The Swiss Federal Supreme Court Bans References to Animals in Plant-based Foods
On May 2, 2025, the Swiss Federal Supreme Court ruled that designations referring to animal species are not allowed to label plant-based meat substitutes (here is the official press release, in French, 2C_26/2023). The full judgment is not yet available, so we cannot provide a more in-depth analysis of the arguments of Switzerland’s supreme judges, and the information below is based solely on the press release.
In 2021, the Zurich Cantonal Laboratory banned a company from labelling its pea protein meat substitutes with names referring to animal species; the company appealed this ban, and the Administrative Court of the Canton of Zurich decided in its favor in 2022, allowing the use of references to animal meat in its products. However, in its judgment of May 2, 2025, the Federal Supreme Court upheld the appeal filed by the Federal Department of Home Affairs, annulling the first instance decision of the Zurich Administrative Court and thus ruling against the company.
According to the press release, food products destined for consumers made exclusively with vegetable proteins (i.e., those usually defined as ‘plant-based meat’) cannot be designated by names of animal species, even if these are accompanied by an indication specifying the vegetable origin of the product, such as ‘planted chicken,’ ‘chicken-like,’ ‘pork-like,’ ‘vegan pork,’ or ‘vegan chicken.’ In fact, the term ‘chicken’ refers to poultry; therefore, it cannot be used for products that do not contain a meat component, as it would be misleading for consumers. In other words, plant-based products alternative to meat must be labelled in such a way as to enable the consumer to recognize the type of foodstuff and to differentiate it from products that they aim to substitute.
BETO Updates 45ZCF-GREET Model to Incorporate New Methods of Alternative Fuel Production
On May 30, 2025, the U.S. Department of Energy (DOE) Bioenergy Technologies Office (BETO) announced that it “removed barriers to domestic bioenergy production by updating its 45ZCF-GREET modeling tool to account for new feedstocks and methods of production, including ethanol from corn wet-milling and natural gas from coal-mine methane.” According to BETO, these measures will allow a wider range of farmers and companies to do business in the alternative fuels market. BETO notes that the U.S. Department of the Treasury adopted the 45ZCF-GREET model to help transportation fuel producers assess their eligibility for 45Z, also known as the Clean Fuel Production Credit, a provision in the Internal Revenue Code that provides tax credits for the production of certain clean transportation fuels. The latest GREET® (Greenhouse gases, Regulated Emissions, and Energy use in Technologies) model, updated user manual, and a log of all changes are available online. For questions on how to use the model, contact [email protected].
Rethinking University Research: Innovating the Innovation Ecosystem to Support Life Sciences and Personalized Medicine
Personalized medicine—tailoring treatments to individual patients based on their genetic makeup, lifestyle, and environment—is transforming healthcare. But this revolution didn’t begin in the private sector. It was sparked and shaped by decades of strategic investment from the U.S. government, especially the National Institutes of Health (NIH).
Genomics as the Foundation
The Human Genome Project, completed in 2003 with major NIH support, provided the genetic blueprint of human life. Follow-on initiatives like The Cancer Genome Atlas Program (TCGA), the Encyclopedia of DNA Elements (ENCODE), and the Genotype-Tissue Expression Project (GTEx) linked DNA variants to disease risk.
All of Us: A New Era of Data
NIH’s All of Us research program, aiming to enroll over one million participants, is creating one of the world’s most diverse and comprehensive health datasets. It’s enabling insights into how genes, the environment, and behavior intersect to shape health.
Pharmacogenomics in Practice
NIH’s Pharmacogenomics Research Network seeks to understand how individual genetic differences affect drug response, which can improve dosing precision and reduce adverse effects.
The Evolving Landscape of Federally Funded Research
While federal grants and investments have helped translate genomic insights into clinical impact, much of that foundational work begins in academic labs. Many fundamental discoveries take place in universities—long before they appear in clinical trials or investor pitch decks. Yet, the sustainability of this engine of innovation depends heavily on continued federal support. As funding pressures grow, especially in areas that don’t promise immediate commercial return, the need to protect and strengthen university research funding has never been more urgent.
The evolving financial landscape of university-led academic research was addressed by Dr. Julio Frenk at the 2025 LABEST Bioscience Conference. Overall, Dr. Frenk painted a hopeful picture of the future of academic research, encouraging universities to embrace change and seize opportunities for growth and success. His insights provide valuable guidance for navigating the evolving financial landscape and ensuring the continued advancement of knowledge and discovery.
A powerful idea was presented that challenges traditional notions of university research: the need to “innovate the innovation.” This concept, also described as meta-innovation, calls on research institutions to not only produce groundbreaking discoveries but to reimagine the entire process by which those discoveries are made, translated, and applied.
From Research to Real-World Impact
Universities have long been hubs of knowledge creation, but Dr. Frenk emphasized that in today’s complex world, that’s no longer enough. Academic institutions should drive research to link innovation with societal benefits.
A few of Dr. Frenk’s solutions include:
Dissolving the divide between basic and applied research. Universities should foster a more integrated approach that allows ideas to move more fluidly from theory to practical application.
Partner earlier and more intentionally with industry and philanthropic investors. Diversifying funding sources and collaborating sooner in the research cycle can speed up the path from concept to impact.
Redefine the university’s mission beyond knowledge creation to include translation—turning discoveries into technologies and evidence that inform policy and improve lives.
Build new physical and intellectual spaces, like the UCLA Research Park, that support interdisciplinary collaboration, entrepreneurship, and commercialization.
Embrace innovation in education and governance, ensuring the way the United States and academic institutions teach, organize, and evaluate research evolves alongside science itself.
The Future of Innovation is Integrated
This call to action urges universities to adopt agile, impact-focused systems instead of traditional academic models. By aligning excellence with relevance, and forging new types of collaboration, universities can remain at the forefront of solving humanity’s most urgent challenges.
In sum, the question isn’t just what we discover—but how we innovate to make that discovery matter.
Oregon Federal Judge Strikes Down State Law Requiring Labor Peace Agreements for Cannabis Licensure and Certification – OLCC Will No Longer Enforce State Requirement
On Tuesday May 20, 2025, U.S. District Judge for the District of Oregon, Michael H. Simon issued a decision in Casala LLC, d/b/a Bubble’s Hash and Rec Rehab Consulting LLC, d/b/a Ascend Dispensary v. Tina Kotek, in her official capacity as Governor of the State of Oregon, et al., Case No. 3:25-cv-244-SI (D.Or. May 20, 2025), striking down Oregon’s United for Cannabis Workers Act and holding that the law is preempted by the National Labor Relations Act (“NLRA”) in violation of the Supremacy Clause and the First Amendment of the United States Constitution.
Shortly after Oregon’s United for Cannabis Workers Act took effect, two cannabis employers Bubble’s Hash and Ascend Dispensary (collectively, “Plaintiffs”), filed suit for declaratory and injunctive relief, and sought a permanent injunction to enjoin the Oregon Governor, Oregon Attorney General, Chair of the Oregon Liquor and Cannabis Commission (“OLCC”), and Executive Director of the OLCC (collectively, “Defendants”), from enforcing the United for Cannabis Workers Act against them.
Plaintiffs alleged that the law: (1) was preempted by the NLRA and its enforcement would be in violation of the Supremacy Clause of the United States Constitution; (2) was void for vagueness in violation of the Due Process Clause of the United States Constitution; (3) abridged Plaintiffs’ freedom of speech in violation of the First Amendment, as made applicable to the States by the Fourteenth Amendment; (4) infringed on Plaintiffs’ right to equal protection in violation of the Fourteenth Amendment; and (5) disrupts Plaintiffs’ contractual arrangements in violation of the Contract Clause of the United States Constitution.
Following hearing argument on the merits, the Court granted Plaintiffs’ requested declaratory and permanent injunctive relief, concluding that the law was preempted by the NLRA, violated the Supremacy Clause and violated Plaintiffs’ First Amendment rights, and that the requirements for permanent injunctive relief were satisfied. With this decision, the Oregon District Court became the first U.S. District Court to strike down a state law that required cannabis employers to enter into labor peace agreements in order to receive or renew a license to sell cannabis.
On May 29, the OLCC issued the following statement concerning Judge Simon’s May 20 decision: “Earlier this month, a federal judge issued a ruling barring the enforcement of Ballot Measure 119. Given this ruling and in consultation with the Oregon Department of Justice, the OLCC will no longer require labor peace agreements as part of cannabis license application and license renewals.”
United for Cannabis Workers Act
The United for Cannabis Workers Act was passed by an initiative approved by Oregon voters in November 2024 as Ballot Measure 119 (“Measure 119”) and took effect December 5, 2024. Measure 119 requires businesses licensed to sell or process cannabis to enter into labor peace agreements with labor organizations or sign an attestation affirming that the business has entered into such agreement. The businesses must submit such agreements or attestations with their applications for a license, certification of renewal of a license, or certification to dispense cannabis. Oregon law defines a “labor peace agreement” (“LPA”) as “an agreement under which, at a minimum, an applicant or licensee agrees to remain neutral with respect to a bona fide labor organization’s representatives communicating with the employees of the applicant or the licensee about the rights afforded to such employees.
Plaintiffs had both been unable to enter into LPAs at the time of filing.
The District Court’s Decision
As an initial issue, the Court determined that the NLRA likely applied to cannabis businesses and does not limit its jurisdiction to “lawful commerce” or “legal substance” as some other federal laws do. Judge Simon pointed out that the National Labor Relations Board (“NLRB”) has issued advisory memoranda back to 2013 which stated that the medical marijuana industry is within the NLRB’s jurisdiction if the business meets the NLRA’s jurisdictional monetary requirements.
The Court determined that Measure 119 is preempted by the NLRA under Garmon preemption because it does not distinguish between permissible employer speech and threatening or coercive speech and thus impermissibly conditions a state license on an employer “refraining from conduct protected by federal labor law,” which “chills one side of the ‘robust debate which has been protected under the NLRA.’” In other words, Measure 119 chills an employer’s right to speech under section 8(c).
In terms of Machinist preemption, the Court held that by seeking to regulate and forbid certain truthful, non-deceptive, non-coercive speech about unionization and by conditioning license renewal on signing an LPA, Measure 119 sought to regulate the relationship between unions and employers, upsetting the balance Congress struck in passing the NLRA. Thus, it is preempted under Machinist preemption.
With respect to the First Amendment, the Court determined that because Measure 119 requires Plaintiffs to remain neutral with respect to labor organization’s representatives communicating with employees of the applicant or licensee and does not limit its restrictions to only threatening, coercive, false, or misleading speech, it violates Plaintiffs’ First Amendment rights to free speech.
Other States With Similar Labor Peace Agreement Requirements
While not binding on other courts outside of Oregon, given that the decision is the first to strike down a law that requires LPAs for licensure, the decision is likely to be utilized by cannabis businesses in other states with similar requirements, such as California, Rhode Island, New York, New Jersey, Connecticut, and Delaware, among others.[1]
The decision acknowledged and Defendants cited to a recent decision analyzing the California version of Measure 119, the Medicinal and Adult-Use Cannabis Regulation and Safety Act (“MAUCRSA”) Ctrl Alt Destroy v. Elliott, 2025 WL 790963 at *7 n.8 (S.D. Cal. Mar 12, 2025) which held that Garmon preemption did not apply because of the local responsibility exception. Judge Simon rejected this conclusion of Ctrl Alt Destroy, pointing out that Measure 119 and MAUCRSA regulate only labor relations of cannabis businesses and do not regulate the sale or use of cannabis. Similarly, Judge Simon rejected the conclusion from the Ctrl Alt Destroy decision on Machinists preemption. Judge Simon reasoned that Machinists preemption seeks to protect balancing only in the labor relations context, not to regulation of the underlying market. Thus, Measure 119 regulates an area that Congress intended to leave to the free play of economic forces.
Takeaways
The OLCC will no longer require labor peace agreements as part of cannabis license application and license renewals in Oregon.
Employers seeking to challenge similar state LPA licensure requirements in other states are encouraged to speak with experienced labor counsel to discuss their options. We will continue to monitor similar challenges as they are filed, and provide additional updates.
FOOTNOTES
[1] Additionally, states including Illinois and Pennsylvania grant preferential treatment to businesses with LPAs when applying for licensure.
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Minnesota Employment Legislative Update 2025, Part III: Regular Session Ends in Stalemate and Stagnation
On May 19, 2025, the Minnesota Legislature’s regular session adjourned without completing the two-year budget, leaving a long list of outstanding bills in limbo. The Minnesota Legislature will now enter a special session to tackle unfinished business. Despite the regular session’s anti-climactic ending, state lawmakers managed to pass a handful of bills that have been signed by Governor Tim Walz and will create new obligations for employers.
Quick Hits
Minnesota’s regular legislative session adjourned on May 19, 2025, but a special session is expected to convene soon to complete remaining budgetary matters.
Governor Walz signed the Brady Aune and Joseph Anderson Safety Act, imposing new requirements on employers with commercial scuba divers.
The legislature amended Minnesota’s medical cannabis law, among other laws, which creates new obligations for employers.
Other significant proposed bills aimed at amending existing labor and employment laws failed to make it to Governor Walz’s desk for approval.
Brady Aune and Joseph Anderson Safety Act
A new statute, Minn. Stat. § 182.679, titled the “Brady Aune and Joseph Anderson Safety Act,” applies to “persons who are conducting self-contained underwater breathing apparatus (scuba) diving at a place of employment while making improvements to the land, including the removal of aquatic plants” took effect May 2, 2025. Under this new statute, which is included in the Minnesota Occupational Safety and Health Act (Minn. Stat. § 182), employers:
may not allow an individual to scuba dive unless the individual has an acceptable open-water scuba diver certificate;
must require certain equipment when an individual is scuba diving;
must ensure that a standby diver is available while a diver is in the water; and
must ensure all individuals scuba diving or serving as standby divers are trained in CPR and first aid.
An employer may be cited by the commissioner of labor and industry for violations under this statute.
Amendments to Minnesota’s Medical Cannabis Law
Minnesota’s medical cannabis law (Minn. Stat. § 342.57) went into effect on March 1, 2025, and prohibits employers from discriminating against a person in hiring, termination of employment, or any term or condition of employment if the discrimination was based on the person’s enrollment in a cannabis registry program. It also prohibits employers from taking adverse action against an employee for a positive drug test for cannabis components or metabolites, unless the employee used, possessed, sold, transported, or was impaired by medical cannabis flower or a medical cannabinoid product on work premises, during working hours, or while using an employer’s vehicle, equipment, or machinery. These protections apply unless compliance would violate federal or state laws or regulations or cause an employer to lose a monetary or licensing-related benefit under federal law or regulations.
Senate File (SF) 2370 / House File (HF) 1615 amended Minnesota’s medical cannabis law in several ways, including:
expanding the protection of this bill to cover employees who are enrolled in a Tribal medical cannabis program. Thus, an employer may not take any adverse action against an employee based on the employee’s enrollment in this type of program;
requiring an employer to notify employees at least fourteen days before the employer takes an adverse employment action due to the specific federal law or regulation the employer believes would be violated if it does not take the action and the monetary or licensing-related benefit the employer would lose if it does not take the action;
prohibiting employers from retaliating against an employee for asserting the employee’s rights or seeking remedies under the Minn. Stat. §§ 342.57 or 152.32;
increasing the civil penalty for violating Minn. Stat. §§ 342.57, subds. 3, 4, or 5 from $100 to $1,000.
giving employees the option to seek injunctive relief to prevent or end a violation of Minn. Stat. §§ 342.57, subds. 3 to 6a.
Governor Walz signed the bill on May 23, 2025, and it took effect the following day.
Amendments to Wage Theft and Whistleblower Laws
On May 23, 2025, Governor Walz also signed bills that amended Minnesota’s wage theft and whistleblower statutes.
Wage Theft: SF 1417 / HF 2432 amends Minn. Stat. § 388.23 to give the county attorney (or deputy attorney if authorized by the county attorney in writing) the authority to subpoena and require the production of records of an employer or business entity that is the subject of or has information related to a wage theft investigation, including: accounting and financial records (such as books, registers, payrolls, banking records, credit card records, securities records, and records of money transfers); records required to be kept pursuant to section 177.30, paragraph (a); and other records that relate to the wages or other income paid, hours worked, and other conditions of employment or of work performed by independent contractors, and records of any payments to contractors, and records of workers’ compensation insurance.
SF 1417 / HF 2432 will go into effect on August 1, 2025.
Whistleblowers: SF 3045 / HF 2783: Amends Minn. Stat. § 181.931 (Minnesota’s whistleblower law) to add definitions of “fraud,” “misuse,” and “personal gain”:
“Fraud” means an intentional or deceptive act, or failure to act, to gain an unlawful benefit.
“Misuse” means the improper use of authority or position for personal gain or to cause harm to others, including the improper use of public resources or programs contrary to their intended purpose.
“Personal gain” means a benefit to a person; a person’s spouse, parent, child, or other legal dependent; or an in-law of the person or the person’s child.
SF 3045 / HF 2783 will go into effect on July 1, 2025.
Looking Ahead
Several omnibus bills include provisions that, if enacted, would amend Minnesota’s meal and rest break law, add employer unemployment insurance fraud penalties, make “political activity” a new protected characteristic under the Minnesota Human Rights Act, revise Minnesota Paid Family and Medical Leave and Earned Sick and Safe Time laws, and create valid circumstances for noncompete agreements. However, when the regular session ended, these bills were stranded in the legislative pipeline, awaiting potential revival in the special session.
The legislature has until July 1, 2025, to enact the rest of its budget to avoid a government shutdown, and Governor Walz is expected to call the special session soon after Memorial Day. With a track record of embedding labor and employment laws into lengthy budget bills, employers may want to prepare for any developments from the special session.
Find the previous parts of this series here: Part I & Part II
Court Strikes Down Fentanyl and Reciprocal Tariffs, but Appeals Court Temporarily Stays Impact
Key Takeaways
The U.S. Court of International Trade struck down President Trump’s fentanyl and reciprocal tariffs imposed under the International Emergency Economic Powers Act of 1977 (IEEPA), ruling the statute did not authorize such broad actions.
The court’s order halts future tariff collection, requires refunds of duties collected since February 2025, and has nationwide impact across all U.S. importers and ports.
The government has appealed the decision and requested a stay of the court’s order, which the Federal Circuit granted. This temporary stay pauses the unwinding of the tariffs, resulting in continued tariff collection in the interim and delayed refunds to importers.
The ruling is limited to IEEPA-based tariffs and does not affect existing or future tariffs imposed under Section 232 or Section 301 authorities.
On May 28, 2025, the U.S. Court of International Trade (USCIT) struck down the earliest and broadest of President Trump’s second term tariff actions: the tariffs imposed against Canada, Mexico and China starting in February and March (the fentanyl tariffs) and the tariffs imposed against nearly all other countries in early April (the reciprocal tariffs). These actions, together as subsequently modified, subjected most U.S. imports to additional import duties of between 10% and 25%. The court’s order wipes those executive tariff impositions off the table, eliminating prior and prospective collection, including the planned increase of the 10% reciprocal tariffs later this summer. If the opinion and order stand, all fentanyl and reciprocal duties collected since February 2025 will be refunded. The court’s order does not impact tariffs imposed under other tariff authorities like Section 232 or Section 301.
The court’s opinion, issued on May 28, impacts multiple tariff executive orders issued by the President invoking the IEEPA. The court specifically found that that statute did not authorize the President “to impose unlimited tariffs on goods from nearly every country in the world.”
On February 1, President Trump first invoked IEEPA to announce tariffs imposed on U.S. imports from Canada, China and Mexico intended to address the flow of fentanyl and its precursors from those countries crossing the U.S. border; the actions against Canada and Mexico were also intended to address migration flows from those two countries. The tariffs, set to take effect on February 4, were ultimately deferred with regard to Canada and Mexico until early March. Since that time, these tariffs have been revised on several occasions, for example, exempting U.S. imports eligible for preferential treatment under the U.S.-Mexico-Canada Agreement (USMCA) from the fentanyl tariffs.
Later, on April 2, President Trump announced 10% tariffs on the vast majority of imports from the vast majority of countries, effective April 5; these tariffs were intended to rebalance U.S. trade flows and achieve “reciprocal” trading treatment. For certain countries, those 10% tariffs briefly increased to higher country-specific rates at 12:01 am ET on April 9, 2025. That same date, however, President Trump paused the increase in reciprocal duty tariff rates for those countries with enhanced rates above 10% for all countries other thanChina, with the higher rates deferred for 90 days (to July 8, 2025). With regard to shipments from China, President Trump announced escalating tariff rates peaking at 125%. The 125% tariffs were subsequently temporarily decreased to 10%, effective May 16, 2025, following productive negotiations between the U.S. and China; higher rates previously in effect are expected to be reimposed effective August 12.
The court’s action from May 28 eliminates the entire IEEPA tariff framework, ordering U.S. Customs and Border Protection to refund the fentanyl and reciprocal tariffs collected and cease collection of new duties. This order has national effect, thereby impacting across all U.S. importers and ports.
Although the court invalidates the tariffs and orders that the tariffs be unwound within 10 calendar days of its opinion’s issuance, the government has already appealed the court’s ruling to the U.S. Court of Appeals for the Federal Circuit and has sought a stay of the court’s order pending resolution of the appeal, which the Federal Circuit granted. This temporary stay pauses the unwinding of the tariffs, resulting in continued tariff collection in the interim and delayed refunds to importers. Whichever party prevails on appeal before the Federal Circuit will have an opportunity to seek further review by the U.S. Supreme Court.
The USCIT’s judgment is limited to the IEEPA-based tariff regimes and does not impact tariffs imposed under other legal mechanisms, for example, tariffs imposed to date or potentially imposed in the future on certain sectors under national security investigations conducted under Section 232 of the Trade Expansion Act of 1962 (such as on steel, aluminum or autos) or under Section 301 of the Trade Act of 1974 (as imposed by President Trump during his first term against certain imports from China and expanded during the Biden Administration). This opinion also does not impact future potential Section 232 actions, such as those that may be taken for pharmaceuticals, critical minerals, semiconductors and heavy trucks following the outcome of those investigations.
Talc Safety Subject of New Independent Scientific Expert Panel Led by FDA
A panel of scientific experts met last week at the request of federal regulators to discuss the potential side effects of talc and cancer risks to consumers. Specifically, the independent panel discussed the safety of talc in food, drug, and cosmetic products.
The event, led by FDA Commissioner Dr. Martin Makary, marked the start of a broader effort to publicly evaluate controversial ingredients tied to serious health risks. Talc is a soft mineral used in baby powder, cosmetics, and pharmaceutical tablets. Talc is often mined near asbestos, a known carcinogen that can cause mesothelioma, asbestosis, and lung cancer, among other serious diseases. Talc litigation is rampant across the country, with plaintiffs’ lawyers and experts arguing that talc products can become contaminated with asbestos fibers, ultimately leading to disease and death.
In addition to these contamination risks, some researchers have raised concerns that even asbestos-free talc may pose health hazards. In litigation, plaintiffs’ experts point to studies that suggest talc particles, when applied to the genital area, can migrate into the body and may increase the risk of ovarian cancer through chronic inflammation. These concerns were amplified in June 2024, when the World Health Organization’s International Agency for Research on Cancer (IARC) classified talc as “probably carcinogenic” to humans, even when it is asbestos-free.
There have been thousands of lawsuits filed against talc companies, suppliers, and manufacturers, each raising similar allegations that various talc-based products were often contaminated with asbestos, causing plaintiffs to develop mesothelioma, ovarian cancer, and other injuries after applying and breathing in the powder.
Panel Promotes Shift Away From Talc Use
During the roundtable discussion, the panel of researchers, pathologists, and toxicologists reached a consensus that manufacturers “should move away from using talc” based on a risk-benefit analysis. Ultimately, the panelists agreed there are safer, reasonably priced alternatives to talcum powder that should be used instead (e.g. cornstarch).
Still, the panel underscored the need for continued research on the potential side effects of talc, not only on the cancer risks but also on the broader impact of exposure. While the panel does not have authority to implement regulatory changes itself, its expert findings carry significant weight in shaping future FDA policy decisions.
Talcum Powder Lawsuits
The panel’s recommendations echo concerns that have been central to a growing number of lawsuits filed over the past decade by plaintiffs who developed mesothelioma, ovarian cancer, and other serious injuries after using talc-based products. These lawsuits allege that manufacturers and suppliers failed to warn consumers about the risks associated with talc, including potential asbestos contamination.
Tens of thousands of lawsuits have been filed in the last decade by individuals who allege they developed mesothelioma, ovarian cancer, and other diseases from using talc-based products. In response, several manufacturers have pledged to remove talc from their products, although the companies and their experts have denied that use of talc-based products pose health risks.
With a recent mix of plaintiff and defense verdicts in talc litigation across the country, it will be interesting to see what impact, if any, the FDA’s recommendations have. Presumably, plaintiffs’ counsel will point to the FDA’s shift away from talc use as evidence of its risks, while defense counsel and their experts will cite the FDA’s risk-benefit analysis – instead of new definitive scientific findings and studies.
FDA Shifts Inspections to States and AI to Help Boost Efficiency
After a slowdown in FDA inspections during the first quarter of 2025 and the mass departure of over 3,500 employees, FDA is pivoting to state authority and generative AI technology to help the agency “do more with less.” FDA currently has contracts with forty-three states and plans to expand this program to have more states conduct FDA inspections of food and beverage facilities.
Following the shift in responsibility, food and drug manufacturers have recently seen an uptick in inspection notices. Foreign facilities are experiencing more unannounced inspections as FDA seeks to treat foreign firms like domestic firms with less lead time before inspections, as we previously blogged.
FDA Commissioner Marty Makary has also directed FDA centers to begin using AI for premarket scientific reviews, giving the agency an “aggressive timeline” of full integration by June 30, 2025. Makary claims that the use of AI will reduce the amount of “non-productive busywork” that consumes a large part of the scientific review process.
FDA has announced that they will be releasing additional details about the use of AI later in June. Keller and Heckman will continue to report on these developments.
Senator Calls for Food Safety Oversight Reform
On May 21, Senator Tom Cotton (R-Arkansas) introduced a bill titled the “Study And Framework for Efficiency in Food Oversight and Organizational Design Act of 2025” or the “SAFE FOOD Act of 2025” which would direct the Secretary of Agriculture to conduct a study on the consolidation of federal agencies with a “primary role in ensuring food safety in the United States” into a single agency.
The bill explicitly lists the Food Safety and Inspection Service (FSIS), the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC) as agencies targeted for consolidation. (More realistically, the food regulatory components of FDA and the CDC would be considered for consolidation with FSIS.) FDA and CDC are within the Department of Health and Human Services (HHS) while FSIS is within the U.S. Department of Agriculture (USDA). FDA has broad authority to regulate food and food additives under the Federal Food, Drug, and Cosmetic Act, while USDA-FSIS regulates meat, poultry, and egg products under the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act. CDC, in collaboration with FDA and other partners, plays a critical role in responding to foodborne illness outbreaks.
Senator Cotton claimed that spreading food safety oversight “across multiple federal, state, and local agencies . . . decreases efficacy, creates gaps, and slows response times to potential public health risks” and that his bill “is a commonsense step to expanding government efficiency and enhancing public health protection by unifying our food safety agencies.” As readers likely know, this is not the first time a single food agency has been considered. It probably will not be the last time either.
Montana and Indiana Pass Laws Targeting Cultured Meat Products
On May 1, Montana Governor Greg Gianforte signed HB401, which bans the sale, distribution, and manufacture of “cell-cultured edible products.” HB 401 defines the term “cell-cultured edible product” as “the concept of meat, including but not limited to muscle cells, fat cells, connective tissue, blood, and other components produced via cell culture, rather than from a whole slaughtered animal.” Violations of the ban are punishable by a fine of up to $250, imprisonment for not more than 3 months, or both. Mont. Code § 50-31-506.
On May 6, Indiana Governor Mike Braun signed HB 1425, which begins a two-year moratorium on the sale and manufacture of “cultivated meat products,” which are defined as “animal protein grown in a facility from extracted animal stem cells and arranged in a similar structure as animal tissues to replicate the sensory and nutritional profiles of meat products.” The moratorium will be in force from July 1, 2025 to June 30, 2027. Following the temporary ban, cultivated meat products may be sold within the state, but they must be advertised, labeled, and sold in a manner that clearly indicates that the product is a cultivated meat product. In particular, the words “this is an imitation meat product” must be on the package. Violations of the ban are punishable by fines of up to $10,000.
As previously reported, Alabama, Florida, and Mississippi have also enacted bans on the sale or manufacture of lab-grown meat.
This Week in 340B: May 20 – 26, 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: Contract Pharmacy; Other; Rebate Model
In four cases challenging Utah state law governing contract pharmacy arrangements, amici filed a motion for leave to file an amicus brief.
In one case challenging Nebraska state law governing contract pharmacy arrangements, the plaintiffs filed an opposition to an amicus curiae brief and an opposition to defendants’ motion to dismiss.
A trade association of drug manufacturers filed a complaint challenging a Tennessee state law governing contract pharmacy arrangements.
A drug manufacturer filed a complaint challenging a Utah state law governing contract pharmacy arrangements.
In an appealed case challenging a Louisiana law governing contract pharmacy arrangements, the court denied the intervenor-defendant’s motion for leave to file a sur-reply to appellant’s reply brief.
In a case by a covered entity against the government, the covered entity filed a motion for leave to file a response to the intervenors’ amicus brief.
In two cases against the government related to rebate models, the plaintiff filed an appeal to the circuit court.
Supreme Court Addresses Fraudulent Concealment and Indemnification in Post-Closing Dispute
The Delaware Supreme Court provides useful clarification regarding when a fraudulent concealment claim tolls the statute of limitations for indemnification claims, in LGM Holdings, LLC v. Gideon Schurder, et al., Del. Supr., No. 314, 2024 (April 22, 2025).
Background
In this post-closing dispute involving claims of intentional breach of representations and warranties in an acquisition agreement as well as fraudulent concealment, the court considered evidence of wrongdoing the sellers found after closing and in connection with an investigation by the FDA and the United States DOJ.
The post-closing investigation was the basis for claims that triggered indemnification. After the investigation, a separate letter agreement between the parties imposed caps on indemnification–but only for certain claims related to the government investigation.
Key Legal Principles
The high court explained that when contract interpretation is at issue, the trial court may not grant a motion to dismiss when there is more than one reasonable interpretation. See Slip op. at 16, 20-21.
The Supreme Court also instructed that when additional support for a key argument made at the trial level is presented for the first time on appeal, that additional support is not waived even if not presented to the trial court. Slip op. at 20.
The court addressed when fraudulent concealment will–or will not–toll the statute of limitations. The court’s analysis should be reviewed in its entirety but a few highlights include the following:
Under the doctrine of fraudulent concealment, the statute of limitations can be disregarded, like “stopping a clock,” when a defendant has fraudulently concealed from a plaintiff facts necessary to put the plaintiff on notice of the truth.
Specifically, a plaintiff must allege “an affirmative act of actual artifice” by the defendant that either prevented the plaintiff from being aware of material facts or led the plaintiff away from the truth. Slip op. at 22.
The statute of limitations begins to run when the plaintiff is objectively aware of the facts giving rise to the wrong, i.e., on inquiry notice. Slip op. at 23.
The tolling stops on the date the plaintiff was put on inquiry notice of the claim—if the plaintiff successfully proves fraudulent concealment. Slip at 25. The trial court erred when it instead held that the plaintiff was put on inquiry notice such that the plaintiff had sufficient time to file a claim. Id.
Partial disclosure of facts in a misleading or incomplete way can rise to the level of the requisite actual artifice. Slip op. at 26.