West Virginia bans 7 artificial food dyes, citing health concerns
On Monday, West Virginia Gov. Patrick Morrisey signed into law a bill that was passed earlier by legislators to eliminate seven artificial dyes — Red Dye No. 3, Red Dye No. 40, Yellow Dye No. 5, Yellow Dye No. 6, Blue Dye No. 1, Blue Dye No. 2 and Green Dye No. 3 — from food products and drugs sold in the state. The preservatives butylated hydroxyanisole and propylparaben will also be banned.
The dyes will not be allowed in meals served as part of school nutrition programs starting on Aug. 1 this year, while the dyes and the two preservatives will not be permitted in drugs and food sold in the state starting on Jan. 1, 2028, according to the governor's office.
"West Virginia ranks at the bottom of many public health metrics, which is why there's no better place to lead the Make America Healthy Again mission," Morrisey said in a statement, citing the campaign slogan popularized by Health and Human Services Secretary Robert F. Kennedy Jr., who has said he is prioritizing the removal of artificial dyes from food and drinks sold around the United States. "By eliminating harmful chemicals from our food, we're taking steps toward improving the health of our residents and protecting our children from significant long-term health and learning challenges."
The latest ban in West Virginia follows a pair of laws passed in California in recent years to remove some additives from foods sold statewide and synthetic dyes from school meals. Dozens of other U.S. states have introduced legislation to ban or more strictly regulate certain food additives, including artificial dyes, since the beginning of the year, according to the Environmental Working Group, an advocacy organization focused on food safety.
Thirty-six color additives are approved by the Federal Drug Administration for use in food and drinks in the U.S., including nine artificial dyes.
Rising concerns from advocacy groups and scientists about possible health consequences of synthetic food components, particularly for children, prompted the FDA to undertake a new effort in December to review previously approved additives, although the agency's deputy commissioner for human foods warned at the time that budget restrictions might prevent a timely turnaround. In January, the FDA announced its decision to revoke the authorization for one dye, Red 3, to be added to foods, after evidence showed a link between the dye and cancer in laboratory animals.
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Business Wire
28 minutes ago
- Business Wire
Rocket Pharmaceuticals Announces FDA Has Lifted the Clinical Hold on the Pivotal Phase 2 Trial of RP-A501 for the Treatment of Danon Disease
BUSINESS WIRE)-- Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a fully integrated, late-stage biotechnology company advancing a sustainable pipeline of genetic therapies for rare disorders with high unmet need, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Company's pivotal Phase 2 trial of RP-A501 for the treatment of Danon disease. The hold was lifted in under three months, underscoring the efficiency of the FDA's review process and Rocket's commitment to expeditiously optimize safety and resume the trial. In its correspondence, the FDA confirmed that Rocket satisfactorily addressed issues outlined in the clinical hold. The FDA authorized the pivotal study to resume first with a recalibrated dose of 3.8 x 10¹³ GC/kg of RP-A501 in three patients, treated sequentially with a minimum four-week interval between each treatment. This adjusted dose aligns with the lower range of administered doses that were associated with efficacy across multiple biomarkers, echocardiographic and clinical endpoints in the Phase 1 study, and has been determined as most likely to confer the safety and efficacy identified in the low-dose Phase 1 cohorts. In addition, Rocket will collaborate with investigators to implement an immunomodulatory regimen more closely reflecting that administered in the Phase 1 pediatric cohort. The revised regimen discontinues prophylactic use of a C3 complement inhibitor, while maintaining sirolimus, rituximab, and steroids. Additionally, the protocol will specify a lower threshold for administering a C5 inhibitor (eculizumab) in response to impending complement activation. To date, six patients with Danon disease have been treated in the Phase 2 study with RP-A501. Further updates about the Phase 2 study can be expected following review of data from the next three patients. RP-A501 Phase 2 Pivotal Trial Overview The global, single-arm, multi-center 12-patient Phase 2 pivotal trial evaluates the efficacy and safety of RP-A501 for the treatment of Danon disease. The trial began with a pediatric safety run-in (n=2) and treated a total of six patients at a dose level of 6.7 x 10 13 GC/kg. Per alignment with the FDA upon lifting of the clinical hold, three additional patients are expected to be treated at a dose level of 3.8 x 10 13 GC/kg with a minimum four-week interval between dosing, followed by additional patients to complete the trial. To support accelerated approval, the study assesses the efficacy of RP-A501 as measured by the biomarker-based co-primary endpoint consisting of improvements in LAMP2 protein expression, and reductions in left ventricular mass. The key secondary endpoint is change in troponin. 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RP-A501 consists of a recombinant adeno-associated serotype 9 (AAV9) capsid containing a functional version of the human LAMP2B transgene ( which is administered as a single intravenous (IV) infusion. In clinical studies, RP-A501 has been shown to target cardiac cells (cardiomyocytes) and deliver the functional LAMP2B gene to heart tissue, which led to improved cardiac structure and function in patients. RP-A501 holds FDA RMAT, Fast Track, Rare Pediatric, and Orphan Drug designations in the U.S. along with ATMP and PRIME designations in the EU. About Danon Disease Danon disease is a rare X-linked inherited, multi-organ lysosomal-associated disorder with a devastating clinical course. The causative mutation has been identified in the gene encoding for lysosome-associated membrane protein, otherwise known as LAMP2, an important mediator of autophagy and primarily expressed in heart, skeletal muscle and brain tissue. This mutation results in accumulation of autophagosomes and glycogen, particularly in cardiac muscle and other tissues, which ultimately leads to heart failure, and for male patients, frequent death during adolescence or early adulthood. The only available treatment option for Danon disease is cardiac transplantation, which is associated with substantial complications and is not considered curative, representing the high unmet medical need for patients with Danon disease. It is estimated to have a prevalence of 15,000 to 30,000 patients in the U.S. and Europe. In 2023, Rocket secured an ICD-10 code from the Centers for Medicare and Medicaid Services (CMS) to document patients with LAMP2 deficiency in Danon disease. About Rocket Pharmaceuticals, Inc. Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) is a fully integrated, late-stage biotechnology company advancing a sustainable pipeline of investigational genetic therapies designed to correct the root cause of complex and rare disorders. Rocket's innovative multi-platform approach allows us to design the optimal gene therapy for each indication, creating potentially transformative options that enable people living with devastating rare diseases to experience long and full lives. Rocket's adeno-associated viral (AAV) vector-based cardiovascular portfolio includes a late-stage clinical program for Danon Disease, a devastating heart failure condition resulting in thickening of the heart, and an early-stage clinical program for PKP2-arrhythmogenic cardiomyopathy (ACM), a life-threatening heart failure disease causing ventricular arrhythmias and sudden cardiac death. Rocket has also received IND clearance for its AAV-based gene therapy for BAG3-associated dilated cardiomyopathy (DCM), a heart failure condition that causes enlarged ventricles. 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Rocket Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements concerning Rocket's future expectations, plans and prospects that involve risks and uncertainties, as well as assumptions that, if they do not materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. All statements other than statements of historical facts contained in this release are forward-looking statements. You should not place reliance on these forward-looking statements, which often include words such as 'could,' 'believe,' 'expect,' 'anticipate,' 'intend,' 'plan,' 'will give,' 'estimate,' 'seek,' 'will,' 'may,' 'suggest' or similar terms, variations of such terms or the negative of those terms. These forward-looking statements include, but are not limited to, statements concerning expectations regarding the safety and effectiveness of product candidates that Rocket is developing to treat Fanconi Anemia (FA), Leukocyte Adhesion Deficiency-I (LAD-I), Pyruvate Kinase Deficiency (PKD), Danon Disease (DD) and other diseases, the expected timing and data readouts of Rocket's ongoing and planned clinical trials, the expected timing and outcome of Rocket's regulatory interactions and planned submissions, including the timing and outcome of the FDA's review of the additional CMC information that Rocket will provide in response to the FDA's request, the safety, effectiveness and timing of pre-clinical studies and clinical trials, Rocket's ability to establish key collaborations and vendor relationships for its product candidates, Rocket's ability to develop sales and marketing capabilities or enter into agreements with third parties to sell and market its product candidates, Rocket's ability to expand its pipeline to target additional indications that are compatible with its gene therapy technologies, Rocket's ability to transition to a commercial stage pharmaceutical company, and Rocket's expectation that its cash, cash equivalents and investments will be sufficient to fund its operations into the second quarter of 2027. Although Rocket believes that the expectations reflected in the forward-looking statements are reasonable, Rocket cannot guarantee such outcomes. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Rocket's dependence on third parties for development, manufacture, marketing, sales and distribution of product candidates, the outcome of litigation, unexpected expenditures, Rocket's competitors' activities, including decisions as to the timing of competing product launches, pricing and discounting, Rocket's ability to develop, acquire and advance product candidates into, enroll a sufficient number of patients into, and successfully complete, clinical studies, the integration of new executive team members and the effectiveness of the newly configured corporate leadership team, Rocket's ability to acquire additional businesses, form strategic alliances or create joint ventures and its ability to realize the benefit of such acquisitions, alliances or joint ventures, Rocket's ability to obtain and enforce patents to protect its product candidates, and its ability to successfully defend against unforeseen third-party infringement claims, as well as those risks more fully discussed in the section entitled 'Risk Factors' in Rocket's Annual Report on Form 10-K for the year ended December 31, 2024, filed February 27, 2025 with the SEC and subsequent filings with the SEC including our Quarterly Reports on Form 10-Q. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and Rocket undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
NBC News
an hour ago
- NBC News
Doctors say medical misinformation has gotten worse, survey finds
A survey of doctors released Wednesday showed how pervasive medical falsehoods have become — not only online, but also within the walls of medical exam rooms where doctors and patients talk. The survey from the Physicians Foundation, a nonprofit research group, found that 61% of doctors said they encountered patients influenced by misinformation or disinformation a moderate amount or a great deal of the time over the past year. An overwhelming majority of physicians, 86%, said the incidence of such falsehoods among patients had increased over the past five years, a period that includes most of the Covid pandemic, with 50% saying it had increased significantly. The survey is a rare look into how often doctors encounter pseudoscience in their everyday practice of medicine, and it indicates how their jobs are changing in response to a new information environment in which distorted health claims spread easily online and sometimes have the backing of government authorities. Dr. Gary Price, president of the Physicians Foundation, said the organization set out to conduct the survey because it knew doctors were frustrated by medical falsehoods and wanted to find out the extent of the problem. 'It's frustrating. It's demoralizing,' he said in a phone interview. 'It cuts to the core of what motivates most physicians, and that's a desire to help people in the most fundamental of ways. And in a way, it's a repudiation of all the different things that lead people to practice medicine.' A majority of doctors in the survey, 57%, said they believed misinformation and disinformation had at least a moderate impact on their ability to provide quality care to patients. Price, a plastic surgeon, said medical falsehoods are making physicians' jobs harder or, in some cases, impossible. He said one of his patients decided to cancel an operation during the Covid pandemic because the patient refused to take a Covid test, not believing the virus was dangerous. 'Even though you feel personally responsible for your patient's health and, in many ways, the system holds you responsible for it, you no longer have any reasonable control over the outcome,' he said. For doctors, he added, 'that's a setup for burnout.' False health claims are widespread, especially on the internet, and they affect a wide array of subjects, from vaccines to dietary supplements. The survey did not ask about specific types of misinformation, but its respondents were a cross-section of the profession: primary care physicians and specialists, early-career doctors and more experienced ones, and doctors in urban, suburban and rural areas. The online survey of 1,002 physicians was conducted in May. The survey arrives when misinformation appears to be on the upswing, both online and in the federal government. Health and Human Services Secretary Robert F. Kennedy Jr., who has a history of making false or misleading claims about vaccines and other topics, has continued to attack medical research and worry infectious disease experts with his actions and rhetoric since he took office. Anti-vaccine myths surged on social media ahead of this month's shooting at the Centers for Disease Control and Prevention headquarters in Atlanta. The gunman blamed a Covid vaccine for his mental health issues, including depression, despite no clear evidence showing a link. Price said Kennedy and others in authority have a duty to be accurate. 'Public health officials, elected or not, have a fundamental obligation to make sure that the public gets information that's accurate and that can be trusted and ... to continue to ensure that the entire system can be trusted,' he said. A representative for Kennedy did not immediately respond to a request for comment Tuesday, ahead of the survey's release. Dr. Seema Yasmin, a clinical assistant professor of medicine at Stanford University who was not involved in the survey, said the results show the very difficult position that medical professionals are in. 'It's too much to expect a physician or nurse practitioner, for example, to address complex, deep-seated beliefs in an eight-to-twelve minute consult,' she said in an email. 'Healthcare workers are on the frontlines, they are hearing pseudoscientific statements day in and day out, and it takes great effort to correct these and to provide accurate information to patients, while maintaining relationships in which patients can share things they've heard or that they believe,' she said. Yasmin, author of ' What the Fact?,' a book about media literacy and conspiracy theories, said further research could look at how many physicians admit to having fallen for false information themselves. 'Sadly, sometimes our colleagues fall for the falsehoods, too,' she said. 'We need to be aware of our own vulnerabilities.' The Physicians Foundation was founded in 2003 with proceeds from a class action settlement, in which doctors sued health insurance companies over billing practices. It provides grants to universities, hospitals and other institutions for medical research and to address physician well-being. At least one other survey of physicians has shown similar results. In a 2023 survey by the de Beaumont Foundation, a public health organization, 72% of physicians said misinformation had made it harder to treat patients for Covid, and the same share said it had negatively affected outcomes. Other surveys have shown that misinformation spreads widely among the public. In an April poll, the nonprofit health policy foundation KFF found that 63% of U.S. adults had read about or heard about the false myth that the measles vaccine causes autism. Price said he would like to see more physicians turn to social media as part of their jobs to counter medical misinformation on the platforms where it often spreads. 'The medical profession needs to get into that channel of communications, but not just by posting studies there,' he said. 'We need to learn how to communicate better in that medium. We're just way behind. And I think the way I think about it, we need to be just as rigorous about examining the best way to do that as we are at trying to figure out the best ways to do an operation or develop a new medication.'
CNBC
an hour ago
- CNBC
Walmart shrimp may have been exposed to radioactive material, FDA says
The Food and Drug Administration said Tuesday that the public should avoid eating certain frozen shrimp sold at Walmart due to concerns that the seafood may have been contaminated with radioactive material. Health officials said in a news release that it is investigating reports of Cesium-137 (Cs-137) contamination in shipping containers and frozen shrimp products processed by an Indonesian company, PT. Bahari Makmur Sejati of Indonesia, also known as BMS Food. Some of the raw frozen shrimp products processed by an Indonesian company are sold at Walmart stores in 13 states, including Alabama, Arkansas, Florida, Georgia, Kentucky, Louisiana, Missouri, Mississippi, Ohio, Oklahoma, Pennsylvania, Texas and West Virginia, according to the FDA. Among the products includes Walmart's "great value brand frozen shrimp," the health agency said. "If you have recently purchased raw frozen shrimp from Walmart that matches this description, throw it away," the FDA said. "Do not eat or serve this product." Health officials advised people to talk to their health care providers if they think they've been exposed to elevated levels of the contaminant. PT. Bahari Makmur Sejati and Walmart did not immediately return requests for comment. Cs-137 is the radioactive form of Cesium, "a soft, flexible, silvery-white metal that becomes liquid near room temperature" used for medical devices and gauges, according to the Environmental Protection Agency. Repeated exposure to low doses of Cs-137 can increase the risk of cancer, "resulting from damage to DNA within living cells of the body," health officials said in their news release. The FDA said that the U.S. Customs and Border Protection alerted the health agency to the detection of Cs-137 in shipping containers in Los Angeles, Houston, Miami and Savannah, Georgia. It said that all containers and products that tested positive for Cs-137 were denied entry into the country. Health officials also cautioned that it did not detect Cs-137 in any product above the current derived intervention levels for Cs-137, of 1200 Bq/kg. However, the FDA said that "the level detected in the breaded shrimp sample could represent a potential health concern" if it is combined with radiation in the environment or from medical procedures.
