Search results for: agenda

  • 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 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.
  • On June 29, 2026, FDA’s Human Foods Program (HFP) released its updated 2026 guidance agenda, which includes priority topics for HFP guidance documents. Subjects of particular interest include:
    • Caffeine content labeling in foods and beverages;
    • Questions and answers regarding the use of “healthy” claims;
    • Action levels for cadmium and inorganic arsenic in food for babies and young children;
    • Fruit juice and vegetable juice as color additives in food;
    • Identity and safety information about new dietary ingredients (NDIs); and
    • Multiple guidances to reduce chemical and microbiological hazards in food
  • While guidance documents do not impose legally enforceable requirements, they represent FDA’s current thinking and interpretation on a specific topic that the industry can use as practical guidance.
  • FDA is accepting comments on the proposed topics at www.regulations.gov, using Docket FDA-2022-D-2088. Keller and Heckman will be happy to assist in drafting comments on behalf of interested companies.

  • FDA’s Human Foods Program has released an updated list of priority research, data, and method needs to support food safety and nutrition oversight. While aimed at researchers, the agenda also offers industry insight into scientific research likely to influence future regulatory decisions for foods, beverages, dietary supplements, and food contact materials.
  • The priorities span nutrition, consumer behavior, microbiological and chemical safety, and risk assessment. FDA highlights needs related to nutrient intake and bioavailability, infant and child nutrition, ultra‑processed foods, consumer understanding of labeling and additives, pathogen detection and prevention, and improved methods for assessing emerging chemical risks.
  • Human behavior research features include consumer interpretation of allergen labeling, perceptions of food chemicals and additives, responses to novel food ingredients, and changes in purchasing or consumption behavior following labeling or policy interventions.
  • From a food safety perspective, the priorities reinforce FDA’s ongoing emphasis on prevention, detection, and root‑cause analysis. Microbiological research needs focus on pathogen prevalence, survival under real‑world processing and retail conditions, effectiveness of sanitation and processing controls, and expanded use of genomic and geospatial tools to support outbreak investigations and environmental monitoring. Similarly, chemical safety priorities emphasize improved detection methods, targeted surveillance of known and emerging hazards, and development of novel testing approaches, such as new approach methodologies (NAMs), to assess safety where traditional data may be limited.
  • Keller and Heckman will continue to monitor developments related to FDA’s Human Foods Program research priorities and their potential implications for food and dietary supplement stakeholders.
  • On September 4, 2025, FDA published its Unified Regulatory Agenda, which describes regulations currently under development or recently completed, providing a preview of the Agency’s top regulatory priorities. The agenda includes three significant regulations that could affect food and dietary supplements: a proposed generally recognized as safe (GRAS) substances rule; a final front-of-package (FOP) labeling rule; and a proposed rule finding a specific ingredient is not excluded from the dietary supplement definition.
  • The proposed GRAS rule would amend FDA’s regulations in 21 CFR parts 170 and 570 to “require the mandatory submission of GRAS notices” for substances purported to be GRAS for use in human or animal food. Substances that are currently subject to a GRAS regulation or a “no questions letter” in FDA’s GRAS inventory would be exempt from the rule. The proposed rule would also clarify that FDA maintain a public GRAS notice inventory, as well as the process to determine that a substance is not GRAS. As we previously blogged, FDA recently submitted a collection for information relating to the GRAS notification process, and in early 2025, the Agency was directed to explore a rulemaking to revise the GRAS final rule and related guidance to eliminate the self-affirmed GRAS pathway. The proposed rule is scheduled to be published in October 2025, though this is subject to change.
  • The FOP final rule would require the front labels on food packages to display certain nutrition information to help consumers make more informed dietary choices. FDA issued the proposed FOP rule in January 2025, later extending the comment period to July 15, as we previously blogged. At a high level, the rule would require the inclusion of a Nutrition Info box on the principal display panel of most foods that would display interpretive information on the amount of saturated fat, sodium, and added sugars in the product. FDA received more than 13,000 comments on the proposed rule. The final rule is scheduled to be published in May 2026, though this is subject to change.
  • Finally, the proposed rule related to a dietary supplement ingredient “would find that a specific ingredient would not be excluded from the dietary supplement definition.” Thus, products containing the ingredient could be lawfully marketed as dietary supplements, assuming they otherwise meet the dietary supplement definition. This may be related to nicotinamide mononucleotide, which is the subject of a citizen petition seeking regulatory clarity on its use as a dietary ingredient. The proposed rule is scheduled to be published in January 2026, though, once again, this is subject to change.
  • Keller and Heckman will continue to monitor FDA’s regulatory agenda and provide updates on all proposed and final rules the Agency releases.
  • 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 Monday, June 30, 2025, FDA’s Human Food Program published its proposed 2025 guidance agenda (FDA’s news release shown here). The agenda contains possible new topics for guidance documents or revisions to existing guidance documents.
  • The entire list of new guidance topics under the 2025 agenda can be found here. The potential new topics include:
    • New Dietary Ingredient (NDI) Notifications and Related Issues: Identity and Safety Information About the NDI: Guidance for Industry
    • Food Colors Derived from Natural Sources: Fruit Juice and Vegetable Juice as Color Additives in Food; Draft Guidance for Industry
    • Action Levels for Cadmium in Food Intended for Babies and Young Children; Draft Guidance for Industry
  • Importantly, guidance documents do not establish legally enforceable rights or responsibilities (see here). Rather, guidance documents represent FDA’s “current thinking” on a particular topic and serve merely as a resource for businesses and organizations. FDA’s good guidance practices outlined in 21 CFR 10.115 provide, among other things, that the agency will seek public comment on any guidance documents that address more than minor changes in interpretation or policy (Level 1 guidance).
  • Keller and Heckman will continue to monitor developments related to FDA’s forthcoming guidance documents.
  • Earlier this month, the White House’s Office of Information and Regulatory Affairs (OIRA) announced the release of the 2024 Spring Unified Regulatory Agenda. The unified agenda, which is published twice a year, summarizes agencies’ proposed timelines for anticipated regulatory actions, although the timelines are subject to change and are frequently inaccurate, particularly in election years.
  • FDA’s proposed regulatory actions in the spring agenda include a proposed rule which, “if finalized, would provide by regulation that an ingredient is not excluded from the dietary supplement definition” (0910-AI91).  Although the ingredient is not referenced in the regulatory agenda, it is widely believed that the referenced ingredient is N-acetyl-L-cysteine. As we previously reported, FDA previously concluded N-acetyl-L-cysteine was excluded from the definition of a dietary supplement based on its use as a drug but would be subject to enforcement discretion pending a decision on whether to allow for its use through the issuance of a regulation.
  • Among FDA’s many other proposed actions are a proposed rule regarding front of pack nutrition labeling (0910-AI80); changes to standards of identity (SOI), including a proposed rule to modernize the SOI for maple syrup (0910-AI96) and a proposed rule to modernize the way in which changes to SOIs are considered (0910-AI79); a proposed rule to change certain written assurance provisions in the HARPC rules (0910-AH77); a final rule for the definition of “healthy” (0910-AI13); and a final rule regarding soy protein and coronary heart disease health claims (0910-AH43).
  • Notable actions on USDA’s regulatory agenda include a proposed rule to establish requirements for labeling of meat or poultry products made using animal cell-culture technology (0583-AD89) and a proposed rule to establish a new framework to reduce Salmonella illness associated with poultry products (0583-AD96).
  • The Executive Office of the President recently released the Spring 2019 Unified Agenda. As we described in our post for the release of the Fall 2018 Unified Agenda, twice a year, federal agencies publish this comprehensive report describing regulations currently under development or recently completed. The agenda provides stakeholders with a preview of agencies’ top regulatory priorities for the coming months.
  • The agenda includes significant regulatory undertakings by the U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA). Of particular note for USDA is the hemp production program rule, which the Unified Agenda indicates will be released as an interim final rule in August 2019.  As readers of this blog may recall, the 2018 Farm Bill removed hemp from the Controlled Substances Act, and assigned regulation of the growth of hemp to the states with oversight by USDA.  The Secretary of USDA, Sonny Purdue announced in March his intent to have a final rule in place in late 2019 in time for the 2020 growing season.  Though many were skeptical due to the time generally required to promulgate a regulation, if USDA adheres to its estimated completion date of August 2019 (estimated completion dates for regulations published in the Unified Agenda are often inaccurate), Mr. Purdue’s promise may be fulfilled.   Other USDA regulatory priorities include USDA’s National Organic Program plan to strengthen oversight of organic imports to deter fraud, enhance enforcement and protect organic integrity and swine slaughter inspection.
  • Interim FDA commissioner Sharpless, in an FDA Voice blog, highlighted several of the agency’s proposed regulatory actions related to tobacco and standards of identity for food. The Unified Agenda includes several actions related to tobacco products, including implementing safety standards for Electronic Nicotine Delivery Systems, product standards for characterizing flavors in cigars and nicotine levels in products.  As was also the case in the Fall 2018 Unified Agenda, FDA still plans to update the definition of the claim “healthy” on food labels, to revoke outdated standards of identity for French salad dressing and frozen cherry pie, and to reopen the comment period (expected September 2019) on the proposed rule establishing general principles to update the framework for standards of identity.  FDA also continues to state that they will issue a proposed rule on the revocation of uses of partially hydrogenated oils in food, a final rule on gluten-free labeling of fermented, hydrolyzed, or distilled foods, and a final rule regarding the soy protein and coronary heart disease health claim.  A new item on the Spring 2019 Unified Agenda includes a final rule regarding calorie labeling for foods sold from certain vending machines and front of package type size.
  • The Executive Office of the President recently released its Fall 2018 Unified Agenda of Regulatory and Deregulatory Actions. Twice a year, federal agencies publish this comprehensive report describing regulations currently under development or recently completed. The agenda provides stakeholders with a preview of agencies’ top regulatory priorities for the coming months.
  • This fall’s agenda highlights significant regulatory undertakings by the U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA). Of note for USDA is USDA’s National Organic Program plan to strengthen oversight of organic imports to deter fraud, enhance enforcement and protect organic integrity. This blog has actively covered the issues surrounding organic enforcement. In addition, USDA’s Animal and Plant Health Inspection Service is looking to revise its regulations regarding genetically engineered plants. This blog will continue to monitor developments surrounding genetically modified organisms, and specifically, gene-edited technologies, both in the U.S. and abroad.
  • In an FDA Voice blog, FDA Commissioner Gottlieb highlighted a number of the agency’s proposed regulatory actions related to tobacco, food claims and labeling. The Unified Agenda includes several actions related to tobacco products, including implementing product standards for testing battery safety of e-cigarettes and administrative detention of tobacco products. FDA also plans to remove all mention of partially hydrogenated oils in its regulations and revoke all prior sanctioned uses, and it has plans to update the definition of the claim “healthy” on food labels. Further, FDA is planning to revoke outdated standards of identity, including for French salad dressing and frozen cherry pie and will reopen the comment period on the proposed rule establishing general principles to update the framework for standards of identity.