Oregon’s Cannabis Labor Peace Law Struck Down
On May 20, 2025, a federal district court in Oregon issued a landmark decision invalidating Measure 119, also known as the United for Cannabis Workers Act. This law, approved by Oregon voters in November 2024 and effective as of December 2024, required all state-licensed cannabis businesses to enter into labor peace agreements (“LPAs”) with unions as a condition for obtaining or renewing their licenses. The law also mandated employer neutrality regarding union organizing efforts.
Background
Two cannabis businesses, Bubble’s Hash and Ascend Dispensary, challenged Measure 119 in court, naming several Oregon state officials as defendants. The plaintiffs argued that the law infringed on their constitutional rights and was preempted by federal labor law, specifically the National Labor Relations Act (“NLRA”).
Court’s Analysis and Ruling
The court granted a permanent injunction, barring Oregon from enforcing Measure 119.
NLRA Preemption
The court determined that the NLRA preempted state law based on two primary grounds:
Garmon Preemption: The court found that Measure 119 was preempted by the NLRA under the doctrine established in San Diego Building Trades Council v. Garmon[1]. This doctrine prohibits states from regulating conduct that is either protected or prohibited by the NLRA, or even arguably so. The court determined that the LPA requirement directly implicated rights protected by the NLRA, particularly an employer’s right to express views about unionization (as protected by Section 8 of the Act).
Machinists Preemption: The court also found that Measure 119 was preempted under the Machinists[2] doctrine, which bars states from regulating areas that Congress intended to leave to the “free play of economic forces.” The court found that conditioning license renewal on signing an LPA and mandating employer neutrality, upset the balance of power between labor and management that Congress intended to preserve.
Violation of First Amendment Rights
The court also held that Measure 119’s requirement for employer neutrality violated plaintiffs’ First Amendment rights to free speech. The law did not merely prohibit coercive or threatening speech, but instead broadly required employers to remain “neutral” on unionization, effectively silencing any non-coercive, non-threatening opinions or arguments against unionization.
The court cited Supreme Court precedent affirming that employers have a First Amendment right to communicate their views about unionization to employees, so long as the communication is not coercive or threatening. Measure 119’s neutrality mandate was found to infringe on this right.
Irreparable Harm and Public Interest
The court found that the plaintiffs faced irreparable harm because they were forced to choose between complying with an unconstitutional law (and incurring costs or unfair bargaining leverage) or risking the loss of their business licenses and customer goodwill.
The public interest, the court concluded, is best served by upholding the Supremacy Clause and protecting constitutional rights, even if it means enjoining a law enacted by popular vote.
Key Takeaways
Cannabis is heavily regulated at the state level and remains illegal federally. However, the court here found that the NLRA still applies to cannabis businesses that meet its jurisdictional thresholds. This decision, which invalidated the requirement to enter into LPAs in the cannabis industry, could be persuasive to courts in other jurisdiction evaluating the constitutionality of similar restrictions on obtaining or renewing business licenses in other industries. However, a critical determination in this analysis is whether the state or locality is regulating public safety or violence, as opposed to labor relations. The Oregon court struck down the law because the judge held that it focused on labor relations, and thus did not fall under the “local responsibility” preemption exception.
An appeal to the Ninth Circuit could be filed, however, after the order was issued, the Oregon Liquor and Cannabis Commission announced that it is no longer requiring cannabis businesses to enter into LPAs in order to obtain or renew a cannabis license.
FOOTNOTES
[1] 359 U.S. 236 (1959).
[2] 427 U.S. 132 (1976).
Chobani “Zero Sugar” Lawsuit Dismissed Due to Federal Preemption
On Thursday, May 29, 2025, Judge John J. Tharp, Jr. at the U.S. District Court for the Northern District of Illinois filed an order granting Chobani’s motion to dismiss a class action lawsuit that alleged “Chobani Zero Sugar” yogurt was misbranded. Chobani’s yogurt contained allulose, a naturally occurring monosaccharide found in figs and raisins, which the plaintiffs argued made any “zero sugar” or “no sugar” claims misleading and deceptive.
In its defense, Chobani cited to the Temporary Marketing Permit (TMP) granted by FDA authorizing to the sale of its “Zero Sugar” yogurt that contained “nonnutritive sweeteners.” The Company also referenced FDA Guidance in which FDA stated the agency is exercising enforcement discretion by excluding allulose from the amount of “Total Sugars” on product labels.
FDA based its decision on data that showed allulose does not promote cavities, produces a negligible increase in glycemic and insulinemic responses, and substantially reduces the number of total calories in products in which it replaces added sugars.
The Court agreed with Chobani that though the guidance is nonbinding, it still represents FDA’s interpretation of how allulose is regulated under 21 C.F.R. § 101.9(c)(6)(ii). This view of the regulation is controlling if it is not “plainly erroneous” or inconsistent with the regulation itself. Because of this, the Court concluded the plaintiff’s claims are expressly preempted by federal law since allulose is not a sugar under the allulose guidance.
Keller and Heckman will continue to monitor litigation trends related to product labeling and marketing claims.
California’s E-Waste EPR Program Continues to Exclude E-Cigarettes
The California Department of Resources Recycling and Recovery (CalRecycle) is currently working on a rulemaking to implement SB 1215, which revised the state’s Covered Electronic Waste Recycling Program (E-Waste Recycling Program) to include covered battery-embedded products. These are generally products containing batteries that are “not designed to be easily removed from the product by the user of the product with no more than commonly used household tools.” Notably, products that meet the federal definition of an “electronic nicotine delivery system” (ENDS) are excluded from California’s E-Waste Recycling Program. These include e-cigarettes, e-hookahs, e-cigars, vape pens, advanced refillable personal vaporizers, e-pipes and any component, part, or accessory of such devices.
The purpose of SB 1215 is to improve the safe collection and recycling of batteries in products and reduce fires from improper disposal. Managing disposal of ENDS, which have special disposal considerations due to the presence of nicotine, arguably goes beyond this limited objective. As there is no separate EPR program for ENDS, either in California or elsewhere (although some states, like New York, are considering such programs), individuals and businesses should continue to consult guidance from the U.S. Environmental Protection Agency (EPA) or their local waste management services for proper disposal of these products. More information on the SB 1215 rulemaking is available here.
What to Watch: FDA Shifts Attention on Artificial Intelligence
In an interesting and somewhat unexpected turnabout over the last six months, FDA has pivoted its focus from regulating industry’s use of artificial intelligence (“AI”) to how the agency itself utilizes AI. This internal shift marks a departure from FDA’s development of AI guidance over the last few years.
2024 marked an active year for AI regulation by FDA, with establishment of the CDER AI Council as well as the development and release of various white papers and guidance documents. Even at the beginning of 2025, FDA released much-anticipated drug and device guidance documents. As the agency has undergone transformation in the first half of 2025, it has been notably quiet on the release of policy statements or guidance documents impacting the industry’s use of AI. Instead, FDA announced in May a short timeline to scale the use of AI internally across FDA’s various centers, and in early June, rolled out Elsa, an AI tool to, among other uses, accelerate clinical protocol reviews, scientific evaluations, and identify high-priority inspection targets. The way in which Elsa will affect FDA’s processes and timelines is certainly an area to keep any eye on.
Also, as FDA continues to prioritize its internal use of AI, the gap created by FDA’s deceleration on industry regulation and the continued emergence of state AI laws impacting industry is creating a tension that requires attention from in-house privacy, legal and compliance teams.
Decree for the Promotion of Pharmaceutical Investment and the So-Called “Plant Requirement”
On June 2, 2025, the “DECREE to promote investment within the national territory to strengthen the development of the pharmaceutical industry and the production of health products, as well as the development of national scientific research” was published in the Official Gazette of the Federation.
This decree outlines new provisions applicable to consolidated public procurement procedures for medicines and medical devices, which will begin to be implemented in 2026 for deliveries in 2027.
The Decree aims to consolidate a strong and self-sufficient pharmaceutical industry by promoting national investment in the production of health products (medicines and medical devices) and fostering scientific research and the development of innovative products in the country.
In summary, the Decree establishes the following:
The Ministry of Health must promote the participation of companies with national investment in the production chain or those initiating the installation of related infrastructure (factories, laboratories, warehouses), as well as those conducting scientific research or innovation in health. In this regard, the Ministry of Health must issue the corresponding guidelines within 90 days following the publication of the decree.
COFEPRIS will implement measures to expedite procedures related to sanitary registrations, research protocols, import permits, and export certificates to facilitate national manufacturing.
In public procurement procedures for generic medicines, the points and percentage criterion will be applied, favoring those who demonstrate national investment in the production chain or scientific innovation activities.
A “Pharmaceutical Investment Promotion Committee” must be created, which will be formed of representatives from the Ministries of Health, Economy, and Anticorruption, and will be chaired by the Ministry of Health.
The committee’s objective is to analyze investment proposals, considering the estimated amount of public procurement, investment level, productive capacity, and degree of research in Mexico; it will also be responsible for facilitating dialogue with the industry.
Finally, the committee’s decisions on investments will be formalized in action coordination agreements between the government and interested companies, including production plants, laboratories, and scientific innovation initiatives.
Unlike the previous scheme in effect until 2008, when Article 168 of the Health Law Regulations required a manufacturing sanitary license in Mexico as a condition to obtain a marketing authorization, implying the presence of a production plant in the country, the new decree does not reestablish this “plant requirement” as an obligation to obtain a marketing authorization and eventually commercialize the medicines. However, it incorporates, adapts, and includes it in the Decree as a preferential criterion in public procurement procedures, so having a plant or investment in the national territory is not mandatory but provides advantages in public procurement procedures. It is important to note that this plant requirement established in Mexican regulation was repealed in 2008 due to a dispute arising from non-compliance with a free trade agreement between Mexico and a neighboring Central American country.
Although this measure aims to encourage national investment and strengthen the pharmaceutical industry, it may generate legal uncertainty and is inherently discriminatory and restrictive. The lack of specific and targeted guidelines contradicts the principles of fair competition, equality, and non-discrimination established in the Constitution and international treaties.
Therefore, we consider that the Agreement is subject to challenge upon its entry into force, as it contravenes various constitutional provisions, as well as several provisions and international treaties signed with Mexico’s trading partners, which include the principle of national treatment in these international instruments.
Thus, the guidelines issued by the Ministry of Health to ensure transparency, objectivity, and proportionality will be essential to avoid creating indirect barriers that affect the legality and effectiveness of public procurement processes in the health sector. We will remain vigilant.
Color Me Bad: The Push to Remove Color Additives from Food [Podcast]
In this episode, Keller & Heckman LLP Partner Eve Pelonis joins us to dive deep into the colorful world of color additives for food, drugs, and cosmetics, clearing up common misconceptions. We touch on important issues, including whether the GRAS exemption is applicable to color additives, and the recent attention on synthetic color additives by Secretary Robert F. Kennedy Jr. and the new administration’s push for natural alternatives.
False Claims Act Enforcement of Pharmacy Pricing & Prescribing Practices: The Walgreens Cases
The Department of Justice has launched a number of enforcement actions targeting pharmacies for alleged violations of the False Claims Act (FCA). Recently, Walgreens has been the subject of two noteworthy government settlements related to alleged FCA violations.
Allegations Related to Medicaid Billing for Generic Medications
In the first, on March 27, 2025, the U.S. Attorney’s Office for the District of Massachusetts announced that it had reached a $2.8 million settlement with Walgreens concerning allegations that the company overbilled Medicaid programs in Massachusetts and Georgia. Relators filed the qui tam case in 2019 and the government intervened for settlement purposes. The United States, Massachusetts, and Georgia alleged that, from 2008 to 2023, Walgreens submitted claims to MassHealth (Massachusetts’ Medicaid program) and Georgia Medicaid for certain generic medications that were higher than the customary price point for those drugs. Doing so, the government alleged, violated the federal FCA, as well as the states’ respective False Claims Acts.
Medicaid programs reimburse pharmacies for dispensing generic medications using the lowest of four reporting price points, one of which is the pharmacy’s “usual and customary price” as determined by the pharmacy. In this case, Walgreens submitted a higher price for the generic medications and failed to report the correct “usual and customary price,” causing the states’ Medicaid programs to overpay for those generic medications. Instead of the standard retail price (which is typically used to calculate the usual and customary price), Walgreens allegedly submitted the “gross amount due” when it was higher than the standard retail price. The extensive list of medications at issue included both over the counter and prescription generic medications. Notably, the claims against Walgreens in this case are similar to those brought in a pair of whistleblower FCA suits against retail drug pharmacies that reached the U.S. Supreme Court in 2023, a case we previously analyzed here that established the current scienter (knowledge) standard for potential liability under the FCA.
Of the $2.8 million settlement, roughly $1.4 million will go to the federal government, Georgia will receive $352,000, and Massachusetts will receive $1.1 million.
Allegations Related to Prescriptions of Controlled Substances
Less than a month later, on April 21, 2025, the government announced the second settlement. Under this settlement agreement, Walgreens will pay the federal government $300 million, with an additional $50 million owed if the company (or a significant portion of its assets) is sold, merged, or transferred to a non-affiliated entity before 2032. The settlement resolves allegations that, from 2012 to 2023, Walgreens filled millions of unlawful controlled substance prescriptions in violation of the Controlled Substances Act, and then sought payment for those prescriptions from federal programs in violation of the FCA.
In its complaint, the government alleged that Walgreens pharmacy staff knew that many of these prescriptions were likely to be unlawful (because they were not issued in the usual course of professional practice, or were not issued for a legitimate medical purpose, or both), and some had been issued by practitioners known to regularly prescribe controlled substances in an unlawful manner. The complaint alleged that Walgreens filled such prescriptions “without resolving the significant concerns those prescriptions raised.” For example, according to the government, many of the prescriptions were for opioids prescribed in excessive quantities, filled too early, or prescribed in a dangerous and commonly abused combination with other drugs – i.e., the “trinity” of drugs (which term refers to the combination of an opioid, a benzodiazepine, and a muscle relaxant, and which is viewed as a prescribing “red flag” by the government). Walgreens allegedly “systematically pressured” pharmacy staff to fill these prescriptions quickly, without allowing them sufficient time to verify their legitimacy and necessity and doing so despite “clear red flags.” The complaint described a corporate culture “wherein pharmacists who diligently observed their responsibility to verify the legitimacy of controlled-substance prescriptions were subject to reprimand.” Further, Walgreens compliance officials allegedly prevented these practices being curtailed by withholding prescriber information from pharmacists which would have allowed them to identify patterns of unlawful prescribing and warn one another about problematic practitioners.
The settlement stipulates several terms of payment, including one aimed at preventing employee bonuses from being used as a method of evading payment of the settlement with the government: If bonuses cumulatively exceed $400 million in a given year, the excess amount factors into the calculation of Walgreens’ annual payment amount. In addition to the settlement payment, Walgreens has agreed to several monitoring and oversight requirements going forward, including an agreement with the DEA to implement and maintain certain compliance measures for the next seven years. This agreement with the DEA requires Walgreens to establish and maintain policies requiring pharmacists to validate prescriptions for controlled substances and dispense them appropriately, provide annual training to pharmacy employees regarding their legal obligations relating to controlled substances and ensure appropriate pharmacy staffing. As part of the settlement, Walgreens is also under a five-year Corporate Integrity Agreement with HHS-OIG, which further requires a corporate compliance program.
Conclusion
These cases underscore the government’s focus on using the FCA to police fraud and abuse in pharmacy pricing and prescribing practices. It also continues to highlight a prudent approach for companies to monitor red flags and outliers and have a robust compliance program. We will continue to monitor pharmacy-related enforcement actions.
This post was co-authored with Ivy Miller, legal intern at Robinson+Cole. Ivy is not admitted to practice law.
Alabama Cannabis Court Faces Dilemma: To Treat Applicants Fairly or Equally?
“Equal is not fair, and fair is not equal. Equal is obtainable but fair is not.”
The Montgomery County Circuit Court overseeing the launch of Alabama’s medical cannabis program has an interesting dilemma on its hands. It has previously ruled that awards to integrated facility applicants were illegal because the underlying basis of the awards – specifically, that an emergency rule promulgated by the Alabama Medical Cannabis Commission that allowed for the awarding of licenses was invalid because there was no emergency. That ruling was immediately appealed, and the Alabama Court of Civil Appeals agreed to hear the appeal on an expedited basis and stayed the circuit court’s order enjoining the AMCC from proceeding with the issuance of integrated facility licenses.
Last week, the circuit court heard arguments about whether dispensary applicants should be similarly enjoined (with the order stayed) in light of the fact that the same emergency rule ruled invalid by the circuit court but stayed by the appellate court while that court hears expedited briefing.
On the one hand, it seems entirely logical that the trial court would attempt to place apparently similar applicants in similar legal standing. On the other hand, one could reasonably assume that the appellate court is poised to overturn the trial court’s decision given its expedited review of the integrated facility order and its previous decisions overruling the trial court. If that is the correct assumption, is the court right to simply put the different categories in similar legal standing or should it read the tea leaves and simply choose not to rule on the question until it gets word of the appellate court’s appellate review?
That’s a pickle. My takeaway from oral arguments is that the court will enter a similar injunction and simultaneously stay its decision pending a ruling on the broader emergency rule issue from the appellate court. That would be treating the different categories of applicants equally, but is it fair in light of the appellate court’s apparent disapproval of the trial court’s ruling?
As a mentor once told me, a fair is a circus with pigs. And as always in this case, nothing is as simple as it appears.
Listen to this post
Healthcare Preview for the Week of: June 9, 2025 [Podcast]
Senate Continues Reconciliation Consideration
This week, Senate consideration of the reconciliation package will continue, and more text will be made public as the process begins to move out from behind closed doors. Senate committees of jurisdiction are unlikely to hold markups of updated legislative text and instead are releasing their text leading up to Senate floor consideration, targeted for the week of June 23, 2025.
Committees without health jurisdiction started this process last week, and this week we expect text from health committees. The Senate Health, Education, Labor, and Pensions Committee has some jurisdiction over the Affordable Care Act (ACA) and is likely to release its text as early as Tuesday. The Senate Finance Committee has jurisdiction over the bulk of the reconciliation package – including Medicare, Medicaid, the ACA, and taxes – and will likely be the last committee to release text, which could happen as early as this Friday, June 13 (we’re trying not to read into that).
Released text is still subject to change, as Senate Republican leadership works to whip votes in their own body while also trying to ensure that any changes made will still enable the House to pass the bill again before it can go to the president for his signature. The process of striking provisions that do not comply with the Byrd rule is also ongoing, but final Byrd rule decisions will not be made until the bill is on the Senate floor. Republicans have just three weeks to pass the updated package in the Senate and send it back for House consideration before their self-imposed deadline of July 4, 2025. If any step does not occur on time during these next three weeks, this timeline could slip into later July.
On the other side of Capitol Hill, the House will vote on the rescissions package sent by the White House last week that would rescind more than $9.4 billion of previously appropriated funding. Most of the rescinded funding targets global development and public broadcasting funding. The package would rescind $900 million of global health funding, including $400 million for the President’s Emergency Plan for AIDS Relief. The House Rules Committee will meet on Tuesday to consider the legislation, known as H.R. 4. On both the House and Senate floors, only a simple majority is needed to approve the rescissions, but the package has received more outspoken Republican criticism in the Senate, including from Senate Appropriations Committee Chair Collins (R-ME).
Fiscal year (FY) 2026 appropriations markups continue this week, with the House Appropriations Committee meeting to mark up the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Bill that advanced through subcommittee last week by a party line vote. The Labor, Health and Human Services, Education, and Related Agencies Bill will be considered in late July; the full schedule of markups is available here. National Institutes of Health (NIH) Director Bhattacharya will testify at the Senate Appropriations Committee on the President’s FY 2026 NIH budget request, although discussion likely will also focus on concerns about delays or cuts to FY 2025 grant funding.
Today’s Podcast
Debbie Curtis and Rodney Whitlock join Julia Grabo to discuss the busy week ahead of Congress, including where they are in the reconciliation, recissions, and appropriations processes.
PBMs Sue Arkansas Over Restrictive PBM Ownership Law
On April 16, 2025, Arkansas enacted Act 624 (the Act), an unprecedented law prohibiting pharmacy benefit managers (PBMs) from owning or operating pharmacies in the state. As we discussed in our May 2025 blog post, the law’s passage has already resulted in market disruptions, and PBMs with vertically integrated business models have cautioned that the law will limit patients’ access to drugs and cost many local jobs.
Now, two of the nation’s largest PBMs, CVS Health and Cigna’s Express Scripts (ESI), have filed federal lawsuits seeking to block implementation of the Act on the grounds that the Act is unconstitutional, preempted by federal law, and harmful to Arkansans.
Industry Pushback: Legal and Operational Threats
Within weeks of the law’s signing, CVS and Express Scripts filed suit in the U.S. District Court for the Eastern District of Arkansas, arguing that the Act is unconstitutional on multiple grounds. They claim the law would force a reorganization of national operations and disrupt mail-order prescription services relied upon by thousands of Arkansas residents.
While Governor Sarah Huckabee Sanders has framed the legislation as a stand against PBMs, CVS Health contends that the law is “bad policy that accomplishes just the opposite,” stating that the law will lead to the closure of 23 CVS Pharmacy® locations, eliminate hundreds of jobs, and increase the cost of prescription drugs by millions of dollars. Similarly, ESI argues in its complaint against members of the Arkansas State Board of Pharmacy that the law will create “pharmacy ‘deserts’ for the nearly 40% of Arkansans who live in rural areas,” and deny many Arkansans access to “lifesaving drugs at affordable prices.”
The lawsuits also argue that the Act is unconstitutional. In its complaint, CVS Health argues that the law was not implemented to protect patients but, rather, to exclude CVS Health specifically in favor of independent, in-state pharmacies that often charge higher prices for their prescription medicines. CVS asserts this practice violates the Constitution’s Dormant Commerce Clause and Equal Protection rights because it discriminates against out-of-state pharmacies to offer a boon to the state’s local pharmacies. CVS further alleges that the law is preempted by two federal laws: the Employee Retirement and Income Security Act (ERISA), because it interferes with benefit plan design, and the Medicare Prescription Drug Improvement and Modernization Act of 2003, because “it seeks to regulate Medicare Advantage and Medicare Part D plans that Congress intended for federal standards to exclusively govern.”
ESI’s complaint brings a similar claim under the Dormant Commerce Clause based on the Act’s alleged discrimination against out-of-state pharmacies, but also adds three additional grounds to strike down the Act. ESI alleges that the Act violates the Constitution’s Privileges and Immunities Clause by prohibiting out-of-state entities from working and providing services in Arkansas and that it violates the Bill of Attainder Clause by specifically targeting the nation’s three largest PBMs and barring them from participating in their vocation. ESI additionally contends the Act is preempted by the federal government’s TRICARE program—which delivers the military health benefits through private contractors—because ESI is the government’s principal mail-order-pharmacy TRICARE provider, and the Act thus attempts to force the federal government to select a new provider for Arkansas.
State Response and National Implications
This is not Arkansas’s first challenge to PBM practices. In Rutledge v. Pharmaceutical Care Management Association (2020), the U.S. Supreme Court upheld the state’s authority to regulate PBM reimbursement rates. However, the Act goes further by targeting companies’ rights to vertically integrate PBMs with pharmacies, raising new legal questions about how far states can go in regulating PBMs.
Similar to Rutledge, the outcome of these lawsuits could have significant ripple effects across the country. Numerous states are reportedly considering similar legislation, and a court ruling upholding Arkansas’s law could embolden those efforts. Conversely, if the law is struck down on constitutional or preemption grounds, it may set firm limits on states’ ability to regulate PBM structure and ownership. The Arkansas Attorney General Tim Griffin pledged to defend the Act vigorously.
This legal battle may also influence broader discussions in Congress, where bipartisan interest in PBM reform continues to grow.
What Comes Next
The lawsuits are in their early stages, but we could see previews of the court’s approach to the legal issues in the near term. Both lawsuits request preliminary injunctive relief which, if granted by the Court, would push back the Act’s effective date and stave off its immediate effects, and could set up a rapid pursuit of appeals to higher courts. While the legal issues will ultimately be decided in federal court, the policy debate over PBM reform is far from settled.
FDA Lessens Hurdles for Color Additive Changes in Drugs
On May 30, 2025, FDA issued a draft guidance titled “Replacing Color Additives in Approved or Marketed Drug Products.”
Neither the draft guidance nor FDA’s Federal Register notice announcing its availability refers explicitly to the recent effort by HHS and FDA to encourage food manufacturers to discontinue the use of certified color additives in food or to FDA’s revocation of its regulations authorizing the use of FD&C Red 3 in foods and ingested drugs. However, the draft guidance will be helpful to any drug manufacturer wishing to replace color additives for any reason.
Unlike other inactive ingredients in drug products, color additives must be used only in accordance with a regulation issued by FDA authorizing their use. The color additives that are authorized by FDA for use in drugs can be found in 21 CFR part 74, subpart B (those that are subject to batch certification) and 21 CFR part 73, subpart B (those that are exempt from batch certification). Color additives that are provisionally listed for use in drugs can also be found in 21 CFR part 82.
Ordinarily, the holder of an approved new drug application (NDA) or an approved abbreviated new drug application (ANDA) must submit a prior approval supplement (PAS) to FDA asking FDA to approve any changes to their drug formula (even if just replacing one inactive ingredient with a new one).
This draft guidance proposes that holders of approved NDAs and ANDAs would generally be able to submit a “changes-being-effected supplement” (CBE-30) prior to making a color additive change to their drug formula. The CBE-30 gives FDA 30 days’ notice of a proposed color additive change, but holders of an approved NDA or ANDA can implement that change without waiting for FDA to approve it. Effectively, FDA is downgrading the regulatory hurdle from PAS to CBE-30 for color additive changes.
Importantly, this change only applies to drugs marketed under an approved NDA or ANDA. Drugs marketed under an OTC monograph do not have approved applications, so those manufacturers would not submit a CBE-30. However, manufacturers without approved applications still must meet other requirements, as noted in the draft guidance.
Keller and Heckman will continue to monitor regulatory developments related to color additives.
Anyone can comment on FDA guidance at any time. To ensure comments on this draft guidance are considered before FDA prepares a final version, they must be submitted by July 29, 2025.
California Bill Would Ban Ultra-Processed Foods in Schools
Earlier this year a bipartisan group of California lawmakers introduced AB 1264, which directs the California Office of Environmental Health Hazard Assessment (OEHHA) to define “ultra-processed foods” (UPFs) and phase out identified prohibited foods from school meals beginning January 1, 2028. The bill also targets certain additives from being used in schools, including Red 40. The bill broadly defines UPFs as foods that contain one or more of certain functional ingredients, such as colorants, flavorings, sweeteners, emulsifiers, and thickening agents.
If passed, beginning July 1, 2035, the bill would prohibit schools from offering meals that include “particularly harmful ultra-processed foods,” and from “selling food or beverages . . . containing those particularly harmful ultra-processed foods,” except for food items sold as part of a school fundraising event.
AB 1264 would also require vendors to report the total quantity of food product sold to schools and identify whether the product is “particularly harmful.” OEHHA must submit a report to the California legislature with “recommendations for state and local legislative actions that could reduce the consumption of ultra-processed foods and particularly harmful ultra-processed foods in schools.”
As we’ve previously reported, multiple states have proposed bans on various food additives and “ultra-processed foods.”
The bill is currently before the California Senate. Keller and Heckman will continue to monitor and relay any legislative updates in this area.