• The Non-GMO Project released its “Non-UPF Verified” Standard earlier this month. The release follows the launch of the new certification standard earlier this year.
  • The Standard, which attempts to define so-called “ultra-processed foods” (UPF), prohibits the use of any ingredient contained in “Annex B – Harmonized Prohibited Ingredients List,” which it indicates reflects a “selected collection of prohibited ingredients from quality standards and governmental regulations.” The Standard also divides food processing methods into prohibited, conditional, and permissible categories, which are in turn divided based on alleged differences in degree of processing (the permissible bucket consists of methods deemed to be “minimal” or “moderate”). A non-exhaustive (and very short) table (A.1) groups certain processing methods into these categories.
  • Notably, the processing criteria only apply to “ingredients declared on the product’s ingredient panel” and not to “sub-ingredients or processing aids that are not required to appear on-pack under applicable labeling regulations.”
  • The Standard ostensibly doesn’t apply to processing methods that are “demonstrably essential for food safety,” but it permits conditionally processed foods only up to 30% of the finished product, “regardless of food safety justification.” The Standard also contains limits on added sugars.
  • There is no consensus on how to meaningfully classify foods based on processing, and the science regarding the effects of so-called “ultra-processed food” remains unsettled. Indeed, the Standard incorporates ingredient bans and added sugar limits, neither of which directly relate to the term “processing.”
  • Infant formula maker ByHeart has recalled all batches of its Whole Nutrition Infant Formula cans and Anywhere Pack sticks due to an outbreak of infantile botulism linked to the company’s products. ByHeart initiated the recall of two batches of formula on November 8, 2025, after it was notified of approximately 13 reported cases of botulism in infants that had consumed its products throughout the U.S. The company expanded the recall three days later after an additional 10 cases were reported.
  • California officials reported that a sample taken from an open can of ByHeart formula contained Clostridium botulinum, which leads to botulism infection. According to ByHeart, no previously unopened product has tested positive for the bacteria. In addition to recalling product, the company is conducting testing of every batch of formula through a third-party laboratory and providing FDA and the California Department of Public Health access to its facilities and unopened product for testing.  
  • The families of at least two babies who were treated for botulism have sued ByHeart, alleging the company negligently sold defective formula that they purchased because they viewed it “as a natural, healthier alternative to traditional baby formulas.” The families are seeking payment for medical bills, emotional distress, and other harm.  
  • Illnesses linked to ByHeart formula began between August 9 and November 11 and were reported in 13 states. Investigators have not identified any other infant formula brands or other sources of exposure in the outbreak.
  • Keller and Heckman will continue to monitor and report on this and other foodborne illness outbreaks.
  • On November 12, 2025, The “Make America Healthy Again” (MAHA) Summit was held under a veil of secrecy at the Waldorf Astoria in Washington, D.C. The summit brought together a high-profile mix of government officials, biotech leaders, wellness influencers, and policy advocates. Attendees included Health Secretary Robert F. Kennedy Jr., Vice President J.D. Vance, Centers for Medicare & Medicaid Services (CMS) Administrator Mehmet Oz, Food and Drug Administration (FDA) Commissioner Marty Makary, and National Institutes of Health (NIH) Director Jay Bhattacharya, among others.
  • The summit was a private, invitation-only event with no press access or livestream. When asked about attendance, organizers directed inquiries back to event coordinators. Although the daylong event was closed to the press, the agenda showed that a broad range of health topics were covered. Panel sessions covered the future evolution of FDA and NIH, innovations in compounding and pharmacy, the therapeutic potential of psychedelics, reversing aging, biohacking, and food as medicine.
  • In a livestreamed session, Vice President Vance commended Robert F. Kennedy Jr. for challenging conventional health approaches, emphasizing a focus on necessary rather than routine medication. Kennedy outlined goals to reduce artificial additives, address ultra-processed foods, update dietary guidelines, and limit environmental toxins.
  • Critics raised concerns about transparency and potential erosion of trust in established science, while organizers framed the event as a milestone for health policy reform.
  • Keller and Heckman will continue to monitor developments related to the MAHA movement and its potential impact on U.S. health policy.
  • 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.