• 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  • FDA has withdrawn a proposed rule that would have required cosmetics manufacturers to test for asbestos in their talc products.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.
  • The Non-GMO Project released its “Non-UPF Verified” Standard earlier this month. The release follows the launch of the new certification standard earlier this year.
  • The Standard, which attempts to define so-called “ultra-processed foods” (UPF), prohibits the use of any ingredient contained in “Annex B – Harmonized Prohibited Ingredients List,” which it indicates reflects a “selected collection of prohibited ingredients from quality standards and governmental regulations.” The Standard also divides food processing methods into prohibited, conditional, and permissible categories, which are in turn divided based on alleged differences in degree of processing (the permissible bucket consists of methods deemed to be “minimal” or “moderate”). A non-exhaustive (and very short) table (A.1) groups certain processing methods into these categories.
  • Notably, the processing criteria only apply to “ingredients declared on the product’s ingredient panel” and not to “sub-ingredients or processing aids that are not required to appear on-pack under applicable labeling regulations.”
  • The Standard ostensibly doesn’t apply to processing methods that are “demonstrably essential for food safety,” but it permits conditionally processed foods only up to 30% of the finished product, “regardless of food safety justification.” The Standard also contains limits on added sugars.
  • There is no consensus on how to meaningfully classify foods based on processing, and the science regarding the effects of so-called “ultra-processed food” remains unsettled. Indeed, the Standard incorporates ingredient bans and added sugar limits, neither of which directly relate to the term “processing.”
  • Infant formula maker ByHeart has recalled all batches of its Whole Nutrition Infant Formula cans and Anywhere Pack sticks due to an outbreak of infantile botulism linked to the company’s products. ByHeart initiated the recall of two batches of formula on November 8, 2025, after it was notified of approximately 13 reported cases of botulism in infants that had consumed its products throughout the U.S. The company expanded the recall three days later after an additional 10 cases were reported.
  • California officials reported that a sample taken from an open can of ByHeart formula contained Clostridium botulinum, which leads to botulism infection. According to ByHeart, no previously unopened product has tested positive for the bacteria. In addition to recalling product, the company is conducting testing of every batch of formula through a third-party laboratory and providing FDA and the California Department of Public Health access to its facilities and unopened product for testing.  
  • The families of at least two babies who were treated for botulism have sued ByHeart, alleging the company negligently sold defective formula that they purchased because they viewed it “as a natural, healthier alternative to traditional baby formulas.” The families are seeking payment for medical bills, emotional distress, and other harm.  
  • Illnesses linked to ByHeart formula began between August 9 and November 11 and were reported in 13 states. Investigators have not identified any other infant formula brands or other sources of exposure in the outbreak.
  • Keller and Heckman will continue to monitor and report on this and other foodborne illness outbreaks.
  • On November 12, 2025, The “Make America Healthy Again” (MAHA) Summit was held under a veil of secrecy at the Waldorf Astoria in Washington, D.C. The summit brought together a high-profile mix of government officials, biotech leaders, wellness influencers, and policy advocates. Attendees included Health Secretary Robert F. Kennedy Jr., Vice President J.D. Vance, Centers for Medicare & Medicaid Services (CMS) Administrator Mehmet Oz, Food and Drug Administration (FDA) Commissioner Marty Makary, and National Institutes of Health (NIH) Director Jay Bhattacharya, among others.
  • The summit was a private, invitation-only event with no press access or livestream. When asked about attendance, organizers directed inquiries back to event coordinators. Although the daylong event was closed to the press, the agenda showed that a broad range of health topics were covered. Panel sessions covered the future evolution of FDA and NIH, innovations in compounding and pharmacy, the therapeutic potential of psychedelics, reversing aging, biohacking, and food as medicine.
  • In a livestreamed session, Vice President Vance commended Robert F. Kennedy Jr. for challenging conventional health approaches, emphasizing a focus on necessary rather than routine medication. Kennedy outlined goals to reduce artificial additives, address ultra-processed foods, update dietary guidelines, and limit environmental toxins.
  • Critics raised concerns about transparency and potential erosion of trust in established science, while organizers framed the event as a milestone for health policy reform.
  • Keller and Heckman will continue to monitor developments related to the MAHA movement and its potential impact on U.S. health policy.