Avocado Oil Company Moves to Dismiss False Labeling Suit
Sovena USA Inc. has filed a motion to dismiss a proposed class action alleging that the company falsely labeled its avocado oil as “100% pure” despite diluting it with “cheaper” seed oils. According to Sovena, “the suit lacks evidence and is part of a ‘baseless’ litigation campaign meant to undermine the industry.”
The class action stems from a study by UC Davis researchers that showed fatty acid profiles beyond the types of fatty acids that would be expected to be in pure avocado oil, suggesting that there are other oils mixed into Sovena’s Olivari avocado oil. However, Sovena says that rather than testing for inferior oils, the researchers used a “theoretical ‘purity standard’” that they applied to a single bottle of Olivari oil. Thus, the study did not demonstrate that other oils are present in the Olivari oil or any of the other samples tested, but instead that the samples contained an “indicator” of other oils, “could have” other oils, or that the samples otherwise failed the researchers “ad hoc purity standards.”
According to Sovena, because the study does not definitively identify adulteration in the avocado oil, it cannot provide a plausible basis for the plaintiffs’ claims. Therefore, Sovena says the case should be dismissed with prejudice as “just one of multiple no-injury, no-deception class action suits aimed at avocado industry members.” The motion references other suits against Kroger and Walmart, which were both dismissed at the pleading stage.
Keller and Heckman will continue to monitor this and other food labeling litigation.
New Proposed Bill in Louisiana Targets Synthetic Dyes and Food Additives
On March 18, 2025, Louisiana introduced Senate Bill 14, a bill that would require products containing artificial dyes, chemical additives, and other ingredients to include a warning label on the product where the substances are banned or not authorized in other countries. The bill lists 51 different ingredients that would require the warning, including several synthetic dyes, synthetic or artificial vanillin, propylparaben, potassium bromate, melatonin, bleached flour, and others. Any food items containing any of the listed ingredients would be required to bear the following warning label, “WARNING: This product contains an artificial color, chemical, or food additive that is banned in Australia, Canada, the European Union, or the United Kingdom.”
Additionally, SB 14 would prohibit public schools and non-public schools receiving state funds from serving ultra-processed foods. The bill defines ultra-processed food as any food or beverage that contains the following: Blue dye 1, Blue dye 2, Green dye 3, Red dye 3, Red dye 40, Yellow dye 5, Yellow dye 6, azodicarbonamide, Butylated hydroxyanisole (BHA), Butylated hydroxytoluene (BHT), Potassium bromate, propylparaben, and titanium dioxide.
Some additional provisions of the bill would also require any food service establishment that cooks or prepares food using seed oil to display a disclaimer on the menu or other clearly visible location, prohibit soft drinks from SNAP eligibility, and require physicians and physician assistants to complete continuing education on nutrition and metabolic health.
This bill mirrors Texas SB 25, as we’ve previously blogged about, which would also require warning labels on packaged food products containing artificial colors, chemicals, or food additives that do not have a regulatory clearance in other countries.
LA SB 14 is the latest in a host of newly proposed bills this legislative cycle targeting synthetic dyes and various other food additives, which, if adopted, will create a divided and complicated regulatory scheme across the country.
Keller and Heckman will continue to monitor developments related to state legislative efforts to prohibit food additives.
Australia and New Zealand Approve First Cell-Cultured Food Product
Food Standards Australia and New Zealand (FSANZ) have approved a cell-cultured quail product produced by Vow, an Australian company. Under the approval, either the term “cell-cultured” or “cell-cultivated” must be displayed on the labeling.
The approval follows two rounds of public consultations on Vow’s novel food application, originally submitted in January 2023.
The approval will now be sent to the Food Ministers (of the Commonwealth, States and Territories, and New Zealand) who have 60 days to accept, amend, or seek a review of the proposed change to the Food Standards Code. If accepted, the product can then be commercialized.
Caffeine Warning Bill Introduced in House of Representatives
A new bill introduced in the U.S. House of Representatives would require a “high caffeine” warning on beverages that contain more than 150 milligrams of caffeine, as well as require manufacturers to declare the amount of caffeine in their products.
Representative Robert Menendez introduced H.R.2511, the Sarah Katz Caffeine Safety Act, stating that “the bill is about transparency and safety,” aimed at preventing tragedies such as the death of Sarah Katz, a college student who died after drinking a highly caffeinated beverage. As we previously blogged, Katz’s parents filed a lawsuit alleging that Panera Bread Company’s “Charged Lemonade” caused their daughter’s death and that the beverage contained anywhere from 260-390 mg of caffeine, depending on the size of the beverage.
The bill would require menu items in chain restaurants containing at least 150 mg of caffeine to bear a statement such as “high caffeine” on the menu. In addition, the bill amends Section 403 of the Food, Drug, and Cosmetic Act to consider foods and dietary supplements containing more than 10 mg of caffeine as misbranded unless the label includes the amount of caffeine in the product, a statement of whether the caffeine is naturally occurring or an additive, and an advisory statement regarding FDA’s daily recommended limit of caffeine for healthy adults.
The bill also directs FDA to define “added caffeine” and review the status of caffeine and other stimulants as generally recognized as safe (GRAS). Specifically, FDA would be directed to consider:
Whether caffeine should be considered GRAS;
The safety of caffeine or other stimulants, either alone or in a blend;
The safety of guarana, taurine, and similar substances in food and dietary supplements with added caffeine;
Thresholds for the amount of caffeine or blends of caffeine and other stimulants; and
Whether any regulations relating to caffeine in food and dietary supplements should be issued or updated.
Finally, the National Institutes of Health would be required to conduct or support a review of the effect of caffeine consumption in vulnerable populations, and FDA and CDC would be required to conduct a public education campaign on caffeine safety.
FDA’s webpage on caffeine indicates that 400 mg a day is “not generally associated with dangerous, negative effects,” but that the level of sensitivity can vary widely.
Keller and Heckman will continue to monitor this bill and other developments regarding caffeinated beverages.
Getting Clear on Compiling Random Drug Testing Pools in Iowa
The Iowa Supreme Court recently clarified that a compliant random drug testing program under Iowa law requires excluding those who are not scheduled to work the day of the testing from the pool of employees who could be selected. Hampe v. Charles Gabus Motors Inc. d/b/a Toyota of Des Moines et ano., No. 22-1599 (Iowa Sup. Ct. Apr. 11, 2025).
Iowa has one of the most technical drug testing laws in the country. It allows unannounced random testing of:
(1) The entire employee population at a particular work site of the employer except for employees not subject to testing pursuant to a collective bargaining agreement, or employees who are not scheduled to be at work at the time the testing is conducted because of the status of the employees or who have been excused from work pursuant to the employer’s work policy prior to the time the testing is announced to employees.
(2) The entire full-time active employee population at a particular work site except for employees not subject to testing pursuant to a collective bargaining agreement, or employees who are not scheduled to be at work at the time the testing is to be conducted because of the status of the employee or who have been excused from work pursuant to the employer’s working policy.
(3) All employees at a particular work site who are in a pool of employees in a safety-sensitive position and who are scheduled to be at work at the time testing is conducted, other than employees not subject to testing pursuant to a collective bargaining agreement, or employees who are not scheduled to be at work at the time the testing is to be conducted or who have been excused from work pursuant to the employer’s work policy prior to the time the testing is announced to employees.
Iowa Code 730.5(8)(a).
In the case before the Supreme Court, the employer used a random testing pool that consisted of all employees. The employer did not exclude employees who were not scheduled to be at work at the time the testing was conducted or who were excused from work pursuant to the employer’s policy. Instead, the employer had a list of alternate employees who could be tested if selected employees were not at work on the day the testing was conducted.
The Iowa Supreme Court held that this practice did not “substantially comply” with the law. Strict compliance with the law is not required, it explained, but substantial compliance is required. The Court held that the employer did not substantially comply with the law when it made no attempt to exclude employees who were not scheduled to be at work or because they had been excused pursuant to an employer policy.
Focusing on the plain language of the statute, the Court stated that it is the way the random pool is constructed that matters, even if, as a practical matter, it is difficult to comply with the statute’s requirements given the “fluid circumstances” of today’s workplace.
Pricing Under Pressure: Prepare for Enhanced Antitrust Scrutiny amid Tariff Uncertainty
In an era of increased tariff pressures, U.S. antitrust enforcers have signaled that they remain vigilant for attempts by businesses to exploit the situation through anticompetitive conduct, especially in sectors already strained by supply shocks, volatile input costs, and shifting demand patterns.
Roger Alford, Principal Deputy Assistant Attorney General at the U.S. Department of Justice’s Antitrust Division, recently emphasized the need for competition authorities to remain vigilant for signs of collusion and manipulation of dynamic pricing models, particularly as companies adjust to heightened tariff levels. He warned that the imposition of trade barriers — such as tariffs that could reduce competition from abroad — can lead to market concentration, reducing the number of active suppliers and thereby increasing the risk of coordinated pricing or supply restrictions.
A case in point is the DOJ’s recent investigation into record-high egg prices. Despite arguments that egg price inflation resulted from market factors such as avian influenza outbreaks disrupting supply, after the DOJ issued subpoenas to major egg producers to examine potential collusion, prices dropped sharply from $8 to $3 per dozen. Alford cited this as an example of the heightened risk that companies may engage in anticompetitive conduct under the cover of external pressures.
Companies in the consumer packaged goods (CPG) sector are particularly exposed to these risks. Especially when facing thin margins, concentrated supply chains, commoditized inputs, or inelastic demand, CPG firms may be perceived as being especially vulnerable to engaging in coordinated responses to external shocks, whether explicit or tacit. Jurisdictions outside the U.S. have already begun scrutinizing the pricing behavior of such companies for potentially using inflation as a pretext to coordinate higher prices. For example, the Korea Fair Trade Commission recently launched investigations into several CPG companies following claims of collusion to raise prices on confectionaries and beverages. In Australia, Prime Minister Anthony Albanese recently pledged to crack down on alleged price gouging by the country’s supermarkets if reelected.
This is not the first time regulators have taken a more aggressive posture during periods of systemic disruption. For example, during the COVID-19 pandemic, the DOJ and FTC issued joint guidance stating they were on the alert for individuals and businesses using the pandemic as “an opportunity to subvert competition or prey on vulnerable Americans.” The guidance further stated that the agencies would stand ready to “pursue civil violations of the antitrust laws, which include agreements between individuals and business to restrain competition through increased prices, lower wages, decreased output, or reduced quality as well as efforts by monopolists to use their market power to engage in exclusionary conduct,” as well as “prosecute any criminal violations of the antitrust laws, which typically involve agreements or conspiracies between individuals or businesses to fix prices or wages, rig bids, or allocate markets.”
In light of this renewed scrutiny, companies in the CPG and similar sectors should consider the following measures:
Document the bases for pricing decisions, to create a record reflecting the independence of and any business justifications for those decisions.
Train commercial teams to recognize and steer clear of “soft signals” of collusion, particularly in discussions of tariffs or supply shortages.
Review pricing and supply chain practices for potential antitrust sensitivities, and engage antitrust counsel when appropriate.
FDA v. Wages and White Lion Investments (No. 23-1038)
In 2021, after a multi-year regulatory process, the Food and Drug Administration denied more than a million applications from tobacco manufacturers seeking to sell various flavored e-cigarette products. After that process concluded, an en banc Fifth Circuit vacated the FDA’s denial of those products’ applications, concluding that the agency performed a “surprise switcheroo” by relying on criteria for evaluating applications that the Fifth Circuit found were inconsistent with the agency’s pre-application industry guidance. But as has happened more than once in recent years, in FDA v. Wages and White Lion Investments, LLC (No. 23-1038), the Supreme Court concluded that the Fifth Circuit was getting a bit too far over its skis. In a lengthy and thorough decision by Justice Alito, the Court unanimously vacated the Fifth Circuit, concluding that it had misapplied administrative law’s “change-in-position” doctrine by being too eager to read ambiguous and caveat-filled guidance from the FDA as stating a definitive agency position, meaning the FDA’s later rejection of manufacturers’ applications was not inconsistent with any actual position announced by the agency in the run-up to its decisions.
For nearly a hundred years, the FDA has had the statutory authority to regulate drugs, which it does primarily through an extensive premarket authorization process. Until 2009, however, the FDA’s regulatory authority did not extend to tobacco products. That changed when Congress enacted the Family Smoking Prevention and Tobacco Control Act of 2009, which gave the FDA the authority to regulate the marketing, sale, and distribution of tobacco products. Among other regulatory tools, that law subjected any “new tobacco products”—defined as products not marketed in the United States before February 15, 2007—to a premarket authorization process not unlike the one the FDA uses for drugs. Initially, this new regulatory authority didn’t mean a whole lot, because the most commonly used tobacco products were hardly “new.” But in the 2010s, the use of e-cigarettes, particularly flavored e-cigarettes, exploded among younger Americans. In 2016, the FDA responded by issuing a rule finding that e-cigarettes and e-liquids (the liquid one buys to refill some varieties of e-cigarettes) constituted “new tobacco products” under the TCA, subjecting them to the Act’s pre-authorization requirements even though these products had by then been on the market for several years.
To give manufacturers of e-cigarettes time to obtain “premarket” authorization for the products they had already been selling, the FDA announced that it would be delaying enforcement of any ban on e-cigarette products for a few years. Any manufacturers who wanted to continue to sell their products after that, though, would have to apply for and receive preauthorization. To help them with the application process, the FDA issued various pieces of external guidance and developed internal memoranda addressing how applications would be reviewed and evaluated. While the FDA’s guidance as to its thought process is too long to summarize here, it addressed four main topics: (1) evidence manufacturers would need to provide regarding their products’ health effects, (2) comparisons of the risk posed by their products compared with other tobacco products, (3) the FDA’s enforcement priorities, and (4) information about manufacturers’ marketing plans for their products.
The FDA ultimately received applications from more than 500 companies covering 6.5 million e-cigarette products, including several from respondents Wages and White Lion Investments. The FDA denied a substantial portion of these applications, including essentially all applications for flavored e-cigarette products, finding that these products were particularly attractive, and hence harmful, to young adults. Wages and White Lion Investments’ products were among those rejected by the FDA. It sought review of the FDA’s denials in the Fifth Circuit, where a divided merits panel affirmed the FDA’s decision. But the Fifth Circuit then took up the case en banc and reversed, with that court’s majority concluding that the FDA had acted arbitrarily and capriciously. In the en banc majority’s view, the FDA had performed a “surprise switcheroo” (their term) by changing its position on things like the kind of scientific evidence it expected manufacturers to provide in support of their application and by not even considering manufacturers’ marketing plans. Because that decision conflicted with those of other circuits, the Court granted certiorari.
In an opinion written by Justice Alito, the court unanimously vacated the en banc Fifth Circuit’s decision. Alito began by trying to pin down exactly what this case was about. While the en banc Fifth Circuit’s decision was complex, it ultimately boiled down to the concern that the FDA had effectively changed the requirements for premarket authorization between the time when it issued guidance to manufacturers and the time when it denied their applications. Administrative law addresses that concern with the “change-in-position” doctrine, which essentially asks whether an agency has changed its course and if so whether it offered satisfactory reasons for the change. For the most part, the Fifth Circuit’s criticisms of the FDA’s application decisions failed on the first prong: The FDA had never taken a “position” in the first place, so there was no “change” it needed to explain. Take, for example, the FDA’s stance on the type of scientific evidence it expected manufacturers to provide regarding their products’ health risks. While the respondents pointed to various snippets in FDA pronouncements suggesting that one or another type of study would or would not be looked on favorably, none of these statements amounted to a “hard-and-fast commitment” from the agency; they were full of the hems, haws, and caveats one typically sees in regulatory guidance. The same was true for the Fifth Circuit’s conclusions regarding comparative studies and agency priorities: For each, the Supreme Court saw no clear pre-application statement from the FDA about what it was expecting that was at odds with the ultimate grounds for its application decisions. On all these points, the basic flaw with the Fifth Circuit’s analysis was too much tea-leaf reading: The change-in-position doctrine requires a true change in a definitive policy, not an inconsistency in the hints one might draw from vague agency pronouncements.
That said, there was one aspect of the FDA’s decisionmaking where the Court was inclined to see a change of position: marketing plans. As the FDA itself conceded, it had changed its position on that point, as it indicated in its guidance documents that it would consider manufacturers’ plans, but when it came time to act on their applications, it ignored the plans entirely. But that was not a basis to vacate its decisions, the FDA argued, because any change in position was harmless: nothing in those ignored marketing plans could have saved applications, like Respondents’, that were deficient in other respects. But is harmless error applicable when courts review agency action? The en banc Fifth Circuit concluded it was not, interpreting the Court’s per curiam decision in Calcutt v. FDIC (2023) to mean that when an agency has erred, a court must remand the case to the agency for re-consideration unless the agency was legally required to take the action it ultimately took. That reading of Calcutt was too strong, Alito concluded, as prior decisions had recognized that remand to an agency is not required when the agency’s error “had no bearing on the procedure used or the substance of the decision reached.” So when exactly is an agency’s error harmless? Alito declined to say, deciding that the better course was to simply vacate the Fifth Circuit’s decision, which relied on its misreading of Calcutt and let that court decide in the first instance whether the Respondents had shown enough prejudice from the FDA’s change in position.
Justice Sotomayor concurred with one-paragraph intended to “clarify” a point. While Alito’s opinion sometimes characterized the FDA as an agency “feeling its way toward a final stance” and “unable or unwilling to say in clear and specific terms precisely what applicants would have to provide,” she thought its guidance was better seen as reasonably giving manufacturers flexibility to decide for themselves what sort of evidence was necessary.
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 European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “A Qualification System to Accelerate Development and Regulatory Implementation of New Approach Methodologies (NAMs)” by Andrea Haase, Ph.D., German Federal Institute for Risk Assessment (BfR), Shirin M. Usmani, Ph.D., BfR, Irene Cattaneo, European Food Safety Authority (EFSA), Maria Chiara Astuto, EFSA, and Francesco Cubadda, Ph.D., National Institute of Health (ISS). The authors explain how the NAMs4NANO project, funded by 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 fluids; and toxicity screening. According to the authors, the proposed system has been tested initially for one selected model as an example that can be applied to investigate nanomaterial uptake and transport across intestinal barrier, and to evaluate the nanomaterial effects on barrier integrity. The authors note that more case studies are currently ongoing to qualify selected NAMs in the forthcoming implementation plan of the qualification system. The authors invite key stakeholders to collaborate on relevant case studies that can be used to test the qualification system.
Post‑Chevron Spotlight: Federal Court Nixes FDA Rule Reclassifying Laboratory Services as Medical Devices
In another rebuke to federal regulatory overreach, the U.S. District Court for the Eastern District of Texas (“District Court”) has vacated the Food and Drug Administration’s (“FDA”) 2024 final rule that sought to bring laboratory‑developed test services (“LDTs”) within the scope of the agency’s medical device regulatory framework. The case, American Clinical Laboratory Association et al. v. FDA, Nos. 4:24 CV 479 and 4:24 CV 824, marks a watershed moment for clinical laboratories and diagnostic providers in a post‑Chevron landscape and underscores the judiciary’s growing willingness to police the limits of agency authority in the wake of Loper Bright Enterprises v. Raimondo.
The Regulatory Framework Governing LDTs
LDTs are diagnostic services developed, validated, and performed by professionals within a single clinical laboratory, often in response to individual physician orders. These services, which range from standard pathology tests to advanced genomic sequencing, have long been regulated under the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”), which are administered by the Centers for Medicare & Medicaid Services (“CMS”). CLIA’s framework—developed after its predecessor law, the Clinical Laboratories Improvement Act of 1967—was designed to govern services, not products. It imposes requirements on laboratory staffing, quality control, methodology validation, and proficiency testing. Laboratories are certified under CLIA and must meet rigorous federal and accreditation‑based standards.
By contrast, the Federal Food, Drug, and Cosmetic Act (“FDCA”), enacted in 1938 and amended in 1976 by the Medical Device Amendments (“MDA”), grants the FDA authority to regulate products—specifically, drugs, devices, foods, and cosmetics. The FDCA’s definition of a “device” encompasses physical items such as instruments, machines, and reagents—not intangible services performed within clinical settings. Notably, Congress’s enactment of CLIA in 1988, more than a decade after the MDA, reaffirmed this division of regulatory labor: the FDA governs devices while CMS governs services. Since then, Congress has repeatedly declined to legislate FDA oversight of LDTs, instead preserving CLIA as the operative statute governing the field.
The Final Rule: A Costly Expansion of Authority
The FDA’s final rule, issued May 6, 2024, would have upended this regulatory equilibrium by reclassifying LDTs as medical devices. Specifically, the rule, as amended, sought to clarify that in vitro diagnostic products “are devices . . . including when the manufacturer of these products is a laboratory.” In effect, the rule would have treated LDTs as manufactured devices, requiring laboratories to obtain premarket authorization for each test and to comply with the FDA’s Quality System Regulation. This dramatic shift would have affected more than 79,000 existing tests and over 10,000 new tests annually. The FDA further estimated that compliance costs would have exceeded $1 billion per year, with total implementation costs ranging from $12.5 billion to $79 billion over twenty years, potentially forcing some LDTs off the market and suppressing future innovation.
Judicial Review in a Post‑Chevron Era: Loper Bright Takes Center Stage
In response to the FDA’s proposed expansion of its authority, a coalition of plaintiffs—including the American Clinical Laboratory Association, the Association for Molecular Pathology, HealthTrackRX, and a practicing clinical pathologist—filed suit in the Eastern District of Texas, arguing that the final rule exceeded the agency’s statutory mandate and moved for summary judgment under the Administrative Procedure Act. On summary judgment, the Court’s analysis turned on Loper Bright, which overturned Chevron deference and restored the task of interpreting statutes to the courts. Applying this new standard, the District Court declined to defer to the FDA’s interpretation of the FDCA, instead undertaking its own statutory analysis.
In its analysis, the District Court found that the term “device” under the FDCA referred to tangible articles—not professional services. It emphasized that none of the listed terms in the FDCA’s definition section (“instrument,” “machine,” “in vitro reagent,” etc.) could be read to encompass laboratory services. The Court also rejected the FDA’s argument that laboratories’ use of devices during diagnostic testing somehow converted those services into devices subject to the FDA oversight. The District Court further held that Congress clearly intended to treat laboratory services separately from devices when it enacted CLIA in 1988, reaffirming a services‑based regulatory regime administered by CMS.
Importantly, the District Court also noted that Congress had multiple opportunities to legislate FDA oversight of LDTs—and yet declined to do so. On the contrary, the District Court observed, the statutory framework governing LDTs has remained unchanged since 1988, and the FDA’s rule was an impermissible attempt to rewrite that framework through regulation. As a result, the District Court granted summary judgment for the plaintiffs, vacated the final rule, and denied the FDA’s cross‑motion, concluding that remand without vacatur was inappropriate given the final rule’s legal defects and the absence of any persuasive justification from the agency.
What’s Next? Another Brick in the Post‑Chevron Wall
This decision is the latest in a growing line of federal court rulings reining in agency authority in the wake of Loper Bright. As with recent invalidations of other federal agency rules across multiple courts, this decision reflects a reshaped judicial posture that demands clear congressional authorization before agencies can regulate new areas or expand their reach. Providers and regulated entities should, thus, take note: in this evolving legal landscape, agency interpretations of rules may no longer suffice. Courts are now scrutinizing regulatory assertions with fresh eyes and heightened textual rigor. For diagnostic labs and other stakeholders in particular, this ruling marks not only a reprieve, but also a call to vigilance as Congress and agencies revisit regulatory pathways for diagnostics and digital health.
Old North State Report – April 14, 2025
UPCOMING EVENTS
April 14, 2025
Raleigh Chamber Business After Hours – Raleigh
April 16, 2025
Federalist Society Housing Policy and Regulation in NC – Raleigh
April 17, 2025
NC Chamber Building NC – Durham
April 22, 2025
NC Chamber Spring Member Roundtable – Asheville
April 24, 2025
Raleigh Chamber Young Professionals Network Social – Raleigh
RTAC – Association of Corporate Counsel Spring Reception – (Raleigh)
April 28, 2025
Thinkers Lunch: Rob Christensen
LEGISLATIVE NEWS
SENATE BUDGET TO BE RELEASED NEXT WEEK
The Senate is set to release its budget bill Monday afternoon, according to Republican Senate leader Phil Berger (R-Rockingham), who spoke to reporters after the Senate session on Tuesday evening.
This budget is a two-year spending plan that will likely exceed $30 billion, funding raises for state employees and teachers, and replenish the rainy-day fund to get back to the $4.75 billion it contained before Hurricane Helene.
Leadership in the House and the Senate have agreed the budget can grow by 2.75% in fiscal 2025-2026 and 2.25% above that in fiscal 2026-2027. The current budget appropriated $29.7 billion for general fund spending in fiscal 2023-2024 and $30.8 billion in fiscal 2024-2025.
The process begins with the Senate version going through committees on Tuesday, with floor votes on Wednesday and Thursday. The House is expected to pass its version in May, followed by negotiations among Republican leaders for a final budget.
Read more by Under the Dome/The News & Observer
LAST-MINUTE HOUSE PROPOSALS FILED AHEAD OF BILL FILING DEADLINE
Offering on-site childcare for state employees, allowing private school students to take classes at local public schools, addressing issues with loose dogs, and dealing with slow drivers in the left lane are among the last-minute proposals filed by House members before the Thursday deadline. House lawmakers had a deadline to file bills by 3 p.m., resulting in more than 100 new proposals. This brings the total number of bills introduced this session to nearly 2,000, reflecting emerging policy goals.
Education and public safety were key themes among the last-minute bills, with many aimed at attracting and keeping teachers. There were also efforts to increase penalties for loose dogs and new rules for domestic violence cases. A unique proposal allows tax payments in cryptocurrencies, amid fluctuations in the market. Some proposals from Democrats, like those focusing on environmental issues, may not succeed in the Republican-majority legislature, though a few may have potential.
Bipartisan sponsors back some bills, including Jesse’s Law, which would provide training for judges and mediators on recognizing signs of domestic violence and child abuse. This initiative is inspired by the tragic murder of a 3-year-old boy.
Other important bills include reforms to liquor laws to allow Sunday openings for ABC stores, legalizing video poker, creating a disaster response fund, and increasing penalties for various public safety violations. Additional initiatives aim to expand childcare options, support social conservative causes like restrictions on gender-reassignment lawsuits and abortion, and enhance educational transparency and teaching standards. There are also bills addressing drug arrests, protecting teenagers’ social media data, exploring cryptocurrency and AI research, directing the Legislative Research Commission to study the abolition of contributory negligence, and proposing the removal of barriers to employment due to court debt.
The crossover deadline, the date set by the legislature for a bill to be approved in its originating chamber to continue being reviewed by the opposite chamber, is May 8. Lawmakers are anticipated to increase their activity in the weeks ahead to make certain that any important legislation stays eligible for consideration during this session.
Read more WRAL News
PROPOSED HOUSE BILL TO EXPAND AUDITOR’S INVESTIGATIVE POWERS
A North Carolina House panel approved a bill on Tuesday that expands the investigative powers of the state auditor’s office, despite some concerns about which agencies and individuals could be investigated. The Judiciary 1 Committee voted for House Bill 549 after hearing from its sponsor, Representative Brenden Jones (R-Columbus), and Kirk O’Steen, the Director of Government Affairs for the auditor’s office. The bill will next go to the Committee on State and Local Government for further consideration.
If passed, the bill would allow the auditor to investigate any entity receiving state or federal funds for reports of improper activities, including fraud and misappropriation. It would also grant the auditor unrestricted access to necessary databases and exempt the office from certain regulations. Additionally, the Senate approved Senate Bill 474 to create a new team to oversee state spending and job openings.
Read more by NC Newsline (Kingdollar)
Read more by NC Newsline (Bacharier)
SENATE’S PBM BILL APPROVED BY HEALTH CARE COMMITTEE
The Senate is entering the debate over pharmacy benefits managers (PBMs) with the approval of Senate Bill 479 by the Health Care Committee. This bill provides an alternative to the House’s approach regarding PBMs, which act as intermediaries between drug manufacturers and insurers or drugstores. Unlike the House’s proposal, Senate Bill 479 does not include a provision that would require PBMs to pay drugstores a $10.24 dispensing fee. Senator Benton Sawrey (R-Johnston), a lead sponsor of the bill known as the SCRIPT Act, prefers to avoid any cost increases for consumers.
The bill is supported by key Senate leaders, and it will undergo further revisions as it progresses through additional committees. Key aspects of the Senate bill include allowing insurers to offer higher reimbursements to drugstores in areas without pharmacies, licensing pharmacy services administrative organizations, and requiring PBMs to provide more data to state officials. It also prohibits PBMs from paying pharmacies less than their acquisition costs for medications and from treating independent pharmacies unfairly compared to their owned drugstores. Independent pharmacies could refer patients to other drugstores if necessary.
The bill does not currently impact the State Health Plan, a point of concern for some senators. Meanwhile, the House’s PBM legislation remains under discussion in committee, with its previous iteration receiving unanimous approval before being stalled in the Senate without a counterproposal.
Business North Carolina (Ray Gronberg – [email protected])
LOWER LEGAL ALCOHOL LIMIT FOR DRIVERS PROPOSED
North Carolina lawmakers are collaborating to support a bill introduced this year to reduce the legal blood alcohol concentration limit for driving from 0.08 to 0.05.
House Bill 108 will also increase penalties for adults who help minors buy alcohol, particularly in cases of serious injury, and will allow repeat offenders to regain limited driving privileges by proving sobriety. Additionally, the measure mandates the recording of district court proceedings and public reporting on impaired-driving cases.
Representative Eric Ager (D-Buncombe) will hold a press conference on Tuesday at noon regarding the bill, joined by Ellen Pitt from the WNC Regional DWI Task Force, law enforcement, and families impacted by drunk driving.
Ager and Representative Mike Clampitt (R-Jackson) are the primary sponsors, along with Representatives Keith Kidwell (R-Beaufort) and Brian Echevarria (R-Cabarrus). The bill is currently in the House Alcoholic Beverage Control Committee.
Read more by Under the Dome/The News & Observer
TRAUMATIC BRAIN INJURIES TREATMENT FOR VETERANS
A bill that would enable treatment of traumatic brain injuries in veterans was introduced on March 27. House Bill 572 allows the Department of Military and Veterans Affairs to create a pilot program for veterans, first responders, and their immediate families to treat traumatic brain injuries as well as sleep disorders and substance abuse.
Representative David Willis (R-Union), mentioned that the treatment called eTMS, or electroencephalogram combined transcranial magnetic stimulation, was suggested by veterans seeking similar programs in other states. Willis noted that the program aims to support both first responders and veterans, citing successful outcomes in other states.
Representative Grant Campbell (R-Cabarrus), a former Army Lieutenant Colonel, also endorsed the bill. “There is significant data to show that there are high rates of these patients being able to discontinue current chronic therapy once they undergo this. This is an incredibly promising intervention,” Campbell said.
On Tuesday, the bill received a favorable report and has been referred to the Health Committee.
Read more by State Affairs Pro
HHS Restructuring and Workforce Reductions – Key Implications for the Health Care Industry
As spring arrived in the mid-Atlantic region, the Department of Health and Human Services (HHS) under Robert F. Kennedy, Jr. followed through with a previously announced Reduction in Force (RIF) that reduced the department’s workforce by a reported 10,000 employees and started the process of restructuring the organization as a whole. Now that the dust is starting to settle, we are beginning to analyze the RIFs and how they could impact key health care stakeholders, including Medicare Advantage Plans, providers, and biopharmaceutical and medical device manufacturers. This post provides a brief overview of the restructuring to date, HHS’s reduction in workforce, and their potential impacts. We will continue to monitor these developments and provide future updates to Mintz clients and friends.
Overview of Restructuring & Workforce Reductions
As part of the department-wide restructuring plan, HHS is in the process of consolidating 28 different divisions into 15 divisions. As of April 4, 2025, it had also reduced the number of Regional Offices from ten to five. The March 27th press release initially announcing the restructuring stated that the current HHS organization contains many “redundant” units and that the restructuring plan will “centralize core functions” of the department, such as Human Resources, Information Technology (IT), Procurement, External Affairs, and Policy. Separately, on March 14th, HHS published an announcement about a reorganization with its Office of the General Counsel (HHS-OGC).
Although HHS has not released a comprehensive list of the offices directly impacted by the RIF as of the date of this post, HHS or independent news outlets have reported the following:
HHS Regional Offices: As noted above, HHS has reduced the number of Regional Offices to five. The remaining offices include those located in Philadelphia, Denver, Kansas City, Dallas, and Atlanta. Accordingly, it appears that HHS has closed its Regional Offices in New York, Boston, Chicago, Seattle, and San Francisco. The HHS-OGC also closed its office in Dallas.
Centers for Medicare & Medicaid Services (CMS): CMS reportedly lost approximately 300 employees. CNN reported that the RIFs included the entire Office of Equal Opportunity and Civil Rights. The Medicare-Medicaid Coordination Office lost its office of Models, Demonstrations and Analysis. At this time, it appears that the CMS central office divisions directly responsible for overseeing and setting policy for Medicare and Medicaid policy were not significantly impacted by the RIF. Further, numerous staff of the Administration of Community Living were terminated and that particular office may end up being shuttered.
Food & Drug Administration (FDA): The HHS press release announced that 3,500 full-time employees – or about 19% of FDA’s workforce – would be cut. All of the agency’s product centers experienced staffing reductions when the RIF began, with the drug, biologic, device, and tobacco centers hit particularly hard. Many of the individuals in longstanding FDA career leadership positions either have been terminated or have departed as part of the recent RIF or in the weeks leading up to it, including directors of the Center for Biologics Evaluation and Research (CBER), the Office of New Drugs within the Center for Drug Evaluation and Research (CDER), and the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH). HHS also terminated the FDA Chief Information Officer, a new leadership position created by the agency through planned modernization activities. Between the recent RIFs, voluntary retirements, and the earlier firings of probationary workers, CDER has apparently lost more than 1,000 employees over the past three months. Reports emerging from affected FDA staff also indicate that artificial intelligence experts have been disproportionately affected, with approximately 40 individuals out of the over 260 fired from CDRH coming from CDRH’s recently established Digital Health Center of Excellence, where very little knowledge redundancies existed. Policy-focused offices such as CDER’s Office of Medical Policy, CBER’s Office of Regulatory Operations, the CDRH Office of Women’s Health, and the Division of Policy Development within the Office of Generic Drug Policy, have been rendered effectively non-functional and are expected to be terminated during the departmental restructuring.
Centers for Disease Control and Prevention (CDC): Reports indicate that the CDC lost divisions related to workplace health and safety, HIV, injury prevention, reproductive health, smoking, and violence prevention, among others. All of the CDC’s staff working to process Freedom of Information Act (FOIA) requests were also terminated, per CBS reporting.
National Institutes of Health (NIH): There were a reported 1,300 employees laid off at the NIH, with NPR reporting that most of the cuts were to individuals with support positions such as communications, IT, and human resources. Grant and contract management officers were also affected, which may make it more difficult for research grantees – including those that are part of large academic medical centers – to obtain timely responses and information from the NIH.
In addition to these recent actions taking place within HHS, detailed agency-specific restructuring plans were due to be submitted to the White House Office of Management and Budget (OMB) on April 14, 2025, per an OMB memorandum issued in late February.
Potential Near-Term Impact on Selected Stakeholders
The RIFs and large-scale restructuring of HHS will impact the entire health care industry, with certain stakeholders facing more of the brunt in the short term. We address each of those stakeholder groups briefly below.
Medicare Advantage and Part D Plans
As of the date of this post, we understand that most CMS offices addressing Medicare Part C and Part D operations remain intact and were not significantly impacted by the RIF. However, all Medicare Advantage plans’ account managers are located in the HHS Regional Offices. Many Medicare Advantage (MA) and Part D plans likely lost their account managers and will need to be assigned new ones. This will result in those remaining account managers having increased caseloads, and being responsible for more plans. This is likely to result in delays in communication with account managers.
Health Care Providers
The consolidation of the Regional Offices will likely impact provider enrollment processes, provider surveying, Change of Ownership (CHOW) determinations and approvals, and the processing of CMS-specific enforcement activities, including reasonable assurance determinations. While CMS had previously transitioned certain Regional Office enrollment and survey functions for some provider types to CMS’s Center for Program Integrity and to the Medicare Administrative Contractors (MACs), the Regional Offices still play a key role in enrollment, surveys, and CHOW functions. For example, the Regional Offices of HHS-OGC advise on challenging CHOW questions and issues. HHS Regional Offices also still process and determine reasonable assurance periods. The consolidation of Regional Offices could create delays and bottlenecks for CHOW approvals, especially with more challenging CHOWs that require input from HHS-OGC.
The Regional Office consolidation will also impact provider audits performed by MACs, Unified Program Integrity Contractors, and other contractors. HHS-OGC provides oversight and training to these contractors and helps ensure uniformity in enforcement across regions. Consolidation and reduction in legal support to these entities may result both in delays in enforcement and inconsistent enforcement across providers.
Biopharmaceutical and Medical Device Manufacturers
The cuts to date of FDA staff have caused profound disruption at the agency and, in the short term, will almost certainly result in delays and longer timelines for approving new drugs, biological products, and innovative medical devices. With the firings of staff focused on digital health and artificial intelligence, it also seems likely that FDA will become more conservative when it comes to making policy, regulatory, and enforcement decisions in that space, depending upon the level of uncertainty at play. Developers of gene therapies, cell therapies, and rare disease treatments – who had benefitted from FDA’s increasing willingness to exercise “regulatory flexibility” and approve such products in the face of scientific uncertainty – also may see a marked shift now that the agency’s institutional expertise and leadership in those areas have been decimated. This puts more cutting-edge and innovative products at greater risk of not receiving FDA marketing approvals than they had pre-RIF. Concerns about delays in medical product reviews and a potential increase in denied applications are being exacerbated by the likelihood that developers will have a more difficult time getting informal and formal feedback from the agency, as a result of fewer employees and the fact that reviewers will no longer have regulatory policy, research, or administrative colleagues (among others) to support that complex work. Indeed, around April 11, 2025 a nonpartisan and highly experienced group of investors and executives from the medical products research and development enterprise sent a letter to Senate leadership expressing their alarm at what is occurring at FDA and describing slowdowns and bottlenecks that are already manifesting as a result of the RIF.
In addition, although HHS’s restructuring announcement stated that “those with roles in drug, medical device or food reviews or inspections” would not be adversely affected, in reality, the continuity and timeliness of both review activities and inspections will be harmed by the loss of nearly 25% of FDA’s workforce since January 2025. For example, inspections of manufacturing facilities cannot take place if the teams can’t get to the site – but press reports indicate that support staff in the Office of Inspections and Investigations that handle travel and other logistics have been terminated. Facility inspections occur not only to monitor the safety of American foods, medicines, and devices but also to support new product approvals, so delays in the agency’s inspectional functions may negatively affect the approval and launch of medical products. The ability to convene advisory committee meetings, which in some cases are required by law prior to a new product approval, is also likely to be adversely impacted without support staff to organize such large-scale events.
Finally, from a general FDA mission standpoint, the apparently haphazard nature of the RIF also means that industry complaints about non-compliance by competitors will likely go un-investigated and enforcement actions will decrease across the board. While the possibility of less enforcement may sound good to a regulated company, in practical effect a weaker FDA will make patient injuries, tort lawsuits, and expensive legal challenges by competitors much more likely. And the significant loss of FOIA and public communications staff from the agency will make obtaining documents about competitors, similar products, FDA’s analyses of certain regulatory issues, and other such valuable information much slower, if not impossible, for industry and the public alike.
New Mexico Will Phase Out Products Containing Intentionally Added PFAS and Require Reporting; Exemptions Include Fluoropolymers
On April 8, 2025, New Mexico Governor Michelle Lujan Grisham (D) signed the Per- and Poly-Fluoroalkyl Substances (PFAS) Protection Act (HB 212). Like Minnesota and Maine, New Mexico will begin phasing out certain consumer products containing intentionally added PFAS, defining PFAS as “a substance in a class of fluorinated organic chemicals containing at least one fully fluorinated carbon atom.” In 2032, New Mexico will prohibit products containing intentionally added PFAS unless the use of the PFAS is designated as a currently unavoidable use (CUU). Similar to Minnesota, New Mexico will also require manufacturers of products containing intentionally added PFAS to report certain information. New Mexico will exempt several products, however, from both the prohibition and reporting requirements. Most notably, the exemptions include products containing certain fluoropolymers.
Prohibited Products
In New Mexico, beginning January 1, 2027, a manufacturer may not sell, offer for sale, distribute, or distribute for sale the following products containing intentionally added PFAS:
Cookware;
Food packaging;
Dental floss;
Juvenile products; and
Firefighting foam.
Beginning January 1, 2028, New Mexico will prohibit manufacturers from selling, offering for sale, distributing, or distributing for sale the following products containing intentionally added PFAS:
Carpets or rugs;
Cleaning products;
Cosmetics;
Fabric treatments;
Feminine hygiene products;
Textiles;
Textile furnishings;
Ski wax; and
Upholstered furniture.
Beginning January 1, 2032, products containing intentionally added PFAS that are not exempt under New Mexico’s statute will be banned unless the use of the PFAS is determined to be a currently unavoidable use (CUU).
The products that New Mexico will prohibit are similar to the products that Minnesota and Maine have already prohibited or will be prohibiting. On January 1, 2025, Minnesota prohibited intentionally added PFAS in carpets or rugs, cleaning products, cookware, cosmetics, dental floss, fabric treatments, juvenile products, menstruation products, textile furnishings, ski wax, and upholstered furniture. As of January 1, 2025, Maine prohibits intentionally added PFAS in carpets or rugs, fabric treatments, and fabric treatments that do not contain intentionally added PFAS but are sold, offered for sale, or distributed for sale in a fluorinated container or in a container that otherwise contains intentionally added PFAS. Beginning January 1, 2026, Maine will prohibit intentionally added PFAS in cleaning products, cookware, cosmetics, dental floss, juvenile products, menstruation products, textile articles (with exception), ski wax, upholstered furniture, and products listed that do not contain intentionally added PFAS but are sold, offered for sale, or distributed for sale in a fluorinated container or in a container that otherwise contains intentionally added PFAS. Beginning January 1, 2029, Maine will prohibit intentionally added PFAS in artificial turf and outdoor apparel for severe wet conditions unless accompanied with a disclosure: “Made with PFAS chemicals.” Both Minnesota and Maine will prohibit products containing intentionally added PFAS beginning January 1, 2032, unless the use is a CUU, and Maine will prohibit products that do not contain intentionally added PFAS but that are sold, offered for sale, or distributed for sale in a fluorinated container or in a container that otherwise contains intentionally added PFAS. As amended last year, Maine will prohibit intentionally added PFAS in cooling, heating, ventilation, air conditioning, and refrigeration equipment, as well as in refrigerants, foams, and aerosol propellants as of January 1, 2040.
Reporting Requirements
On or before January 1, 2027, New Mexico will require manufacturers of products containing intentionally added PFAS to report certain information, including:
A brief description of the product, including a universal product code (UPC), stock keeping unit (SKU), or other numeric code assigned to the product;
The purpose for which the PFAS is used in the product;
The amount of each PFAS in the product, identified by its Chemical Abstracts Service Registry Number® (CAS RN®) and reported as an exact quantity determined using commercially available analytical methods or as falling within a range approved for reporting purposes by the New Mexico Environment Department (NMED);
The name and address of the manufacturer and the name, address, and phone number of a contact person for the manufacturer; and
Any additional information requested by NMED as necessary.
NMED may grant a waiver to a manufacturer if NMED determines that substantially equivalent information is publicly available. NMED may enter into an agreement with one or more states to collect information and may accept information from a shared system as meeting the information requirements.
As reported in our June 14, 2023, blog item, Minnesota will require manufacturers of products containing intentionally added PFAS to submit similar information on or before January 1, 2026. According to the Minnesota Pollution Control Agency (MPCA), it is working with the Interstate Chemicals Clearinghouse (IC2) to modify its High Priority Chemicals Data System (HPCDS) database as the reporting platform for its requirement. Maine had a similar reporting requirement in the statute enacted in 2021, but the governor signed a bill in April 2024 amending the statute so that the reporting requirement applies only to products that receive a CUU determination. More information on the 2024 amendments to Maine’s statute are available in our May 24, 2024, blog item.
Exemptions
New Mexico exempts several products from both the prohibition and reporting requirement. As stated earlier, Maine amended its reporting requirement to apply only to products with a CUU determination. Maine’s 2024 amendments included the addition of several exemptions to the statute as noted below. Minnesota’s statute has fewer exemptions, which are also noted below. The exemptions in New Mexico include:
A product for which federal law governs the presence of a PFAS in the product in a manner that preempts state authority (Maine);
Used products offered for sale or resale (Maine, Minnesota);
Medical devices or drugs and the packaging of the medical devices or drugs that are regulated by the U.S. Food and Drug Administration (FDA), including prosthetic and orthotic devices (Maine, Minnesota (reporting will still be required));
Cooling, heating, ventilation, air conditioning, or refrigeration equipment that contains intentionally added PFAS or refrigerants listed as acceptable, acceptable subject to use conditions, or acceptable to narrowed use limits by the U.S. Environmental Protection Agency (EPA) pursuant to the Significant New Alternatives Policy (SNAP) Program, 40 C.F.R. Part 82, Subpart G and sold, offered for sale, or distributed for sale for the use for which the refrigerant is listed pursuant to that program (Maine will prohibit these products on January 1, 2040);
A veterinary product and its packaging intended for use in or on animals, including diagnostic equipment or test kits and the veterinary product’s components and any product that is a veterinary medical device, drug, biologic, or parasiticide or that is otherwise used in a veterinary medical setting or in veterinary medical applications that are regulated by or under the jurisdiction of:
FDA;
The U.S. Department of Agriculture (USDA) pursuant to the federal Virus-Serum-Toxin Act; or
EPA pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), except that any such products approved by EPA pursuant to that law for aerial and land application are not exempt from this section (Maine);
A product developed or manufactured for the purpose of public health or environmental or water quality testing (Maine);
A motor vehicle or motor vehicle equipment regulated under a federal motor vehicle safety standard, as defined in 49 U.S.C. Section 30102(a)(10), except that the exemption does not apply to any textile article or refrigerant that is included in or as a component part of such products (Maine);
Any other motor vehicle, including an off-highway vehicle or a specialty motor vehicle, such as an all-terrain vehicle, a side-by-side vehicle, farm equipment, or a personal assistive mobility device (Maine);
A watercraft, an aircraft, a lighter-than-air aircraft or a seaplane (Maine);
A semiconductor, including semiconductors incorporated in electronic equipment, and materials used in the manufacture of semiconductors (Maine);
Non-consumer electronics and non-consumer laboratory equipment not ordinarily used for personal, family, or household purposes (Maine);
A product that contains intentionally added PFAS with uses that are currently listed as acceptable, acceptable subject to use conditions, or acceptable subject to narrowed use limits in EPA’s rules under the SNAP Program; provided that the product contains PFAS that are being used as substitutes for ozone-depleting substances under the conditions specified in the rules;
A product used for the generation, distribution, or storage of electricity;
Equipment directly used in the manufacture or development of the products listed above;
A product for which the NMED Environmental Improvement Board (EIB) has adopted a rule providing that the use of PFAS in that product is a CUU; or
A product that contains fluoropolymers consisting of polymeric substances for which the backbone of the polymer is either a per- or polyfluorinated carbon-only backbone or a perfluorinated polyether backbone that is a solid at standard temperature and pressure.
Testing Required and Certificate of Compliance
If NMED has reason to believe that a product containing an intentionally added PFAS is being sold, offered for sale, distributed, or distributed for sale, it may direct the manufacturer to provide it with testing results within 30 days that demonstrate the amount of each PFAS in the product, identified by its CAS RN and reported as an exact quantity or as falling within a range approved for reporting. If testing demonstrates that the product does not contain intentionally added PFAS, the manufacturer will provide NMED with a certificate of compliance attesting that the product does not contain an intentionally added PFAS, the testing results, and any other relevant information.
Minnesota has similar provisions regarding testing and certificates of compliance. The Maine Department of Environmental Protection (MDEP) may direct the manufacturer to provide within 30 days a certificate attesting that the product does not contain intentionally added PFAS.
Commentary
Although the requirements enacted by New Mexico, Maine, and Minnesota are similar, there are some key differences. Most of the products exempted in 2024 from Maine’s prohibitions are included in New Mexico’s statute, as well as a provision exempting fluoropolymers that “consist[] of polymeric substances for which the backbone of the polymer is either a per- or polyfluorinated carbon-only backbone or a perfluorinated polyether backbone that is a solid at standard temperature and pressure.” Bergeson & Campbell, P.C. (B&C) agrees that fluoropolymers should be distinguished from the broad class of PFAS. The exemption here may lead, however, to future litigation or amendment. The enacted definition includes the fluoropolymer polytetrafluoroethylene (PTFE), better known as TeflonTM. While New Mexico will ban cookware containing intentionally added PFAS, the best known example — Teflon-coated frying pans — will be exempt from both the prohibition and reporting requirements. Non-governmental organizations (NGO) may argue that legislatures lacking a chemical background did not appreciate that the exemption would extend to Teflon-coated cookware, while manufacturers will maintain the safety of fluoropolymers. The inclusion of the exemption is scientifically grounded and reflects the entirely sensible view that products posing no risk should not be banned. Other states are expected to follow New Mexico’s lead.
Each state varies in what reporting will be necessary. Maine dropped its broad reporting requirement and will require reporting only for products with a CUU determination. Minnesota will require reporting for all products, including those otherwise exempt from the prohibition requirements, including medical devices. New Mexico will require reporting only for products that do not have an exemption (thus excluding products that have a CUU determination and medical devices). Minnesota and New Mexico will require similar information, and with Minnesota’s reporting currently due on or before January 1, 2026, it may be that reporting to New Mexico will not be necessary since the enacted law allows NMED to grant a waiver to a manufacturer if NMED determines that substantially equivalent information is publicly available. NMED may also accept information from a shared system as meeting the information requirements.
The testing envisioned by New Mexico and Minnesota that can demonstrate the amount of each PFAS in the product, identified by CAS RN and reported as an exact quantity or as falling within an approved range, all within 30 days, is beyond the current technical capabilities. With thousands of substances meeting the states’ definition of PFAS as “a class of fluorinated organic chemicals containing at least one fully fluorinated carbon atom,” it is not yet possible to run a single test and determine the specific PFAS in a particular product. To date, the current test used, total organic fluorine (TOF), measures only the total amount of fluorine in a sample that is bound to organic compounds.
Since enacting its statute in 2021, Maine has amended it several times, and there are currently several bills in the Minnesota legislature that would amend its law. As reported in our April 11, 2025, blog item, the Maine Board of Environmental Protection (MBEP) approved MDEP’s December 2024 proposed rule regarding PFAS products during its April 7, 2025, meeting. Under the approved rule, CUU requests for products scheduled to be prohibited January 1, 2026, in Maine are due June 1, 2025. Although Minnesota requested comments in November 2024 on its planned PFAS in products reporting and fee rule, it has yet to issue a proposed rule, despite the rapidly approaching January 1, 2026, deadline. The state regulatory landscape remains fluid, and stakeholders are advised to stay tuned.