Federal agencies won't disclose the name of the grower behind a deadly E. coli lettuce outbreak
The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) won't disclose the name of the grower behind a deadly E. coli outbreak linked to romaine lettuce in 2024. According to February reports obtained by Food Safety News, both agencies revealed that the same grower was responsible for an outbreak in 2021.
In the 2024 outbreak — which occurred in November and December — a total of 89 individuals became ill across 15 states. Seven individuals developed hemolytic uremic syndrome, a serious complication that causes kidney failure, and one person died.
The FDA explained that the grower is not named in its report because 'by the time the investigation was over, the implicated lot of romaine lettuce was no longer available for sale,' Food Safety News reported. Additionally, the agency redacted the names of all firms and companies that handled and processed the tainted lettuce.
'The three traceback legs identified 4 distribution centers, broker, processors, [redacted] grower, and [redacted] ranch,' the FDA report outlined. 'The traceback investigation determined that [redacted], the sole processor, sourced romaine lettuce from [redacted] grower, [redacted].'
'This romaine was available at all points of service (POS) during the specified timeframe of interest. Additionally, romaine lettuce supplied to [redacted] POS was traced back to a common ranch and lot,' the report continued. 'Through analysis of records, [redacted] lots of romaine lettuce were implicated, resulting in confirmation of romaine lettuce as the vehicle.'
The FDA added that seven subclusters of E. Coli infections were part of the outbreak. They included catered events in Missouri, an Ohio school, an Indiana restaurant, an Illinois restaurant and an Illinois catered event, per Food Safety News. An investigation by the CDC found that out of 65 individuals who were part of the subclusters, 95% said they ate a mix of leafy greens before falling sick. 88% of individuals who could remember what leafy greens they ate said they consumed romaine lettuce.
'The traceback investigation determined that a sole processor sourced romaine lettuce from [redacted] grower that would have been available at all points of service during the timeframe of interest,' the FDA said in its report. 'Additionally, romaine lettuce supplied to [redacted] POS was traced back to a common ranch and lot.'

Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles


Business Insider
42 minutes ago
- Business Insider
KalVista says FDA will not meet PDUFA goal date for Sebetralstat NDA
KalVista (KALV) Pharmaceuticals nnounced that the U.S. Food and Drug Administration has notified the company that it will not meet the PDUFA goal date for the New Drug Application for sebetralstat, the company's investigational oral on-demand treatment for hereditary angioedema. The FDA notified the company on June 13, 2025, that the previously disclosed June 17, 2025 PDUFA goal date will not be met due to heavy workload and limited resources. The FDA indicated that it expects to deliver a decision within approximately four weeks. The FDA has not requested additional data or studies and has not raised any concerns regarding the safety, efficacy or approvability of sebetralstat. KalVista has addressed all prior information requests in a timely manner, and the company believes the only remaining item under FDA review is the finalization of the labelling. 'We are disappointed by this delay, most importantly because we know how much people living with HAE are looking forward to an oral on-demand option to treat their HAE attacks,' said Ben Palleiko, CEO of KalVista. 'At the same time, we remain confident in the near-term approval of sebetralstat. We are continuing to work closely with the FDA to support the completion of their review. Our commitment to bringing this important therapy to people living with HAE remains unwavering.'
Yahoo
3 hours ago
- Yahoo
Cherokee Nation hosts second annual Rare Disease Summit
TAHLEQUAH, Okla. — Rare diseases affect an estimated 1 in 10 Americans and consist of over 7,000 known conditions. These staggering figures prompted the Cherokee Nation to host its second Rare Disease Summit this week. The summit brought together health care professionals, medical specialists, and the community to better address the unique challenges facing tribal citizens with rare medical conditions. 'Cherokee Nation has always been committed to meeting the health care needs of our citizens, no matter how complex or challenging those needs may be.' Principal Chief Chuck Hoskin Jr. According to the National Institute of Health, any disease affecting fewer than 200,000 people in the United States is rare, and more than 90 percent lack FDA-approved treatments. 'Our second annual Rare Disease Summit demonstrates our unwavering dedication to ensuring that no Cherokee citizen faces a rare disease diagnosis alone,' Hoskin said. 'By bringing together leading medical experts, patients, families, and advocates, we're building a stronger support network and advancing care options that can make a real difference in people's lives.' He said that this summit represents the Cherokee values of working together and leaving no one behind. This year's summit featured expert speakers across multiple medical specialties, including neurology, rheumatology, optometry, infectious disease, and pediatrics. Attendees participated in an interactive question-and-answer panel and explored a resource fair designed to provide comprehensive information and support. Summit attendees also had the opportunity to take part in various breakout sessions throughout the day that covered the following topics: the Newborn and Rare Disease Screening Program; building partnerships to optimize Cystic Fibrosis care in children and adults; genetic testing for epilepsies; mental health in the perinatal period; rare genetic variants and their role in diabetes and vascular diseases; Pediatric Neurovascular Disease; Ehlers Danlos Syndrome; and Spina Bifida and Chiari. Cherokee Nation's health care system, the largest tribally operated health system in Indian Country, is committed to finding solutions and increasing resources for people with rare disease conditions by raising awareness, advocating for policy change, and building a growing support network. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.


CNN
4 hours ago
- CNN
RFK Jr.'s new vaccine advisers include ER doctor who posted Islamophobic commentary online, expert witnesses against vaccines
Among the eight people who Robert F. Kennedy Jr. announced would make up his new group of outside vaccine advisers to the US Centers for Disease Control and Prevention are an emergency physician who posted Islamophobic commentary on social media and two doctors who were paid to provide expert testimony in trials against a vaccine maker. Kennedy, who was himself an influential anti-vaccine advocate before taking the helm at the US Department of Health and Human Services this year, dismissed the previous 17-member Advisory Committee on Immunization Practices, or ACIP, saying the group was 'plagued with conflicts of interest.' He pledged that their replacements wouldn't be 'ideological anti-vaxxers.' Some, though, have been accused of spreading false or misleading information about the safety of vaccines. Among the new members is Dr. Vicky Pebsworth, who holds a Ph.D. in nursing and public health, and who serves as volunteer director of research and patient safety for the National Vaccine Information Center, which advocates for vaccine exemptions and has argued that mRNA Covid-19 vaccines should not be recommended for anyone. Dr. Retsef Levi, a professor of operations research at MIT, has a 2023 post pinned to the top of his account on X that says, 'The evidence is mounting and indisputable that MRNA vaccines cause serious harm including death, especially among young people. We have to stop giving them immediately!' despite studies showing that they are safe and effective and research showing that they have saved millions of lives. Dr. Robert Malone, an early researcher of mRNA technology, has suggested that Covid-19 vaccines may cause cancer, something regulatory agencies say is not the case. Malone also served as a paid expert witness in an antitrust lawsuit over Merck's measles, mumps and rubella vaccine, testifying that plaintiffs compensated him at a rate of $350 per hour. Malone noted at the time that his compensation did 'not depend on the outcome of this litigation or my conclusions.' Fellow new ACIP member Dr. Martin Kulldorff, who has called vaccines 'vital,' served as a paid witness in a vaccine trial against Merck over the safety of its HPV vaccine, Gardasil. The committee's conflict-of-interest policy says members of its work groups 'should agree that they will not serve as a paid litigation consultant or expert witness in litigation involving a vaccine or manufacturer under the purview of the [work group].' Dorit Reiss, a professor of law at UC Law San Francisco, noted that 'past expert witness work may not be a bar, but that's true of the [conflicts of interest] Kennedy used to justify dismissing' the previous members. Kulldorff did not respond to requests for comment about his testimony and whether he would recuse himself from discussions related to Gardasil. Malone also didn't respond to CNN's request for comment. An HHS spokesperson told CNN that the agency 'takes conflicts of interest very seriously' and will 'make sure anyone participating in the meetings do not have any conflicts of interest in the agenda they'll be meeting on.' Several of the new appointees have been in Kennedy's orbit for years. He dedicated his 2021 book, 'The Real Anthony Fauci,' to the 'battle-hardened cadre of heroic scientists and physicians' who fought Fauci's pandemic strategies, including Kulldorff and Malone. He also listed Pebsworth on a 'heroic healers honor roll.' Others are less well-known. Emergency physician Dr. James Pagano doesn't appear to have shared his vaccine views publicly. An X account bearing his name most recently includes supportive replies to posts about President Donald Trump, Elon Musk and Kennedy. About 10 years ago, Pagano posted on the account, 'What's wrong with being an islamophobe? There's so much there not to like.' Pagano didn't respond to CNN's request for comment. A spokesperson for HHS told CNN, 'This was a tongue-in-cheek post made ten years ago that was a reference to the news cycle at the time. It has nothing to do with his qualifications' to serve on ACIP. Pagano is a 'highly qualified medical doctor that will take these issues very seriously.' Caleb Kieffer, a senior research analyst for the Intelligence Project at the Southern Poverty Law Center, called the post 'concerning and problematic, whether it's kind of a one-off or not. … Islamophobia is a recognized form of bigotry. It was a recognized form of bigotry when this was posted in 2015, and it remains a recognized form of bigotry and problem today.' The committee is scheduled to meet June 25 to discuss vaccines for Covid-19, cytomegalovirus, HPV, flu and other diseases. According to the Federal Register, recommendation votes are scheduled for multiple vaccines, including for the Vaccines for Children program, which provides vaccines at no cost to those whose parents or guardians may not be able to afford them. An HHS spokesperson said the new members' ethics agreements will be made public before they start. 'Every ACIP member will be vetted in accordance with their ethics agreement before they are permitted to participate in each meeting agenda item,' HHS Director of Communications Andrew Nixon said in a statement. 'Secretary Kennedy has replaced vaccine groupthink with a diversity of viewpoints on ACIP.' Here's a look at all the new committee members. Hibbeln is a former NIH researcher focused on nutrition and psychiatry, with a particular interest in seafood: He is an unpaid adviser to Positively Groundfish, a nonprofit trade association supporting the fishing industry. Though his vaccine views haven't been made clear, a paper he co-authored in 2018 notes that a connection between a form of mercury in vaccines, thimerosal, and autism 'has been largely repudiated.' Kennedy noted in his X post that, while at the NIH, Hibbeln 'led research on immune regulation, neurodevelopment, and mental health' and that his work has 'informed US public health guidelines, particularly in maternal and child health.' Hibbeln declined to comment when reached by email. Kulldorff was a prominent early critic of the US government's coronavirus response, namely broad shutdowns and school closures, and later the Covid-19 vaccines and what he has argued was federal collusion with social media companies to censor his and others' views. The Swedish epidemiologist and biostatistician teamed up with Oxford professor Dr. Sunetra Gupta and Stanford professor Dr. Jay Bhattacharya, now director of the National Institutes of Health, to write the October 2020 'Great Barrington Declaration,' which argued for fewer social distancing requirements for young, healthy people rather than broad lockdowns. That alliance carried on as Bhattacharya assumed his federal role. Kulldorff's name swirled in the early days of the second Trump administration as HHS officials discussed potential hires around the agencies and appointments to advisory panels, according to a personal familiar with the discussions who asked to remain anonymous because they were not authorized to speak with CNN. Kennedy also seemed to suggest in April that Kulldorff was part of the agency's effort to research the causes of autism. 'This is all being run by Jay Bhattacharya and by, I think, Martin Kulldorff, maybe also working on this, on designing the grant proposals,' Kennedy said April 16. Asked by reporters a few days later about Kulldorff's level of involvement in the autism initiative, Bhattacharya declined to discuss 'any personnel decisions specifically' but added that 'this is public knowledge. I'm very close friends with Martin, and we talk all the time.' Kulldorff wrote in a commentary in the urban policy magazine City Journal that 'vaccines are a vital medical invention' but that clinical trials for Covid-19 shots were not properly designed. He also said he has 'spent decades studying drug and vaccine adverse reactions without taking any money from pharmaceutical companies.' Levi is a professor of operations management at MIT and trained as a mathematician. His bio on the MIT website says he studies food supply chains. He also spent nearly 12 years as an intelligence officer in the Israeli Defense Forces. In an email to CNN, Levi said that he has nearly '19 years of extensive work with healthcare systems and health data,' including 'work on quality and safety of manufacturing of biologic drugs, post marketing safety signal detection, epidemiological models and more generally data driven and statistical/AI enabled frameworks and decision support tools to manage and optimize risk-benefit tradeoffs.' 'I also have been conducting research specifically on the COVID-19 vaccines,' he wrote. In 2022, Levi co-authored a study that looked at the relationship between Covid-19 vaccination rates in Israel and emergency calls for heart problems in teens and young adults. Levi and his co-authors reported a 25% increase in these heart-related emergencies in the early months of 2021 compared with 2019 through 2020. They concluded that this increase was not due to a wave of Covid-19 illnesses — which can cause heart problems — but instead was associated with the timing of the first and second doses of mRNA vaccines in this age group. Observational studies like this one can be misleading because while they may show that two things happen at the same time, they can't prove that one caused the other. In order to prove that vaccines caused an increase in heart-related emergencies in Israel, the researchers would have needed to know the vaccination status of patients in the study and to show that heart-related emergencies increased in vaccinated compared with unvaccinated individuals. The study authors didn't have that information, according to an independent fact check of the study's claims. More recently, Levi has co-authored a study with Florida's surgeon general, Dr. Joseph Ladapo, who in 2024 called for a halt in the use of the Covid-19 vaccine in the state, even for adults over age 65. This new study, which was posted as a preprint — meaning it hadn't been scrutinized by outside experts or published in medical journal — compared death risks in 1.4 million Florida adults who received either the Pfizer or Moderna Covid vaccines in the year after vaccination. The study authors say that they found a higher risk of dying from any cause, and from heart-related causes, in Floridians who received Pfizer's Covid-19 vaccines than in those who received shots from Moderna and that this indicates the vaccines have different 'non-specific' effects. In an email, Levi said that nonspecific effects relate to 'health outcomes broader than and beyond the target virus,' such as deaths from any cause or heart-related deaths. But the study didn't compare death rates in the vaccinated groups with those in people who were unvaccinated. Other studies have found that Covid-19 contributed to excess deaths during the years of the pandemic and to heart-related deaths specifically. The study also didn't account for different dosages in the Pfizer and Moderna vaccines, noted Dr. Peter Hotez, a pediatrician and infectious disease expert who is co-director of the Center for Vaccine Development at Texas Children's Hospital. Moderna's shots had a higher dose of mRNA than Pfizer's: 100 micrograms vs. about 30 micrograms. If the excess deaths were caused by Covid, greater protection from the Moderna vaccines might explain the higher death risk in the Pfizer-vaccinated group, Hotez said. When asked whether the different dosing of mRNA in the vaccines might account for the findings, Levi wrote, 'I think that the hypothesis that Moderna has protective effects against non-COVID deaths and even against cardiovascular deaths, while cannot be fully dismissed, is highly implausible, and not supported by evidence.' In fact, Hotez said, it is supported by evidence. Hotez said in an email that this kind of messaging 'cherry picks a weakly supported factoid, and blows it up until it defies reality but supports their false narrative, while simultaneously ignoring a mountain of counter evidence.' The study authors used the findings to try to sow doubt about the vaccines. In a social media post, Ladapo wrote, 'Did your doctor tell you that you might be more likely to die if you took Pfizer instead of Moderna? That's what we found in Florida, and other studies have shown similar results. The system is rotten and we need more honest scientists.' Although Malone made some key early innovations in mRNA and its potential use in drug therapies, the biochemist has argued in recent years that mRNA-based Covid-19 vaccines are risky and that drug regulators too rapidly authorized their use. In 2023, Malone told House representatives during an event on Covid-19 vaccine injury led by Georgia Republican Marjorie Taylor Greene that he believes mRNA shots can cause cancer, a claim that is not backed by peer-reviewed scientific literature and the FDAand the National Cancer Institute say there is no evidence of a link. Malone's criticisms extend beyond mRNA immunizations. In April, he suggested that a number of measles cases in the current outbreak were caused by the vaccines themselves – although the CDC says they are rare breakthrough cases due to community spread, not cases from shots. In December, he wrote that early polio shots caused cancer because of contamination with the simian 40 virus. The CDC has said that although that virus has caused cancer in some animals, there is no evidence that it caused human cancers. More recently, Malone served as a senior medical adviser to Independent Medical Alliance, formerly known as the Frontline COVID-19 Critical Care Alliance, a nonprofit that pushed back on vaccine requirements and touted unproven coronavirus treatments such as ivermectin. The group celebrated Malone's appointment to the panel Wednesday. Asked whether it had any input with HHS on the new ACIP members, IMA President and Chief Medical Officer Dr. Joseph Varon said in an email that the group 'regularly communicates with HHS on public health issues, including vaccine policy. While specifics aren't disclosed, it's part of their mission to guide such processes.' Of all the new appointees, Dr. Cody Meissner has the most vaccine expertise. He is a pediatric infectious disease expert at Dartmouth University who also has a long history of government service. He previously served on ACIP from 2008 to 2012 and served on the group of independent experts who advised the FDA on its vaccine decisions during the pandemic. He's also been a member of vaccine advisory boards, including for the American Academy of Pediatrics, and was the chair of the National Vaccine Injury Compensation Program. He has co-authored dozens of studies and position statements on vaccines. During the pandemic, he co-authored an editorial in The Wall Street Journal with Dr. Marty Makary, who is now commissioner of the FDA, arguing against the use of masks for kids. He recently told Reuters that he supports Kennedy's decision not to recommend Covid-19 vaccines for pregnant women and healthy children. In a social media post, infectious disease expert Dr. Michael Mina called Meissner a 'rigorous scientist and has defended vaccines' and a 'terrific choice.' Meissner did not respond to CNN's request for comment for this story. Kennedy's post about Pagano notes that he's a board-certified emergency medicine physician with more than 40 years of experience, including service on hospital committees, and is a strong advocate for evidence-based medicine. He appears to be licensed in both California and Florida. In posts on a blog linked to the X account with his name, Pagano wrote in 2017 that it was a 'disappointment' that Republicans failed to repeal and replace Obamacare, and he advocated for 'transparent, cost-based pricing' in health care. Pebsworth is a registered nurse and has a doctorate in health services organization and policy. She has worked in health care for more than 45 years, according to a brief bio that Kennedy posted to X. She's a regional director for the National Association of Catholic Nurses. She has served as a consumer representative to the FDA's Vaccines and Related Biological Products Advisory Committee, or VRBPAC, and on subcommittees for HHS's National Vaccine Advisory Committee, along with other federal and congressional appointments. She has been a board member of the National Vaccine Information Center, a group that says it 'is dedicated to preventing vaccine injuries and deaths through public education and advocating for informed consent protections in medical policies and public health laws.' Articles and videos on its website say that vaccine injuries are common while the benefits of immunizations are questionable, call for more study of vaccines on the childhood schedule and promote the false idea that vaccines cause autism. As part of that group, Pebsworth made 'Ask Nurse Vicky' videos talking about vaccine injuries and informed consent. In one of the videos, she shared that she believes her son was injured by vaccines he received during a routine doctor's visit when he was 15 months old. In 2009, disgraced British physician Andrew Wakefield introduced Pebsworth's son before he sang and played keyboards at an autism dinner. Wakefield helped cause a worldwide panic in 1998 after he published a study suggesting that vaccines cause autism, but many subsequent studies have disproven the link. He was stripped of his medical license in 2010. Wakefield called Pebsworth 'my great friend.' Pebsworth did not respond to CNN's request for comment. Kennedy listed Dr. Michael Ross as a clinical professor at George Washington University and Virginia Commonwealth University, although Ross is not currently employed at either institution. A VCU spokesperson told CNN that Ross was an affiliate faculty member with the School of Medicine's Inova Campus from 2006 to 2021, when the VCU and Inova partnership ended. A spokesperson for GWU said Ross began working at the university in 1979, but he has not had a faculty appointment there since 2017. His LinkedIn lists his work there ending in May 2025. The Virginia-based obstetrics and gynecology physician announced a month ago that he had joined Manta Pharma, a Maryland biotech firm focused on AI-based delivery of therapies for autoimmune diseases, diabetes, drug addiction and HIV/AIDS. Ross' other current employer, private equity group Havencrest Capital Management, describes him as a 'serial CEO' who has served on the boards of multiple private health care companies. On his LinkedIn page, Ross says that while CEO of a generic pharmaceutical company, he engineered the acquisition of a stem cell company 'and an investment in a vaccine company.' Ross previously served as president of CPL Inc., the North American division of Indian generic drugmaker Cadila Pharmaceutical, and was a board member of the Generic Pharmaceutical Association. Ross did not respond to a request for comment on the vaccine company investment and potential recusals while serving on ACIP. CNN's Andrew Kaczynski and Em Steck contributed to this report.