• On January 7, 2026, the U.S. Departments of Health & Human Services and Agriculture released the 2025–2030 Dietary Guidelines for Americans, concluding a process that began roughly three years earlier with the first public meeting of the 2025 Dietary Guidelines Advisory Committee. In December 2024, HHS and USDA announced the availability of the Scientific Report of the 2025 Dietary Guidelines Advisory Committee in the Federal Register and solicited public comments.
  • The Administration eventually put aside the Scientific Report of the Advisory Committee and published a streamlined, 10-page “real food” guide accompanied by appendices. The report introduces an “inverted pyramid” that prioritizes protein, full-fat dairy, vegetables, fruits, and healthy fats, while whole grains sit at the bottom.
  • A document titled Scientific Foundation for the Dietary Guidelines for Americans was also made available.  It was developed by nutrition scientists and subject matter experts selected through a federal contracting process. 
  • Key Recommendations include:
    • Protein Intake: Recommendations increased from 0.8 g/kg to 1.2–1.6 g/kg of body weight daily, a 50–100% rise, emphasizing protein as central to every meal.
    • Saturated Fat: The limit remains below 10% of daily calories, but the guidelines highlight foods naturally rich in saturated fat, such as red meat and whole milk.
    • Processed Foods: The report features strong advice to avoid highly processed foods defined in the Scientific Foundation document (page 21) as “any food or beverage or engineered food-like item that is made primarily form substances extracted from food (eg refined sugars, grains, starches, or oils) and/or containing industrially manufacturered chemical additives.”
    • Sugars and Non-Nutritive Sweeteners: For the first time, the guidelines group added sugars and non-nutritive sweeteners under a single recommendation that “no amount of added sugars or non-nutritive sweeteners is recommended or considered part of a healthy or nutritious diet,” whereas the 2020-2025 guidelines raised questions about long-term effectiveness for weight management and did not recommend for children under two, but did not classify non-nutritive sweeteners as nutritionally undesirable.
    • Whole Grains: While still included, whole grains are positioned lower in the new “inverted pyramid,” signaling a shift toward prioritizing protein and healthy fats over carbohydrate sources.
    • Dairy: Emphasis on full-fat dairy as part of a balanced diet, a notable departure from prior guidance favoring low-fat or fat-free options.
  • How this overhaul will align with FDA’s “healthy” label rule and proposed front-of-package (FOP) labeling updates remains unclear. The abrupt shift could disrupt timelines and complicate alignment efforts.
  • Keller and Heckman will continue monitoring developments related to the Dietary Guidelines and other FDA health initiatives.
  • As of January 1, 2026, the U.S. Department of Agriculture’s (USDA) final rule, addressing voluntary US-origin label claims for meat, poultry, and egg products, is now in effect.
  • The March 2024 final rule and accompanying guidelines established stricter standards for making the claim that a product is “Made in the USA.”  Under the new rule, a product must be derived only from animals that were born, raised, slaughtered, and processed in the US to use the claim.  For multi-ingredient products, all FSIS-regulated components must meet this standard, and all other ingredients (excluding spices and flavorings) must also be of US origin.
  • As we previously reported, USDA’s Food Safety and Inspection Service (FSIS) published updated guidelines in December 2025 that provide additional clarification to the rule in response to public comments submitted to FSIS.
  • A civil forfeiture action filed by the government (Plaintiff) in 2023 to seize kratom products held by Botanic Tonics, LLC came to an end on January 5th when the Court issued a judgment ending the action in response to the Plaintiff’s notice of dismissal (without prejudice). The Plaintiff’s notice indicated that Botanic Tonics had represented that the products in question were expired, and that Plaintiff had therefore determined that “it would not be a prudent use of government resources to sustain the action.”
  • The original action had alleged that seizure was appropriate because the products contained a new dietary ingredient (Kratom) for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury (21 USC 342(f)(1)(B)). The government alleged that there were “serious safety concerns” regarding the effect of kratom. A motion to dismiss the action was denied in December of 2025.
  • The case is United States v. 250,000 filled bottles of liquid product (4:23-cv-00168) and was filed in the District Court for the Northern District of Oklahoma.
  • A West Virginia federal judge has granted a preliminary injunction to temporarily block enforcement of the state’s ban on seven synthetic color additives, along with BHA and propylparaben. The judge found that West Virginia’s law “fails to give adequate notice of what conduct is prohibited and lacks sufficient standards to prevent arbitrary enforcement.”
  • In October 2025, the International Association of Color Manufacturers (IACM) filed a lawsuit challenging West Virginia’s HB 2354, as we previously blogged. The lawsuit alleged that the ban on the color additives has no scientific basis, ignores safety determinations FDA made when granting the respective color additive petitions, and offers no new evidence that brings the safety of the additives into question.
  • IACM brought the lawsuit on three grounds, alleging that the law:
    • Violates the Equal Protection Clause because it singles out manufacturers and users of the named additives without offering a basis for why the additives must be banned;
    • Is a prohibited bill of attainder because, by naming enumerated color additives, it singles out the manufacturers and users of those color additives; and
    • Is unconstitutionally vague because it leaves the door open for arbitrary enforcement because it does not define “poisonous and injurious” and does not prevent other additives from being deemed as such.
  • The judge disagreed that the law violates the Equal Protection Clause or is a bill of attainder but granted the preliminary injunction on the grounds that the law is unconstitutionally vague in violation of the Due Process Clause of the Fourteenth Amendment. According to the judge, the law does not define the term “poisonous or injurious,” and the word “including” following that term renders the list of color additives nonexclusive. The law does not include criteria to guide the determination of which color additives are considered “poisonous or injurious,” meaning that “other color additives could be included without any notice for why or how they are being deemed ‘poisonous or injurious.’” Thus, the law fails to give adequate notice of prohibited conduct and invites arbitrary enforcement.
  • Keller and Heckman will continue to monitor this lawsuit and other developments regarding color additives’ regulatory status.
  • On December 22, 2025, the U.S. Food and Drug Administration (FDA) published its annual Pesticide Residue Monitoring Program Report for Fiscal Year 2023, providing a comprehensive overview of pesticide residue levels in human and animal foods.
  • The report covers testing conducted between October 1, 2022, and September 30, 2023, analyzing samples for 781 different pesticides and selected industrial compounds. FDA also introduced the Pesticide Report Data Dashboard, an interactive tool that allows users to explore tables, figures, and underlying data from the report.
  • Companies that grow, produce, or manufacture food products for sale in the United States must comply with pesticide tolerances (maximum residue levels) set by the Environmental Protection Agency (EPA). FDA monitors compliance by testing FDA-regulated foods in interstate commerce. When residues exceed EPA tolerances or appear on foods without an established tolerance, FDA may take regulatory action to protect public health.
  • Key Findings for FY 2023 include:
    • No pesticide residues were detected in 39% of domestic samples and 39.2% of imported samples.
    • 97.2% of domestic samples and 86.5% of imported samples complied with federal regulations.
  • Animal Food Samples:
    • 97% of domestic samples and 97.6% of imported samples were compliant.
    • No residues were detected in 50.5% of domestic samples and 56.1% of imported samples.
  • Overall, the results confirm that US produced foods continue to have a very high compliance rate and imported foods continue to present a higher violation rate than domestic foods. This annual survey is a useful tool and datapoint for industry and may be used in supply chain and Food Safety Plan assessment. Keller and Heckman will continue to monitor developments related to pesticide residue regulations.
  • Today FDA announced that it has rescheduled an expert panel on food allergies for February 25, 2026. The panel had been previously canceled due to the government shutdown.
  • This announcement comes in the wake of the Agency rescheduling a public meeting on allergen thresholds for February 18-20. When the expert panel was initially scheduled, it was reported that the panel was intended to facilitate discussions on the etiology and best treatment for food allergies as well as current health guidelines.
  • FDA Commissioner Marty Makary and Deputy Commissioner for Human Foods Kyle Diamantas will be among the panelists. Additional panelists will be announced closer to the date. The event will be livestreamed over FDA’s YouTube Channel and registration is only required if attendance is in-person.
  • A federal judge has approved (Law360 subscription required) a $10 million settlement over claims that Nabisco falsely advertised Wheat Thins crackers as containing “100% Whole Grains.”
  • The class action against Nabisco was filed in October 2022, alleging that the crackers are deceptively labeled when they actually contain corn starch, which the plaintiffs characterized as a refined grain ingredient, as we previously blogged. According to the plaintiffs, the inclusion of corn starch in the product is misleading because it is derived from the endosperm of corn only and therefore does not meet the definition of a whole grain, which must include the germ, bran, and endosperm.
  • Nabisco and its parent company Mondelez filed a motion for summary judgment in December 2024 that claimed the plaintiffs “had not proven with evidence in the record that a reasonable consumer would be misled by the ‘100% Whole Grain’ representation.” In the Settlement Agreement, Nabisco and Mondelez maintain that the labels were not false or misleading.
  • In addition to the monetary settlement, Nabisco and Mondelez agreed not to use the unqualified statement “100% Whole Grain” on the eight identified Wheat Thins products.
  • Keller and Heckman will continue to monitor and report on litigation related to food labeling and claims.
  • On December 10, 2025, FDA reopened registration for the virtual public meetings on food allergen thresholds. The new dates for the virtual meetings are February 18-20, 2026.
  • The meetings were originally scheduled for November 18-20, 2025, but were postponed due to the government shut-down.
  • The virtual meetings will include presentations and panel discussions on scientific developments related to food allergens and their effects on FDA’s thresholds.  Following the presentations and discussions will be two days of listening sessions that provide an opportunity for participants to provide feedback on several topics related to risk-based food allergen thresholds, labeling, and challenges related to their application.
  • Any questions should be submitted at the time of registration which is currently open and will remain open until the start of the meeting. However, in order to attend the listening sessions, participants must register by February 3, 2026.
  • Beginning February 18, 2026, a docket will open for comments related to the event topics.
  • Keller and Heckman will continue to monitor any developments related to food allergen thresholds.
  • Food companies are likely to be significantly impacted by the European Union’s Packaging and Packaging Waste Regulation (PPWR). The regulation is scheduled to apply from August 12, 2026 (although more time will be given for certain provisions). Notably, where the food packaging or packaged food product is designed or manufactured under the name or trademark of the food company, the food company will typically be considered the “manufacturer” of the packaging/the packaged food product for the purposes of the PPWR. 
  • The PPWR states that manufacturers shall only place packaging on the EU market if it is in conformity with the requirements laid down pursuant to Articles 5 to 12 of the PPWR. This includes requirements with respect to substances of concern in packaging, recyclable packaging, minimum recycled content in plastic packaging, requirements that certain packaging be compostable, that packaging be minimized, that packaging meet certain requirements to be considered reusable, as well as labeling requirements. Exemptions exist from some of these requirements.
  • By August 12, 2026, “manufacturers” are also required to draw up an EU Declaration of Conformity (DoC) and must keep technical documentation on file supporting the DoC, having first carried out a “conformity assessment procedure.” The manufacturer must keep the DoC and technical documentation for 5 years in the case of single-use packaging and 10 years in the case of repeated use packaging from the date that the packaging was placed on the EU market.
  • If the food company is the manufacturer of the packaging for the purposes of the PPWR, the actual manufacturer of the packaging will be considered the “supplier” of the packaging or packaging materials. The supplier must provide the food company with all the information and documentation necessary to demonstrate conformity of the packaging and packaging materials with the PPWR.
  • The food company may also have extended producer responsibility (EPR) obligations under the PPWR, but this would need to be assessed on a case-by-case basis. Specifically, the “Producer” (which may be either the manufacturer, importer, or distributor) will have EPR obligations under the PPWR for packaging, including packaging of packaged products, that they make available for the first time on the territory of an EU Member State or that they unpack without being end users.
  • The PPWR also sets other requirements, such as reuse targets for different types of packaging, including transport packaging (which must be met by the economic operators using the packaging), deposit and return schemes, and even requirements regarding green claims for packaging.
  • Please contact the experts at Keller and Heckman if you have any questions regarding the EU’s PPWR Regulation. Our colleagues in the Brussels office would be happy to assist.  
  • On December 11, 2025, the U.S. Food and Drug Administration (FDA) issued a letter to the dietary supplement industry which clarifies the placement of the Dietary Supplement Health and Education Act (DSHEA) disclaimer on dietary supplement product labels.  The letter comes in response to several regulatory requests from industry members.
  • Section 403(r)(6)(C) of DSHEA allows certain statements for a dietary supplement to be made, so long as the statement is accompanied with the following disclaimer: “This statement has not been evaluated by the Food and Drug Administration.  This product is not intended to diagnose, treat, cure, or prevent any disease.”  This is referred to as the DSHEA disclaimer.  Pursuant to 21 CFR § 101.93(d), the DSHEA disclaimer “shall appear on each panel” of a product label where there is a Section 403(r)(6)(C) statement (e.g., a structure or function claim).
  • In the letter, FDA states that it intends to revise 21 CFR § 101.93(d) to remove the requirement for the DSHEA disclaimer to appear on every packaging panel in order to reduce label clutter and unnecessary costs.  The agency also acknowledged that it has rarely, if ever, enforced this requirement, and that it would exercise enforcement discretion during the rulemaking process.
  • Industry members, such as the Council for Responsible Nutrition (CRN), applauded FDA’s decision, stating in its earlier request to FDA that the revision “would maintain adequate levels of consumer protection while reducing unnecessary, redundant regulatory burdens on companies.”
  • Keller and Heckman will continue to relay any developments in the rulemaking process.