• On October 27, 2025, the New Jersey Senate introduced Bill S4748 which would in effect require that all self-determined GRAS conclusions, with the exception of those covering certain substances of natural biological origin and widely consumed prior to 1958, be filed with the state Department of Health, and ultimately published online. The Bill is identical to A4640, which was introduced to the New Jersey General Assembly last year.  
  • The objective of the bill seems to be to require that for each new use of a food ingredient based on self-determined GRAS status, food manufacturers would report that use to New Jersey’s Department of Health in an annual report. The language of the bill, however, would require some revisions. It currently references and incorporates the definition of “food additive” in the Federal Food, Drug, and Cosmetic Act without recognizing that GRAS substances are excluded from the “food additive” definition. The Bill exempts from notification (1) GRAS substances that have received a no questions letter from FDA, (2) any substances recognized in the federal regulations as prior sanctioned or GRAS, (3) any food contact substances subject to an effective food contact notification, (4) any substance “subject to regulation approving its intended use for food” (i.e., food additive regulation), (5) a “food ingredient of natural biological origin that has been widely consumed for its nutrient properties in the United States prior to January 1, 1958 without known detrimental effects, which is subject only to conventional processing as practiced prior to January 1, 1958, and for which no known safety hazard exists,” and (6) “any substance determined safe to be added to food by the commissioner” (of the New Jersey Health Department).
  • In terms of content, the requirements of the notification largely mirror FDA’s GRAS Notification requirements in 21 CFR part 170, subpart E, although it also requires inclusion of “any previous GRAS substance notices submitted to the Food and Drug Administration on the reported substance and any response from the agency.”
  • The Bill requires the notices to be published within 6 months. It permits redaction of trade secret information to the extent such information is not required the establish the GRAS status of the substance.
  • Manufacturers who “sell, distribute, or offer for sale [in New Jersey] any food that contains a new use of a food additive” for which a required notice has not been submitted to New Jersey’s Department of Health are subject to a penalty of up to $1,000 for a first offense, and up to $5,000 dollars for each subsequent offense, with each day constituting a separate violation.
  • The self-determined GRAS pathway has been in the hot seat as of late and there are proposals to require notification of all GRAS substances at the federal level. For example, Senator Marshall has proposed a bill to amend the FD&C Act and require reporting of GRAS substances, while FDA has indicated that it plans to a publish a proposed rule that would establish some form of mandatory GRAS Notification.
  • A coalition of 39 state and territory attorneys general recently submitted a letter to congressional leaders requesting clarification of the federal definition of “hemp” under the Agricultural Improvement Act of 2018 (commonly known as the 2018 Farm Bill). The letter, coordinated by the National Association of Attorneys General (NAAG), expresses concern over what the signatories describe as the unintended consequences of the current statutory language, particularly regarding the proliferation of hemp-derived intoxicating products.
  • The 2018 Farm Bill federally legalized hemp by defining it as cannabis containing no more than 0.3% delta-9 tetrahydrocannabinol (THC) on a dry weight basis. This definition was intended to distinguish non-intoxicating industrial hemp from marijuana, which remains a Schedule I controlled substance under federal law. However, the bill did not explicitly address other cannabinoids derived from hemp, such as delta-8 THC, delta-10 THC, THC-O, and others. These compounds, while chemically distinct from delta-9 THC, can also produce psychoactive effects and are often synthesized from cannabidiol (CBD) extracted from hemp.
  • According to the letter, the attorneys general assert that certain manufacturers are exploiting ambiguities in the Farm Bill’s definition of hemp to produce and sell synthetic THC products that they claim fall within the legal scope of the law. The AGs argue that these products are often more intoxicating than marijuana and are being marketed in ways that appeal to minors, including as gummies, candies, and beverages.
  • The attorneys general are urging Congress to act either through the Fiscal Year 2026 appropriations process or the upcoming reauthorization of the Farm Bill. Specifically, they seek a revision to the definition of hemp that would make clear that intoxicating hemp-derived THC products are not legal under federal law. They emphasize that such clarification would not affect the cultivation of industrial hemp for non-intoxicating uses, which they support.
  • Keller and Heckman will continue to monitor federal legislative developments related to the definition of hemp and the regulation of hemp-derived cannabinoids.
  • The Wisconsin State Assembly introduced Wisconsin Assembly Bill 550 (AB 550) on October 15, 2025. The bill proposes a mandate that manufacturers of packaged food products intended for human consumption must include prominent warning labels if the product contains any of the fifty-one ingredients listed in the bill.
  • Ingredients that would require a warning label include certain artificial colors, sweeteners, preservatives, and other additives, including the FD&C certified colors, titanium dioxide, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), acesulfame potassium, and more. Foods containing these ingredients would be required to bear the 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.”
  • The bill follows similar laws that were recently enacted in Texas and Louisiana, as we previously blogged. Unlike the Texas law, there is no preemption provision in AB 550.
  • Keller and Heckman will continue to monitor this and other bills related to food labeling.
  • During oral arguments on November 4, 2025, Upside Foods Inc. (Upside) urged the US Court of Appeals for the Eleventh Circuit to reverse a lower court’s decision denying a preliminary injunction against Florida’s law banning lab-grown meat, arguing that the state prohibition is federally preempted.
  • As we previously reported, Upside, based in California, originally brought forth this lawsuit in 2024 in the US District Court for the Northern District of Florida, alleging that Florida’s SB 1084 is unconstitutional because it favors in-state businesses over out-of-state competitors.  SB 1084 prohibits the manufacture, distribution, and sale of meat and poultry products grown directly from animal cells.  Shortly after filing its lawsuit, Upside asked the court for a preliminary injunction, but the court denied that request in October 2024.
  • Upside argued to the appeals court that while the lower court said that it was unlikely to prevail on its preemption claims, Upside would continue to suffer harm due to the threat of criminal prosecution.  Upside also argued that the lower court mischaracterized the preemption issue by finding that the Florida ban must conflict with a federal law that requires the use of cultivated poultry cells as an ingredient in its products in order to issue an injunction, rather than merely conflicting with the company’s right to engage in interstate commerce.  Upside’s position is that only the federal government can regulate poultry products under the Poultry Products Inspection Act, and the question of origin of meat and what would be considered a “poultry product” was extensively debated.
  • Keller and Heckman will continue to monitor and relay developments in this case.
  • On October 24, 2025, a bipartisan group of representatives introduced the “Country of Origin Labeling Enforcement Act of 2025,” which would reinstate mandatory country of origin labeling (COOL) requirements for beef (H.R. 5818) by amending the country-of-origin provisions in the Agricultural Marketing Act of 1946 (codified at 7 USC 1638 – 1638d).
  • The only meat products to which the mandatory COOL requirements currently apply are lamb, chicken, and goat, the implementing regulations for which are found at 7 CFR part 65 (a proposed rule to add these requirements for venison has not yet been finalized).
  • Mandatory COOL for beef (and pork) was repealed by the Consolidated Appropriations Act of 2026 (H.R. 2029) following World Trade Organization (WTO) rulings which found that U.S. mandatory COOL requirements for beef and pork violated U.S. international trade obligations. See 81 Fed Reg. 10755 (Mar. 2, 2016) for the rule repealing these requirements. However, the proposed bill expressly states that no ruling by the WTO or other international organization of which the U.S. is a member may be construed to limit its implementation. The bill comes as President Trump has proposed quadrupling the import of low-tariff Argentinian beef in an effort to curb beef prices.
  • The Ninth Circuit has reversed (Law360 subscription required) a district court ruling exempting highly refined foods from the definition of a “bioengineered food.” As we previously blogged, in 2022, the U.S. District Court for the Northern District of California dismissed a challenge by natural and organic grocers and advocacy organizations against USDA’s Agricultural Marketing Service’s (AMS) final regulations implementing mandatory uniform national bioengineered (BE) food disclosure standards for human food.
  • On appeal, the Ninth Circuit agreed with the plaintiffs that AMS’s current rule allowing exemptions if manufacturers conclude the BE ingredients are not “detectable” is not “legally equivalent to saying the food does not  ‘contain’ such material.” Specifically, the court considered what it means to “contain” modified genetic material, determining that a food is considered BE “if it actually has modified genetic material within it.” Thus, the court rejected AMS’s “flawed legal premise that the non-detectability of a substance under the regulation was equivalent to its non-presence.”
  • The court did, however, disagree with the plaintiffs’ contention that AMS lacks any discretionary authority to adopt a detectability exception for highly processed foods made from BE ingredients. Under the statute, the agency is required to determine “the amounts of a bioengineered substance that may be present in food, as appropriate, in order for the food to be a bioengineered food.” Thus, the agency could, for example, adopt a particular limit of detection as fixing the “amount” of a BE substance that may be potentially present, and a showing that the substance cannot be detected within that limit would mean the food does not qualify as BE. According to the court, while that food would otherwise meet the broad statutory definition of BE, “it would not count as a ‘bioengineered’ food under the regulatory standard only because it was excluded under a limit-of-detection-based standard promulgated under the Act.
  • The court remanded the case to the district court with instructions to grant summary judgment to the plaintiffs, remand the regulations to AMS, and determine, after receiving input from the parties, whether any provisions of the regulations should be vacated.
  • The court also affirmed the district court’s decision that AMS was not arbitrary and capricious in requiring the term “bioengineered” in disclosures and reversed the district court’s decision to deny vacatur of disclosure format rules.
  • Keller and Heckman will continue to monitor any developments related to BE foods and labeling.
  • A recent federal court ruling has temporarily halted the Trump administration’s plan to lay off thousands of federal employees during the ongoing government shutdown. U.S. District Judge Susan Illston issued a preliminary injunction in response to lawsuits filed by federal employee unions, which challenged the administration’s use of permanent reductions in force (RIFs) rather than temporary furloughs.
  • Layoffs at the Department of Health and Human Services (HHS) have been part of a broader restructuring initiative announced in March 2025, titled “HHS Announces Transformation to Make America Healthy Again.” The plan aimed to reduce the department’s workforce from 82,000 to 62,000 full-time employees—a loss of 20,000 positions, split evenly between voluntary departures and forced terminations.
  • Attorneys general from nineteen states and the District of Columbia successfully argued that this downsizing violated statutory mandates and constitutional limits on executive power. In July 2025, U.S. District Judge Melissa DuBose issued an injunction against the HHS layoffs, stating that “critical offices were left unable to perform statutory functions.”
  • FDA Commissioner Marty Makary assured staff that the agency was “exempted” from the current shutdown-induced layoffs due to its public safety mission and unique funding structure and FDA has retained approximately 86% of its staff during the shutdown primarily due to carryover user fees. Nonetheless, the agency has paused many non-urgent regulatory activities, including food safety initiatives and oversight of compounded drugs, with estimates that delays in functions could be upwards of 3-6 months. FDA is also not accepting new applications, which will likely delay product reviews and approvals.
  • Keller and Heckman will continue to monitor developments related to federal agency oversight and operations, including those affecting HHS, FDA, and other key regulatory bodies.
  • This week, twenty-five US states and the District of Columbia (DC) filed suit in the US District Court of Massachusetts against the US Department of Agriculture (USDA) and US Office of Management and Budget (OMB), arguing that the agency’s decision to suspend Supplemental Nutrition Assistance Program (SNAP) benefits amid the ongoing government shutdown is an abuse of discretion. 
  • The coalition seeks a declaration that the impending November 1 suspension is “both contrary to law and arbitrary and capricious under the Administrative Procedure Act.”  The complaint states that Congress has appropriated $6 billion for the SNAP contingency fund and that USDA also has access to a Section 32 fund that are available to cover the November benefits.  The complaint goes on to state that, “[s]uspending benefits will ultimately transfer costs to state and local governments and community organizations, as families increasingly rely on emergency services and public safety net programs, such as local food pantries.”
  • SNAP is a mandatory entitlement program that provides roughly 42 million US residents an average of $187/month in food aid.  The program costs roughly $8 billion/month to fund, which is allocated through annual congressional appropriations.  As we previously reported, various groups have already reached out to USDA, urging USDA Secretary Brooke Rollins to use all available resources to avoid disruptions to SNAP.  Currently, the USDA SNAP webpage includes a banner stating that the “well has run dry” and blaming Senate Democrats for USDA’s decision not to send out benefits on November 1.
  • In a memorandum provided to NPR, USDA stated that SNAP contingency funds “are only available to supplement regular monthly benefits when amounts have been appropriated for, but are insufficient to cover, benefits.”  Those contingency funds are intended by law “for use only in such amounts and at such times as may become necessary to carry out program operations.”
  • Plaintiffs seek a temporary restraining order enjoining the suspension of SNAP benefits and have requested an emergency hearing, which is scheduled for October 30, 2025.  Keller and Heckman will report any developments with this lawsuit.
  • We have previously blogged about NYC’s updated Food Standards for foods and beverages which go into effect July 1, 2026. NYC’s Food Standards were first introduced in 2008 and are now mandated to be updated every three years. The Food Standards apply to meals served by agencies such as the Department of Education, Health and Hospitals, Department of Correction, and Human Resources Administration among others. The updated Food Standards would, among other things, change nutritional requirements, ban certain additives, and eliminate processed meats.
  • The National Chicken Council (NCC) sent a letter to NYC mayor Eric Adams earlier this month expressing concerns that the updated Food Standards might eliminate products such as chicken nuggets and patties which it argues provide high quality nutrition in a form which is palatable to children. The letter argues that a “process-first definition of ‘healthy’ overlooks what truly matters: nutrient composition.”
  • The letter concludes by requesting “administrative clarification” confirming that “formed and breaded poultry products meeting New York City’s nutrient and additive standards remain eligible for purchase and service.” The Food Standards define “processed meat” as “meat that has been transformed to enhance flavor or improve preservation” by curing, fermentation, salting, or smoking.

  • The Campbell’s Company has been sued (Law360 subscription required) for allegedly falsely advertising its Cape Cod Kettle Cooked Potato Chips as containing “no artificial colors, flavors, or preservatives,” despite containing citric acid, which is synthetic, according to the complaint.
  • The plaintiff alleges that the label on the Cape Cod chips “puts forth a straightforward, material message: the Products contain only coloring, flavoring and preservative ingredients that are natural and not synthetic.” According to the plaintiff, the claims are made to “capitalize on the growing market for natural products,” for which consumers are willing to pay a premium.
  • The complaint further alleges that natural citric acid is no longer commercially available, and only synthetic citric acid is used in packaged foods. Further, the complaint cites FDA Warning Letters from 2001 that state products could not be labeled as “natural” because they contained citric acid.
  • Finally, the complaint states—without citing to any evidence—that synthetic citric acid consumption has been linked with various adverse health effects.
  • Keller and Heckman will continue to monitor this and other food related litigation.