• FDA recently shared the final results from the testing of domestic and imported bottled water collected at retail locations across the U.S. for per- and polyfluoroalkyl substances (PFAS). Of the 197 samples of purified, artesian, spring, and mineral waters tested, ten samples had detectable levels of PFAS. However, none of those had levels that would have exceeded the EPA’s maximum contaminant levels (MCLs) for PFAS in public drinking water.
  • PFAS are a diverse group of widely used, long lasting chemicals that do not easily break down and can accumulate in the environment and human tissues with negative health consequences. PFAS have been the subject of various testing efforts, lawsuits, and legislation, as we have previously blogged.
  • In the bottled water study, FDA tested for 18 types of PFAS, including the six types with EPA-established MCLs. The ten samples with detectable PFAS levels contained a range of one to four different PFAS in domestic samples and one to two different PFAS in imported samples. Of these, four PFAS were below EPA MCLs for drinking water, and two PFAS detected do not have established MCLs.
  • The Food, Drug, and Cosmetic Act requires FDA to establish a standard of quality regulation for contaminants in bottled water whenever the EPA establishes MCLs for public drinking water as part of a National Primary Drinking Water Regulation. If FDA does not establish a standard for the contaminants or finds that such standards are not necessary to protect public health, then the EPA levels are considered the applicable regulation for bottled water. FDA can then take action against bottled water that presents a safety concern even if there is no standard of quality for a contaminant.
  • Keller and Heckman will continue to monitor activity surrounding PFAS in bottled water and other foods.
  • The U.S. Food and Drug Administration (FDA) has recently suspended its food safety quality checks due to significant staff cuts at the Department of Health and Human Services (HHS).  FDA had been drawing up plans in anticipation of the staff cuts, and outsourcing oversight to state and local authorities.  This decision has raised concerns about the potential impact on public health and food safety standards.
  • FDA’s proficiency testing program, part of the Food Emergency Response Network (FERN), is designed to ensure consistency and accuracy in food testing laboratories.  The network comprises approximately 170 labs that test food for pathogens and contaminants to prevent foodborne illness. 
  • The suspension of this program follows the firing and departure of up to 20,000 HHS employees, including key personnel such as quality assurance officers, analytical chemists, and microbiologists.  The program will be suspended at least through September 30, 2025.
  • The staff cuts have also impacted FDA’s work in other areas such as its bird flu response and drug reviews.  FDA had already suspended efforts to improve testing for bird flu in milk, cheese, and pet food earlier in April due to staffing issues.
  • Keller and Heckman will continue to monitor developments related to staff cuts and program suspensions, and any other significant changes at FDA.
  • The Alliance for Natural Health (ANH) has published a white paper calling for the “balanced reform” of the GRAS system.
  • The ANH announcement comes shortly after HHS Secretary Robert F. Kennedy, Jr.’s directive for FDA to explore potential rulemaking to eliminate the pathway for companies to self-affirm food ingredients as GRAS, a move which Secretary Kennedy stated would “provide transparency to consumers.”
  • While the ANH white paper does not support the complete elimination of self-GRAS, it does propose several key reforms:
    • Prioritization of removal for specific unsafe ingredients such as potassium bromate, propylparaben, and brominated vegetable oil;
    • Creation of a comprehensive online database of all GRAS determinations;
    • Implementation of a four-tier system that calibrates evidence requirements based on an ingredient’s history and safety profile;
    • Creation of a pathway for ingredients with a documented history of safe use to be officially recognized by FDA as “historically safe;”
    • Use of warnings, rather than outright bans, for ingredients that are generally safe but may be harmful to specific populations.
  • We will continue to monitor and report on developments regarding GRAS.
  • Secretary of Health and Human Services Robert F. Kennedy Jr. has been critical of seed oils, alleging that they are harmful to human health and that consumers have been “unknowingly poisoned.”  (See Twitter Post). This view is not shared by most of the scientific community. Indeed, FDA has approved qualified health claims for canola, corn, and soybean oils (all types of seed oils) and reduction in the risk of coronary heart disease. See Qualified Health Claims: Letters of Enforcement Discretion | FDA. However, this has not stopped Sweetgreen from announcing a seed-oil free menu earlier this year.
  • Although no seed oils bans have been proposed, a recent study conducted by the World Agricultural Economic and Environmental Association found that any such ban would significantly increase consumer vegetable oil prices and would have deleterious effects on the U.S. farm industry (non-seed oils like olive, palm, and peanut oil are largely imported).
  • Specifically, the study found that per capita spending on vegetable oils and fats would be 42.8% higher per year if overall vegetable oil consumption remained the same (non-seed vegetable oils substituted completely for seed oils). A second scenario assumed that the oils are not fully substitutable, resulting in a 21.1 pound per capita drop in vegetable oil consumption and an 8% greater per capita spending on vegetable oils per year.
  • The study characterizes the simulated effects as having an unprecedented shock on the oilseed market.
  • Sovena USA Inc. has filed a motion to dismiss (Law360 required) a proposed class action alleging that the company falsely labeled its avocado oil as “100% pure” despite diluting it with “cheaper” seed oils. According to Sovena, “the suit lacks evidence and is part of a ‘baseless’ litigation campaign meant to undermine the industry.”
  • The class action stems from a study by UC Davis researchers that showed fatty acid profiles beyond the types of fatty acids that would be expected to be in pure avocado oil, suggesting that there are other oils mixed into Sovena’s Olivari avocado oil. However, Sovena says that rather than testing for inferior oils, the researchers used a “theoretical ‘purity standard’” that they applied to a single bottle of Olivari oil. Thus, the study did not demonstrate that other oils are present in the Olivari oil or any of the other samples tested, but instead that the samples contained an “indicator” of other oils, “could have” other oils, or that the samples otherwise failed the researchers “ad hoc purity standards.”
  • According to Sovena, because the study does not definitively identify adulteration in the avocado oil, it cannot provide a plausible basis for the plaintiffs’ claims. Therefore, Sovena says the case should be dismissed with prejudice as “just one of multiple no-injury, no-deception class action suits aimed at avocado industry members.” The motion references other suits against Kroger and Walmart, which were both dismissed at the pleading stage.
  • Keller and Heckman will continue to monitor this and other food labeling litigation.
  • On April 9, 2025, the White House issued a memorandum titled “Directing the Repeal of Unlawful Regulations,” directing agency heads to repeal rules without notice and comment, where doing so is consistent with the “good cause” exception in the Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)). The “good cause” exception allows agencies to dispense with notice-and-comment rulemaking when that process would be “impracticable, unnecessary, or contrary to the public interest.”
  • This review-and-repeal effort directs agencies to evaluate existing regulation’s lawfulness under several recent Supreme Court decisions such as Loper Bright Enterprises v. Raimondo and West Virginia v. EPA—decisions which limited the power of federal agencies to promulgate regulations absent explicit congressional authorization.
  • The memorandum is intended to reinforce Executive Order 14219, published on February 19, 2025, which directed the heads of all executive departments and agencies to identify categories of unlawful and potentially unlawful regulations within 60 days and begin plans to repeal them.
  • Following the 60-day review period ordered in Executive Order 14219, agencies are instructed to immediately take steps to effectuate the repeal of any regulation, or the portion of any regulation, that “clearly exceeds the agency’s statutory authority or is otherwise unlawful.”
  • Keller and Heckman will continue to monitor developments related to the repeal of regulations and provide updates on how these changes impact regulated industries.
  • On April 5, 2025, Texas Attorney General Ken Paxton announced an investigation of W.K. Kellogg Co. (Kellogg) for potential violation of Texas consumer protection laws, alleging that Kellogg’s marketing of its cereals as “healthy” is deceptive marketing because they include artificial food dyes and butylated hydroxytoluene (BHT).
  • As we previously reported, the Texas Senate recently passed SB 25, which if passed into law would require food labels to warn Texas consumers if a food product contains ingredients banned in other countries.  The bill is now under review with the Texas House Committee on Public Health.  AG Paxton’s announcement signals the Texas government’s continued focus on food additives and “healthy” claims by food manufacturers.
  • AG Paxton alleges that Kellogg’s “healthy” claim is deceptive because the artificial dyes “have been linked to hyperactivity, obesity, autoimmune disease, endocrine-related health problems, and cancer in those who consume them.”  However, not all food scientists agree with this link to health issues, and many of the food dyes and additives are currently approved for use by the U.S. Food and Drug Administration (FDA).
  • Keller and Heckman will continue to monitor this investigation and relay any developments.
  • Food Standards Australia and New Zealand (FSANZ) have approved a cell-cultured quail product produced by Vow, an Australian company. Under the approval, either the term “cell-cultured” or “cell-cultivated” must be displayed on the labeling.
  • The approval follows two rounds of public consultations on Vow’s novel food application, originally submitted in January 2023.
  • The approval will now be sent to the Food Ministers (of the Commonwealth, States and Territories, and New Zealand) who have 60 days to accept, amend, or seek a review of the proposed change to the Food Standards Code. If accepted, the product can then be commercialized. 

  • A new bill introduced in the U.S. House of Representatives would require a “high caffeine” warning on beverages that contain more than 150 milligrams of caffeine, as well as require manufacturers to declare the amount of caffeine in their products.
  • Representative Robert Menendez introduced H.R.2511, the Sarah Katz Caffeine Safety Act, stating that (Law360 subscription required) “the bill is about transparency and safety,” aimed at preventing tragedies such as the death of Sarah Katz, a college student who died after drinking a highly caffeinated beverage. As we previously blogged, Katz’s parents filed a lawsuit alleging that Panera Bread Company’s “Charged Lemonade” caused their daughter’s death and that the beverage contained anywhere from 260-390 mg of caffeine, depending on the size of the beverage.
  • The bill would require menu items in chain restaurants containing at least 150 mg of caffeine to bear a statement such as “high caffeine” on the menu. In addition, the bill amends Section 403 of the Food, Drug, and Cosmetic Act to consider foods and dietary supplements containing more than 10 mg of caffeine as misbranded unless the label includes the amount of caffeine in the product, a statement of whether the caffeine is naturally occurring or an additive, and an advisory statement regarding FDA’s daily recommended limit of caffeine for healthy adults.
  • The bill also directs FDA to define “added caffeine” and review the status of caffeine and other stimulants as generally recognized as safe (GRAS). Specifically, FDA would be directed to consider:
    • Whether caffeine should be considered GRAS;
    • The safety of caffeine or other stimulants, either alone or in a blend;
    • The safety of guarana, taurine, and similar substances in food and dietary supplements with added caffeine;
    • Thresholds for the amount of caffeine or blends of caffeine and other stimulants; and
    • Whether any regulations relating to caffeine in food and dietary supplements should be issued or updated.
  • Finally, the National Institutes of Health would be required to conduct or support a review of the effect of caffeine consumption in vulnerable populations, and FDA and CDC would be required to conduct a public education campaign on caffeine safety.
  • FDA’s webpage on caffeine indicates that 400 mg a day is “not generally associated with dangerous, negative effects,” but that the level of sensitivity can vary widely.
  • Keller and Heckman will continue to monitor this bill and other developments regarding caffeinated beverages.
  • On March 18, 2025, Louisiana introduced Senate Bill 14, a bill that would require products containing artificial dyes, chemical additives, and other ingredients to include a warning label on the product where the substances are banned or not authorized in other countries.  The bill lists 51 different ingredients that would require the warning, including several synthetic dyes, synthetic or artificial vanillin, propylparaben, potassium bromate, melatonin, bleached flour, and others.  Any food items containing any of the listed ingredients would be required to bear the following warning label, “WARNING: This product contains an artificial color, chemical, or food additive that is banned in Australia, Canada, the European Union, or the United Kingdom.” 
  • Additionally, SB 14 would prohibit public schools and non-public schools receiving state funds from serving ultra-processed foods.  The bill defines ultra-processed food as any food or beverage that contains the following: Blue dye 1, Blue dye 2, Green dye 3, Red dye 3, Red dye 40, Yellow dye 5, Yellow dye 6, azodicarbonamide, Butylated hydroxyanisole (BHA), Butylated hydroxytoluene (BHT), Potassium bromate, propylparaben, and titanium dioxide.
  • Some additional provisions of the bill would also require any food service establishment that cooks or prepares food using seed oil to display a disclaimer on the menu or other clearly visible location, prohibit soft drinks from SNAP eligibility, and require physicians and physician assistants to complete continuing education on nutrition and metabolic health.
  • This bill mirrors Texas SB 25, as we’ve previously blogged about, which would also require warning labels on packaged food products containing artificial colors, chemicals, or food additives that do not have a regulatory clearance in other countries.
  • LA SB 14 is the latest in a host of newly proposed bills this legislative cycle targeting synthetic dyes and various other food additives, which, if adopted, will create a divided and complicated regulatory scheme across the country.
  • Keller and Heckman will continue to monitor developments related to state legislative efforts to prohibit food additives.