• On July 22, 2026, the U.S. Food and Drug Administration (FDA) announced actions targeting two color additives in food by issuing a final order revoking the authorized use of Orange B (21 CFR 74.250) and proposing to revoke the authorized use of Citrus Red No.2 (21 CFR 74.302).
  • Last year, as we previously posted, FDA announced a proposed order to revoke the color additive regulation for Orange B. Following an evaluation of public comments on the proposal, FDA did not receive information that changed its conclusion that the authorized use of Orange B had been abandoned by industry, which led to the final order.
  • FDA’s proposal to revoke the color additive regulation for Citrus Red No.2 is also based on the agency’s tentative conclusion that this use has been abandoned by industry.
  • These regulatory changes are part of the “Make America Healthy Again” initiative with Secretary of Health and Human Services (HHS) Robert F. Kennedy, Jr. stating that “by working to eliminate outdated authorization for petroleum-based color additives that are no longer used, we are modernizing our food safety regulations and helping to Make America Healthy Again.” FDA is also continuing to track voluntary industry commitments to remove certain color additives in food through its Tracking Food Industry Pledges to Remove Petroleum-Based Food Dyes website, which summarizes voluntary commitments as companies transition to alternative color sources.
  • FDA is accepting public comments on the proposed revocation of Citrus No. 2 as a color additive in food at www.regulations.gov, using Docket FDA-2026-N-6304 until August 24, 2026. Keller and Heckman will be happy to assist in drafting comments on behalf of interested companies.
  • On July 2, 2026, California’s Department of Toxic Substances Control (DTSC) announced its finalized rulemaking adding microplastics to the Candidate Chemicals List.
  • This rule defines microplastics as “plastics that are less than 5 millimeters (mm) in their longest dimension, inclusive of those materials that are intentionally manufactured at those dimensions or are generated by the fragmentation of larger plastics.” Several trade associations expressed concern over this definition, pointing out how it could include secondary microplastics, which are generated when larger microplastics break down.
  • A DTSC report marked that food contact articles such as plastic wrappers and single-use tea bags as potential sources of secondary microplastics. The report requested information on potential non-plastic alternatives to these articles.
  • DTSC has also released a Technical Document explaining some of the department’s scientific basis for the rulemaking. The document claims that microplastics are found in environmental sources like water and dust, but also food, industrial coatings, cosmetics, and many other types of products. DTSC Director Katherine Butler called the rulemaking “a critical step” to address widespread environmental contaminants.
  • Despite receiving 189 comments on the proposed rule, DTSC finalized the rulemaking unchanged.
  • While the rulemaking alone does not impose new obligations on manufacturers or retailers, it will initiate agency review to determine whether microplastics should be regulated as a priority chemical through a separate rulemaking process.
  • The Candidate Chemical list also overlaps with California’s AB 1200, which requires manufacturers to disclose candidate chemicals intentionally added to cookware. Manufacturers must print this information on the product label and direct the consumer to an online disclosure. Because the rulemaking regulates plastics from “fragmentation of larger plastics,” it is currently unclear how manufacturers should determine whether a microplastic particle is “intentionally added.”
  • Keller & Heckman will continue to monitor microplastic law developments.
  • The constituent update states that FDA has become aware of a number of issues regarding unnecessary registration and potential misuse of FFR information. The Agency has seen an uptick in businesses registering their facilities with FDA when not required. In addition, third-party businesses are requesting FFR information to log into FDA’s online registration system to verify registration status, and third-party seller platforms are asking food companies to provide a copy of their FDA Food Facility Registration or a registration certificate as part of their product-listing process.
  • According to FDA, registering when not required, then sharing FFR information creates opportunities for bad actors to misuse the registration information for fraudulent purposes such as viewing, changing, or even canceling the FFR. In addition, registering when not required can lead to unnecessary inspections, cause confusion about compliance obligations, and divert FDA resources away from monitoring facilities that are required to register.
  • Under 21 CFR 1.225, food facilities that manufacture, process, pack, or hold food must register their facilities unless exempt. 21 CFR 1.226 provides exemptions for, (1) foreign facilities whose food is further processed outside the U.S.; (2) farms; (3) retail food establishments; (4) restaurants; (5) nonprofit food service establishments; (6) certain fishing vessels; and  (7) facilities regulated entirely by the U.S. Department of Agriculture (USDA) under federal meat, poultry, or egg inspection laws.
  • FDA advises registered facilities to never share the business’ FFR information and to create subaccounts if additional personnel are required to help manage registration and submissions. FDA states that if businesses have shared their FFR information in error, they should consider cancelling the FFR and re-registering the facility.
  • Keller and Heckman will continue to monitor food facility registration developments.
  • USDA recently published its 2026 Unified Agenda, which includes an August 2026 target date for a Notice of Proposed Rulemaking (NPRM) to revise the bioengineered (BE) foods disclosure regulations and address the deficiencies identified by the Ninth Circuit, which held that the absence of detectable modified genetic material is not legally equivalent to a food not containing such material, and invalidated the rule’s detectability exemption as well as its digital and text-message disclosure provisions.
  • The 2016 National Bioengineered Food Disclosure Standard introduced federal disclosure requirements for BE foods, requiring manufacturers to disclose foods that contain BE ingredients.  In December 2018, the USDA published its final regulations, which added a detectability exemption and text-message option. The detectability exemption excluded certain foods from the definition of a BE food if “the genetic material is not detectable,” and USDA added an additional disclosure option of text messaging to “provide additional and comparable methods” to access the BE disclosure. The original requirements only offered three disclosure options: on-label text, symbol, and electronic / digital link. Manufacturers used quick response (QR) codes when using the electronic or digital link disclosure options, and the other two options required a symbol designed by the U.S. Department of Food and Agriculture (USDA) and an on-label text of “bioengineered food” or “contains bioengineered food ingredients.”
  • In July 2020, consumer advocacy groups and organic food retailers sued USDA, arguing that the rule improperly exempted many highly refined foods from disclosure and allowed companies to rely on QR codes and other digital disclosures that were not readily accessible to consumers.
  • As we previously reported, the district court upheld most of the rule in 2022, but in October 2025, the Ninth Circuit invalidated the detectability exemption and the digital and text-message disclosure provisions, while upholding USDA’s use of the term “bioengineered.” The court found that the detectability provision was inconsistent with the statute because the absence of detectable modified genetic material was not equivalent to the food not containing such material.
  • Now, both parties have submitted briefs regarding the appropriate timing for vacatur of the invalidated provisions, with plaintiffs arguing for a January 1, 2028, compliance date, and USDA seeking to delay vacatur of the digital and text-message disclosure provisions until January 1, 2029. While the district court has not yet ruled, both parties agreed on a January 1, 2028, vacatur date (requires PACER login) for the detectability provision.
  • Keller and Heckman will continue to monitor developments regarding bioengineered food disclosure standards.

  • On July 9, 2026, USDA’s Food Safety and Inspection Service (FSIS), FDA, and EPA announced a Memorandum of Understanding (MOU) coordinating agency efforts to address drug residues, pesticide residues and other chemical contaminants in meat, poultry, and egg products under FSIS jurisdiction, food-producing animals while under FSIS or FDA jurisdiction, and food for food-producing animals. The MOU aligns with FSIS’s efforts to modernize heavy metal testing in food products and further MAHA’s goals of reducing children’s exposure to harmful contaminants.
  • As the MOU notes, evaluating chemical residues and contaminants in agriculture products is a shared responsibility among agencies. USDA is responsible for the safety and regulation of meat, poultry, and egg products, FDA is responsible for investigating residues reported by FSIS, and EPA is responsible for sale, distribution, and use of pesticides.
  • To foster interagency cooperation, the MOU requires FSIS to provide FDA with weekly residue reports and keep FDA and EPA informed of residue testing programs. FDA and EPA must be transparent with FSIS on sampling frequency, production classes sampled, and chemical compounds tested on an annual basis. Agencies are also expected to coordinate and collaborate in development of action or screening levels for contaminants in meat, poultry, and egg products.
  • Keller & Heckman will continue to monitor USDA and other agency developments.
  • On July 13, 2026, FDA issued a letter to infant formula manufacturers and their supply chain partners in response to several serious public health events, calling on the industry to increase vigilance to “ensure ingredient and infant formula safety.”
  • The letter details FDA’s investigation into two multistate outbreaks of infant botulism that led to voluntary recalls of powdered infant formula, as we previously reported. The investigation identified Clostridium botulinum contamination in a dairy-based ingredient, which FDA linked to both affected formulas. In addition, the letter discusses a global outbreak of cereulide intoxication, which resulted in an ingredient supplier being placed on an FDA Import Alert.
  • In the letter, FDA emphasizes that these incidents reflect a pattern of risks entering through the supply chain. The letter outlines FDA’s expectation for manufacturers to conduct supplier audits and verification activities, as well as monitor recalls, outbreak investigations, and FDA Import Alerts. The letter also reminds the industry of its obligations under 21 CFR Parts 106 and 117 and the Food and Drug Omnibus Reform Act of 2022.
  • The letter concludes by stating that FDA is continuing its investigations into the root causes of the 2025 and 2026 infant botulism outbreaks and provides industry with a list of resources, including Information for Infant Formula Manufacturers and Retailers and Guidance for Industry: Hazard Analysis and Risk-Based Preventative Controls for Human Food.
  • Keller and Heckman will continue to report on developments related to infant formula manufacturing.
  • On June 22, 2026, FDA posted a Response Letter denying a citizen petition brought by the Tucson Environmental Justice Task Force and two other individuals requesting that FDA set New Temporary Tolerances at the method detection limit (MDL) for various per-fluoroalkyl substances (PFAS). The petition specifically requested limits be established for 30 different PFAS substances that may be inadvertently transferred to foods including lettuce, blueberries, ready-to-eat bread, milk, eggs, salmon, clams, corn silage, and corn snaplage. The requested tolerances were generally based on an MDL of 0.05 micrograms/kg (0.05 ppb) for the relevant PFAS analytes in these food matrices.
  • Under the Federal Food, Drug, and Cosmetic Act (FFDCA), food may be deemed adulterated if it contains a poisonous or deleterious substance that may render it injurious to health. For unavoidable environmental contaminants, FDA may establish action levels, tolerances, or other regulatory limits. FDA has not established broad regulatory limits for PFAS in food as FDA only establishes tolerances when they believe these will not need significant adjustments in the future.
  • As we have previously blogged, the parties filed the petition on November 1, 2023. Following a court order requiring FDA to issue a final response, FDA released the response letter, dated June 17, 2026.
  • In its response letter, FDA explained that the science surrounding PFAS detection, exposure, and potential human health effects continues to evolve rapidly, making it difficult to establish such limits at this time. FDA does intend to continue evaluating PFAS contamination in the food supply and to establish action levels for PFAS in some products, where appropriate. Here, FDA found that the petitioners lacked sufficient evidence to obligate FDA to set temporary tolerances for PFAS.
  • The petitioners attempted to invoke the Delaney Clause which prohibits FDA from approving “food additives” if those additives have “been shown ‘to induce cancer in man or animal.’” Because the PFAS in question are food contaminants, rather than food additives, the Agency rejected this argument.
  • Keller & Heckman will continue to monitor PFAS food law developments.
  • On June 25, 2026, the U.S. House Oversight Committee held a hearing on “Combating Waste, Fraud, and Abuse in SNAP,” where House Republicans questioned the alleged influence of the food and beverage industry on the nutritional policies under the Supplemental Nutrition Assistance Program (SNAP).
  • SNAP is the federal government’s anti-hunger program that serves more than 40 million low-income Americans in providing electronic benefits that can be used like cash to purchase food. Under SNAP, all foods for human consumption, except alcoholic beverages and hot foods prepared for immediate consumption are eligible under federal law.
  • During the hearing, Committee Chair Tim Burchett (R-Tenn.) raised questions about SNAP, stating that while “every SNAP dollar is intended to help feed eligible individuals in need… that’s not where every dollar goes.” House Republicans also argued that SNAP benefits were improperly paid out by states and that the program has experienced different types of fraud such as SNAP card skimming where fraudsters drain the benefits of legitimate program participants or SNAP trafficking where some retailers allow beneficiaries to trade electronic benefits transfer (EBT) cards for cash which is then used to purchase non-allowable goods such as cigarettes or drugs.
  • House Republicans also raised concerns regarding the ability of SNAP recipients to purchase sugar-sweetened drinks through the program, claiming that current SNAP rules are written to encourage consumption of unhealthy processed and packaged foods rather than healthy fresh foods. As we have previously reported, the Trump administration, through the “Make America Healthy Again” initiative, has been encouraging states to apply for waivers that allow the restriction of soda purchases with SNAP dollars. So far, 23 states have approved waivers to restrict the purchase of “unhealthy” foods such as soda, candy, and energy drinks, but waivers in Colorado, Iowa, Nebraska, Tennessee, and West Virginia have been vacated.
  • Keller and Heckman will continue to monitor developments related to SNAP.
  • On June 30, 2026, the U.S. District Court for the Eastern District of Pennsylvania dismissed with prejudice an amended complaint which alleged that eleven producers of “Ultra Processed Foods” (UPFs) had sold Plaintiff UPFs that allegedly were addictive and caused him to develop Type 2 Diabetes and Non-Alcoholic Fatty Liver Disease (NAFLD). The initial complaint was dismissed last year for a variety of deficiencies including a failure to explain how consumption of the UPFs led to his diagnoses.
  • The Court’s latest dismissal was principally based on Plaintiff’s failure to establish a causal link between consumption of UPFs and his injury. The Court noted the “unique challenge” in proving causation where a large number of products were consumed over a lengthy time period and found the allegations of increased risk of disease to be insufficient to show that any particular product caused the diseases. Any correlation would be insufficient to demonstrate causation.
  • Relatedly, the Court rejected the application of a theory of joint liability. Application of joint liability is only appropriate where each defendant acted tortiously but it is not possible to determine who was the cause of the alleged harm. Such a theory could not be applied where the cause of the alleged harm is not established. Furthermore, application of the theory also failed because it requires showing that the allegedly harmful products are identical and share the same defective qualities. In contrast, the products at issue were different and the allegations implied “varying quantities and types of harmful ingredients, indicating varying levels of danger.”
  • The case number is 2:25-cv-0037. Keller & Heckman will continue to monitor UPF developments.
  • On July 3, 2026, the White House’s Office of Information and Regulatory Affairs (OIRA) released its 2026 Regulatory Agenda, listing agencies’ projected regulatory actions and the timelines for them (although the actions and timelines are subject to change).
  • A closely watched item on the Regulatory Agenda is a proposed rule (which we previously blogged about) that would amend FDA’s regulations at 21 CFR parts 170 and 570 to require the submission of a generally recognized as safe (GRAS) notice for the use of a human or animal food substance that is purported to be GRAS under the conditions of its intended use (0910-AJ02). Under the proposed rule, FDA would maintain and update a GRAS notice inventory for all substances subject to the mandatory notification requirement and would clarify the process by which the agency determines that a substance’s use is not GRAS. The proposed rule is tentatively scheduled to be published in December 2026.
  • Other proposed rules include: (1) updating nutrient content claims for added sugars (0910-AJ20); (2) revoking standards of identity for (a) certain canned fruits and vegetables for foods no longer sold in the United States (0910-AJ21); (b) certain bakery products and cereal flours (0910-AJ22); (c) frozen peas and definitions associated with them (0910-AJ23); and (3) establishing conditions under which a specific ingredient would not be excluded from the dietary supplement definition, allowing products containing the ingredient to be lawfully marketed as dietary supplements, assuming they otherwise meet the dietary supplement definition (0910-AI91).
  • The Regulatory Agenda also includes plans to finalize rules to: (1) permit the use of fluid ultrafiltered milk, fluid ultrafiltered nonfat milk, fluid microfiltered milk, and fluid microfiltered nonfat milk in the manufacture of standardized cheeses and related cheese products (0910-AI42); (2) require the display of front-of-package (FOP) nutrition labeling for food products (0910-AI80); (3) permit the use of salt substitutes in standardized foods in which salt is a required or optional ingredient (0910-AI72); and (4) reduce the minimum soluble solids requirement for pasteurized orange juice (exclusive of the solids from any added optional sweetening ingredients) (0910-AI98).
  • Keller and Heckman will continue to monitor food related regulations in the Federal Register.