• Today FDA rejected an objection and request for a public hearing on the Agency’s final order to repeal the color additive regulations for FD&C Red No. 3 when used in food (21 CFR 74.303) and in ingested drugs (21 CFR 74.1303). The objection and request was submitted on behalf of Micro-Tracers, a company that uses tracers containing Red 3 in medicated feeds to verify the presence and uniform mixing of components of the feed.
  • We have previously blogged on FDA’s revocation of the color additive listings for Red 3. The revocation was based on studies showing that high doses of Red 3 can cause cancer in rats through a mechanism of action not applicable to humans. Thus, although FDA did not find a safety issue with the authorized uses of Red 3, it revoked the authorizations as a matter of law, based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act.
  • The objection and hearing request raised objections to: (1) the scientific basis for the revocation of the Red 3 authorizations, (2) FDA’s failure to consider the specific use in tracers, and (3) FDA’s failure to exempt the intended use in tracers from the revocation or permit the intended use through the establishment of a safe tolerance.
  • FDA rejected each of these arguments. With respect to Objection 2, FDA stated that the revocation of the Red 3 listings was a legal decision and was not based on the safety of a specific intended use. The Agency also rejected the argument that the intended use in tracers was not subject to the Delaney clause because it was neither a color additive nor a food additive. FDA stated that Red 3 was added “for purposes of imparting color during a quality assurance testing phase,” and was therefore a color additive. Furthermore, even if not a color additive, it was a food additive because it was intentionally added.
  • The filing of the objection had operated as an automatic stay of FDA’s repeal of the color additive authorizations. FDA’s denial of the objection ended the stay and confirms the effective dates for the repeal of the authorizations for Red 3; January 15, 2027, for use in food and January 18, 2028, for use in ingested drugs.  
  • A Ninth Circuit panel has partially revived (Law360 subscription required) a lawsuit alleging that FDA and USDA nutrient content claim regulations violate First Amendment rights by preventing the inclusion of certain information about fermentable oligosaccharides, disaccharides, monosaccharides, and poloyols (FODMAPs) on food labels.
  • The lawsuit was initially filed against FDA, USDA, and USDA’s Food Safety Inspection Service (FSIS) in March 2023 after one plaintiff submitted a label to FSIS for approval. FSIS denied the approval, telling the company that it must “remove all references to digestible, gut loving, and fodmap.” According to the plaintiff, FDA had never raised concerns about the claims on labels of FDA-regulated foods.
  • According to the Ninth Circuit, FSIS told the company that it discussed the proposed label with FDA, and FDA agreed that the FODMAP claims were impermissible nutrient content claims. The company modified the label, then filed the lawsuit along with a consumer plaintiff. The plaintiffs claim that the challenged regulations violate their rights to speak and to receive information. The district court dismissed the case, concluding that the plaintiffs failed to show they had standing and exhausted their administrative remedies.
  • The panel reversed that decision in part, finding that the consumer plaintiff adequately showed standing as a “listener” under the First Amendment, based on needs for a low-FODMAP diet and because she alleged that food producers “would be reasonably likely to include FODMAP-related information on food labels in the absence of the challenged FDA and USDA regulations.” The panel also found that the company plaintiff sufficiently pleaded standing related to claims on FDA-regulated products based on the Agency’s threatened enforcement of its regulations. However, the panel found that the company plaintiff did not exhaust its administrative remedies and, therefore, upheld the lower court’s ruling on that issue.
  • While this ruling deals only with the standing issue in the case, it highlights that both consumers and companies may have standing to challenge food labeling regulations on a First Amendment basis. Here, the claims that food products are “low-FODMPAP foods” would currently be considered an impermissible nutrient content claim because “low” claims must be made in accordance with the definitions in 21 CFR 101 Subpart D, 9 CFR 317 Subpart B, and 9 CFR 381 Subpart Y.
  • Keller and Heckman will continue to monitor food labeling litigation.
  • On July 29, 2026, U.S. Senators Richard Blumenthal (D-CT) and Cory Booker (D-NJ) announced the introduction of the Senate companion to H.R. 8385, the Food Labeling Modernization Act of 2026, which was introduced in the House on April 20, 2026, by Representatives Frank Pallone Jr. (D-NJ) and Rosa DeLauro (D-CT). The legislation seeks to update federal food labeling requirements and expand nutrition disclosure obligations.
  • The bill would direct the Secretary of Health and Human Services to establish a single, standardized front-of-package nutrition labeling system for foods that are required to bear nutrition information. Supporters argue that a uniform labeling approach could make it easier for consumers to compare products and understand nutritional content at a glance.
  • The proposal also seeks to address marketing practices that may be perceived as confusing or misleading by consumers. Among other provisions, the legislation would require definitions for terms such as “ultraprocessed” and “not ultraprocessed,” which currently lack standardized federal definitions for food labeling purposes.
  • Additional reforms contemplated by the bill include updates to serving size requirements, clearer allergen labeling, and measures designed to improve the transparency and accessibility of nutrition information. The legislation would also require consumers to have access to comparable nutrition information when purchasing food online as they do when shopping in physical retail stores.
  • Keller and Heckman will continue to monitor legislative and regulatory developments related to food labeling requirements.
  • On July 30, 2026, the U.S. Food and Drug Administration (FDA) announced that in response to stakeholder requests for an extension, they will be reopening the comment period for Butylated Hydroxytoluene (BHT) for 30 days  The new deadline for submission of comments is August 31, 2026.
  • The original request for information was opened for comment May 13, 2026 and closed July 13, 2026.
  • The FDA is requesting information on the current uses and safety data for BHT in human food and as a food contact substance as part of their post-market assessment of chemicals in food.  FDA intends to use the information received and any other available, relevant information to determine if BHT remains safe under its current conditions of use in food and as a food contact substance.
  • Electronic comments may be submitted to www.regulations.gov docket number FDA-2026-N-2526.  Written comments should be submitted to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852 and identify the docket number FDA-2026-N-2526.
  • Today FDA announced fiscal year 2027 user fee rates for importers approved to participate in the Voluntary Qualified Importer Program (VQIP) and for accreditation and certification bodies interested in participating in the Accredited Third-Party Certification Program (TPP). The Federal Food, Drug, and Cosmetic Act authorizes FDA to assess and collect fees from participants in these programs to cover the costs of administration.
  • VQIP expedites the review and import of human and animal food products for participating importers (e.g., through reduced examination and sampling). Participating importers must, among other requirements, have in place a plan to control the safety and security of the food they import (VQIP Quality Assurance Program) and a history of compliance. The detailed requirements for participating in the program can be found on FDA’s VQIP page.
  • TPP is a voluntary program through which FDA recognizes “accreditation bodies” responsible for accrediting third party “certification bodies” which conduct food safety audits and issue certifications of foreign food facilities. Additional information can be found at FDA’s TPP page.
  • The VQIP and TPP user fees can be found in pre-publication versions of the respective federal register notices, both of which are scheduled for publication on July 30, 2026 (VQIP user fees and TPP user fees).
  • FDA Deputy Commissioner for Food Donald Prater recently explained that FDA is focusing on projects to use artificial intelligence (AI) and shift inspections to states, along with reviewing food additives and addressing concerns around ultra-processed foods.
  • FDA’s Human Foods Program began pivoting inspections to state authority in 2025, following a mass departure of employees, as we previously blogged. According to Prater, the Better Regulatory Inspections for Dynamic Government Efficiency (BRIDGE) Project is intended to “further enhance the integrated federal-state food safety system that relies more heavily” on states to conduct routine domestic inspections and sampling. FDA will continue to conduct foreign, non-routine, and high-risk inspections.
  • Prater also discussed FDA’s efforts to use AI to “ensure safety in the food supply,” stating that the Agency is partnering with universities and industry associations to feed data and research into AI models to better predict foodborne illnesses. Current partnerships include:
    • A joint study with Purdue University to study Salmonella and cantaloupes;
    • Working with Mexico to ensure produce import safety; and
    • A pilot project with the Western Growers Association on leafy greens.
  • Prater said that “AI and machine learning is really a game changer for food safety,” so FDA leadership is prioritizing focus on the technology. In addition, he noted that AI tools are being used to predict seafood shipments in violation of U.S. law, which “provides a opportunity to significantly improve the efficiency of our inspection capability.”
  • Keller and Heckman will continue to report on updates from FDA’s Human Foods Program.
  • On July 20, 2026, Congressman Josh Gottheimer (D-NJ) announced a series of bipartisan federal initiatives aimed at strengthening the nation’s response to foodborne illness outbreaks amid a record-setting surge in Cyclospora infections. According to Gottheimer, nearly 7,000 cases and more than 140 hospitalizations have been reported across at least 34 states, representing a significant increase compared to the same period last year. While the source of the current outbreak remains under investigation, the situation has renewed attention on federal food safety surveillance and outbreak response capabilities.
  • Central to the announcement is the bipartisan Foodborne Illness Rapid Response Act, introduced with Rep. Don Bacon (R-NE). The legislation would prohibit staffing reductions and hiring freezes within CDC divisions responsible for foodborne illness surveillance for one year following the declaration of an outbreak. The bill would also seek to restore mandatory federal surveillance for Cyclospora and other foodborne pathogens and improve access to outbreak information for state and local officials involved in food safety investigations.
  • In addition to the proposed legislation, Gottheimer is also supporting the bipartisan Federal and State Food Safety Information Sharing Act, which would grant FDA the authority to share more complete inspection and outbreak-related information with state and local regulators.
  • Recent foodborne illness outbreaks, increased scrutiny of government oversight functions, and broader initiatives aimed at improving public health outcomes have contributed to a growing policy discussion regarding the adequacy of existing food safety systems. As that discussion continues to evolve, we expect Congress to continue considering additional measures affecting food safety oversight.
  • Keller and Heckman will continue to monitor federal legislative and regulatory initiatives related to food safety, foodborne illness surveillance, and public health oversight.
  • 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.