• Yesterday FDA’s Coordinated Outbreak Response & Evaluation (CORE) Network announced the release its 2023 annual report summarizing food-borne outbreak and adverse events in FDA-regulated foods.
  • In 2023, the CORE Signals and Surveillance Team, which evaluates emerging outbreaks and disease surveillance trends in collaboration with CDC, FDA field offices, and state agencies, evaluated 69 incidents, of which 25 were passed for follow up to an FDA Response Team, and 10 resulted in public health advisories. Of the responses with identified products linked to illness, fruit produce made up the greatest share at 31% (4 cases), followed by other produce at 23% (3 cases).
  • The report notes FDA’s continued partnership with Mexican food safety regulators including exchange of outbreak information through the Binational Outbreak Notification Protocol which was initiated for four CORE responses. FDA also conducted two accompanied, but unannounced inspections of Mexican food facilities.
  • Notable outbreaks identified in the report were the lead-contaminated cinnamon apple sauce pouches traced to a cinnamon supplier in Ecuador, adverse reactions (including death) linked to Morel mushrooms served at a Montana restaurant, and an outbreak of Listeria monocytogenes linked to soft serve ice cream in Brooklyn.
  • The Report predates FDA’s October 2024 reorganization into the Human Foods Program. Since the reorganization, CORE has reorganized into the Office of Coordinated Outbreak Response, Evaluation, & Emergency Preparedness (CORE+EP).
  • FDA is “set to rehire some of the staff that was let go during mass firings in the past three months.” Earlier this year around 3,500 FDA employees, or around 20 percent of its workforce, was let go without cause, and many more left due to retirement, voluntary buyout, and resignation.
  • While FDA and the Department of Health and Human Services have not detailed exactly which positions or programs were cut during the mass layoffs, many included food and medical device reviewers, communications staff, and scientists, as well as travel bookers who coordinate trips for inspectors.
  • Many of the travel bookers have been reported to be on the reinstatement list, according to two anonymous FDA staffers. In addition, food scientists have been told they will be reinstated, and some of the communications staff, including some who worked in the FOIA office, will be rehired.
  • Keller and Heckman will continue to report on staffing and other organizational developments at FDA.
  • A recent article titled, “Defining the Role of Processing in Food Classification Systems –The IUFoST Formulation and Processing Approach,” reports on a proposed novel approach to defining ultra-processed food (UPF) known as the IUFoST Formulation and Processing Classification (IF&PC) scheme.
  • As we have previously blogged, there is no formal legal definition of UPF.  Traditional food classification systems, like the NOVA classification, typically categorize foods based on their level of processing, but they often fail to distinguish between the formulation (the selection of ingredients) and the processing (the treatment of food materials). This lack of differentiation can lead to confusion and misinterpretation of the health implications of various foods.
  • The IF&PC scheme evaluates foods based on several key properties:
    • Nutritional Value: How the formulation and processing affect the nutrient content.
    • Safety: The impact on food safety and potential health risks.
    • Sustainability: Environmental considerations related to food production.
    • Palatability: The sensory qualities that affect consumer acceptance.
    • Affordability: Economic factors influencing food accessibility.
    • Convenience: The ease of preparation and consumption.
  • The authors emphasize the importance of ongoing research and collaboration among food scientists, engineers, and nutritionists.  They suggest that further refinement and expansion of the IF&PC scheme could lead to better public understanding and more informed policy-making related to food processing and nutrition.
  • Keller and Heckman will continue to monitor developments related to defining ultra-processed foods.
  • Currently, acesulfame K (E 950) is an authorized food additive in the European Union (EU) in 34 food categories with maximum permitted levels ranging from 25 to 2500 mg/kg in 31 foods categories and at quantum satis in 3 food categories of table-top sweeteners.
  • In its updated scientific assessment, the European Food Safety Authority (EFSA) established an acceptable daily intake (ADI) of 15 mg/kg bw per day based on a no observed adverse effect level (NOAEL) of 1500 mg/kg bw per day and applying an uncertainty factor of 100. This is an interesting outcome on the part of the Authority, as the previously established ADI was much lower (9 mg/kg bw/day, according to the scientific evaluation of the Scientific Committee on Food, EFSA’s predecessor body in the EU, in 2000), but it is unlikely that the European Commission will increase the maximum permitted levels in those 31 food categories.
  • Furthermore, the EFSA Panel recommends the European Commission to amend the specifications of E 950 in Commission Regulation (EU) No. 231/2012 (the Food Additive Specifications Regulation) by
    • Including the CAS number 55589- 62-3;
    • Inserting a maximum limit of 0.1 mg/kg for 5-chloro-acesulfame (unless appropriate genotoxicity data for 5-chloro-acesulfame are provided to the Authority);
    • Inserting a maximum limit of 1 mg/kg for acetylacetamide; and
    • Lowering the limit of lead and mercury.
  • On the other hand, no specifications for microbiological criteria are needed according to the Authority.
  • For more details, see EFSA Panel on Food Additives and Flavourings, 2025. Re-evaluation of acesulfame K (E 950) as food additive. EFSA Journal, 23(4), e9317. https://doi.org/10.2903/j.efsa.2025.9317

  • As first reported by the Washington Post, an internal draft budget document suggests significant cuts to HHS, including cuts to FDA, NIH, and CDC. According to the draft budget documents, the Trump Administration may propose $6.5 billion funding for FDA in 2026, a 17% decrease from the budget in 2023. 
  • In addition to the budget cuts, the document also proposes shifting most of the responsibility for routine food inspections to the states.  However, FDA officials told CBS News that some “higher risk” inspections would likely remain under the control of FDA.
  • Steve Grossman, the former director of the Alliance for a Stronger FDA, posted on his FDA Matters that the viability of moving all routine facilities inspections to the states would turn, among other things, on whether the state contracts would include enough funding to offset increased state costs, whether states have appropriate infrastructure to conduct inspections and whether FDA would have sufficient funding for coordination, enforcement, and/or reinspections.
  • Prior to enactment, the proposed budget must be approved by Congress.  Therefore, the budget may change before it is finalized.  We will continue to monitor changes to the proposed budget and report on any developments as we become aware of them.
  • Kevin Hall, Ph.D, a senior NIH researcher involved in food and metabolism research, including the effects of ultra-processed foods (UPF), resigned earlier this month, alleging that he had experienced censorship regarding his recent research which he said “did not appear to fully support preconceived narratives of my agency’s leadership about ultra-processed food addiction.” He stated that while he had hoped to expand his research on the connection between food and chronic disease, recent events had made him “question whether NIH continues to be a place where I can freely conduct unbiased science.”
  • In 2019 Dr. Hall had authored a paper which linked consumption of UPF to greater energy consumption and weight gain. However, a paper he recently published suggested that UPF are not addictive, at least not in the way that many drugs are addictive (the study found that dopamine response to a UPF milkshake was not significant, highly variable, and not related to adiposity).
  • He also alleged to CBS News that the administration had prevented him from discussing his research, had edited written answers to the media, and had threatened to remove him as an author to the paper if he did not comply with their demands. The administration has denied these accusations.
  • Last week, Pennsylvania introduced HB 1130, a bill that would introduce mandatory reporting and transparency requirements for substances considered “safe” under federal law.  If passed, companies using generally recognized as safe (GRAS) substances in food products will be required to make food safety disclosures pertaining to those ingredients.
  • Under the house bill, if companies use a GRAS substance in their product, they will need to file a report with the Pennsylvania Department of Agriculture detailing why the ingredient is safe, and ensure the ingredient is listed in a new Pennsylvania database before selling or manufacturing the product in the state.  Additionally, any proof companies provide about an ingredient’s safety must be made available to the public through that database.  If an ingredient has already been reviewed by the U.S. Food and Drug Administration (FDA), is approved by federal law, or is a well-known natural food product, companies may be exempt.  Pennsylvania would also be able to reject a company’s filing if it does not provide enough information.
  • HB 1130 was introduced along with seven other bills aimed at food safety, which include greater chemical disclosures on food labels, bans on the sale of foods with color additives blue 1, blue 2, green 3, red 40, yellow 5, and yellow 6 in schools (HB 1131), creating a statutory definition of ultra processed foods and prohibiting their sale in schools (HB 1132), a warning on foods that contain BHA (HB 1133),  a warning on foods that contain blue 1, blue 2, green 3, red 40, yellow 5 or yellow 6 (HB 1134), and others.
  • The lawmakers sponsoring HB 1130 state that it is estimated that over 10,000 chemicals have come into the food supply with no evidence they chemicals are safe for consumption through the “GRAS loophole” that allows food companies to add new chemicals to food without FDA approval or any type of independent review.
  • HB 1130 was referred to the Committee on Consumer Protection, Technology, and Utilities on April 21, 2025. Keller and Heckman will continue to monitor and relay any legislative developments regarding these bills.
  • On April 25, 2025, the United States Department of Agriculture (USDA) announced the withdrawal of a proposed regulation titled, Salmonella Framework for Raw Poultry Products, that would have determined poultry products contaminated with certain serotypes of Salmonella to be adulterated.
  • The proposed rule aimed to classify raw chicken carcasses, chicken parts, comminuted chicken, and comminuted turkey products contaminated with certain levels and serotypes of Salmonella as adulterated under the Poultry Products Inspection Act (PPIA). The withdrawn proposal also included a requirement that all poultry slaughter establishments develop, implement, and maintain written procedures to prevent contamination by enteric pathogens, through a microbial monitoring program (MMP) with statistical process control (SPC) methods, sampling at rehang instead of pre-chill, and paired sampling at rehang and post-chill.
  • The proposal underwent an extensive public comment period, during which the FSIS received 7,089 comments.  In its withdrawal announcement, USDA cited the need for further review of the issues raised during the comment period.  
  • The agency acknowledged the goal of reducing Salmonella illnesses but indicated that the proposed framework required additional consideration.  FSIS stated that it would continue to support efforts to reduce Salmonella contamination through other means. 
  • Keller and Heckman will continue to monitor updates related to updates on proposed rulemakings.
  • Yesterday, FDA and HHS announced a series of actions intended to phase out the use of petroleum-based synthetic food dyes. The news release can be found here and a video of the press conference here. Specifically, the agency announced that it would:
    • Establish a national standard and timeline to transition from petroleum-based dyes to natural alternatives.
    • Initiate the process to revoke authorizations for Citrus Red No. 2 (21 CFR 74.302) and Orange B (21 CFR 74.250).
    • Work with the industry to eliminate the remaining six synthetic dyes – Green No. 3, Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1, and Blue No. 2 – from the food supply by the end of the year.
    • Authorize four new natural color additives – calcium phosphate, Galdieria extract blue, gardenia blue, and buttery fly pea flower extract (expanded uses) –in the coming weeks and accelerate the review and approval of others.
    • Partner with the National Institutes of Health (NIH) to conduct comprehensive research on how food additives impact children’s health and development.
    • Request that companies remove Red No. 3 sooner than the previously required 2027-2028 deadline.
  • Speakers at the press conference included HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary. Sweeping claims about the harms of the dyes, in particular to children, were made. Although the health effects of many of the dyes have been brought into question, there is little scientific consensus on the subject. See e.g., CA Department of Public Health Rejection of Synthetic Dye Warnings. FDA has not released any document providing an explanation for the agency’s change in position or providing a risk assessment to support its position. The speakers also discussed variations of state additive bans and the market harms of patchwork state regulation.
  • Neither the press release nor the news conference referenced any formal process to revoke the authorizations for the synthetic food dyes that are not Citrus Red No. 2 and Orange B, and FDA will likely rely on voluntary phase out by industry and state additive bans to implement its plans.  
  • 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.