Search results for: agenda

  • 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.
  • FDA sent a proposed rule related to GRAS determinations to the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) on Monday December 1st. The proposed rule is expected to restrict self-affirmed GRAS determinations as a legal basis for the use of food ingredients and require submission of GRAS conclusions to FDA. FDA’s statutory authority to require such submissions has been questioned and is the subject of pending draft legislation.
  • Health and Human Services Secretary Robert F. Kennedy Jr. had directed FDA to explore rulemaking of this nature in March of this year and the proposed rule appeared in the Unified Regulatory Agenda published in September.
  • OMB will be under pressure to complete its review quickly and we anticipate that OMB will complete its review, and that proposed rule will be published, in the coming weeks. Keller and Heckman would be glad to answer questions or assist anyone wishing to submit comments on the proposed rule.
  • 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.
  • 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.