• On October 1, 2025, the US federal government shut down after lawmakers failed to pass a new appropriations bill.  Federal agencies and departments have certain operational procedures during shutdowns, and some government services will be temporarily suspended, as an estimated 41% of the federal workforce will be put on unpaid leave. 
  • The US Department of Health and Human Services (HHS) recently issued its FY 2026 Contingency Staffing Plan for Operations in the Absence of Enacted Annual Appropriations.  The plan states that it expects more than 32,000 of its nearly 80,000 workers to be furloughed during the shutdown.  As a result, certain aspects of U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) operations will be affected.  The plan indicates that FDA will continue with its core functions to “handle and respond to emergencies” and that “FDA activities related to imminent threats safety of human life” will continue.  These include responding to public health emergencies and foodborne illness outbreaks; review of import entries; conducting for cause and certain surveillance inspections of regulated facilities; and criminal enforcement work.
  • Although FDA will continue to respond to foodborne illness outbreaks, FDA’s Coordinated Outbreak Response and Evaluation (CORE) Response Teams stated that these outbreaks will no longer be reported: “Due to the absence of either a fiscal year 2026 appropriation or a Continuing Resolution, only certain government activities will continue.  While FDA will continue to conduct foodborne outbreak surveillance and response activities, the CORE Investigation Table will not be updated weekly during this time.  FDA will continue to issue public warnings if there is actionable information to protect consumers from foodborne illness.”  FDA did not note whether it will continue to post recall notices.
  • Regulated entities should expect delays in routine inspections and submissions.  This may affect the review timeline for submitted GRAS notices.  Additionally, customs entry review and Foreign Supplier Verification Program (FSVP) checks may experience slow processing, leading to potential shipment delays.  A prolonged shutdown could also have a significant impact on the Supplemental Nutrition Assistance Program (SNAP).  The effect on the Supplemental Nutrition Program for Women, Infants, and Children (WIC) food programs will be dependent on whether states can access other contingency funds. 
  • Keller and Heckman will continue to provide updates regarding the government shutdown and its implications.
  • USDA’s Animal and Plant Health Inspection Service (APHIS) is “deregulating” a genetically engineered (GE) corn (strain MON 95379) which has been modified to resist pests, including corn earworms, fall armyworms, and sugar cane borers.  The docket on regulations.gov is APHIS-2020-0113.
  • APHIS has the authority to regulate genetically engineered organisms that are plant pests or for which there is a reason to believe that they are plant pests. See Regulations in 7 CFR Part 340 including definition of “regulated article.” However, under 7 CFR 340.6, a petition may be submitted for determination of non-regulated status, which requires demonstrating that the organism is unlikely to pose a greater plant pest risk than the unmodified organism. A list of deregulated organisms can be found at Petitions for Determination of Nonregulated Status | Animal and Plant Health Inspection Service.
  • The petition process that resulted in this action was restarted after the U.S. District Court for the Northern District of California vacated USDA’s final rule for organisms developed using genetic engineering. Prior to that decision, USDA had replaced the petition process with a streamlined regulatory status review (RSR) process. RSRs issued prior to the court order remain in place.
  • The Texas Department of State Health Services (DSHS) has published its proposed rule (see p. 29, 50 TexReg 6301) implementing The “Make Texas Healthy Again” law (SB25) that was signed in June 2025, as we previously blogged. The law includes a provision requiring on-pack warning labels for food and beverage products that contain any of 44 listed substances, including certified food colors and titanium dioxide.
  • The proposed rule would add sections 229.1001-1005 to the Texas Health and Safety Code and would require the statement “WARNING: This product contains an ingredient that is not recommended for human consumption by the appropriate authority in Australia, Canada, the European Union, or the United Kingdom” on the label of any food containing one of the listed ingredients unless an exemption applies. The proposed rule also outlines formatting and placement requirements for the warning statement.
  • The proposed rule includes exemptions for products not intended for human consumption; food labeled, prepared, served, or sold in a restaurant or retail food establishment; products regulated by USDA; products bearing a governmental warning from the surgeon general of the United States Public Health Service; drugs and dietary supplements; and pesticide chemicals, soil or plant nutrients, or other agricultural chemicals used on raw agricultural commodities.
  • Notably, the proposed rule includes the federal preemption provision found in the statute. Section 229.1003(b) of the proposed rule states that it does “not apply to an ingredient, including a food additive and color additive, if a federal law or regulation issued by [FDA] or USDA: (1) prohibits the use of the ingredient; (2) sets conditions for using the ingredient, such as needing a warning or disclosure statement; (3) says an ingredient or group of ingredients is safe for people to eat; or (4) requires a labeling statement for foods that are ultra-processed or processed.” This regulatory language mirrors the statutory language without elaborating on its impact.  In our view, the statute and this regulatory language should significantly limit the impact of the proposed rule because it would mean a warning label will not be required if FDA has issued a regulation authorizing the use of an ingredient. Many of the ingredients listed in the proposed rule are subject to an FDA food additive or generally recognized as safe (GRAS) regulation.  We note, however, that Texas’s proposed regulatory language (an FDA regulation “says an ingredient . . . is safe for people to eat”) differs slightly from the corresponding statutory language (an FDA regulation “determines an ingredient . . . is safe for human consumption”) and would ideally refer in a more straightforward way to the existence of an FDA food additive or GRAS regulation reflecting FDA’s determination that the ingredient is safe.
  • In addition to the exemptions listed above, the Fiscal Note accompanying the proposed rule clarifies that the requirement will only apply to labels that are developed or copyrighted on or after January 1, 2027, and “[i]f labels are never changed, businesses are not required to comply.”
  • DSHS is accepting comments on the proposed rule until October 27, 2025 (31 days after the proposed rule was published in the Texas Register). Keller and Heckman will continue to monitor this proposed rule.
  • On October 3, 2025, the U.S. Food and Drug Administration (FDA) announced that, beginning October 31, 2025, it will require import certification for certain shrimp and spices from Indonesia—marking the agency’s first use of certification authority under Section 801(q) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as established by the Food Safety Modernization Act (FSMA).
  • The certification requirement applies to products originating from the Island of Java and Lampung Province on Sumatra, following confirmed contamination with Cesium-137 (a radioactive isotope) detected in multiple shipments of shrimp and cloves. FDA’s action, prompted by findings from U.S. Customs and FDA labs, aims to ensure that only products meeting U.S. safety standards are allowed entry, while minimizing disruption to compliant trade.
  • This move represents an additional application of FDA’s import oversight tools, supplementing existing mechanisms such as Import Alerts and detention without physical examination (DWPE). Import Alert #99-52 outlines the specific certification requirements and establishes a tiered approach based on contamination risk levels.
  • The agency has also launched a dedicated webpage to guide stakeholders through the certification process and clarify how this authority integrates with broader food safety and import control frameworks. Industry participants are encouraged to review the alert and certification guidance to ensure compliance and avoid disruptions in supply chains.
  • Keller and Heckman will continue to monitor FDA’s implementation of import certification authority and provide updates as new developments arise.
  • At a September Food & Drug Law Institute (FDLI) conference, Mark Hartman, Director of FDA’s Office of Food Chemical Safety, Dietary Supplements and Innovation, indicated that FDA intends to revisit its previously withdrawn draft guidance on the use of fruit juice and vegetable juice as color additives.  
  • An additive that imparts color and meets the regulatory definition of “color additive” requires a color additive authorization, unless it is “used in a way that any color imparted is clearly unimportant insofar as the appearance, value, marketability, or consumer acceptability is concerned.” (21 CFR 70.3). Therefore, the use of fruit and vegetable juice can require a color additive authorization.
  • The draft guidance document, which was issued in 2016, and withdrawn the following year after significant industry pushback, was intended to clarify which ingredients are encompassed by the color additive regulations in 21 CFR 73.250 (“Fruit juice”) and 21 CFR 73.260 (“Vegetable juice”). Among other uncertainties, the regulations include undefined terms such as “mature,” “fresh,” and “edible.”
  • FDA’s now-withdrawn draft guidance interpreted the regulations in a manner that industry declared was inconsistent with the regulations and with industry practice. For example, the withdrawn draft guidance stated that only “minimal processing methods” may be used in the production of color additives from fruit and vegetable juices. However, this term is not used in either regulation, and FDA interpreted it to encompass processing techniques that were ubiquitous and important for food safety (e.g., pasteurization).
  • FDA’s intention to revisit this draft guidance is also reflected on the guidance agenda for FDA’s Human Foods Program as something expected to publish by the end of December 2025.
  • FDA has revised its previous interpretation of a clause of the Federal Food, Drug, and Cosmetic Act (FDCA) that states an ingredient that is first a drug cannot then become a dietary ingredient. In 2022, FDA had reiterated that the definition of a new dietary supplement excludes articles “authorized for investigation as a new drug . . . for which substantial clinical investigation have been instituted and for which the existence of such investigations have been made public,” unless the article was previously marketed as a food or dietary supplement, in its determination that β-Nicotinamide Mononucleotide (NMN) is not a dietary supplement, as we previously blogged.
  • Now, FDA has determined that NMN may be lawfully used in dietary supplements in response to Citizen Petitions from the Natural Products Association, the Alliance for Natural Health USA, and the Council for Responsible Nutrition (CRN). The Agency has determined that the “race-to-market” framework in which a dietary supplement or food must have been lawfully marketed before the approval of a new drug is not the “best reading” of the statute. Thus, FDA will no longer evaluate whether the supplement or food was lawfully marketed when determining its status, but any marketing—legal or not—must have occurred in the U.S.
  • In reevaluating its position on NMN, FDA noted that there is evidence that the substance was marketed in the U.S. as a dietary supplement as early as 2017 (before NMN was authorized for investigation as a new drug and substantial clinical investigations had been made public). As a result, it is not precluded from the dietary supplement definition.
  • While FDA’s decision states clearly that NMN may be legally used in dietary supplements, the Agency left open questions about the wider race-to-market clause. According to CRN, FDA’s response to its petition “fail[ed] to address the core structural problems that sparked the NMN confusion to begin with.”
  • Keller and Heckman will continue to provide updates about FDA’s interpretation of the race-to-market provision and other decisions related to marketing dietary supplements.
  • On September 25, 2025, the U.S. Food and Drug Administration (FDA) finalized amendments to its regulation governing prior notice requirements for imported human and animal food. These changes aim to enhance the agency’s ability to identify and inspect food shipments that may pose risks to public health, particularly those arriving via international mail.
  • Under the new rule, prior notice submissions must now include the name of the mail service and a mail tracking number for food articles sent through international mail. This information will enable FDA to better coordinate with the U.S. Postal Service, Customs and Border Protection, and other agencies to track and inspect potentially hazardous shipments, including those flagged as bioterrorism risks.
  • Additionally, the rule introduces a new requirement for timely submission of prior notice and food facility registration information when a shipment has been refused or placed on hold. By establishing a timeframe for these “post-refusal” and “post-hold” submissions, FDA aims to reduce delays at ports of entry and minimize associated costs.
  • The final rule is part of Docket No. FDA-2011-N-0179 and builds on earlier proposals to strengthen oversight of food imports, particularly those entering the country through less traditional channels like international mail.
  • Keller and Heckman will continue to monitor FDA regulatory developments related to food imports.
  • On September 3, 2025, and in response to a food additive petition filed by Cargill, FDA published an expansion to the secondary direct additive clearance for hydrogen peroxide in 21 CFR 173.356. The previous version of Section 173.356 permitted the use of hydrogen peroxide as an antimicrobial agent in the production of modified whey at a level not to exceed 0.001% by weight of the whey. The revised version more broadly permits the use of hydrogen peroxide at levels consistent with GMP as an antimicrobial agent, oxidizing and reducing agent, bleaching agent, and to remove sulfur dioxide.
  • The revised regulation maintains the requirement to remove residual hydrogen peroxide. FDA does not expect the expanded uses authorized by the regulation to increase dietary exposure to hydrogen peroxide because of this removal requirement and the inherent instability of hydrogen peroxide.
  • FDA is also updating the regulation to cross-reference the specifications in the hydrogen peroxide monograph in the 14th edition of the Food Chemicals Codex (FCC) instead of the previously listed 7th edition. However, this is just a technicality, and the FCC monograph for hydrogen peroxide has not changed between editions.
  • Hydrogen peroxide is also affirmed as GRAS in 21 CFR 184.1366 for a variety of other uses. The GRAS affirmation was issued pursuant to 21 CFR 184.1(b)(2), which purports to require a food additive regulation for any extension of use.
  • Florida Natural Growers, Inc., was recently sued for allegedly falsely representing its Florida’s Natural orange juice products as being exclusively made from premium Florida orange juice despite being blended with juice from other countries. The plaintiff claims that Florida Natural knew that consumers would rely on Florida representations made on the label and be willing to pay more for Florida orange juice.
  • According to the complaint, labeling on the front of the package claiming “Owned by Florida Farmers” next to an American flag, as well as language on the side panel of the package about why the company is “different,” imply that the orange juice is made exclusively from Florida oranges. Further, the American flag is claimed to be an implied “Made in the USA” claim, which is regulated by the Federal Trade Commission and only permissible where “all or virtually all ingredients . . . are made and sourced in the United States.” 16 CFR 323.2.
  • The complaint also alleges that there is a strong connection between Florida and the citrus industry such that “consumers overwhelmingly preferred Florida orange juice” and are willing to pay a premium of approximately 50% for 100% Florida orange juice.
  • However, according to the plaintiff, because of a decline in citrus groves in Florida due to plant diseases, Florida Natural began including orange juice from Mexico and Brazil in its products beginning in 2022. Thus, the plaintiff claims, the claims on the orange juice label are misleading and deceptive.
  • Keller and Heckman will continue to monitor this case and other class action lawsuits related to food labeling.
  • The U.S. Food and Drug Administration (FDA) has announced a three-day virtual public meeting and listening session series focused on food allergen thresholds and their potential applications, scheduled for November 18–20, 2025.
  • Food allergies affect an estimated 32 million Americans, and even trace amounts of allergens can trigger severe reactions. To help consumers avoid unintended exposure, some food manufacturers voluntarily include allergen advisory statements (AAS), such as “may contain” or “produced in a facility that also processes” on product labels. However, there are currently no specific FDA requirements governing when or how AAS should be used.
  • A 2024 Food and Agriculture Organization (FAO) consultation panel recommended adopting the use of risk-based thresholds, which refers to a scientifically determined level of an allergenic substance below which the vast majority of allergic individuals are unlikely to experience an adverse reaction. While FDA has issued guidance documents addressing allergen risk assessment and management, it has not established or endorsed any specific threshold levels to date.
  • Registration for the public meetings is required for all sessions. While registration for the November 18 meeting will remain open until the event begins, those wishing to join the listening sessions must register by November 3, 2025.
  • Keller and Heckman will continue to monitor developments related to allergen thresholds.