• 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.
  • On December 10, 2025, USDA’s Food Safety and Inspection Service (FSIS) announced the availability of updated guidelines for label approval which reflect changes to clarify the conditions under which voluntary U.S. origin claims can be made.
  • By way of background, FSIS published a final rule in March 2024 defining the conditions under which FSIS-regulated products may bear voluntary U.S. origin claims (89 FR 19470) and concurrently updated its labeling guidelines. Under the final rule FSIS will generically approve “Product of USA” and “Made in the USA” claims for multi-ingredient FSIS-regulated products if: (1) all FSIS-regulated products in the multi-ingredient product are derived from animals born, raised, slaughtered, and processed in the United States; (2) all other ingredients, other than spices and flavorings, are of domestic origin; and (3) the preparation and processing steps for the multi-ingredient product have occurred in the United States.
  • The changes to guidelines include clarifying:
    • that the meaning of “raised” is “from birth to slaughter,”
    • that the term “harvested” may be use to mean “slaughtered,”
    • that the U.S. origin requirements do not apply to sub-ingredients,
    • the definitions of “spices” and “flavorings,”
    • that “Product of North America” is permitted if truthful and not misleading,
    • the conditions under which a multi-origin label claim including the U.S. may be made, and
    • that the term “produced” may not be used as a stand-alone label claim.
  • A group of food industry trade associations filed a complaint (Law360 subscription required) against the State of Texas on December 5, 2025, claiming that the recent “Make Texas Healthy Again Act” is unconstitutional because the government is forcing the industry to spread false information about the safety of products and that the law undermines the domestic regulation of food safety.
  • Texas Senate Bill 25 was signed into law in June 2025 to require companies to either remove or place a warning label on any product that contains any of the 44 listed substances, as we previously blogged. The warning label must read “WARNING: This product contains an ingredient that is not recommended for human consumption by the appropriate authority in Australia, Canada, the European Union, or the United Kingdom.” The requirement applies to food product labels developed or copyrighted after January 1, 2027, and the law includes a preemption provision that should limit its warning label requirements.
  • According to the food industry groups, Section 9 of the Act violates Texans’ First Amendment rights “by compelling businesses to speak government-scripted messages—and to repeat inaccurate and misleading messages at that.” The complaint alleges that the government does not have a legitimate interest in “forcing businesses to spread false messages to consumers that don’t advance safety and transparency.” Further, the plaintiffs say that the provision “fails every prong of the First Amendment compelled commercial speech test.”
  • The complaint goes on to say that the provision is preempted by federal law because FDA already regulates the same ingredients the provision targets. In addition, the complaint alleges that Section 9 is void for vagueness due to its preemption provision. Because businesses cannot be reasonably certain whether their products are subject to the warning label provision, they could “face severe penalties if they guess wrong,” according to the plaintiffs.
  • Finally, the complaint alleges that the provision violates the dormant Commerce Clause because businesses would be forced to change their products or labels throughout the nation to meet Texas’s unique rules, disrupting the national market and creating a confusing patchwork of state laws.
  • The complaint emphasizes that the groups agree that “safe, clearly labeled foods and beverages are of paramount importance” and that Section 9 undermines that goal by compelling inaccurate and misleading free speech.
  • Keller and Heckman will continue to monitor this lawsuit and other developments related to state and federal food labeling requirements.
  • On December 1, 2025, Representatives Don Beyer (D-VA), Mike Lawler (R-NY), and Scott Peters (D-CA) introduced the Childhood Diabetes Reduction Act, a bipartisan bill aimed at reducing childhood obesity and diet-related chronic diseases.
  • The legislation would require the following front-of-package health warning labels on:
    • Sugar-sweetened beverages: “Food and Drug Administration Warning: Drinking beverages with added sugar can contribute to obesity, type 2 diabetes, and tooth decay. Not recommended for children.”
    • Foods containing non-sugar sweeteners: “Food and Drug Administration Warning: Contains non-sugar sweeteners. Not recommended for children.”
    • Ultra-processed foods: “Food and Drug Administration Warning: Consuming ultra-processed foods and drinks can cause weight gain, which increases the risk of obesity and type 2 diabetes.”
    • Foods high in nutrients of concern (such as added sugar, saturated fat, or sodium): Label must state “High in [specific nutrient]” for each nutrient exceeding thresholds set by FDA.
  • The bill would also prohibit marketing or advertising of foods requiring these labels in ways that appear directed at children, including use of cartoon characters, fantasy themes, athletes, celebrities, influencers, or animation.
  • Additional provisions include convening an expert panel to define “ultra-processed foods,” expanding NIH research on their health effects, and directing the CDC to lead a national education campaign on nutrient warnings and associated risks.
  • Keller and Heckman will continue to monitor developments related to the Childhood Diabetes Reduction Act and other food labeling and marketing regulations.
  • On December 2, 2025, the city of San Francisco announced that it is suing ten leading food manufacturers of “ultra-processed foods,” alleging that the companies knowingly sold food products that have been linked to serious health conditions.  The city claims that the “unfair and deceptive” marketing of ultra-processed foods violates California’s Unfair Competition Law and public nuisance statute.
  • City Attorney David Chiu stated that the lawsuit is the first of its kind.  According to Chiu, “[the defendants] took food and made it unrecognizable and harmful to the human body… These companies engineered a public health crisis, they profited handsomely, and now they need to take responsibility for the harm they have caused.”  As we previously reported, California is also the first state to develop a clear definition of “ultra-processed foods” under AB 1264. 
  • The lawsuit claims that the defendant companies knowingly created a public health crisis and designed the foods to be addictive to drive sales.  It also alleges that they marketed the foods to deliberately target children, similar to the techniques utilized by “Big Tobacco.”
  • The city is seeking an order for the companies to refrain from deceptive marketing and to take corrective action, along with restitution and civil penalties.
  • 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.
  • FDA has withdrawn a proposed rule that would have required cosmetics manufacturers to test for asbestos in their talc products. According to the Agency, the proposed rule may have unintended consequences beyond cosmetics containing talc.
  • FDA introduced the proposed rule on December 27, 2024. It would have required “testing of talc-containing cosmetic products using standardized testing methods for detecting and identifying asbestos that may be present as a contaminant in talc.” The rule would have applied to all manufacturers of talc cosmetic products, including cosmetic products that are also drugs.
  • According to FDA’s withdrawal, the Agency intends to “reconsider best means of addressing the issues covered by the proposed rule and broader principles to reduce exposure to asbestos.” FDA said it had received comments that requested aligning the proposed definition of asbestos with the definition used by other federal agencies; other comments pointed out testing issues, such as potential for the proposed method to yield false positives. In addition, because talc is used in healthcare products, including some drugs, manufacturers may be forced to find replacements or take products off the market “for reasons having nothing to do with product safety,” according to some comments.
  • In addition to addressing the potential presence of asbestos in talc product through rulemaking, FDA also convened a scientific expert panel on talc in May 2025, as we previously blogged. Keller and Heckman will continue to monitor developments related to talc.
  • On November 18, 2025, The U.S. Department of Agriculture (USDA) issued an interim final rule (IFR) revising its grading standards for pasteurized orange juice to align with the Food and Drug Administration’s (FDA) proposed modernization of the standard of identity (SOI).
  • This action follows FDA’s August 2025 proposed rule to lower the minimum Brix requirement for pastuerized orange juice from 10.5 percent to 10 percent Brix, reflecting the naturally lower sugar content of Florida oranges due to citrus greening and severe weather conditions.  In a video created by FDA and USDA, FDA Commissioner Marty Makary, emphasized the broader policy goals behind this change: “For years, we’ve been wasting beautiful American oranges simply due to an outdated regulation, while relying on a high volume of imports.”
  • As we have previously blogged, FDA’s proposed rule (90 FR 37817) recognizes that Brix levels are “subject to the vagaries of nature” and outside manufacturers’ control.
  • Accordingly, USDA removed its own minimum Brix values for Grade B pasteurized orange juice and now defers to FDA’s standard of identity, which FDA has proposed to lower from 10.5 percent to 10 percent Brix. This means grading will follow FDA’s updated approach rather than USDA’s previous fixed values.
  • USDA concluded that the revisions are non-controversial, well-supported by industry, and unlikely to draw adverse comments. Therefore, the changes are effective immediately, and AMS will later issue a final notice to confirm the revisions.
  • Keller & Heckman will continue to monitor developments related to Brix requirements and other food standards modernization efforts.