• 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.
  • Spencer Sheehan is a lawyer well known for having brought many class-action lawsuits against food companies. The majority of his lawsuits have been dismissed and he has been sanctioned by courts for his conduct, including a pattern of duplicating lawsuits deemed frivolous.
  • As we reported last year, a Florida District Court ordered him to pay attorney fees in one such duplicate case, which featured allegations of other questionable conduct, including the alleged fabrication of a lab result, and an argument that he was not an attorney of record in the Florida case (and therefore not responsible) because he had not complied with a court order to file a motion for pro hac vice admission.
  • In an August 2025 decision, the 11th Circuit reviewed the District Court’s decision to award $144,047 in attorney fees, finding that the hours and hourly rates used to compute the awarded fees were reasonable.
  • A group of plaintiffs has filed a lawsuit against the state of Florida following the state’s ban on 7-hydroxymitragynine (7-OH). In July 2025, the state issued an emergency rule, which took immediate effect, classifying isolated and/or concentrated 7-OH from kratom as a Schedule I controlled substance in Florida. The rule made it illegal to sell, possess, or distribute any isolated or concentrated form of 7-OH in Florida.
  • The complaint argues that “the emergency order was issued without public notice or hearings” and that the state’s actions were “unlawful, unnecessary and carried out without due process.” According to the complaint, 7-OH presents no public safety threat and has been legally sold in Florida for years under the Kratom Consumer Protection Act. Further, the rule was issued without due process and is arbitrary and inconsistent because it bans 7-OH but allows the mitragynine alkaloid, which the human body naturally converts into 7-OH. Finally, the ban has harmed consumers and small businesses.
  • FDA has requested that the Drug Enforcement Administration issue a federal scheduling action to control 7-OH products nationwide under the Controlled Substances Act. Further, in July 2025, FDA sent several Warning Letters for illegally marketing products containing 7-OH, which FDA views as a novel potent opioid that has “not been proven safe or effective for any use,” as we previously blogged. FDA Commissioner Marty Makary has said that 7-OH products are “dangerous opioids” found in every community in America.
  • Keller and Heckman will continue to monitor activity related to the sale of 7-OH and kratom products.
  • On November 12, 2025, the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act was signed, as part of the reopening the federal government.  In addition to a $26 billion spending package, language was included in the bill that would severely limit hemp products, essentially undoing the hemp industry framework established under the 2018 Farm Bill.
  • The Act revises the “hemp” definition to limit the material to “a total tetrahydrocannabinols [THC] concentration (including tetrahydrocannabinolic acid) of not more than 0.3 percent on a dry weight basis” (no longer focusing on just the delta-9 THC level). 
  • The Act also prohibits final hemp-derived cannabinoid products from containing the following: (1) cannabinoids that are not capable of being naturally produced by a cannabis plant; (2) cannabinoids that are capable of being naturally produced by a cannabis plant and are synthesized or manufactured outside the plant; and (3) more than 0.4 milligrams combined total per container of (a) total THCs (including tetrahydrocannabinolic acid) and (b) “any other cannabinoids that have similar effects (or are marketed to have similar effects) on humans or animals as a tetrahydrocannabinol.”
  • The revisions are expected to drastically limit (if not effectively eliminate) the availability of hemp-derived cannabinoid products (including those containing cannabidiol (CBD)) given the new “hemp” criteria.
  • Within 90 days of enactment, the U.S. Food and Drug Administration (FDA) is to work with other agencies to publish a list of: (1) all cannabinoids known to be capable of being naturally produced by a Cannabis sativa L. plant; (2) all THC class cannabinoids known to be naturally occurring the plant; and (3) all other known cannabinoids with similar effects to, or marketed to have similar effects to, THC class cannabinoids.
  • These provisions are scheduled to take effect on November 12, 2026, at which point many currently-permitted products would become prohibited controlled substances.  The cannabis products industry has a limited window in which to pursue a new legislative framework.