST-283) which states that the sale of “cold cut platters” is taxable.
The Decision: While generally food sales are exempt from tax, if the food is “prepared” by the seller, it is taxable. Thus, the sole issue before the Tribunal was whether the party platters are considered “prepared foods” within the meaning of the sales tax law. The Tribunal found that the party platters were prepared because the Petitioner compiled a number of items in ready-to-eat form either as-is or through some further preparation such as by making a sandwich with the products provided. Petitioner’s preparation included separating the condiments into individual packaging and providing pre-sliced lettuce, tomatoes, and onions.
The Tribunal upheld the ALJ’s decision, rejecting Petitioner’s argument that “the opportunity for additional preparation, such as by making sandwiches…, negates his own preparation or the readily consumable nature of the foods provided.” The Tribunal noted that “[m]any foods that are ready to eat can be augmented in some fashion and so we decline to adopt [Petitioner’s] reasoning.” Following the ALJ’s lead, the Tribunal also relied on Tax Bulletin TB-ST-283, which explicitly states that cold cut platters are considered prepared food and are subject to sales tax.
The Takeaway: A rationale for not taxing unprepared food is to make basic food necessities more affordable. If Petitioner sold sliced cold cuts by weight but did not arrange them on a platter, the sale would not be taxable. Petitioner’s argument here—that the party platters were not prepared foods because the customer would make additional preparations—appears to have some merit, as the Department’s Tax Bulletin relied on by both the ALJ and the Tribunal defines prepared food as “ready to be eaten” and not requiring further preparation. While technically the cold cuts on the platter could be consumed as-is, it was contemplated that customers would prepare sandwiches.
Whether an item is taxable can hinge on seemingly trivial details. While the distinctions can seem absurd at times, they have real financial implications for businesses. Given the complexity and potential for costly mistakes, businesses must be vigilant about the details and should consult with a tax professional to ensure compliance. By staying informed and seeking professional advice, businesses can avoid unexpected tax liabilities. Understanding the rules can make all the difference.

Federal Judge in Pennsylvania Reverses Dismissal of Medical Marijuana Cardholder’s Disability Discrimination Claim

On April 11, 2025, a federal judge for the U.S. Western District of Pennsylvania reversed his recent decision to dismiss a disability discrimination claim from a job applicant with a medical marijuana card who alleged he had a job offer rescinded following a pre-employment drug screen.

Quick Hits

A federal judge reinstated a disability discrimination claim after a job applicant with a medical marijuana card alleged that his job offer was rescinded without proper consideration of reasonable accommodations for his underlying medical conditions.
The judge had previously dismissed the disability discrimination claim after finding that status as a medical marijuana cardholder was not a qualifying disability.
The ruling underscores the legal uncertainty surrounding the protection of employees’ lawful medical marijuana use under the Pennsylvania Human Relations Act.

While considering a motion to certify an appeal, U.S. District Judge Robert J. Colville reversed his March 2025 dismissal of a disability discrimination claim under the Pennsylvania Human Relations Act (PHRA) brought by a job applicant who alleged a construction company failed to accommodate his medical marijuana use.
Judge Colville said he had “failed to give due consideration” to the allegation the employer did not discuss any reasonable accommodations for the job applicant’s disability other than his medical marijuana use.
The plaintiff, Brian Davis, alleged that Albert M. Higley Company, LLC, rescinded the job offer for a project engineer position following a pre-employment drug screen. Davis alleged that he was diagnosed with anxiety, depression, and attention-deficit/hyperactivity disorder (ADHD) and was certified to use medical marijuana to treat the conditions along with other prescription drugs.
On March 7, 2025, Judge Colville dismissed Davis’s claim for disability discrimination under the PHRA. Still, the judge allowed the suit to continue on a separate claim that the company refused to hire him in violation of Pennsylvania’s Medical Marijuana Act (MMA).
In that ruling, Judge Colville stated he was “constrained” by the 2020 Commonwealth Court of Pennsylvania decision in Harrisburg Area Community College (HACC) v. Pennsylvania Human Rights Commission, which held the PHRA does not require accommodation of an individual’s legal medical marijuana use because it is not a qualified disability.
The ruling was significant in that it was potentially the first instance of a federal court finding that lawful medical marijuana use was not a qualifying disability under the PHRA.
However, in his latest decision, Judge Colville declined to certify the issue for an immediate appeal. Instead, he reinstated the disability discrimination claim “to the extent that it asserts that Defendant failed to engage in the interactive process in good faith by failing to discuss or consider reasonable accommodations other than Plaintiff’s marijuana use.” (Emphasis in the original.)
“To be clear, the Court did not hold that an individual with a disability who is also a medical marijuana user is not entitled to any reasonable accommodation for their disability under the PHRA,” Judge Colville said. “Rather, the Court simply held that continued marijuana use is not a reasonable accommodation under the PHRA.” (Emphasis in the original.)
Notably, the judge said the job applicant had support in a 2020 decision by the U.S. District Court for the Eastern District of Pennsylvania in Hudnell v. Thomas Jefferson University Hospitals, Inc., which had allowed a similar claim to continue where a plaintiff had “alleged a disability apart from her medical marijuana use.”
Judge Colville said that even if the PHRA does not require off-duty marijuana use as an accommodation, the allegations were that the company “summarily rescinded its offer of employment” without exploring various other potential accommodations. Therefore, the company potentially failed to engage in the required interactive process under the PHRA.
“The Court believes that the issue of good faith is a factual question that cannot be resolved at this time,” Judge Colville said.
Next Steps
Judge Colville’s reversal highlights the legal uncertainty around whether employees’ lawful, off-duty medical marijuana use is protected under the PHRA. Several courts have allowed disability discrimination claims for medical marijuana under the PHRA to continue. However, the recent ruling suggests that such claims may only be able to proceed if the medical marijuana use is simply indicative of a separate qualified disability that employers have an obligation to reasonably accommodate. Judge Colville maintained that medical marijuana use itself is not a reasonable accommodation and denied an immediate appeal on that issue.
As such, employers may want to review their drug testing and accommodations policies regarding medical marijuana cardholders in Pennsylvania. Additionally, employers may want to consider engaging in an interactive process with employees who are medical marijuana cardholders, at least to gauge the extent to which there may be another reasonable accommodation for an employee or job applicant with a qualifying disability aside from medical marijuana use.

CMS Issues CY 2026 Medicare Advantage and Part D Final Rule

On April 4, 2025, the Centers for Medicare & Medicaid Services (“CMS”) released the contract year (“CY”) 2026 final rule for the Medicare Advantage (“MA”) program, Medicare Prescription Drug Benefit Program (“Part D”), Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (the “Final Rule”). While CMS finalized several proposals of its Proposed Rule, it did not finalize many of its key proposals, including on anti-obesity medication (“AOM”) coverage, enhanced guardrails for artificial intelligence (“AI”), and various health equity related initiatives in MA and Part D.
Summarized below are some of the key provisions of the Final Rule.
MA and Part D Proposals Not Finalized
Perhaps most notable from the CY 2026 Final Rule are those proposals that CMS did not finalize. These include the following:

Part D Coverage of Anti-Obesity Medications (AOMs) and Application to the Medicaid Program—CMS declined to finalize a proposal to “reinterpret” the statutory definition of a covered Part D drug at section 1860D–2(e)(2) of the Social Security Act (SSA), which excludes coverage for certain drugs and uses, including those that may be excluded by Medicaid under SSA § 1927(d)(2) as ‘‘agents when used for . . . weight loss.’’ The proposal would have applied to both Medicare and Medicaid to allow coverage for AOMs when used for the treatment of obesity, with a hefty, estimated price tag of $25 billion in Medicare spending and $15 billion in Medicaid spending over the course of a decade. As the proposal was not finalized, the current policy remains in place—the Medicare and Medicaid programs will only cover AOMs when used to treat another medically accepted condition (e.g., type 2 diabetes or cardiovascular risk).
Enhancing Health Equity Analyses: Annual Health Equity Analysis of Utilization Management Policies and Procedures — CMS did not finalize its proposal to require Medicare Advantage organizations to conduct annual health equity analyses of utilization management policies. CMS stated that this proposal remains under review for potential future rulemaking in line with Executive Order 14192’s directive to ensure consistency and avoid unnecessary burden.
Guardrails for Artificial Intelligence (AI) / Ensuring Equitable Access to Medicare Advantage Services — CMS opted not to finalize proposals related to the use of AI and algorithmic decision-making in MA, including proposals requiring plans to utilize AI in a manner that preserves equitable access, to adhere to existing Medicare regulations prohibiting discrimination, and requiring disclosure of use of AI tools. In declining to finalize these proposals, CMS acknowledged strong stakeholder interest and stated that the agency would “consider the extent to which it may be appropriate to engage in future rulemaking in this area.”
Behavioral Health Parity — Although CMS acknowledged significant stakeholder concern regarding access to behavioral health care in MA plans, it did not finalize proposals to establish stricter parity protections or expand network adequacy standards in the Final Rule. The proposed behavioral health parity provisions would have applied new requirements to ensure equitable access to mental health and substance use disorder services in Medicare Advantage plans. CMS acknowledged ongoing concerns, especially in dual-eligible special needs plans, but stated that the proposed changes are still under review. Future rulemaking may revisit these policies in coordination with broader parity and access initiatives.
Prior Authorization — While CMS finalized prior authorization requirements applicable to inpatient admissions (discussed below), CMS did not finalize proposals to establish guardrails on the use of AI in prior authorization processes.
Agent and Broker Oversight — Despite recent scrutiny of agent and broker practices, CMS did not finalize key proposed marketing reforms. Among other things, these included broadening the definition of “marketing” to enhance agency oversight of materials submitted to CMS as well as promoting informed choice by requiring agents and brokers to provide more comprehensive information to potential enrollees, such as low-income assistance options and implications of switching to traditional Medicare.
Promoting Transparency for Pharmacies — CMS did not finalize or address a proposal to require Part D sponsors (or their FDRs) to allow pharmacies the right to terminate their network contracts without cause following the same notice period that Part D sponsors have for terminating contracts without cause. Had this proposal been finalized, it would have likely faced legal challenges for violating the Part D statute’s noninterference requirement.
Formulary Placement of Generics and Biosimilars — CMS did not finalize a proposal to include an additional step in the formulary review process to check that Part D sponsors provide broad access to generics, biosimilars, and other lower cost drugs. However, CMS noted that “may consider codifying additional requirements regarding formularies in future rulemaking if necessary.”
Administration of Supplemental Benefits through Debit Cards — CMS did not finalize its proposal to impose new requirements on the use debit cards to administer plan-covered benefits, including new guardrails to ensure that beneficiaries are fully aware of covered supplemental benefits and how to access those benefits.
Community-Based Services and In-Home Service Contractors — CMS did not finalize or directly address proposals related to improving transparency and beneficiary protections through expanded provider directory requirements. These proposals included codifying definitions for community-based organizations and in-home supplemental benefit providers, and requiring their inclusion in provider directories.
Part D Medication Therapy Management (“MTM”) Program — CMS deferred for subsequent rulemaking a proposal to expand the regulatory list of core chronic diseases used to identify Part D enrollees who have multiple chronic diseases for purposes of determining eligibility for Medication Therapy Management (“MTM”) enrollment to include other causes of dementia in addition to Alzheimer’s.

Moreover, CMS indicated that various currently effective regulations and policies are currently under review by the Trump Administration “to ensure consistency with the Executive Order 14192, Unleashing Prosperity Through Deregulation.” According to CMS, policies currently under review include the following:

Health Equity Index Reward for the Parts C and D Star Ratings
Annual health equity analysis of utilization management policies and procedures
Requirements for MA plans to provide culturally and linguistically appropriate services
Quality improvement and health risk assessments (“HRAs”) focused on equity and social determinants of health (“SDOH”)

FINALIZED MA AND PART D PROPOSALS
Covered Insulin Products and Vaccines
CMS finalized a proposal to codify a relatively modest expansion of the definition of a “covered insulin product” to include Part D coverage for drug products that are a combination of more than one type of insulin or both insulin and non-insulin drugs, which is consistent with existing CMS guidance. CMS also finalized proposals to eliminate cost sharing for both covered insulin products and for adult vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) covered under Part D.
Medicare Prescription Payment Plan
CMS finalized regulatory requirements for the Medicare Prescription Payment Plan for 2026 and subsequent years, codifying provisions previously established in two-part guidance for 2025. The program, created under section 11202 of the Inflation Reduction Act, requires all Medicare Part D and MA-PD plan sponsors to offer enrollees the option to pay capped monthly installments on their out-of-pocket Part D drug costs, rather than paying the full amount at the point of sale. The goal is to ease financial pressure—especially for beneficiaries who incur high drug costs early in the year.
Most provisions from prior guidance were finalized without modification, including operational processes, election procedures, and outreach requirements. CMS also finalized several new provisions:

Automatic Renewal: Beginning in 2026, enrollees who participate in the program will be automatically re-enrolled the following year unless they opt out. A separate renewal notice must be sent after the end of the annual election period and include the plan’s upcoming terms and conditions.
Voluntary Termination: CMS adjusted its original proposal and will now require plan sponsors to process opt-out requests within 3 calendar days, rather than the initially proposed 24-hour timeframe, to reduce administrative burden.
Standardized Communications: New requirements were finalized for model and standardized materials, including the “likely to benefit” notice, voluntary and involuntary termination notices, and renewal notices. Part D sponsor websites must also display information about the program.
Waiver for LI NET: CMS confirmed that the Medicare Prescription Payment Plan requirements will not apply to the Limited Income Newly Eligible Transition (LI NET) program, consistent with prior guidance.
Election Processing and Real-Time Requirements: While CMS finalized the 24-hour processing requirement for election requests received during the plan year, it did not finalize a proposed real-time processing requirement for phone or web-based requests, citing stakeholder concerns about operational feasibility. CMS may revisit this in future rulemaking.

CMS stated that its approach was intended to limit disruption, reduce burden on plans, and give stakeholders time to gain experience with the program. The agency will continue to evaluate program implementation and consider refinements in future years.
Timely Submission Requirements for Prescription Drug Event (PDE) Records
CMS has finalized new regulatory requirements under § 423.325 to codify timely submission of Prescription Drug Event (PDE) records by Medicare Part D sponsors. These records are essential for payment accuracy and program integrity, especially for programs like the Coverage Gap Discount Program, the Manufacturer Discount Program, and the Medicare Drug Price Negotiation Program.
Previously guided by subregulatory policy, CMS now formalizes specific submission timelines:

General PDEs: Within 30 days of claim receipt.
Adjustments/deletions: Within 90 days of issue discovery.
Rejected PDEs: Resubmitted within 90 days of rejection notice.
Selected drugs (Negotiation Program): Initial PDEs due within 7 days to support timely Manufacturer Fair Price refunds.

Despite concerns about the 7-day timeline, CMS finalized it without changes, citing that most PDEs are already submitted within this window. The 90-day deadlines for adjustments and rejections remain unchanged. These timelines are now enforceable, and noncompliance may trigger CMS actions.
Medicare Transaction Facilitator Requirements for Network Pharmacy Agreements
CMS finalized the proposal requiring that Part D sponsors’ network participation agreements with contracting pharmacies, including any FDR contracts, require network pharmacies to be enrolled in the Medicare Drug Price Negotiation Program’s (‘‘Negotiation Program’’) Medicare Transaction Facilitator Data Module (‘‘MTF DM’’) and that such pharmacies certify the accuracy and completeness of their enrollment information in the MTF DM. According to CMS, the MTF DM will contain several key functionalities that are necessary and appropriate for administration of the Negotiation Program and the Part D program. Through each of these functionalities, the dispensing pharmacy’s enrollment in the MTF DM would help ensure continued access to selected drugs that are covered under Part D for beneficiaries and pharmacies and help maintain the accuracy of Part D claims information and payment. These functionalities are:

The MTF DM will provide pharmacies enrolled in the MTF DM with remittances or ERAs to reconcile Maximum Fair Price (“MFP”) refund payments when a Primary Manufacturer of a drug selected by CMS for price negotiation chooses to pass payment to the pharmacy through the MTF PM rather than prospectively ensuring that the price paid by the pharmacy entity when acquiring the drug is no greater than the MFP.
There will be streamlined access for pharmacies that are enrolled in the MTF DM to submit complaints and disputes within the MTF DM to help identify issues with timely MFP refund payment, supporting pharmacies to continue efficient operations and prevent undue financial hardship, while maintaining accuracy of Part D claims information and payment.
The MTF DM will serve as a central repository for information about pharmacies enrolled in the MTF DM that self-report that they anticipate material cashflow concerns due to the reliance on retrospective MFP refunds within the 14-day prompt MFP payment window.
CMS intends that pharmacies will be able to view the status of MFP refunds from Primary Manufacturers through the MTF DM.
The MTF DM will collect and share financial information belonging to pharmacies enrolled in the MTF DM with Primary Manufacturers that pay MFP refunds to pharmacies outside the MTF PM.

CMS published new guidance on its webpage on Tuesday, April 8th to provide pharmacies and other dispensing entities with resources for engaging with the new MTF system. Enrollment in the MTF is expected to begin in June 2025.
Clarifying MA Organization Determinations to Enhance Enrollee Protections in Inpatient Settings
In the Final Rule, CMS clarifies and expands the definition of “organization determinations” under § 422.566 to explicitly include decisions made while a beneficiary is receiving care, particularly inpatient services. The key reforms include the following:

Whether a decision is made before, during, or after a service is provided, it must be treated as a formal organization determination. This change is intended to prevent MA plans from not affording appeal rights by reclassifying care decisions as claims reviews.
MA organizations may not retroactively deny or downgrade previously authorized inpatient admissions, even based on clinical data collected after admission. The only exceptions are fraud or qualifying good cause.
The Final Rule also clarifies that a beneficiary’s financial liability does not attach until an MA plan has made a formal claim determination, aligning liability with appeal rights.

These finalized requirements are intended to eliminate surprise denials, ensure transparency for providers and beneficiaries, and create a consistent standard across MA plans for inpatient decision-making. The Final Rule also introduces certain limited protections for beneficiaries and providers navigating MA plans’ prior authorization (“PA”) processes, including several provisions that restrict a plan’s ability to retroactively deny care after initial approval. Beginning in 2026:

Approved services, including inpatient admissions, cannot be retroactively denied unless there is evidence of fraud or a valid reason under CMS’s “good cause” standard as defined in 42 CFR § 405.986.
All coverage decisions made during or after an inpatient stay must be treated as formal determinations, granting enrollees full appeal rights.
Plans must notify both providers and enrollees of all coverage decisions, and beneficiaries cannot be held financially responsible until a claims payment determination is made.

Non-Allowable Special Supplemental Benefits for the Chronically Ill (SSBCI)
In the Final Rule, CMS adopts new regulatory restrictions for SSBCI. With some modifications from the Proposed Rule, CMS finalized a non-exhaustive list of non-allowable SSBCI benefits, codified at 42 C.F.R. § 422.102(f)(1)(iii).
Under existing regulations, SSBCI are not required to be primarily health related but must have a reasonable expectation of improving or maintaining the health or overall function of the enrollee, as established by the MA plan based on a bibliography of relevant acceptable evidence. In the Final Rule, CMS adopts a non-exhaustive list of non-primarily health related items or services that do not meet the standard of having a reasonable expectation of improving or maintaining the health or overall function of the enrollee. As finalized at 42 C.F.R. § 422.102(f)(1)(iii), examples of items or services that may not be offered as SSBCI include all of the following:

Procedures that are solely cosmetic in nature and do not extend upon Traditional Medicare coverage (for example, cosmetic surgery, such as facelifts, or cosmetic treatments for facial lines, atrophy of collagen and fat, and bone loss due to aging)
Hospital indemnity insurance
Funeral planning and expenses
Life insurance
Alcohol
Tobacco
Cannabis products
Broad membership programs inclusive of multiple unrelated services and discounts
Non-healthy food

Modifications from the Proposed Rule include the addition of “non-healthy food” to the non-allowable SSBCI list. According to CMS, the addition of non-healthy food addresses comments requesting clarification on how plans may provide “Food is Medicine” (an initiative of HHS’ Office of Disease Prevention and Health Promotion) within the parameters of supplemental benefit requirements. In addition, CMS did not finalize proposals to expressly incorporate as non-allowable SSBCI “cash and monetary rebates” (which are prohibited by SSA § 1851(h)(4)(A)) or “gambling items (e.g., online casino games, lottery tickets), firearms and ammunition.”
Improving Experiences for Dually Eligible Enrollees
CMS finalized its proposed requirements for certain dual-eligible Special Needs Plans (“D-SNPs”) to further streamline and integrate care delivery for dual eligible beneficiaries. Specifically, finalized proposals include:

Requiring integrated member ID cards for both Medicare and Medicaid plans. The proposal is limited to Applicable Integrated Plans (“AIPs”);
Requiring AIPs to conduct a single, integrated Health Risk Assessment (“HRA”) for both Medicare and Medicaid, replacing the separate HRAs currently utilized for each. However, CMS delayed the implementation date of this provision to January 1, 2027.
Codifying timeframes for all SNPs to conduct HRAs and develop Individualized Care Plans (“ICPs”), emphasizing active participation by enrollees or their representatives in the ICP development process. Specifically, CMS proposes to require that SNPs conduct the initial HRA within 90 days of the effective date of enrollment.
Establish new requirements for all SNPs related to outreach to enrollees regarding completion of the HRA. Specifically, SNPs make at least three non-automated phone call attempts, unless the enrollee agrees or declines to participate in the HRA before three attempts are made, on different days at different times. If the enrollee has not responded, the SNP must send a follow-up letter. The SNP must document attempts to contact the enrollee, and if applicable, the enrollee’s choice not to participate.

Require that SNPs update ICPs as warranted when there are changes in an enrollee’s health status or they have a healthcare transition.
Risk Adjustment Data
CMS finalized as proposed various technical changes to the definitions related to risk adjustment data, including a technical change to the definition of Hierarchical Condition Categories (HCCs) at § 422.2 to remove the reference to a specific version of the ICD to keep the HCC definition current as newer versions of the ICD become available and are adopted by CMS, as well as substituting the terms “disease codes” with “diagnosis codes” and “disease groupings” with “diagnosis groupings” to be consistent with ICD terminology. CMS also finalized its proposal to codify existing practice of requiring mandatory submission of risk adjustment data by PACE organizations and Section 1876 Cost plans, consistent with the risk adjustment data requirements applicable to MA plans.
Medical Loss Ratio (MLR) Reporting
In the Proposed Rule, CMS proposed a number of regulatory changes intended to improve the meaningfulness and comparability of the MLR across plan contracts, as well as align the MA and Part D MLR regulations with the regulations in the commercial and Medicaid MLR programs. However, in the Final Rule, CMS adopted only one MLR-related proposal — to exclude Medicare Prescription Payment Plan unsettled balances from the MLR numerator.
MLR related proposals that were not finalized include the following:

Requiring provider incentive and bonus arrangements are tied to clinical or quality improvement standards in order to be included in the MA MLR numerator;
Requiring administrative costs to be excluded from quality-improving activities in the MA and Part D MLR numerators; and
Codifying the current practice by which MA and Part D MLR reports include a description of how expenses are allocated across lines of business.

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The Missing Piece to Your Business’ Litigation Team: Using A National Coordinating Counsel to Manage Your Mass Tort Litigation

Businesses, large and small, can find themselves overwhelmed by litigation quickly, if and when they find themselves in the crosshairs of a developing litigation. For years, the best example of these crosshairs was those focused mainly on asbestos and those entities that either supplied or manufactured with asbestos. However, over recent years we have seen that focus shift to other types of litigation, including cosmetic and pharmaceutical talc, industrial talc, crystalline silica, benzene, PFAS, pharmaceuticals, and many others. With most of these developing litigations, there are plaintiff firms that specialize in investigating entities involved with the products or activities at issue, and then bringing an onslaught of suits against those entities. Once an alleged tie is found between any mass litigation and an entity, the entity can find themselves named in almost every suit filed across the nation by national plaintiff firms. This often happens before an entity can truly appreciate the magnitude of the impact of these lawsuits.
Many entities attempt to manage this litigation in-house, not knowing that they have options on how best to manage their entity’s litigation issues. However, many times a better alternative is to hire a National Coordinating Counsel (“NCC”) to assist in managing the litigation for the entity. The NCC’s job is to manage every aspect of an entity’s litigation across jurisdictions relating to a specific topic or topics. The use of an NCC allows for streamlined work, implementation of national litigation strategies, and better and more predictable litigation outcomes.
In particular, there are advantages to hiring an NCC at every level of litigation. Below we will outline the basics of why hiring an NCC can benefit your entity at different levels of litigation. We will be publishing a series of follow-up articles on each specific aspect of litigation mentioned below and how hiring an NCC can assist in bringing more value to your entity as compared to attempting to manage the litigation in-house.

Case Management

The NCC’s main role is to manage your entity’s litigation across jurisdictions. This will include tracking all of the relevant deadlines in your cases, including trial dates, expert discovery deadlines, written discovery deadlines, depositions, and motion practice. The NCC tracks this information in real time by having open lines of communication with local counsel in each jurisdiction and creating reports based on that communication so that the information can be presented in a quick and easily digestible manner to your entity. However, this role goes well beyond just tracking relevant events in cases. The NCC is able to report trends involving different plaintiff firms, experts, product identification, and strategies for defenses. The NCC will use these trends and information from across jurisdictions to help develop and implement defense strategies.
For example, Personal Jurisdiction and Forum Non-Conveniens defenses can be suggested based on not only the facts of a case, but also the knowledge of different jurisdictions case specific laws regarding causation, available defenses, damages, as well as others. The NCC is also able to track litigation in each jurisdiction to determine which jurisdictions are more likely to go to trial, jurisdictions with higher settlement values, and jurisdictions that plaintiffs are likely to refile cases against your entity as the sole defendant after a successful Personal Jurisdiction or Forum Non-Conveniens motion. The NCC is able to communicate with local counsels to determine all the facts so your entity can be confronted with only issues and possible solutions rather than having to find those solutions yourselves. This case management also branches out too many other aspects of the case, including discovery, corporate representatives, experts, and trials, as mentioned below.

Discovery

Perhaps one of the biggest roles an NCC can play to ease the burden of litigation on an entity is to manage written discovery. When responding to discovery across cases and across jurisdictions, a national strategy is required. This strategy will ensure that responses are uniform across cases and that your entity is not committing discovery fraud. An NCC can draft all discovery responses across jurisdictions to ensure that all objections and responses are phrased the same way nationwide. However, it is also possible to have local counsel draft your responses and to have the NCC review these responses to ensure similar objections and responses. Either way, the NCC ensures that each inquiry made to your entity is responded to in a uniform way. It avoids contradictions that, when discovered by plaintiff firms, can lead to motion practice and accusations of discovery fraud, which can lead to hefty and punitive penalties.
An NCC ensures that document productions are consistent nationwide to similar requests. When a plaintiff firm is filing cases against your entity in multiple jurisdictions, they are expecting to receive the same documents in response to their requests regardless of the jurisdiction. Without an NCC providing oversight, it is possible that documents can be omitted from disclosure or that documents can be accidentally produced. Either way, this can lead to discovery motions and/or sanctions for discovery fraud. Discovery fraud is a serious risk if your discovery responses and document productions are not managed at a national level, the consequences of which can plague your entity for the rest of its life in the litigation.
Furthermore, an NCC can assist in the drafting and use of confidentiality orders to protect your documents. This needs to be done on a national level, as disclosure in one jurisdiction would require disclosure in all jurisdictions. Tracking your documents and protecting your interests on a national level requires a national strategy that would need to be micromanaged by your entity’s legal department if your entity is not using an NCC.
Beyond written discovery, having an NCC can help ensure that a national strategy is undertaken for gathering discovery in cases. This includes the use of subpoenas for records, the use of private investigators, and the use of other resources. Additionally, having an NCC can assist in gathering discovery across states, as they can link local counsel across jurisdictions for more efficient use of interstate discovery subpoenas or Freedom of Information/Open Public Records Act requests. Overall, they implement a strategy across jurisdictions with the local counsels so that your entity can leave no stone unturned while not having to dedicate resources within your entity to do so.

Corporate Representative Depositions and Trial Testimony

Corporate Representative depositions and trial testimony are another opportunity for an NCC to provide your entity value. First, if your entity is new to the litigation, an NCC can assist in determining the best person or persons to serve as a corporate representative. They can assist in the search by interviewing possible candidates and providing your entity with the pros and cons of each candidate. Once a corporate representative is established, the use of an NCC allows for consistent preparation of your corporate representative for all depositions and trial testimony to ensure that the testimony given on behalf of your entity is consistent. Part of this preparation is the development of a corporate story, for which your corporate representative will be the mouthpiece. This is of the upmost importance, as this will be how your entity is represented to a jury at trial. A compelling corporate story can be the difference between a large plaintiff verdict and a defense verdict.
The preparation of your entity’s corporate story, as well as your corporate representative, can include mock depositions, document reviews, and review of written discovery. This implementation of a consistent strategy across cases and jurisdictions avoids the issues presented when each local counsel is responsible for preparing a corporate representative. This also saves time and resources that would be required if each local counsel had to prepare for each corporate representative deposition by reviewing transcripts and discovery from other jurisdictions. An NCC can constantly be up-to-date without constant review of what has previously happened with a corporate representative. This makes your corporate representative testimony consistent for the witness, the client, and for plaintiff counsel. This leads to positive and predictable outcomes.

Experts

An NCC team allows for efficient management of experts and expert discovery across cases and jurisdictions. An NCC team allows for each expert to have a specific point of contact. This creates a consistent relationship and avoids issues with ensuring the experts are provided with materials and payments consistently. It allows for consistent reports and more involved strategy development across cases. It also allows for a better relationship to develop, which often allows for experts to be more forgiving if issues to arise and reports are needed on an expedited basis. In-house management or management by local counsels of these issues may not result in as favorable outcomes.
Further, as a part of an overall expert strategy, having an NCC allows for a more tactical approach to retaining experts. This includes using multiple experts from the same field across different cases so that that your entity is not reliant on one expert in case there is conflicting trial dates, a conflict with a co-defendant, or an issue with retention in any particular case. Further, this allows for more in-depth management of costs. This also allows for experts to better manage their time while your entity’s entire case load is getting the full attention it deserves. This level of management is possible with an NCC because they are able to dedicate the time and their expertise in a way that local counsel and in-house attorneys cannot.
Further, an NCC team allows for consistent expert depositions, Daubert hearings, and trial testimony from your experts. This is similar to corporate representatives, discussed above. The consistent time spent in preparation for depositions and reviewing reports allows for a direct relationship on behalf of your entity with the expert, as well as a consistent strategy that builds and adapts over time. Further, this facilitates inclusion of cutting edge science and publications within your experts opinions, which substantially supplements your entity’s defenses. This is just another way an NCC team adds value to your entity.

Trial Teams

While no entity wants to find itself at trial, the fact of the matter is that every entity named in a lawsuit must prepare as if a trial is inevitable. This ensures that the entity is prepared in the unlikely event that a matter goes to trial. An NCC team is your entity’s insurance policy that a trial team will be prepared under those circumstances. An NCC team helps create consistent work product for both pre-trial filings and trial itself. This stems from having developed a trial strategy that can be used as a basis for every case. Different elements of this strategy would include development of a corporate story, development of defenses such as expert defenses or state-of-the-art defenses, development of cross-examinations of plaintiff’s experts, and more. An NCC team will constantly be developing and perfecting motions in limine, openings and closings, and cross-examinations that will come together to form a trial handbook. This will allow trial counsel to have a step-by-step plan of how your entity should be defended at trial.
Moreover, this NCC work helps lead to a more consistent and predictable defense, which helps manage outcomes. The NCC team manages trial dates across jurisdictions so that an entity can ensure it is prepared for any trial issues that may come up in any of their cases. This also allows for the entity to have better forecasting of what cases will go to trial, which cases will resolve, and what issues may arise at any time. Due to this, an entity can be better prepared for outcomes and can prepare for what can be expected during any particular time period.

Case Resolution

Resolving cases outside of trial is also the job of your NCC. An NCC can more effectively resolve cases than individual local counsel because they can do so on a larger scale. Further, an NCC can devote more resources and time to forming the relationships with plaintiff firms that allow for these resolutions. Your NCC team can create value when negotiating by creating group settlements across jurisdictions, but your NCC can also create value by producing creative solutions when negotiating with plaintiff firms. They can take advantage of early settlement opportunities or could develop different frameworks depending on your entity’s circumstances.
It is easier for your NCC team to develop creative deals as compared to local counsels or in-house counsel because they will be dedicating more time and resources to building a relationship with the different plaintiffs’ firms on behalf of your entity. Further, they will spend more time on behalf of your client developing relationships with co-defendants on behalf of your entity. This can help develop your defenses, which will impact the overall outcomes of your cases.
Your NCC team will also be tracking different points of data regarding the outcomes in your cases to allow for better projections for future matters. This includes the past history of cases with each plaintiff firm, past history of cases with each product, past history of cases with product use during different time periods, past history in each jurisdiction, as well as many other data points. All of this combines for more information so that your entity can be better prepared to handle the litigation it faces and can navigate a future given its involvement in the litigation.
Overall, an NCC team is the missing piece to your business’ litigation team. An NCC team manages your litigation, but more importantly, they add value to produce better and more predictable outcomes. For your organization to continue to succeed, it should be proactive regarding the possibility of mass litigation. This includes involving an NCC as soon as possible, as it allows your NCC to provide as much value as possible by preparing as much as they can before the cases start rolling in.

New Rx for High Drug Prices? Senate Judiciary Committee Advances Six Bills With Heavy Dose of Options

The US Senate Judiciary Committee advanced to the full Senate six bills intended to reduce pharmaceutical prices and enhance market competitiveness. The package collectively targets several aspects of the pharmaceutical landscape, including pharmaceutical benefit manager (PBM) pricing practices, next-generation drug releases, patent portfolio assertions, and use of US Food and Drug Administration (FDA) regulatory mechanisms. Many of the bills’ proposals have been proposed before, but it is significant that the six bills were moved to the full Senate with bipartisan support.
The Affordable Prescriptions for Patients Act, if passed, would limit how many patents a reference product sponsor can assert in a Biologics Price Competition and Innovation Act (BPCIA) litigation against a biosimilar applicant, although such limits could be surpassed with court approval. A biologics license holder could assert up to 20 patents in a BPCIA case. Certain patents, such as method of treatment patents, would fall outside the limitation.
Against the backdrop of the Supreme Court’s 2013 holding in FTC v. Watson that certain “pay for delay” agreements are prohibited as anticompetitive, the Preserve Access to Affordable Generics and Biosimilars Act would add precision to the boundaries of permissible settlements in the pharmaceutical industry. The Federal Trade Commission (FTC) would have specific authority to institute a civil action to recover penalties, and certain presumptions would apply. For example, any agreement providing a generic or biosimilar applicant with “anything of value, including an exclusive license,” would be presumptively anticompetitive, with certain exceptions and exclusions. Terms that would remain permissible include a pre-expiration launch date, reasonable litigation expenses, and covenants not to sue for patent infringement.
Targeting the concern that branded small molecule and biologics drug manufacturers release new products with patent protection and withdraw or unfairly disincentivize older products to avoid generic competition, the Drug Competition Enhancement Act would deem the alleged practice of “product hopping” unfair competition subject to enforcement actions. The bill would define a hard switch as when a branded or biologics manufacturer discontinues or withdraws an application and introduces a follow-on product within a certain period relative to generic or biosimilar approval. It would define a soft switch as when the brand manufacturer took actions that “that unfairly disadvantage the listed drug or reference product relative to [a] follow-on product.” The bill would provide specific exclusions and justifications for branded manufacturer actions that would otherwise constitute a hard or soft switch.
Seeking to curb perceived abuses of the FDA citizen petition process, the Stop Significant and Time-Wasting Abuse Limiting Legitimate Innovation of New Generics (Stop STALLING) Act would grant the FTC the authority to bring a civil action against those filing “sham petitions” with the FDA, with penalties up to $50,000 per calendar day of review or the revenue earned by the seller of the branded product, whichever is greater. A petition could be classified as a sham based on its own objective unreasonableness, an intention to delay approval of a generic or biosimilar product, or as part of a series of covered petitions.
Based on the belief that FDA applications may include information relevant to patentability but not presented to patent examiners, the Interagency Patent Coordination and Improvement Act would create an FDA-US Patent & Trademark Office task force to establish processes for sharing submitted information. The goal would be for patent examiners to be able to access and review FDA applications where appropriate, subject to confidentiality restrictions. One area expressly identified for use is the public availability of inventions (i.e., whether subject matter in patent applications was on sale before the relevant effective date).
Finally, the Prescription Pricing for the People Act, if enacted, would require the FTC to publish a report analyzing the pharmaceutical supply chain, with specific inquiries about PBM pricing practices. The bill also calls for the report to describe FTC complaints received about, and authority to act against, sole-source drug manufacturers.

Prosecution Disclaimer Alive and Well, Especially in Closed Claim

The US Court of Appeals for the Federal Circuit affirmed a district court’s noninfringement determination, finding that the presence of a disclaimed compound in the accused product precluded infringement. Azurity Pharm., Inc. v. Alkem Lab’ys Ltd., Case No. 23-1977 (Fed. Cir. Apr. 8, 2025) (Moore, Chen, Murphy, JJ.)
Azurity owns a patent directed to a nonsterile, stable liquid formulation of vancomycin hydrochloride, specifically designed for oral administration to treat Clostridium difficile infections. Following Alkem’s submission of an Abbreviated New Drug Application (ANDA), Azurity brought a Hatch-Waxman Act claim against Alkem for infringement of certain claims of the patent. The district court found that Azurity had disclaimed the presence of propylene glycol in the claimed formulation during the prosecution. Since Alkem’s ANDA product contained propylene glycol, the district court held that it did not infringe. Azurity appealed.
The Federal Circuit affirmed, focusing on the patent’s prosecution history and noting that Azurity used the lack of propylene glycol to distinguish its claimed invention from the prior art. The Court noted that this distinction was made during prosecution multiple times in response to the examiner’s rejections, and that Azurity had added negative claim limitations that specifically omitted propylene glycol from the scope of the claims.
The Federal Circuit also noted that Azurity used a “consisting of” transitional phrase to narrow the claims and relied on the closed transition to overcome the prior art. The Court explained that “consisting of” is a closed transition that limits the claim scope to only the recited components. By using this transition and not including propylene glycol as one of the claim components, Azurity effectively disclaimed propylene glycol from the invention. Therefore, the Court found that omission of propylene glycol during patent prosecution was “clean, unambiguous, and complete.”
Azurity argued that a pretrial stipulation between the parties, which stated that “[s]uitable flavoring agents for use in the asserted claims include flavoring agents with or without propylene glycol,” should preclude the application of the disclaimer. The Federal Circuit did not find this argument persuasive, concluding that the stipulation did not alter the clear and unambiguous disclaimer made during prosecution, nor did it affect the noninfringement finding. Since Alkem’s ANDA product contained propylene glycol and Azurity disclaimed inclusion of propylene glycol, there was no infringement.

Ethylene Oxide Case Starts Trial In Georgia

Ethylene Oxide (EtO) is an industrial solvent widely used as a sterilizing agent for medical and other equipment that cannot otherwise be sterilized by heat/steam. EtO may also be used as a component for producing other chemicals, including glycol and polyglycol ethers, emulsifiers, detergents, and solvents. Allegations that exposure to EtO increases the risk of certain cancers has led to governmental regulation as well as private tort actions against companies that operate sterilization facilities that utilize EtO. The most recent example of the latter is a trial that started this week in Georgia.
Ethylene Oxide Trial History
The first ethylene oxide case to go to trial was the Kamuda matter, in which an Illinois jury awarded $263 million in September of 2022 against Sterigenics for ethylene oxide exposure from that company’s Willowbrook facility. A subsequent trial in the same jurisdiction against the same defendant resulted in a defense verdict. Ultimately, Sterigenics resolved its pending claims involving the Willowbrook plant in the amount of $408 million. In December of 2024, a Philadelphia Court of Common Pleas jury found the defendant B. Braun Manufacturing Inc. not liable on all counts. The plaintiff had alleged that her husband developed leukemia as a result of working at the defendant’s sterilization plant in Allentown, Pennsylvania for seven years. Notably, unlike the Illinois trials, the Philadelphia trial involved an employee at the sterilization facility as opposed to the Illinois plaintiffs who did not work at the Willowbrook plant but resided nearby.
Last month, a Colorado jury rendered a verdict in favor of defendant Terumo BCT Inc. (Isaacks et al. v. Terumo BCT Sterilization Services Inc. et al. in the First Judicial District of Colorado (docket number 2022CV031124). This was a bellwether trial that lasted six weeks, and involved four female plaintiffs. The jury determined that the defendant was not negligent in its handling of emissions from its Lakewood plant. The plaintiffs had sought $217 million in damages for their alleged physical impairment and also $7.5 million for past and future medical expenses as well as punitive damages. In light of the fact that the six person jury found the defendant Terumo not negligent, it did not need to consider damages or causation. Notably, there remain hundreds more pending claims against Terumo in Colorado. In fact, plaintiffs’ counsel filed almost 25 more cases while the trial was in progress. All of the plaintiffs alleged that they had developed cancer as a result of ethylene oxide emissions from the Terumo facility. One plaintiff alleged breast cancer as a result of 23 years of exposure from the plant, while another alleged breast cancer after almost 35 years of exposure (these two plaintiffs were neighbors). Another plaintiff alleged multiple myeloma while the fourth plaintiff alleged Hodgkin’s lymphoma.
Georgia Trial Starts
Earlier this week, an EtO trial commenced against CR. Bard in Georgia. At issue is the company’s medical equipment sterilization plant in Covington, Georgia. The plaintiff, who had been a truck driver, alleges that he would make pickups at the plant on a regular basis, and, coupled with the fact that he resided one and half miles from the plant, was exposed to EtO and developed non-Hodgkin lymphoma. The plaintiff alleges that the company failed to take appropriate steps to protect he and the community from EtO. According to plaintiff’s allegations, the Covington facility emitted 9.8 million pounds of EtO from 1970 to 2017, that there were no controls until 1990, and that there were multiple instances of unintended EtO releases. Further, there are claims that Union Carbide, which had suppled EtO to the plant, had warned the company. Until 1990 there was nothing at all interfering with the release of the gas outside the plant, he said, claiming to the jury that any controls the plant put in place were done because the company was “forced” to, and that there were numerous “unintended” release incidents over the years. Even Bard’s EtO supplier, Union Carbide, had warned Bard, Daniel said.
For its part, Bard and Becton Dickinson (Bard’s parent company), maintain that the plant has always been a good corporate citizen and that the plaintiff’s cancer was not caused by EtO but rather by a random DNA mutation. Plaintiff counsel told the jury that the Food and Drug Administration has noted the critical role that EtO plays in the country’s healthcare system and that over 50% of medical products are sterilized with EtO.
Analysis
Recently, we’ve seen increased trial activity with respect to EtO trials. As set out above, there have now been cases taken to verdict in Illinois, Pennsylvania, and Colorado. And now a case has started trial in Georgia. There is also EtO litigation activity in California, though those cases are still in the discovery phase. As noted in previous postings, we expect that plaintiff firms will recruit new clients who allege some type of cancer as a result of residing in the vicinity of an ethylene oxide plant, particularly if the Georgia trial results in a plaintiff verdict. How long will it be until we see television advertisements run by plaintiff firms seeking new plaintiffs? We’ve seen this in asbestos, talc, contaminated water, firefighting foam, defective earplugs, and other types of litigation. It is not out of the realm of possibility to think that we will see this with ethylene oxide litigation at some point in the near future.

This Week in 340B: April 8 – 14, 2025

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick summary of relevant updates from the prior week in this industry-shaping body of litigation.
Issues at Stake: Rebate Model; Contract Pharmacy

In five cases against the Health Resources and Services Administration (HRSA) related to rebate models:

In one case, amici filed an amicus brief in support of the government.
In one case, a plaintiff filed a brief in opposition to defendants’ cross motion for summary judgment and reply in support of summary judgment.
In four cases, intervenor defendants filed a reply brief in support of their cross motion for summary judgment.

In a case challenging a Utah law that would restrict manufacturers’ ability to restrict contract pharmacy arrangements, the plaintiffs filed a motion for a preliminary injunction.
In two appealed cases challenging a Louisiana law governing contract pharmacy arrangements, the defendant and intervenor-defendant filed their briefs.
In a case by a drug manufacturer challenging an Arkansas state law governing contract pharmacy arrangements, the drug manufacturer filed a motion to strike a declaration.
Two drug manufacturer filed four separate complaints to challenge four state laws restricting contract pharmacy arrangements.

Reuben Bank and Deepika Raj also contributed to this article.

March 2025 Bounty Hunter Plaintiff Claims

California’s Proposition 65 (“Prop. 65”), the Safe Drinking Water and Toxic Enforcement Act of 1986, requires, among other things, sellers of products to provide a “clear and reasonable warning” if use of the product results in a knowing and intentional exposure to one of more than 900 different chemicals “known to the State of California” to cause cancer or reproductive toxicity, which are included on The Proposition 65 List. For additional background information, see the Special Focus article, California’s Proposition 65: A Regulatory Conundrum.
Because Prop. 65 permits enforcement of the law by private individuals (the so-called bounty hunter provision), this section of the statute has long been a source of significant claims and litigation in California. It has also gone a long way in helping to create a plaintiff’s bar that specializes in such lawsuits. This is because the statute allows recovery of attorney’s fees, in addition to the imposition of civil penalties as high as $2,500 per day per violation. Thus, the costs of litigation and settlement can be substantial.
In March of 2025, product manufacturers, distributors, and retailers were the targets of 283 new Notices of Violation (“Notices”), as well as 75 amended Notices, alleging a violation of Prop. 65 for failure to provide a warning for their products. This was based on the alleged presence of the following chemicals in these products. Noteworthy trends and categories from new Notices sent in March 2025 are excerpted and discussed below. A complete list of all new and amended Notices sent in March 2025 can be found on the California Attorney General’s website, located here: 60-Day Notice Search.

Food and Drug

Product Category
Notice(s)
Alleged Chemicals

Assorted Prepared Food and Snacks: Notices include sunflower seeds, granola, instant soup, chips, crackers, and energy bars
50Notices
Cadmium, Lead and Lead Compounds, Mercury and Mercury Compounds

Dietary Supplements: Notices include pea protein powder, protein shake blends, dietary fiber supplements, and cinnamon supplements
33Notices
Cadmium, Mercury and Mercury Compounds, Lead and Lead Compounds, Bisphenol A, Perfluorooctanoic Acid (PFOA), and Perfluorooctane Sulfonate (PFOS)

Fruits and Vegetables: Notices include pickled ginger, kale chips, and dried mango slices
12Notices
Lead and Lead Compounds

Seafood: Notices include shrimp, crab cakes, mussels, and anchovies
9Notices
Cadmium and Lead and Lead Compounds

Assorted Prepared Food and Snacks: Notices include coconut water, black beans, and plant-based chicken
5Notices
Bisphenol A (BPA)

Cannabinoid Products: Notices include gummies and coffee
5Notices
Delta-9-tetrahydrocannabinol

Seafood: Notices include anchovies, smoked clams, and sardines
5Notices
Perfluorononanoic acid (PFNA) and its salts, Perfluorooctanoic Acid (PFOA), and Perfluorooctane Sulfonate (PFOS)

Noodles, Pasta, and Grains: Notices include penne and gluten-free fusilli
4Notices
Lead and Cadmium

Spices and Sauces: Notices include mole, curry, and vegan Bolognese
4Notices
Lead and Lead Compound

Fruits and Vegetables: Notices include mushrooms and pineapple slices
2Notices
Bisphenol A (BPA)

Seafood: Notices include chunk light tuna
1Notice
Bisphenol A

Cosmetics and Personal Care

Product Category
Notice(s)
Alleged Chemicals

Personal Care Items: Notices include shower caps and body tape
6Notices
Perfluorooctanoic Acid (PFOA)

Personal Care Products: Notices include lotion, hair oil, and shave gel
6Notices
Diethanolamine

Personal Care Products: Notices include hair growth jelly
1Notice
Lead

Consumer Products

Product Category
Notice(s)
Alleged Chemicals

Glassware and Ceramics: Notices include serving dishes, mugs, bowls, and vases
34Notices
Lead

Plastic Pouches, Bags, and Accessories: Notices include clutches, toy baskets, travel cases, and cross-body bags
33Notices
Di(2-ethylhexyl)phthalate (DEHP), Diisononyl phthalate (DINP), and Di-n-butyl phthalate (DBP)

Clothing: Notices include jackets, hoodies, shoes, and shorts
15Notices
Di(2-ethylhexyl)phthalate (DEHP), Diisononyl phthalate (DINP), and Di-n-butyl phthalate (DBP)

Housewares: Notices include umbrellas, shower curtain liners, and washcloths
15Notices
Perfluorooctane Sulfonate (PFOS) and Perfluorooctanoic Acid (PFOA)

Housewares: Notices include tablecloths, corkscrews, and rope lights
11Notices
Di(2-ethylhexyl)phthalate (DEHP), Diisononyl phthalate (DINP) and Di-n-butyl phthalate (DBP)

Tools: Notices include first aid kits, clamps, valves, safety vests, and natural gas conversion kits
11Notices
Di(2-ethylhexyl)phthalate (DEHP), Diisononyl phthalate (DINP), and Lead

Gloves
4Notices
Chromium (hexavalent compounds)

Housewares: Notices include lunch bags, generator covers, and athletic tape
4Notices
Perfluorooctanoic Acid (PFOA)

Moth Balls
4Notices
Naphthalene and p-Dichlorobenzene

Housewares: Notices include canes, brass bells, and air fresheners
3Notices
Lead

Jackets
3Notices
Perfluorooctanoic Acid (PFOA)

Sports Equipment: Notices include jump ropes and hockey sticks
2Notices
Di(2-ethylhexyl)phthalate (DEHP)

Furniture Wax
1Notice
Toluene

There are numerous defenses to Prop. 65 claims and proactive measures that industry can take prior to receiving a Prop. 65 Notice in the first place. Keller and Heckman attorneys have extensive experience in defense of Prop. 65 claims and in all aspects of Prop. 65 compliance and risk management. We provide tailored Prop. 65 services to a wide range of industries, including food and beverage, cosmetics and personal care, consumer products, chemical products, e-vapor and tobacco products, household products, plastics and rubber, and retail distribution.

Petitions Filed to Add Chemicals to List of Chemical Substances Subject to Superfund Excise Tax

On April 2 and April 3, 2025, the Internal Revenue Service (IRS) announced that petitions have been filed to add the following chemicals to the list of taxable substances:

Recent Federal Developments for April 15, 2025

TSCA/FIFRA/TRI
EPA Releases New TSCA And FIFRA Enforcement Policies: On January 17, 2025, days before the end of President Biden’s term, the U.S. Environmental Protection Agency (EPA) released two new enforcement documents: (1) Expedited Settlement Agreement Pilot Program Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (FIFRA Settlement Pilot Program or Pilot Program); and (2) Interim Consolidated Enforcement Response and Penalty Policy (CERPP) for the Toxic Substances Control Act (TSCA) New and Existing Chemicals Program. In that both of these enforcement documents were prepared by the prior Administration, their enduring relevance, like so many other issues at EPA, is unclear. As new leadership populates the ranks at EPA program offices, including the Office of Enforcement and Compliance Assurance, we may learn more. For more information on these enforcement documents, please read our March 21, 2025, memorandum.
EPA Argues For Remand Of Final Rule Amending Risk Evaluation Framework: On March 21, 2025, the U.S. Court of Appeals for the District of Columbia Circuit heard oral argument in a case challenging EPA’s May 3, 2024, final rule amending the procedural framework rule for conducting risk evaluations under TSCA. United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union (USW) v. EPA, Consolidated Case No. 24-1151. If you have a couple of hours to spare, listening to the argument is well worth the time. The court was uniquely curious about the litigants’ request for a remand and probed deeply into the difference between a remand and a vacatur. Judge Rao bluntly questioned on what authority the court could rely to remand the case. An answer was not forthcoming, fueling speculation the court will rule on the merits. According to EPA, the court should not rule on the case when the Agency plans to revise and issue a new final rule by April 2026. The court expressed skepticism that EPA can complete a rulemaking so quickly. The court also questioned when TSCA requires that conditions of use (COU) be identified, whether making a single risk determination for a chemical is consistent with TSCA, and whether USW has standing to challenge the May 2024 rule’s provisions regarding personal protective equipment (PPE). More information is available in our March 31, 2025, blog item.
EPA Postpones Effective Date Of Certain Provisions Of TCE Risk Management Rule To June 20, 2025: On April 2, 2025, EPA announced that it is postponing the effectiveness of certain provisions of its December 17, 2024, final risk management rule for trichloroethylene (TCE) until June 20, 2025. 90 Fed. Reg. 14415. EPA states in the April 2, 2025, notice that, in light of pending litigation, it has reconsidered its position from its earlier denial of an administrative stay pending judicial review and determined that justice requires a 90-day postponement of the effective date of the conditions for each of the TSCA Section 6(g) exemptions. According to EPA, petitioners allege that because the interim workplace conditions would require petitioners to reduce TCE exposure levels to the interim existing chemical exposure limit (ECEL) of 0.2 parts per million (ppm), the final rule effectively requires the use of PPE “that cannot feasibly be worn all day, and therefore could cause petitioners to cease operations.” EPA notes that although it does not concede these allegations, “petitioners have raised significant legal challenges and allege significant harms as a result of the workplace conditions required by the final rule’s TSCA section 6(g) exemptions.” EPA states that “[m]oreover, a limited postponement that maintains the status quo for these uses appropriately balances the alleged harm to petitioners and other entities with critical uses against the public interest in the health protections that will be afforded by the broader TCE prohibitions and workplace protections going into effect.”
EPA Announces Changes To Pesticide Data Submission Process For Data Matrix Form: On April 3, 2025, EPA announced changes on how the data matrix form (EPA Form 8570-35) is submitted to EPA, stating this change is an improvement to simplify the process for how companies submit data to EPA as part of a pesticide registration package. EPA states these improvements also will make EPA’s processing of this information more efficient. Companies are required to submit a data matrix form when their pesticide registration packages contain submitted data or cited data from outside sources. Previously, companies submitted two versions of the data matrix form (in either paper or electronic format): one for internal EPA use and one with reference data redacted for public use. EPA states in the interest of reducing burden and, according to EPA, because no information on the data matrix form is confidential business information (CBI), it determined that there is no need for a redacted version and is now only requiring one unredacted version of the form to be submitted for both internal and public use. Additionally, EPA will no longer accept paper submissions of this form and will only accept this information via a web-based portal.
Additional information on the new update is available in EPA’s recently issued Pesticide Registration (PR) Notice 2025-1. Instructions on how to complete and submit the revised forms will be available in the updated Pesticide Registration Manual.
EPA Proposes SNURs For Certain Chemical Substances: EPA proposed significant new use rules (SNUR) on April 4, 2025, for certain chemical substances that were the subject of premanufacture notices (PMN) and are also subject to an Order issued by EPA pursuant to TSCA. 90 Fed. Reg. 14743. The SNURs require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is proposed as a significant new use by this rulemaking to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA’s evaluation of the conditions of that use for that chemical substance. In addition, the manufacture or processing for the significant new use may not commence until EPA has conducted a review of the required notification, made an appropriate determination regarding that notification, and taken such actions as required by that determination. Comments are due May 5, 2025.
RCRA/CERCLA/CWA/CAA/PHMSA/SDWA
States Take Action To Regulate And Limit PFAS In Industrial Effluent Despite Federal Inaction: On January 21, 2025, EPA’s proposed rule seeking to set effluent limitation guidelines for certain PFAS under the Clean Water Act (CWA) was withdrawn from Office of Management and Budget (OMB) review following President Trump’s Executive Order (EO) implementing a regulatory freeze. Federal action may be halted, but states are beginning to enact legislation that seeks to address PFAS contained in industrial effluent. These laws are currently sparse, with Maryland being the most recent state to establish a robust framework that requires industrial sources to limit PFAS in effluent. A handful of other states have laws establishing monitoring and reporting protocols for PFAS in industrial effluent, and other states have similar frameworks planned for future implementation. While these efforts are not yet widespread, heightened scrutiny of PFAS use suggests that more and more states will seek to monitor and limit PFAS in industrial effluent. For more information, please read our March 28, 2025, memorandum.
EPA Accepts Requests For Presidential Exemption Under CAA Section 112: On March 12, 2025, EPA set up an electronic mailbox to allow the regulated community to request a Presidential Exemption under Section 112(i)(4) of the Clean Air Act (CAA). EPA states that the CAA allows the President to exempt stationary sources of air pollution from compliance with any standard or limitation under Section 112 for up to two years if the technology to implement the standard is not available and it is in the national security interests of the United States to do so. EPA notes that submitting a request does not entitle the submitter to an exemption and that the President will make a decision on the merits. An exemption may be extended for up to two additional years and can be renewed, if appropriate. Requests were due March 31, 2025.
EPA Extends Reporting Deadline Under GHG Reporting Rule For 2024 Data: On March 20, 2025, EPA extended the reporting deadline under the Greenhouse Gas (GHG) Reporting Rule for reporting year 2024 data from March 31, 2025, to May 30, 2025. 90 Fed. Reg. 13085. The rule changes only the reporting deadline for annual GHG reports for reporting year 2024. It does not change the reporting deadline for future years, and it does not change the requirements for what regulated entities must report. The rule was effective March 20, 2025.
EPA And Army Corps Of Engineers Announce WOTUS Listening Sessions And Solicit Stakeholder Feedback: On March 24, 2025, EPA and U.S. Army Corps of Engineers announced that they will hold listening sessions on specific key topic areas to hear interested stakeholders’ perspectives on defining “waters of the United States” (WOTUS) consistent with the Supreme Court’s interpretation of the scope of CWA jurisdiction and how to implement that interpretation as the agencies consider next steps. 90 Fed. Reg. 13428. The listening sessions will be held in-person with a virtual option for states, Tribes, industry and agricultural stakeholders, environmental and conservation stakeholders, and the general public. The agencies seek input from a full spectrum of co-regulators and stakeholders on key topic areas related to the definition of WOTUS in light of Sackett v. EPA regarding “continuous surface connection,” “relatively permanent,” and jurisdictional versus non-jurisdictional ditches. The agencies also seek input on implementation challenges related to those key topic areas. Information on the listening sessions is available on EPA’s website. The agencies are also accepting written recommendations from members of the public via a recommendations docket. Written recommendations are due April 23, 2025.
EPA Issues Partial Stay Of Integrated Iron And Steel Manufacturing Facilities Technology Review: By a letter dated August 14, 2024, and supplemented by a letter dated March 5, 2025, the EPA’s Office of Air and Radiation announced the convening of a proceeding for reconsideration of certain requirements in the final rule “National Emission Standards for Hazardous Air Pollutants: Integrated Iron and Steel Manufacturing Facilities Technology Review,” published on April 3, 2024. On March 31, 2025, EPA issued a final rule that stayed provisions establishing compliance deadlines in 2025 for requirements that were added or revised by the April 3, 2024, final rule for 90 days pending reconsideration. 90 Fed. Reg. 14207. EPA states that it will reconsider the following topics from two petitions pursuant to CAA Section 307(d)(7)(B): work practice standards for unmeasured fugitive and intermittent particulate from unplanned bleeder valve openings; the opacity limit for planned bleeder valve openings; work practice standards for bell leaks; and the opacity limit for slag processing and handling. The final rule was effective March 31, 2025.
EPA Will Review NESHAP For Brick And Structural Clay Products Manufacturing And Clay Ceramics Manufacturing: On March 31, 2025, EPA requested comments for a review pursuant to Section 610 of the Regulatory Flexibility Act of the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Brick and Structural Clay Products Manufacturing; and Clay Ceramics Manufacturing (Brick and Clay 610 Review). 90 Fed. Reg. 14227. EPA states that as part of this review, it will consider comments on the following factors: the continued need for the rule; the nature of complaints or comments received concerning the rule; the complexity of the rule; the extent to which the rule overlaps, duplicates, or conflicts with other federal, state, or local government rules; and the degree to which the technology, economic conditions, or other factors have changed in areas affected by the rule. Comments are due May 30, 2025.
EPA Will Review New Science On Fluoride In Drinking Water: EPA announced on April 7, 2025, that it will “expeditiously review new scientific information on potential health risks of fluoride in drinking water.” According to EPA, the evaluation will inform its decisions on the standard for fluoride under the Safe Drinking Water Act (SDWA). EPA notes that the National Toxicology Program (NTP) released a report in August 2024 concluding with “moderate confidence” that fluoride exposure above 1.5 milligrams per liter is associated with lower intelligence quotient (IQ) in children and that more research is needed to understand better if there are health risks associated with exposure to lower fluoride concentrations.  EPA states that it “is committing to conduct a thorough review of these findings and additional peer reviewed studies to prepare an updated health effects assessment for fluoride that will inform any potential revisions to EPA’s fluoride drinking water standard.”
FDA
FDA Provides Summary Data On Cosmetic Product Facility And Product Registration Listing: On March 13, 2025, the U.S. Food and Drug Administration (FDA) updated constituents by providing a tabulated summary of the data collected from its mandatory registration of cosmetic product facilities and listings of cosmetic products under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). MoCRA requires manufacturers and processors to register their facilities and renew registrations every two years. This requirement includes providing details on the type of cosmetic products manufactured or processed, and a list of ingredients used in those products at each facility. The tabulated list includes the number of domestic and foreign registered facilities as of January 1, 2025. There are 1,800 domestic facilities registered and 7,732 foreign facility registrations, with the highest number of facility registrations being noted in China with 4,260.
FDA Announces Chemical Contaminants Tool: On March 20, 2025, FDA announced the Chemical Contaminants Transparency Tool for foods, which is an online database providing a list of contaminant levels used by FDA to evaluate potential health risks of contaminants in human foods. The tool lists thresholds (e.g., action levels, recommended maximum levels) for contaminants such as heavy metals and pesticides, in foods. The FDA Acting Commissioner stated that “Ideally there would be no contaminants in our food supply, but chemical contaminants may occur in food when they are present in the growing, storage or processing environments.”
FDA Intends To Extend Compliance Date For FSMA Program: On March 20, 2025, FDA announced an intention to extend the compliance date for the Food Safety Modernization Act (FSMA) Food Traceability Rule by 30 months. An excerpt from the announcement states that “FDA intends to use the extended time period to continue the agency’s work with stakeholders, including by participating in cross-sector dialogue to identify solutions to implementation challenges and by continuing to provide technical assistance, tools, and other resources to assist industry with implementation.” Additional details for the Food Traceability Rule are available at the link here.
NANOTECHNOLOGY
EC Scientific Committee Begins Public Consultation On Preliminary Opinion On Hydroxyapatite (Nano): On April 3, 2024, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) began a public consultation on its preliminary opinion on the safety of hydroxyapatite (nano) in oral products. The EC asked SCCS if it considers hydroxyapatite (nano) safe when used in toothpaste up to a maximum concentration of 29.5 percent and in mouthwash up to a maximum concentration of ten percent according to the specifications as reported in the submission, taking into account reasonably foreseeable exposure conditions. According to the preliminary opinion, based on the data provided, SCCS considers hydroxyapatite (nano) safe when used at concentrations up to 29.5 percent in toothpaste, and up to ten percent in mouthwash. Comments on the preliminary opinion are due May 30, 2025. More information is available in our April 9, 2025, blog item.
EUON Publishes Nanopinion On Enhancing The Regulatory Application Of NAMs To Assess Nanomaterial Risks In The Food And Feed Sector: On April 8, 2025, the EU Observatory for Nanomaterials (EUON) published a Nanopinion entitled “A Qualification System to Accelerate Development and Regulatory Implementation of New Approach Methodologies (NAMs).” The authors explain how the NAMs4NANO project, funded by the European Food Safety Authority (EFSA), enhances the regulatory application of NAMs for assessing nanomaterial risks in the food and feed sector. The authors propose to establish three qualification programs, covering NAMs for nanomaterial physicochemical characterization, characterization of nanomaterials in relevant biological fluid and toxicity screening. More information is available in our April 15, 2025, blog item.
PUBLIC POLICY AND REGULATION
What It Means To Be “Essential” In The Federal Workforce: Current news on the government efficiency and reform front concerns the near-miss of a government shutdown (the budget would have lapsed at midnight on March 14, 2025). One reason some cited against allowing a shutdown to occur is how it might encourage or otherwise aid in attempts to eliminate positions if they were deemed “essential” or not. The recent potential shutdown was averted, but the essential/non-essential distinction will have little meaningful impact on workforce planning. Federal agencies have long had plans for a possible shutdown, especially in recent years, distinguishing who or what positions were needed if the budget was not authorized in time. These designations are already made, so if the categorization was useful as some kind of autonomous decision mechanism to make personnel decisions, shutdown or no shutdown would not make a difference. For more thoughts on this issue, please read our March 19, 2025, blog item.
Reorganize EPA? A Very Old Idea: Recent press reports tell of rumors of impactful (some fear catastrophic) budget cuts to EPA. The organization of EPA, and how that organization impacts its effectiveness, has been an issue since its founding. From its earliest days, there have been proposals for making EPA a cabinet-level Department. During the George H.W. Bush Administration, to knit together the programs and statutes more coherently, the EPA policy office developed a comprehensive draft of possible ways to reorganize the underlying environmental legislation and a parallel EPA structure. Most recently, and perhaps most important given the current Administration’s efforts at government reform, the subject of “reorganizing” EPA is included as a chapter in the Project 2025 report. That chapter has led to fears from many that budget and personnel cuts are part of a larger plan to upend the Agency. Recent press reports (like The Washington Post’s March 27, 2025, article, “Internal White House document details layoff plans across U.S. agencies”) indicate that the “plan” for EPA is to cut 10 percent of its workforce — which would seem less than some aggregated possibilities discussed in the Project 2025 chapter but could still include “firing up to 1,115 people” from the Office of Research and Development (ORD) alone. Project 2025 suggests large cuts to regional offices, the elimination of the Integrated Risk Information System (IRIS) program, a “reorganization” of the enforcement office and environmental justice programs, and other changes which would seem to add up to less than a 10 percent cut to the workforce. Attrition rates alone are estimated to be an average of 6 percent, and early retirements accelerated by, among other things, the fear of possible cuts, would likely add up to 10 percent or more.
But the goal of reforming, reorganizing, or reducing the workforce is neither a new idea nor one lacking merit. EPA’s organizational structure has been under review since its inception. In the present moment, however, the lack of a cohesive or consistent approach leaves significant questions not only about the underlying motivation but also about the final impact of the effort. “Less bureaucracy” does not necessarily equate to reduced numbers of staff. And as some government functions will now contend with seemingly disorganized staff reductions, public resentment about “the bureaucracy” may only increase. Something to think about as we wait (and hope) to get our social security check or passport — or pesticide registration — on time. More information is available in our April 2, 2025, blog.
The Clock Is Ticking For Republicans To Use The Congressional Review Act: Congress has approximately one month to use the Congressional Review Act (CRA) to undo qualifying Biden Administration-issued regulations. According to an updated analysis by Bloomberg Government, the estimated period to expedite repeal of Biden Administration rules ends May 8, 2025. This gives Congress approximately four weeks to act on the dozens of pending CRA bills. More information is available in our April 10, 2025, blog item.
LEGISLATIVE
House Bill Would Codify EPA’s Office Of Children’s Health Protection: On March 25, 2025, Representatives Jerrold Nadler (D-NY), John Garamendi (D-CA), and Kathy Castor (D-FL) reintroduced the Children’s Health Protection Act of 2025 (H.R. 2339) that would codify into law the only office within EPA dedicated to children’s health, the Office of Children’s Health Protection (OCHP). According to Nadler’s March 25, 2025, press release, this office would be responsible for rulemaking, policy, enforcement actions, research, and applications of science that focus on prenatal and childhood vulnerabilities, safe chemicals management, and coordination of community-based programs. The bill would make the EPA Children’s Health Protection Advisory Committee a permanent advisory committee. This advisory committee will advise the EPA Administrator in regard to the activities of the Office of Children’s Health Protection, all relevant information regarding regulations, research, and communications related to children’s health, and continue to serve the EPA in protecting children from environmental harm.
Nitrate And Arsenic In Drinking Water Act Reintroduced In The House: On Aril 3, 2025, Representatives David Valadao (R-CA) and Norma Torres (D-CA) reintroduced the Nitrate and Arsenic in Drinking Water Act (H.R. 2656). According to Valadao’s April 3, 2025, press release, the bipartisan bill would:

Amend the SDWA to provide grants for nitrate and arsenic reduction;
Authorize $15 million for fiscal year 2026 and every fiscal year after; and
Direct the EPA Administrator to conduct a review on programs under the SDWA, taking into consideration the diverse needs of underserved populations.

Bipartisan Bill Would Clean Up Marine Debris: On April 3, 2025, Representatives Suzanne Bonamici (D-OR), Amata Coleman Radewagen (R-American Samoa-At Large), and James Moylan (R-Guam-At Large) introduced the Save Our Seas (S.O.S.) 2.0 Amendments Act of 2025 (H.R. 2620) to strengthen efforts to combat marine debris and protect the ocean. According to Bonamici’s April 3, 2025, press release, the bipartisan bill builds upon the success of the Save Our Seas 2.0 Act and provides greater flexibility to the National Oceanic and Atmospheric Administration (NOAA) to work with other stakeholders in marine debris prevention and removal efforts.
MISCELLANEOUS
Canada Releases Final State Of PFAS Report And Proposed Risk Management Approach: On March 5, 2025, Environment and Climate Change Canada (ECCC) announced the availability of its final State of Per- and Polyfluoroalkyl Substances (PFAS) Report (State of PFAS Report) and proposed risk management approach for PFAS, excluding fluoropolymers. The State of PFAS Report concludes that the class of PFAS, excluding fluoropolymers, is harmful to human health and the environment. To address these risks, Canada proposed on March 8, 2025, to add the class of PFAS, excluding fluoropolymers, to Part 2 of Schedule 1 to the Canadian Environmental Protection Act, 1999 (CEPA). ECCC states that it will prioritize the protection of health and the environment while considering factors such as the availability of alternatives. Phase 1, starting in 2025, will address PFAS in firefighting foams to protect better firefighters and the environment. Phase 2 will focus on limiting exposure to PFAS in products that are not needed for the protection of human health, safety, or the environment. ECCC notes that this will include products like cosmetics, food packaging materials, and textiles. ECCC states that it will publish a final decision on the proposed addition of 131 individual PFAS to the National Pollutant Release Inventory (NPRI) with reporting to take place by June 2026 for PFAS releases that occurred during the 2025 calendar year. ECCC states that these data will improve its understanding of how PFAS are used in Canada, help it evaluate possible industrial PFAS contamination, and support efforts to reduce environmental and human exposure to harmful substances. Comments on the proposed risk management approach and the proposed order to add the class of PFAS, excluding fluoropolymers, to CEPA Schedule 1 Part 2 are due May 7, 2025. More information is available in our March 24, 2025, memorandum.
Amazon Files Suit Against CPSC, Challenging CPSC’s Determination That Amazon Is A Distributor: On March 14, 2025, Amazon filed suit against the Consumer Product Safety Commission (CPSC) in the U.S. District Court for the District of Maryland, challenging CPSC’s July 29, 2024, and January 16, 2025, orders determining that Amazon is “a ‘distributor’ of certain products that are defective or fail to meet federal consumer product safety standards, and therefore bears legal responsibility for their recall.” According to CPSC’s January 17, 2025, announcement, “[m]ore than 400,000 products are subject to this Order: specifically, faulty carbon monoxide (CO) detectors, hairdryers without electrocution protection, and children’s sleepwear that violated federal flammability standards.” CPSC determined that the products, listed on Amazon.com and sold by third-party sellers using the Fulfillment by Amazon (FBA) program, pose a “substantial product hazard” under the Consumer Product Safety Act (CPSA). In its complaint, Amazon argues that CPSC “overstepped” the statutory limits of the CPSA by ordering “a wide-ranging recall of products that were manufactured, owned, and sold by third parties,” not Amazon itself. Amazon states that CPSC’s recall order “relies on an unprecedented legal theory that stretches the [CPSA] beyond the breaking point and fails to discharge” CPSC’s obligations under the Administrative Procedure Act (APA). More information is available in our March 20, 2025, blog item.
NSF Announces PFAS-Free Certification For Nonfood Compounds And Food Equipment Materials: On March 24, 2025, NSF announced the release of NSF Certification Guideline 537: PFAS-Free Products for Nonfood Compounds and Food Equipment Materials (NSF 537). The press release states that to be certified, nonfood compound products “must first be registered under NSF’s Nonfood Compounds Guidelines or certified by NSF to ISO 21469, Safety of Machinery, Lubricants with Incidental Product Contact-Hygiene Requirements.” According to the press release, food equipment materials “must be certified to NSF/ANSI Standard 51: Food Equipment Materials to ensure that products meet minimum public health and sanitation requirements.” The press release notes that “PFAS-Free means that the product contains no intentionally added PFAS, no post-consumer recycled material, no intentionally used PFAS additives (PPA, etc.) and the Total Organic Fluorine [(TOF)] is less than 50 ppm.” Certification will require that TOF levels be retested annually. NSF will add certified nonfood compounds to the NSF White Book™ and add certified food equipment materials to the NSF Certified Food Equipment listing.
Petitions Filed To Add Chemicals To List Of Chemical Substances Subject To Superfund Excise Tax: On April 2 and April 3, 2025, the Internal Revenue Service (IRS) announced that petitions have been filed to add the following chemicals to the list of taxable substances:

Polyisobutylene (90 Fed. Reg. 14521): Petition filed by TPC Group, Inc., an exporter of polyisobutylene;
Acrylonitrile butadiene styrene (90 Fed. Reg. 14687): Petition filed by Trinseo LLC, an importer and exporter of acrylonitrile butadiene styrene;
Acrylonitrile-butadiene rubber (90 Fed. Reg. 14684): Petition filed by Arlanxeo USA LLC and Arlanxeo Canada Inc., importers and exporters of acrylonitrile-butadiene rubber;
Chloroprene rubber (90 Fed. Reg. 14691): Petition filed by Arlanxeo USA LLC and Arlanxeo Canada Inc., importers and exporters of chloroprene rubber;
Emulsion styrene butadiene rubber (90 Fed. Reg. 14692): Petition filed by Michelin North America, Inc., an importer of emulsion styrene butadiene rubber;
Emulsion styrene-butadiene rubber (90 Fed. Reg. 14686): Petition filed by Arlanxeo USA LLC and Arlanxeo Canada Inc., importers and exporters of emulsion styrene-butadiene rubber;
Ethylene vinyl acetate (VA < 50 percent) (90 Fed. Reg. 14688): Petition filed by Arlanxeo USA LLC and Arlanxeo Canada Inc., importers and exporters of ethylene vinyl acetate (VA < 50 percent); Ethylene vinyl acetate (VA ≥ 50%) (90 Fed. Reg. 14683): Petition filed by Arlanxeo USA LLC and Arlanxeo Canada Inc., importers and exporters of ethylene vinyl acetate (VA ≥ 50 percent); Ethylene-propylene-ethylidene norbornene rubber (90 Fed. Reg. 14695): Petition filed by Arlanxeo USA LLC and Arlanxeo Canada Inc., importers and exporters of ethylene-propylene-ethylidene norbornene rubber; Hydrogenated acrylonitrile-butadiene rubber (90 Fed. Reg. 14686): Petition filed by Arlanxeo USA LLC and Arlanxeo Canada Inc., importers and exporters of hydrogenated acrylonitrile-butadiene rubber; Hydrogenated acrylonitrile-butadiene rubber (90 Fed. Reg. 14685): Petition filed by Zeon Chemicals L.P., an importer and exporter of hydrogenated acrylonitrile-butadiene rubber; Isobutene-isoprene rubber (90 Fed. Reg. 14689): Petition filed by Arlanxeo USA LLC and Arlanxeo Canada Inc., importers and exporters of isobutene-isoprene rubber; Solution styrene-butadiene rubber (90 Fed. Reg. 14690): Petition filed by Arlanxeo USA LLC and Arlanxeo Canada Inc., importers and exporters of solution styrene-butadiene rubber; Bromo-isobutene-isoprene rubber (90 Fed. Reg. 14694): Petition filed by Arlanxeo USA LLC and Arlanxeo Canada Inc., importers and exporters of bromo-isobutene-isoprene rubber; Poly(ethylene-propylene) rubber (90 Fed. Reg. 14690): Petition filed by Arlanxeo USA LLC and Arlanxeo Canada Inc., importers and exporters of poly(ethylene-propylene) rubber; Solution styrene-butadiene rubber (90 Fed. Reg. 14693): Petition filed by Michelin North America, Inc., an importer of solution styrene-butadiene rubber; and Styrene-acrylonitrile (90 Fed. Reg. 14693): Petition filed by Trinseo LLC, an importer and exporter of styrene-acrylonitrile. Comments on the petitions are due June 2, 2025. Maine Board Approves Motion To Adopt Rule On PFAS In Products; CUU Proposals For Products Prohibited As Of January 1, 2026, Are Due June 1, 2025: As reported in our April 1, 2025, blog item, the Maine Board of Environmental Protection (MBEP) was scheduled to consider the Maine Department of Environmental Protection’s (MDEP) December 2024 proposed rule regarding products containing PFAS during its April 7, 2025, meeting. As reported in our December 31, 2024, memorandum, on December 20, 2024, MDEP published a proposed rule that would establish criteria for currently unavoidable uses (CUU) of intentionally added PFAS in products and implement sales prohibitions and notification requirements for products containing intentionally added PFAS but determined to be a CUU. During the April 7, 2025, meeting, MBEP unanimously approved a motion to adopt the Chapter 90 rule, the Chapter 90 basis statement, and MDEP’s response to comments “as presented and with correction of minor typographical errors, and the addition of ‘Maine Department of Transportation’ at section 4(A)(8),” according to MBEP’s draft meeting minutes. Under the approved rule, CUU requests for products scheduled to be prohibited January 1, 2026, are due June 1, 2025. The products containing intentionally added PFAS that are scheduled to be prohibited include: Cleaning products; Cookware; Cosmetics; Dental floss; Juvenile products; Menstruation products; Textile articles. The prohibition does not include: Outdoor apparel for severe wet conditions; or A textile article that is included in or a component part of a watercraft, aircraft or motor vehicle, including an off-highway vehicle; Ski wax; or Upholstered furniture. The January 1, 2026, prohibition applies to any of the products listed that do not contain intentionally added PFAS but that are sold, offered for sale, or distributed for sale in a fluorinated container or container that otherwise contains intentionally added PFAS. More information is available in our April 11, 2025, blog item. OMB RFI Seeks Proposals To Rescind Or Replace Regulations: On April 11, 2025, OMB published a request for information (RFI) to solicit ideas for deregulation. 90 Fed. Reg. 15481. OMB seeks proposals to rescind or replace regulations “that stifle American businesses and American ingenuity,” including regulations “that are unnecessary, unlawful, unduly burdensome, or unsound.” According to the notice, “comments should address the background of the rule and the reasons for the proposed rescission, with particular attention to regulations that are inconsistent with statutory text or the Constitution, where costs exceed benefits, where the regulation is outdated or unnecessary, or where regulation is burdening American businesses in unforeseen ways.” Comments are due May 12, 2025. Earlier in the week, on April 9, 2025, President Trump issued the following memorandum and EOs regarding federal regulations: Presidential Memorandum Regarding Directing the Repeal of Unlawful Regulations; EO on Reducing Anti-Competitive Regulatory Barriers; and EO on Zero-Based Regulatory Budgeting to Unleash American Energy. More information is available in our April 14, 2025, blog item.

Texas Attorney General Investigating “Healthy” Claims in Cereal

On April 5, 2025, Texas Attorney General Ken Paxton announced an investigation of W.K. Kellogg Co. (Kellogg) for potential violation of Texas consumer protection laws, alleging that Kellogg’s marketing of its cereals as “healthy” is deceptive marketing because they include artificial food dyes and butylated hydroxytoluene (BHT).
As we previously reported, the Texas Senate recently passed SB 25, which if passed into law would require food labels to warn Texas consumers if a food product contains ingredients banned in other countries. The bill is now under review with the Texas House Committee on Public Health. AG Paxton’s announcement signals the Texas government’s continued focus on food additives and “healthy” claims by food manufacturers.
AG Paxton alleges that Kellogg’s “healthy” claim is deceptive because the artificial dyes “have been linked to hyperactivity, obesity, autoimmune disease, endocrine-related health problems, and cancer in those who consume them.” However, not all food scientists agree with this link to health issues, and many of the food dyes and additives are currently approved for use by the U.S. Food and Drug Administration (FDA).
Keller and Heckman will continue to monitor this investigation and relay any developments.