• The U.S. Food and Drug Administration (FDA) is considering three new color additive petitions seeking expanded or new uses for non-certified color additives.  Specifically, the petitions seek the following:
    • Approval for safflower extract in foods at levels consistent with good manufacturing practices (GMP);
    • Expanded uses for gardenia blue in foods at levels consistent with GMP; and
    • Revision to the color additive regulations to allow acetone as a solvent in the production of carrot oil.  (Carrot oil is already exempt from certification as a color additive and may be used in foods at levels consistent with GMP).
  • The petitions follow FDA’s announcement last year that it intended to collaborate with industry stakeholders to phase out the use of certified color additives, which FDA refers to in the announcement as “petroleum-based synthetic food dyes”.  The 2026 Deliverables for the Human Foods Program also emphasized FDA’s prioritization of shifting from “petroleum-based food dyes to natural alternatives.”  Many food manufacturers have already voluntarily removed certain certified colors from their formulas.
  • As we have previously reported, states have also independently proposed or passed legislation to prohibit certain color additives and food additives from food, though many of the bills are being challenged in court.
  • Keller and Heckman will continue to monitor developments related to the authorization or revocation of color additives.
  • It has widely been reported this morning that President Trump is expected to nominate Dr. Heidi Overton for FDA Commissioner.
  • Dr. Overton is a physician who currently serves as the deputy assistant to the president for domestic policy. A profile of her in The Atlantic last month described her as “one of the most powerful public health officials in Trump’s orbit” and reported that she has coordinated almost all of the White House’s major health policies in President Trump’s second term. 
  • If nominated by President Trump and confirmed by the Senate, Dr. Overton would succeed Dr. Marty Makary who resigned in May. Kyle Diamantas is currently Acting FDA Commissioner and will continue in that role until an FDA Commissioner is confirmed.
  • Keller and Heckman will continue to monitor and report on the FDA commissioner nomination.
  • The Safe Food Coalition—a group of non-governmental organizations—sent a letter to Congress asking it to rescind an appropriations rider preventing FDA from implementing the final food traceability rule, which the Agency issued in 2022.
  • The final rule, “Requirements for Additional Traceability Records for Certain Foods,” establishes additional traceability recordkeeping requirements for entities that manufacture, process, pack, or hold certain types of foods. FDA proposed to extend the compliance date to January 2028 last year, as we blogged, and the appropriations rider prevents the Agency from implementing the rule until July 2028.
  • The letter references the current Cyclosporiasis outbreak, stating that consumers are currently avoiding fresh produce altogether due to “a crisis in consumer confidence.” However, according to the Coalition, compliance with FDA’s traceability rule “would prevent illness and support healthier diets.”
  • The letter also notes that the delay in implementing the rule undermines food industry investments in anticipation of the rule, as well as erodes confidence in the rule and FDA’s ability to improve on the current “one step forward and one step back” traceability programs.
  • The Coalition urges Congress to “send a message to reassure consumers and food companies alike that the federal government is committed to safer food.”
  • Keller and Heckman will continue to monitor updates related to FDA’s food traceability rule.
  • Food manufacturers have been given until January 1, 2028, to comply with changes to the National Bioengineered Food Disclosure Standard after a federal district court ordered the prospective vacatur of three key USDA regulations governing bioengineered food disclosures. The court rejected the USDA’s request to extend certain provisions until 2029, finding that further delay would perpetuate inadequate consumer access to bioengineering disclosures.
  • The National Bioengineered Food Disclosure Standard (NBFDS) is the federal labeling program established by Congress in 2016 that requires certain foods containing bioengineered ingredients to disclose that fact to consumers. Under USDA regulations implementing the law, manufacturers have been permitted to use on-package text, a USDA symbol, or electronic and digital disclosures such as QR codes. The regulations also exempted certain highly refined foods from disclosure when modified genetic material was not detectable in the finished product. Those digital disclosure and “detectability” provisions became the subject of the Natural Grocers v. Rollins litigation, which resulted in courts invalidating both aspects of the rule.
  • As a result of the litigation, the digital disclosure framework and detectability exemption are scheduled to be vacated effective January 1, 2028, unless the USDA adopts replacement regulations before that date. If replacement rules are not finalized in time, manufacturers relying on QR codes and other digital disclosures may need to transition to on-package text or USDA-approved symbols, while some products previously exempt from disclosure could become subject to labeling requirements.
  • The agency is expected to pursue a new approach to highly refined foods and is conducting additional research on the accessibility of digital disclosures. However, the timeline is compressed, and the agency will need to complete notice-and-comment rulemaking before the court’s deadline takes effect.
  • Keller and Heckman will continue monitoring USDA rulemaking, implementation timelines, and related litigation developments that may affect bioengineered food disclosure obligations.
  • On August 11, 2026, the Food and Drug Administration (FDA) released “Guidance for Industry: Guide to Minimize Biological Hazards in Ready-to-Eat Fresh-Cut Produce.”
  • The final guidance document is intended to help manufacturers and processors of ready-to-eat (RTE) fresh-cut produce comply with the FSMA Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls (PCHF) rule.
  • The guidance highlights the association of RTE fresh-cut produce with numerous foodborne illness outbreaks.
  • The 80-page document identifies requirements that are most relevant to fresh-cut processing establishments and aims to provide specific recommendations for each identified requirement.
  • The final guidance reflects public comments received on the October 2018 draft guidance and replaces the 2008 FDA fresh-cut produce guidance. 
  • In light of recent produce recalls, during an interview the day the guidance was finalized, FDA Commissioner Kyle Diamantas stated, “Americans should feel confident in eating fresh produce, including leafy greens at this point.  The FDA remains confident that all iceberg lettuce related to the cyclospora outbreak has been effectively removed from the market as of the July 17th recall.”
  • A bill (H.R.9988) was introduced into the House on July 30th which would amend the definition of “major food allergen” in Federal Food, Drug, and Cosmetic Act (21 U.S.C 321(qq)) by replacing “wheat” with “gluten-containing grain.” The term “gluten-containing grain” is defined in the bill to include wheat, rye, barley, oats and crossbreeds of such grain (e.g. triticale). Major food allergens are subject to allergen labeling requirements.
  • The bill would also require the Department of Health and Human Services to prepare a report addressing various issues related to celiac disease, including the collection of data related to its prevalence and severity, the development of effective diagnostics and treatments, and methods for preventing its onset and reducing risks related to the disease.
  • Symptoms of celiac disease are triggered by ingestion of gluten proteins. Celiac disease affects an estimated 1% of the U.S. population, and, if not diagnosed and treated, can have devastating effects, including damage to the lining of the intestine and poor absorption of nutrients. Gluten avoidance is critical for those with celiac disease.
  • While celiac disease is similar to an allergic reaction in certain respects, it is an autoimmune disorder and not an allergic response. For example, celiac disease is not mediated by immune specific antibodies like IgE, and celiac symptoms typically develop 48-72 hours after ingestion of gluten. Gluten can also cause non-celiac gluten sensitivities, but these reactions also are not allergic reactions.
  • Currently, there is not a requirement that gluten be affirmatively disclosed in food labeling for the benefit of individuals with celiac disease. There is allergen labeling applicable to wheat-derived ingredients, and FDA has established criteria for voluntary gluten-free claims, 21 CFR 101.91. 
  • We will continue to monitor developments in this area. 
  • On August 5, 2026, FDA posted a Citizen Petition from The Food Foundations Project requesting that the Agency initiate rulemaking to require caffeine disclosures on caffeine-containing dietary supplements. The Petition defines “caffeine-containing dietary supplement” as “a product labeled as a dietary supplement in which caffeine is present in the finished product, whether added directly or contributed by caffeine anhydrous, a botanical, a botanical extract, a proprietary blend, or another ingredient.”
  • The Petition proposes a new section in FDA’s dietary supplement labeling regulations at 21 CFR 101.36 to require:
    • Disclosure of the total caffeine per serving, reflecting the aggregate caffeine in the finished product from every source, including directly added caffeine, caffeine anhydrous, botanicals, botanical extracts, proprietary blends, and other caffeine-contributing ingredients;
    • Disclosure of the total caffeine per container for a single-use container when the unrounded caffeine amount meets or exceeds the final reportable threshold. This requirement is intended to cover single serving units, packages with directions that contemplate consuming the entire contents at one time, small-format shots, and comparable one-dose products, rather than every large multi-use bottle or tub; and
    • Supporting records to substantiate the caffeine declaration.
  • The Petition includes a fallback request for FDA to adopt a narrower rule requiring declaration of caffeine from non-proprietary sources if the Agency determines it does not have the authority to require an aggregate declaration including proprietary sources. In addition, the Petition requests that FDA publish a request for information concerning caffeine amounts and sources and conduct or commission research related to caffeine testing, formulation, consumer understanding, reportable thresholds, and labeling.
  • Finally, the Petition asks FDA to issue guidance recommending caffeine disclosures if the Agency does not initiate rulemaking. According to the Petition, the guidance should include an explanation of approaches for calculations and sampling and announce an enforcement policy “concerning materially misleading voluntary caffeine representations.”
  • The Petition explains that supplement labels currently do not always state the total caffeine dose or explain caffeine sources, which may increase the risk profile of caffeine-containing dietary supplements. The proposed caffeine disclosure is intended to provide consumers with information to help judge the amount of caffeine they consume in a day.
  • Keller and Heckman will continue to monitor updates related to food and dietary supplement labeling.
  • On August 10, 2026, HHS Secretary Robert F. Kennedy Jr., announced that FDA’s long-anticipated proposed GRAS rule has been released. The proposed rule seeks to fundamentally reform FDA’s oversight of food ingredients by converting the current voluntary GRAS notification program into a mandatory system.
  • Key Takeaways from the Proposed Rule:
    • Mandatory GRAS notifications: FDA would replace the existing voluntary notification framework with a mandatory notification requirement for most substances introduced into commerce under the GRAS exemption.
    • New transparency measures: FDA would continue publicly posting filed GRAS notices and agency response letters and would also establish a public inventory for certain existing substances submitted through a new transitional process.
    • Expanded FDA oversight: FDA would expressly reserve the ability to revisit prior GRAS conclusions, ask follow-up questions concerning previously submitted notices, and update or rescind prior “no questions” letters.
  • The proposal includes several exceptions to the mandatory notification requirement, including for certain substances that have already been reviewed by FDA, are already recognized as GRAS under existing regulations, or qualify for a Threshold of Regulation (TOR) exemption, among others.
  • Rather than immediately requiring full GRAS notices for all existing substances, FDA proposes allowing companies to submit a streamlined filing containing basic information regarding the substance, intended uses, use levels, and evidence of commercial marketing. FDA would maintain these submissions on a public list and could later require a full GRAS notice or food additive petition if warranted.
  • The proposal also contains several provisions affecting food-contact substances and packaging materials. FDA would expand the TOR process beyond traditional food-contact articles and would continue to allow manufacturers of food-contact substances to utilize the FCN pathway as an alternative to GRAS notification in certain circumstances.
  • If finalized, FDA proposes that the rule become effective 60 days after publication of the final rule, with a compliance date 18 months later.
  • FDA is accepting comments on the proposal for 120 days following publication in the Federal Register. With publication currently scheduled for August 11, 2026, comments are expected to be due in early December 2026. Comments may be submitted electronically through Regulations.gov under Docket No. FDA-2025-N-3262.
  • Keller & Heckman is continuing to review the proposal, including FDA’s legal authority to require mandatory GRAS notifications under the existing statutory framework. Notably, Secretary Kennedy stated during the August 10 announcement that Congress may need to provide FDA with additional tools and authorities. 
  • On July 31, 2026, the White House Office of Information and Regulatory Affairs (OIRA) completed its review of FDA’s proposed rule addressing GRAS substances.  
  • The OIRA review included the following noteworthy topics:
    • “Consistent with Change” designation: OIRA cleared the proposal as “Consistent with Change,” indicating that revisions were made during interagency review or will be incorporated by FDA before publication, though the substance of those changes is not yet publicly available.
    • Major Rule designation: OIRA classified the proposal as a “major rule” under the Congressional Review Act.  This designation is generally reserved for rules expected to have significant economic impacts, such as annual economic effects exceeding $100 million or other substantial impacts on industry, competition, costs, or investment.
    • Unfunded Mandates Reform Act (UMRA): OIRA changed the proposal’s UMRA status from “Undetermined” to “Private Sector.”  This suggests FDA anticipates the rule could impose significant compliance costs on private-sector stakeholders and will likely need to include additional economic analyses when the proposal is published.
  • There is currently no firm timeline for when FDA will publish the proposed rule.  However, the completed OIRA review marks a major step before a Notice of Proposed Rulemaking (NPRM) is transmitted for publication in the Federal Register.  Also, its earlier than expected completion has prompted speculation that FDA could release the proposal sooner than the December 2026 publication date originally projected in the Administration’s July 2026 Unified Agenda.
  • The Department of Health and Human Services (HHS) has scheduled an event for August 10, 2026, featuring Secretary Kennedy, Acting FDA Commissioner Kyle Diamantas, and other senior officials, to announce two new food policy initiatives.  Although no details have been released, the event comes shortly after completion of the OIRA review of the GRAS proposal and during OIRA review of a white-paper proposed federal definition of ultra-processed foods, making both topics potential candidates for discussion.
  • Keller and Heckman will continue monitoring developments on these matters.
  • 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.