• On August 7, 2025, a New York federal judge ruled in favor of a New York City ban on the sale of steeped kava beverages. The judge’s opinion follows a two-year lawsuit brought by the owners of two locations of a tiki-themed kava café, Kavasutra, alleging that kava mixed with water and no other ingredients was legally a single-ingredient food under the Food, Drug, and Cosmetic Act (FD&C Act) and therefore presumed safe.
  • However, according to the judge, when kava is added to water it is indeed a food additive. The judge found that under the FD&C Act, water on its own is considered a food and adding kava “changes the chemical composition of water from H20 to a liquid that includes kavalactones, chemicals that have hepatotoxic properties.”
  • According to a 2020 memorandum “Review of the published literature pertaining to the safety of Kava for use in conventional foods” cited in the opinion, FDA has noted that there is not enough toxicological data to conclude that kava is safe for indiscriminate use as a beverage. Further, because “there is no food additive regulation in effect that provides for the safe use of kava as an ingredient in conventional foods,” there is no basis for such a use to be considered generally recognized as safe. Thus, FDA “considers kava an unapproved food additive when used as an ingredient in conventional foods.” The opinion also notes that kava is banned in Germany, Switzerland, France, and Canada based on findings that it can cause liver toxicity when ingested.
  • The New York City law considers kava a food adulterant, meaning that the plant itself is not banned, only prohibited from being sold as a food or beverage in food establishments.
  • On August 6, 2025, the U.S. Food and Drug Administration (FDA) announced its proposal to extend the compliance date for the Food Traceability Rule by 30 months to July 20, 2028.  FDA stated that the extension is needed to allow full compliance across all regulated sectors.
  • The final rule establishes additional traceability recordkeeping requirements for persons who manufacture, process, pack, or hold foods that are on the Food Traceability List.  The new requirements of the rule are intended to achieve faster identification and removal of contaminated food to better prevent foodborne illnesses and death. 
  • To achieve the full public health benefits of the rule, all covered entities of the supply chain must comply.  FDA acknowledged that few entities would be able to meet the rule’s requirements by the initial January 2026 compliance date, partly because all members of the supply chain must be in full compliance in order to work with accurate data.  The announcement stated that the “proposal is designed to afford covered entities the additional time necessary to ensure coordination between supply chain partners in order to fully implement the final rule’s requirements—ultimately providing the FDA and consumers with greater transparency and food safety.”
  • Additionally, FDA issued new tools and Frequently Asked Questions (FAQs) that address the Food Traceability Rule and help covered entities reach compliance.  The rule’s webpage now has new FAQs, new examples of traceability plans, new supply chain examples, and At-A-Glance document on the rule, and new translated documents.
  • Keller and Heckman will continue to monitor this proposal and relay new information.
  • In response to a citizen petition filed by the Florida Citrus Processors Association Inc. and Florida Citrus Mutual Inc., FDA has issued a proposed rule (90 FR 37817) which would change the standard of identity for pasteurized orange juice in 21 CFR 146.140 by lowering the required minimum Brix content from 10.5° to 10° Brix. Brix represents the percent of soluble solids by weight of an aqueous solution (calibrated to a sucrose solution). Most of the total soluble solids in Florida oranges are sugars, and the proposed reduction in Brix corresponds to a reduction of 1 g of sugar per 8 oz serving (from 18 g to 17 g/serving).
  • The pasteurized orange juice standard of identity (SOI) was issued in 1963 when the average brix of Florida oranges was 11.8° and the SOI was constructed to reflect the qualities of U.S. oranges at the time. However, since 2010-11 the average brix of Florida oranges has been decreasing due to a bacterial disease called “citrus greening disease” (also known as Huanglongbing) and severe weather. In 2022-2023, the average Brix level of Florida oranges was only 9.7°.
  • In the proposed rule, FDA recognizes that the Brix level in orange juice is “subject to the vagaries of nature,” is outside of the manufacturers control, and that the SOI should be updated to encompass the qualities of present-day Florida oranges. The change would expand the lower bound of acceptable Brix and would not prohibit manufacturers from producing orange juice with higher Brix.  FDA also states that the minor decrease in minimum Brix level is unlikely to affect the taste or flavor of the juice.
  • FDA invites comment on the proposed reduction in minimum Brix from 10.5° to 10°. It also requests comment on whether the minimum Brix level should be further lowered or whether the SOI for pasteurized orange juice should be dispensed of altogether to provide manufacturers with more flexibility. It notes that many juices, including apple juice are not standardized. Furthermore, it requests comment on whether the maximum percentage of citrus reticulata or citrus reticulata hybrids permitted in orange juice should be raised from its current 10% to 15%. Citrus reticulata has a higher sugar content, and therefore higher brix content, than citrus sinensis (scientific name for Florida oranges).
  • Any comments must be submitted by November 4, 2025, to Docket No. FDA-2022-P-1668 for “Food Standards of Identity Modernization; Pasteurized Orange Juice; Proposed Rule.”

  • On June 30, 2025, FDA’s Human Foods Program published its proposed 2025 guidance agenda, including the Agency’s priority topics for new or revised guidance documents, as we previously blogged.  As a recent article discusses, the agenda’s publication comes amid heightened scrutiny on food ingredients, particularly petroleum-based synthetic dyes and transparency concerns. Regardless, the agenda is “a strong signal to industry stakeholders of the FDA’s strategy.” Overall, the topics presented in the agenda reflect public and political pressure for FDA to modernize food and beverage industry oversight.
  • Industry response to the agenda, as well as other recent FDA regulatory proposals, has been mixed. Some stakeholders welcome the Agency’s “proactive stance on chemical safety,” especially in light of years of concern about processes for substances that are generally recognized as safe (GRAS). Meanwhile, others are concerned that “the weight of focus given to synthetic dyes and post-market chemical assessments . . . could divert resources from more urgent issues like food insecurity and nutrition labeling.” Following FDA’s recent effort to phase out certain food colors, some companies have moved to reformulate their products, while others are “questioning the science behind the decision.”
  • Congress is also increasing pressure on FDA to tighten food chemical oversight. Two recent bills aim to reform the GRAS process:
    • The Ensuring Safe and Toxic-Free Foods Act, introduced by Sens. Edward Markey and Cory Booker, would require FDA review and public comment on all GRAS determinations, as well as require FDA to reassess the safety of at least 10 substances or substance classes every three years.
    • In addition, the Food Chemical Reassessment Act, introduced by Reps. Jan Schakowsky and Rosa DeLauro, would also require reassessment of at least 10 substances every three years, starting with Tert-butylhydroquinone, titanium dioxide, red dye 40, yellow dye 5, blue dyes 1 and 2, green dye 3, perchlorate, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), trichloroethylene, methylene chloride, benzene, ethylene chloride, propyl gallate, sodium nitrite, and sodium benzoate.
  • Keller and Heckman will continue to monitor developments related to the regulation of food ingredients and additives.

  • On August 1, 2025, the U.S. Department of Agriculture (USDA) opened a 30-day public comment period inviting feedback on a reorganization plan that would significantly reshape the agency’s structure and functions.
  • The reorganization plan was outlined in a July 24, 2025, memorandum which includes shutting down the agency’s South Building in Washington D.C. and relocating approximately 2,600 positions to various regional hubs around the country.
  • This shift reflects President’s Trump’s second-term commitment to decentralize federal agencies and relocate operations outside of the nation’s capital.
  • The reorganization plan is built around four pillars: (1) aligning USDA’s workforce size with available financial resources and agricultural practices; (2) relocating headquarters staff to regional hubs to better serve constituents; (3) consolidating redundant functions to improve efficiency; and (4) preserving critical public safety and national security roles.
  • USDA has exempted 52 position classifications from the federal hiring freeze. These roles are considered essential for national security and include wildfire responders, FSIS food safety inspectors, and other public safety functions. These positions still remain but may be affected by the relocation.
  • Comments can be submitted via email at reorganization@usda.gov. The comment period is open through August 26, 2025.
  • On July 30, 2025, the U.S. Food and Drug Administration (FDA) released its Expanded Decision Tree (EDT) chemical toxicity and risk screening tool in connection with the agency’s food chemical safety program.  FDA claims that the tool will provide a “consistent, systematic, and science-based approach to support evaluation of the safety of chemicals in food based on their structure and estimated toxicity.”
  • FDA submitted the EDT for external peer review in March 2024, which collected input from external scientific experts pursuant to Information Quality Act requirements.  The EDT was updated based on this review and FDA has now publicly released it to the scientific community for technical consideration.  FDA will also develop software for the EDT for general public use and will further refine the EDT over time.
  • The EDT approach is a modernized version of the Cramer Decision Tree tool and will be used to screen chemicals based on their structural features.  The updated, expanded, and refined set of fully chemical structure-based questions in FDA’s EDT allows classification of chemicals with greater specificity than the Cramer Decision Tree, according to FDA.  It expects the EDT to eventually be used in both pre- and post-market evaluation of chemicals in food.
  • FDA intends to release an informational video to explain the EDT and will hold listening sessions to receive input from interested parties.
  • In Federal Register notices published on July 30, 2025, FDA announced user fees for fiscal year (FY) 2026 for several of its food programs operating under the Food Safety Modernization Act (FSMA).  These include:
  • FDA’s third-party certification program (90 FR 35906 (July 30, 2025)). The FD&C Act directs to FDA to establish a recognition system for entities that accredit third-party certification bodies to conduct food safety audits and issue food and facility certifications to eligible foreign entities. The FD&C Act also directs FDA to establish a reimbursement (user fee) program to assess fees and require reimbursement for FDA’s work in administering this third-party certification program.
    • User fees for the third-party certification program are determined based on estimated costs, considering factors such as hours worked, travel costs, and inflation. Based on its estimated cost assessment, FDA set user fees for the certification program as follows:
      • Initial application fee for accreditation body seeking recognition: $53,440
      • Annual fee for recognized accreditation body: $2,498
      • Annual fee for accredited certification body: $3,122
      • Initial application fee for a certification body seeking direct accreditation from FDA: $53,440
      • Renewal application fee for recognized accreditation body: $32,724
  • FDA’s voluntary qualified import program (VQIP) (90 FR 35863 (July 30, 2025)). FDA also announced the 2026 user fee of $9,620 for its voluntary qualified importer program (VQIP). VQIP provides expedited review and import entry of food entering the U.S. from participating importers.
  • Certain reinspections and failures to comply with recall orders (90 FR 35910 (July 30, 2025)). FDA announced 2026 fee rates for certain domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections. These fees will be charged based on time spent by FDA at an hourly rate of $339 if domestic travel is required and $376 is foreign travel is required.
  • The Reagan-Udall Foundation (RUF) has released its Roadmap to Produce Safety: Summary of the Produce Safety Dialogue, which reflects input from produce sector stakeholders and is intended to serve as a “foundation for transformative change in produce safety management through collaboration.”
  • According to the Roadmap, “the burden of illness associated with microbial and chemical contamination of fresh produce is the most significant and disruptive food safety problem still affecting the U.S. food system,” while fresh produce is also a category that consumers are encouraged to consume more of as part of a healthy diet.
  • The Roadmap makes two primary recommendations to promote the availability of safe produce despite numerous foodborne illnesses and recalls challenging consumer trust and confidence:
    • First, the produce supply chain should “implement a shared responsibility approach,” in which all stakeholders actively participate in risk-based produce safety efforts.
    • Second, the supply chain should “form a structured, stakeholder led collaboration . . . led by influential stakeholders representing the diversity of the produce supply chain.”
  • FDA has stated its commitment to engagement and collaboration with stakeholders to implement strategies to prevent foodborne illness from produce, including seeking executive leadership of the Office of Produce Safety, established under the 2024 reorganization of the Human Foods Program, which we previously blogged about.
  • Keller and Heckman will continue to report on activities related to produce safety.
  • On July 9, 2025, the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) announced a significant update to its procedures for reviewing petitions seeking a determination of nonregulated status for genetically engineered organisms. These changes aim to align APHIS’s petition review process with recent legal developments, particularly amendments to the National Environmental Policy Act (NEPA) and the agency’s authority under the Plant Protection Act (PPA).
  • Under the revised approach, APHIS will focus its review on whether a genetically modified organism (GMO) poses a greater plant pest risk compared to an appropriate comparator. If the organism is found not to be a plant pest, APHIS will conclude its review and issue a determination that the organism is not subject to regulation under 7 C.F.R. part 340.
  • Historically, APHIS included environmental impact assessments as part of its petition process. However, the agency clarified that this practice was discretionary, not mandatory. The 2023 amendments to NEPA, enacted through the Fiscal Responsibility Act, reinforce this position by specifying that federal agencies are not required to prepare environmental documents for nondiscretionary actions where they lack authority to consider environmental factors.
  • Despite these changes, APHIS will continue to publish draft reviews of petitions in the Federal Register, allowing for public comment before final determinations are made.
  • Keller and Heckman will continue to monitor developments related to NEPA implementation and APHIS’ regulatory authority under the Plant Protection Act.
  • On July 23, 2025, the U.S. Department of Health and Human Services (HHS), the U.S. Department of Agriculture (USDA), and the U.S. Food and Drug Administration (FDA) announced a joint Request for Information (RFI) to help the agencies establish a federal definition for ultra-processed foods (UPFs). Specifically, the agencies are requesting comments on what factors and criteria should be included within the UPF definition. The pre-publication RFI is available here and it will be published in the Federal Register on July 25, 2025.
  • Currently, there is not a single, universally accepted definition of UPFs. In its announcement, HHS said that “[a] uniform definition of ultra-processed foods will allow for consistency in research and policy to pave the way for addressing health concerns associated with the consumption of ultra-processed foods.” HHS Secretary Robert F. Kennedy, Jr. also stated that defining UPFs “with a clear, uniform standard” will further empower the agency to fulfill its mission to “Make America Healthy Again.”
  • The UPF RFI follows an announcement on May 9, 2025, that FDA and the National Institutes of Health (NIH) are launching the “Nutrition Regulatory Science Program,” which aims to “implement and accelerate a comprehensive nutrition research agenda” that will inform future food and nutrition policy actions. One of the goals of the program is to understand how and why UPFs harm people’s health. To administer the program, FDA will provide guidance on regulatory science, and NIH will provide the infrastructure for the solicitation, review, and management of scientific research.
  • A uniform definition of UPFs could have broad implications and influence future public health guidance and state or federal legislative efforts. Additionally, foods that are covered under the Supplemental Nutrition Assistance Program (SNAP) could be restricted.
  • Keller and Heckman will continue to monitor developments related to UPFs.