• On August 31, 2026, the U.S. Food and Drug Administration (FDA) and the U.S. Securities and Exchange Commission (SEC) entered into a Memorandum of Understanding (MOU) to establish a formal framework for sharing nonpublic information between themselves related to FDA-regulated products and activities. 
  • According to the press release, the MOU is designed to assist the agencies in “carrying out their respective missions of ensuring the integrity of the financial markets and protecting public health.”  For example, the MOU will help them detect situations where a company may have made false or misleading statements to investors related to “the status of FDA review, product approvals, clinical trial results, or other matters within the FDA’s regulatory authority that could affect investors’ decisions” (see MOU, Background).  Although FDA and SEC have historically coordinated in exchanging information, the MOU formalizes infrastructure that will make this exchange faster and easier.
  • The following are some key provisions from the MOU:
    • Information Sharing:  The agencies agree to share “appropriate information” related to FDA-regulated products and activities, and persons and firms who manufacture, distribute, and sell FDA-regulated products, with the other party, where practicable.
    • Dedicated Points of Contact:  Each agency will designate a principal point of contact to facilitate the information requests.
    • Confidentiality Controls:  Nonpublic information shared under the MOU may not be further disclosed without the providing agency’s written permission. The MOU includes detailed protocols for responding to FOIA requests, subpoenas, congressional inquiries, and other compulsory process.  These would require prompt notification to the providing agency and cooperation in asserting the applicable privileges.
  • The MOU will be effective for three years until August 31, 2029, but may be extended, modified, or terminated by the agencies at any time with 30 days’ notice.
  • Keller and Heckman will continue to relay any developments related to FDA regulation and enforcement.
  • In June the U.S. District Court for the District of Columbia vacated five state Supplemental Nutrition Assistance Program (SNAP) waivers granted by USDA. The waivers permitted states to exclude certain foods deemed to be unhealthy from the scope of their SNAP programs, which the district court held exceeded USDA’s legal authority.
  • On August 21, 2026, USDA filed an appeal of the decision with the U.S. Court of Appeals for the District of Columbia. The parties have not yet briefed the issues. 
  • The June district court decision only vacated the waivers granted to Colorado, Iowa, Nebraska, Tennessee, and West Virginia, but the decision cast doubt on the legality of similar waivers granted to other states.
  • The target implementation dates for the South Carolina and North Dakota SNAP waivers were August 31, 2026, and September 1, 2026, respectively. However, it has been reported that USDA has asked these states to delay implementation of the waivers until November 1, 2026, during which time USDA plans to publish federal register notices regarding the waivers and consider public comment.
  • Many SNAP waivers are already in effect. Indeed, the Arkansas SNAP waiver went into effect on July 1, 2026, only 9 days after the court ruling. State officials maintained that the court ruling does not apply to the Arkansas waiver.
  • The California Legislature has passed Assembly Bill 2244 (AB 2244) to establish a “non-ultra-processed food” certification seal. California Governor Gavin Newson will now have until the end of September to either sign or veto the bill.
  • The bill was introduced in March 2026, as we previously blogged, and would permit food products in the state to bear a “California Certified” seal that is modeled after the “USDA Organic” seal. The seal is “intended to provide consumers with a way to quickly identify ‘healthier’ food options.”
  • If signed into law, the bill would require the California Department of Public Health to accredit certification agents no later than June 1, 2029, and to create the standardized “Non-Ultraprocessed Certified” seal. It would also require grocery stores to make at least three certified food products clearly identifiable such that they are readily distinguished from other products through physical separation, signage, or other visual cues.
  • The bill would also create a Public Health Food and Nutrition Education Fund, which would use registration fees from certification agents to support implementation and education about the label requirements, food products, and nutrition.
  • Keller and Heckman will continue to monitor this and other food related legislation.
  • On August 17, 2026, an individual consumer submitted a citizen petition to the U.S. Food and Drug Administration (FDA) requesting that the agency designate pea protein, including pea protein isolate, pea protein concentrate, and pea flour, as a major food allergen requiring mandatory disclosure in allergen labeling.
  • The petition asks FDA to exercise its authority under section 403(w)(7) of the Federal Food, Drug, and Cosmetic Act to require manufacturers to identify pea protein through clear “Contains” allergen statements on packaged foods. Currently, pea protein is not among the allergens subject to the mandatory labeling requirements established under the Food Allergen Labeling and Consumer Protection Act (FALCPA) and the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act. Those laws currently require labeling for milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame.
  • According to the petition, the increasing use of pea protein in plant-based food products has created challenges for some consumers with pea allergies and other legume sensitivities. The petitioner cites recent product reformulations in which pea protein was introduced into products that had previously relied on soy protein or contained no concentrated pea ingredients. The petition describes examples involving plant-based butter substitutes and vegan mayonnaise products and argues that consumers may not anticipate the presence of pea protein in foods that were previously considered safe.
  • The petitioner further contends that pea protein has become more common in a wide range of foods, including plant-based dairy alternatives, baked goods, and other packaged products. The petition points to reports of IgE-mediated allergic reactions associated with peas and argues that mandatory allergen labeling would help consumers more readily identify products containing pea-derived ingredients.
  • FDA acknowledged receipt of the petition in a letter dated August 26, 2026. As is customary, the agency stated that acceptance of the petition for filing is a procedural matter and does not reflect any determination regarding the substantive merits of the request. The petition has been assigned Docket No. FDA-2026-P-9901, and interested stakeholders may submit comments to the docket through Regulations.gov.
  • Keller and Heckman will continue to monitor developments related to FDA food allergen labeling requirements and any agency response to the petition.
  • On August 24, 2026, two more companies were sued over claims of “0g sugar” where the products contain “allulose.”
  • Earlier last month, the Seventh United States Circuit Court of Appeals in Illinois revived a proposed class action finding that allulose, a naturally occurring sweetener in yogurt, constitutes a sugar under federal regulations.  The inclusion of allulose in the calculation of sugars would disqualify the product from being labeled as “sugar free” because the sugar content would exceed the “less than a half gram of sugar” requirement for such a label.
  • FDA advises in its guidance The Declaration of Allulose and Calories from Allulose on nutrition and Supplement Facts Labels, it intend to exercise enforcement discretion for the exclusion of allulose from the amount of “Total Sugars” and “Added Sugars” declared on the label. For more information on FDA’s Final Guidance on Allulose, please see FDA Issues Final Guidance on Allulose and Solicits Information for Rulemaking on Nutrition Labeling for Sugars That are Metabolized Differently Than Traditional Sugars | The Daily Intake.
  • These similar arguments are now being brought in the Northern District of California and Central District of California over “0g Sugar’ claims on energy drinks and “Zero Added Sugar” claims on cereals.
  • All three cases are still in court.  Keller & Heckman will continue to monitor lawsuits that target sugar claims on products that contain allulose.
    • News outlets including the Washington Post have reported that President Trump’s nomination of Dr. Heidi Overton has been criticized by some elements of the Make America Healthy Again (MAHA) movement who regard her as an establishment figure who has stymied some of their initiatives.
    • Chief among the complaints has been her alleged involvement in drafting a February 2026 executive order which declared the production of elemental phosphorus and glyphosate-based herbicides as critical to the national defense. Glyphosate is an effective herbicide and the active ingredient in Roundup. The executive order found that there were no direct alternatives and that its use is critical to national agricultural productivity.
    • The safety and use of glyphosate has been subject to much litigation, including a June 2026 Supreme Court decision which held that state-law failure to warn claims were preempted by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The U.S. Environmental Protection (EPA) has not identified risks of concern from glyphosate uses, including with respect to cancer, a conclusion that has been echoed by other international agencies including the European Food Safety Authority (EFSA).
    • Kush Desai, Special Assistant to the President & Senior Deputy Press Secretary, denied that Dr. Overton was primarily responsible for drafting the executive order and instead stated that she “pushed as many MAHA-minded edits as possible to a mostly-baked EO that, again, was written with national security considerations in mind.” He also stated that “Pretty much every MAHA win by this Administration absolutely would not have been possible without Heidi often singlehandedly running interagency policy processes.”
    • Keller and Heckman will continue to monitor and report on the confirmation process for FDA commissioner.
    • On August 19, 2026, the Physicians Committee for Responsible Medicine (PCRM) filed a lawsuit against the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA) in the U.S. District Court for the District of Columbia, seeking to have the recently issued Dietary Guidelines for Americans 2025-2030 withdrawn.
    • PCRM alleges that HHS and USDA improperly departed from the traditional Dietary Guidelines development process by relying on a group of outside reviewers that was assembled without the transparency and public oversight required under the Federal Advisory Committee Act (FACA). According to the complaint, this group, which PCRM refers to as a “Secret Panel,” included individuals with ties to the meat, dairy, and diet industries and played a significant role in developing The Scientific Foundation for the Dietary Guidelines for Americans, 2025-2030, a report that allegedly diverged from the findings of the Dietary Guidelines Advisory Committee’s scientific review.
    • The lawsuit claims that the agencies violated FACA and the Administrative Procedure Act by relying on recommendations developed outside the public advisory committee process. PCRM is asking the court to order HHS and USDA to withdraw the current Dietary Guidelines, issue new guidelines through a FACA-compliant process, and disclose documents relied upon by the reviewers.
    • This lawsuit continues PCRM’s longstanding scrutiny of the Dietary Guidelines process. The organization has challenged several prior editions of the Guidelines and earlier this year petitioned the Offices of Inspector General at HHS and USDA to withdraw the 2025-2030 Guidelines, citing alleged industry influence.
    • Keller and Heckman will continue to monitor developments related to the Dietary Guidelines and other challenges to Agency actions.
    • 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.