Latest news with #FDA
Daily Mail
25 minutes ago
- Health
- Daily Mail
Cannabis linked to new 'silent' disease that can kill with no warning signs
Once believed to have minimal long-term side effects, cannabis has now been found to increase the risk of deadly liver damage. A team from the FDA 's Center for Drug Evaluation and Research conducted a randomized double-blind clinical trial – the gold standard for scientific research – involving more than 200 people. Researchers mainly watched for dangerous liver enzyme spikes in people who consumed cannabis. They found eight CBD users developed spikes above the safe threshold, with seven dropping out due to liver concerns between weeks three and four. However, everyone's liver tests normalized after quitting CBD. CBD comes from the marijuana plant, but does not contain THC, the psychoactive chemical that causes a high. The legal substance comes in gummies, tablets, and oils and is generally used to treat aches and pains, though its efficacy is still in question. Marijuana, which induces a mind-altering state and euphoria, has long been thought of as a relatively harmless substance with fewer side effects and risks than alcohol, tobacco, and illegal drugs. Around 62 million Americans 12 and older have used marijuana in the past year and approximately 18 million people use it daily. Chronic cannabis use may affect memory and motivation, while acute use raises heart rate. Some studies link long-term use to heart attack and stroke risks. Rarely, heavy use causes severe, painful vomiting, which can often only be relieved by hot showers. Long-term marijuana use has come under the microscope in recent years on the heels of nationwide laws and ballot measures that legalized marijuana use in adults for medicinal and/or recreational use. Researchers said: 'There are knowledge gaps surrounding potential health risks associated with CBD at doses consistent with unregulated consumer products, including liver damage and male reproductive harm.' Eight of the participants were given 2.5mg of CBD per 2.2lbs of their bodyweight twice a day. They showed higher levels than normal of liver enzymes, which help speed up chemical reactions in the body for metabolism and digestion. High levels of liver enzymes can damage liver cells, and in the study, nearly five percent of participants met the criteria for drug-induced liver injury. However, their enzyme levels returned to normal within about a week after stopping CBD. Healthy people in the study were randomly assigned either CBD – 151 people – or a placebo – 50 people – for 28 days twice a day. The study's main goal was to see how many people had liver enzyme levels (alanine aminotransferase or aspartate aminotransferase) spike to at least three times the normal limit while taking the substance. Liver damage accumulates often without the person knowing, though elevated liver enzymes can cause fatigue, yellowing of the skin or eyes, dark urine, and abdominal pain. Subjects did not display symptoms. Seven people showed signs of possible liver damage from the treatment—two at the three-week mark and five after four weeks—leading them to stop the study early. Healthy volunteers were screened, then stayed overnight at the clinic before starting 28 days of taking either CBD or a placebo at home. They returned for checkups on days seven, 14, 21, and 28, with a final follow-up on day 35. Blood tests tracked liver health and hormones throughout, including testosterone and thyroid levels, compared to the placebo group. Two people had to drop out at week three due to enzyme levels up to five times higher than normal and high white blood cells, while five people dropped out a week later due to enzyme levels greater than five times higher than normal. Liver enzyme levels began to climb by week three and peaked one or two days after people stopped taking CBD before eventually returning to baseline levels. CBD did not cause any changes to testosterone level and thyroid function. While this study only assessed short-term CBD use, the delayed onset of elevated liver enzymes—which occurred without noticeable symptoms—suggests potential risks could still exist with longer-term use, even at doses at or below 5 mg per 2.2lbs per day. Their findings were published in the JAMA Internal Medicine. Liver damage progresses silently, allowing harm to go undetected without regular blood test monitoring or discontinuing CBD. In rare cases, drug-induced liver injury could lead to liver failure or require a liver transplant, but it often reverses if the cause is stopped - such as a certain medication. There are about 14 to 19 cases per 100,000 people - or 2.7 to 3.8million. CBD is popular, with a 2023 study showing that about a fifth of Americans are using it, often at high doses. A survey that same year of more than 5,600 people found nearly a quarter of them consumed more than 200mg daily. 'This clinical trial is part of the FDA efforts to understand the safety of CBD products and inform discussions about safeguards and oversight to manage and minimize risks with CBD products,' the researchers concluded. 'These findings may have important implications for consumers who may otherwise be unaware of potential safety risks.'
NBC News
31 minutes ago
- Health
- NBC News
Even low doses of CBD may cause harm to the liver in some people, FDA study finds
A new clinical trial suggests there are still ongoing questions about the safety of even low doses of cannabidiol, even as CBD capsules, gummies, edibles, oils and lotions have become increasingly omnipresent in the United States in recent years. Scientists from the Food and Drug Administration's Division of Applied Regulatory Science carried out a randomized double-blind placebo-controlled trial last year to assess how low-dose CBD affects liver function in a group of healthy middle-aged men and women. Over the course of four weeks, 201 volunteers received either 5 mg per kilogram of body weight (approximately 2.3 mg per pound or the equivalent of 350 mg for a 154-pound individual) of oral CBD, or a placebo. The goal was to give them a typical amount that might be used by consumers. Participants also underwent weekly laboratory assessments. While the vast majority of people in the trial were unaffected, 5% showed greatly elevated levels of the liver enzyme aminotransferase, a known marker of liver cell damage or inflammation, according to the study published Monday in JAMA Internal Medicine. Women appeared to be more vulnerable than men. The liver enzyme returned to normal within one or two weeks of stopping CBD. Seven participants withdrew from the trial because they were showing clinical signs of potential drug-induced liver injury. The FDA didn't respond immediately to a request for comment. 'This is a significant finding, as it suggests that CBD itself, even in the absence of other drugs, may pose a risk to liver health,' says Amir Englund, a researcher at King's College London who studies cannabinoid psychopharmacology, and was not involved in the new trial. 'The results have important implications for individuals using over-the-counter CBD supplements. Many may be unaware of the potential for liver injury and assume that CBD is entirely benign.' Between 2014 and 2022, CBD product sales in the U.S. increased from $108 million to $1.9 billion, after a landmark bill passed by the Trump administration in 2018 enabled the unrestricted sale of cannabis products containing less than 0.3% THC, the psychoactive element which gets users high. According to various surveys in recent years, the majority of people in the U.S. have now heard of CBD, and around 20% have reported using CBD products in the past 12 months. While CBD products have become a popular way to self-medicate for conditions including pain, anxiety, insomnia and depression, especially among older adults, there's been little evidence on how well they work or guidance on how to use the products safely. Symptoms of liver injury Signs of liver injury include abdominal discomfort, jaundice or yellowing of the skin and eyes, and fatigue. However, research has shown that drug-induced liver injuries don't always become immediately apparent. In the FDA trial, only one of the participants with elevated liver enzymes noticed any symptoms within four weeks. The authors suggested that users may not realize that they are incurring harm and that doctors should ask about regular CBD use as part of routine medical screening. 'This was an important observation from the study,' said Paul Watkins, professor of pharmacy at the University of North Carolina at Chapel Hill. 'When doctors get liver chemistry results back and they're out of whack, they should be aware to ask, 'Were you taking CBD?' Because a lot of people are.' The new trial is not the first study to suggest potential health risks relating to cannabidiol and its effects on the liver. Such concerns were initially described following an FDA review of clinical trial data on CBD-based prescription drugs for childhood epilepsy, with raised liver enzymes being observed in 14% of participants. 'In clinical trials involving epilepsy patients, elevated levels of liver enzymes were among the leading causes of withdrawal from the trials due to serious adverse events,' Englund said 'However, those participants were concurrently taking other anti-epileptic medications, which could have contributed to the observed liver effects.' Watkins was subsequently involved in research investigating why CBD can affect liver cells, and he said that certain doses seem to have an effect similar to acetaminophen, or paracetamol. 'It's interesting because it's also been shown that healthy adults, when they get recurrent therapeutic doses of paracetamol, also have these liver chemistry abnormalities,' Watkins said. In the U.S., acetaminophen, when taken in excess, is among the most common causes of drug-induced liver injury, also called toxic hepatitis. In the last few years, research studies have shown that people most at risk of liver injury are those taking very high oral doses of CBD, exceeding 1000 mg per day. There have still been reports of drug-induced liver injuries in some healthy individuals taking moderate doses of anywhere between 300 mg and 1000 mg per day. Relatively little is known about why some people are more susceptible than others, but it is thought that genetic factors may play a role. According to Englund, CBD can inhibit certain enzymes in the liver which are needed for metabolizing medications. In the new FDA trial, the majority of participants who experienced the most serious liver problems also developed signs of an immune condition called eosinophilia, which is when the body produces an excess of a type of white blood cell called eosinophils. The new results emphasize the importance of tracking liver safety as a potential, unintended adverse effect, Englund said. 'Given the growing interest in CBD as a potential treatment for conditions such as psychosis and cannabis use disorder, these findings underscore the importance of monitoring liver enzyme levels in future clinical trials,' he said. Overall, Watkins — who co-chairs the Drug-Induced Liver Injury Network, a research group backed by the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health — still believes CBD is relatively safe. While over-the-counter supplements are becoming a growing potential cause of significant liver injuries, CBD has yet to be flagged as a source of concern, he said. 'Overall, the liver is very good at adjusting to sources of drug stress [indicated by elevated enzymes],' Watkins said, noting the network hasn't detected a case of serious liver injury attributed to CBD. "There could be people out there whose liver doesn't adjust very well, and as companies compete for market share, you might start getting more potent CBD which could push people into the ranges where they're getting into trouble, but the data we've got suggests it's very safe.'
Yahoo
34 minutes ago
- Business
- Yahoo
Celularity Hails New Florida Law Opening Patient Access to Stem Cell Therapies
New law goes into effect on July 1st authorizing Florida physicians to provide stem cell therapies to their patients for orthopedics, wound care, and pain management FLORHAM PARK, N.J., July 01, 2025 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) ('Celularity' or the 'Company'), a regenerative and cellular medicine company, today hailed a new Florida law taking effect today that opens the door to physicians' use of investigational stem cell therapies in the state in orthopedics, wound care, and pain management. 'Today, a groundbreaking new law takes effect in Florida authorizing physicians to provide stem cell therapies to their patients subject to strict requirements ensuring patient safety and ethical standards,' said Robert J. Hariri, M.D., Ph.D., Celularity CEO and Chairman. 'Celularity is fully prepared to supply the ethically sourced stem cells which enable these treatments, and we look forward to working with Florida physicians to make these innovative therapies available to patients.' The new law authorizes Florida physicians to provide stem cell therapies that have not yet been approved by the US Food and Drug Administration, or FDA, and imposes strict limits on the permissible sources of the stem cells used, which must be manufactured, stored and retrieved in facilities that are FDA registered and certified or accredited by approved organizations. Approved facilities must comply with Good Manufacturing Practices, which are FDA-established standards that mandate strict controls on facilities, processes, and quality control. Additionally, physicians must obtain patient informed consent prior to administering treatments authorized under the new law. 'We applaud Florida's intention to advance medical treatments and improve patient outcomes with this balanced approach to fostering medical innovation while upholding ethical standards,' said Dr. Hariri. 'Celularity is the long-standing leader in the field of ethically sourced stem cell therapies with extensive knowledge and real world data obtained from multiple clinical trials, including wound care and other therapeutic targets authorized under the new Florida law.' In 2001, Celularity's predecessor organization, Anthrogenesis Corporation (later Celgene Cellular Therapeutics) announced a groundbreaking discovery of a method to recover a then-novel kind of stem cell from the postpartum human placenta. President George W. Bush acknowledged this transformational discovery around ethically sourced stem cells in his landmark August 2001 speech on stem cell research. 'We believe Florida's physician-focused approach is a model for other states, insofar as physicians are ideally positioned to assess which therapeutic approach is in a patient's best interest, including investigational stem cell therapies,' said Dr. Hariri, noting the Florida Medical Association's statement that it 'was extensively involved in the crafting of this legislation and sought to ensure that a proper balance was struck between protecting the public from bogus therapies and preventing physician overregulation.' Celularity operates a purpose-built cell therapy manufacturing and storage/retrieval facility with hundreds of units of placenta-derived stem cells in inventory for use in investigational therapies including those authorized under the new Florida law. Celularity's facility is FDA registered and certified/accredited as required by the new Florida law. 'Celularity is positioned right now to supply the stem cells necessary to fulfill the objectives of the new Florida law and we look forward to working with Florida physicians to ensure their patients have access to stem cell therapies,' said Dr. Hariri. About Celularity Celularity Inc. (Nasdaq: CELU) is a regenerative and cellular medicine company developing and commercializing advanced biomaterial products and allogeneic, cryopreserved, placental-derived cell therapies, all derived from the postpartum placenta. Celularity believes that by harnessing the placenta's unique biology and ready availability, it can develop therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies. For more information about Celularity and its cutting-edge regenerative medicine solutions, please visit Forward Looking StatementsCertain statements in this press release are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding: (i) our future sales or sales growth; (ii) our expectations for future financial results, including levels of net sales; (iii) our expectations regarding new products including our 510K products; and (iv) future demand for our products. All statements other than statements of historical facts are 'forward-looking statements,' including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as 'anticipate,' 'believe,' 'can,' 'could,' 'continue,' 'expect,' 'improving,' 'may,' 'observed,' 'potential,' 'promise,' 'should,' and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Forward-looking statements are based on Celularity's current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Many factors could cause actual results to differ materially from those described in these forward-looking statements, including those risk factors set forth under the caption 'Risk Factors' in Celularity's annual report on Form 10-K and Form 10-K/A for the year ended December 31, 2024 filed with the Securities and Exchange Commission (SEC) on May 8, 2025 and May 21, 2025, respectively, and other filings with the SEC. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Celularity does not presently know, or that Celularity currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, these forward-looking statements reflect Celularity's current expectations, plans, or forecasts of future events and views as of the date of this communication. Subsequent events and developments could cause assessments to change. Accordingly, forward-looking statements should not be relied upon as representing Celularity's views as of any subsequent date, and Celularity undertakes no obligation to update forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. Carlos RamirezSenior Vice President, Celularity in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Time Business News
an hour ago
- Business
- Time Business News
Why Do US Printers Trust These Flexo Ink Suppliers for Superior Print Quality?
Flexographic printing, commonly known as flexo printing, has become a preferred choice for packaging and label production across the United States. Known for its speed, efficiency, and ability to print on various substrates, flexo printing requires one key component for exceptional results: high-quality ink. As more printers look to deliver sharper, more consistent results to clients, the role of reliable flexo ink suppliers has become more critical than ever. In this blog, we examine why US printers are placing their trust in specific flexo ink suppliers to achieve superior print quality. From formulation excellence to customer support and innovation, we delve into the top reasons behind this trust. One of the main reasons US printers trust top flexographic ink suppliers is their commitment to high-performance ink formulations. Leading suppliers use advanced chemical engineering to ensure their inks provide excellent adhesion, fast drying times, and high color strength. These characteristics are crucial for producing consistent and vibrant prints on various surfaces like plastic films, paper, and foil. In a competitive printing market, consistency can make or break a brand. Trusted ink suppliers offer products that perform reliably across long print runs, which is essential for packaging companies that operate at scale. Trust also stems from a supplier's ability to meet rigorous quality control standards. Flexo ink suppliers trusted by US printers adhere to federal and industry-specific regulations, including FDA guidelines for food packaging, VOC regulations, and ASTM standards. These companies conduct extensive testing to ensure batch consistency, color accuracy, and overall ink stability. This attention to quality and compliance not only safeguards the end product but also ensures peace of mind for printers and brand owners alike. Flexographic printing is constantly evolving. With trends such as eco-friendly packaging and digital workflow integration gaining momentum, printers need ink suppliers who are agile and forward-thinking. Top flexo ink suppliers are investing in R&D to develop low-VOC, water-based, and UV-curable ink options that meet sustainability goals without compromising performance. US printers trust these suppliers because they stay ahead of the curve, helping businesses transition smoothly into the future of packaging. No two printing operations are exactly alike. Whether it's flexible packaging, corrugated boxes, labels, or shrink sleeves, each requires tailored ink solutions. Reliable flexographic ink suppliers work closely with printers to understand their specific needs and provide customized ink formulations. This collaboration ensures better print performance and improved productivity, making suppliers valuable partners in the printing process. Printers trust these companies not just for products but also for their problem-solving capabilities. Another reason US printers favor certain flexographic ink suppliers is their exceptional technical support. Leading suppliers offer on-site assistance, press-side troubleshooting, and training for press operators. These services minimize downtime and ensure smooth operations. The assurance that help is available when needed builds long-term trust. Printers know that with the right supplier, they are never alone in resolving production challenges. Speed is a crucial factor in the printing business. Printers cannot afford delays in ink supply, especially for time-sensitive projects. Flexo ink suppliers trusted by US printers have efficient logistics networks and multiple distribution centers to ensure fast and reliable delivery. This logistical advantage gives printers confidence that they will receive their ink on time, every time, which keeps production schedules on track and customers satisfied. As sustainability becomes a top priority for many US brands, printers are under pressure to use eco-friendly materials. Trusted flexo ink suppliers lead the charge by offering inks that are low in VOCs, heavy-metal free, and compliant with green certifications. Printers can rely on these suppliers to help them meet environmental regulations and improve their sustainability image without compromising print quality. While quality is essential, cost also plays a significant role. US printers trust flexo ink suppliers who offer the right balance between cost and performance. These suppliers provide cost-effective solutions that reduce waste, lower ink consumption, and increase overall efficiency. This value-driven approach ensures a higher return on investment and contributes to long-term business success. Reputation matters. Printers often rely on peer recommendations, case studies, and proven success stories when selecting an ink supplier. Leading flexographic ink suppliers have built strong reputations through years of reliable service, innovation, and quality. Their proven track record makes them a preferred choice among US printers who want dependable results and professional collaboration. The best suppliers don't rest on their achievements. They continuously improve their ink systems, invest in new technologies, and expand their product lines. This ongoing innovation helps printers stay competitive and meet the evolving demands of modern printing. Printers trust suppliers who are committed to progress because it signals a partnership that will remain relevant and productive in the long run. One notable name in the flexographic ink industry is Vanguard Inks and Coatings. Known for its dedication to quality, innovation, and customer satisfaction, Vanguard has earned the trust of numerous US printers. Its product range includes water-based, UV, and specialty flexo inks tailored to meet the demands of various applications. What sets Vanguard apart is not just its top-tier ink formulations but also its personalized technical support, quick delivery services, and commitment to sustainable practices. Printers who work with Vanguard benefit from consistent print quality, reduced downtime, and a partner who understands the nuances of the printing process. If you're seeking a reliable and experienced flexo ink supplier in the US, Vanguard Inks and Coatings is a name worth exploring. In the fast-paced and quality-driven world of printing, the choice of ink supplier can significantly impact your results. US printers continue to trust leading flexographic ink suppliers because they offer more than just ink—they deliver performance, support, innovation, and peace of mind. By partnering with reliable suppliers like Vanguard Inks and Coatings, printers gain a competitive edge and the confidence to exceed client expectations. For anyone in the printing business aiming for superior print quality, choosing the right ink partner is not just a decision—it's a strategic move. Q1. What makes a flexographic ink supplier trustworthy for US printers? A trustworthy supplier offers consistent quality, complies with US regulations, provides excellent customer service, and delivers on time. Innovation and sustainability are also key trust factors. Q2. Are water-based flexo inks better than solvent-based inks? Water-based inks are more environmentally friendly and suitable for porous substrates like paper and cardboard. However, solvent-based inks may be preferred for certain non-porous materials. The best choice depends on the application. Q3. How do flexographic ink suppliers support printers with technical issues? Top suppliers provide technical support through on-site visits, troubleshooting assistance, ink testing, and press operator training to ensure uninterrupted operations and optimal print results. Q4. What role does sustainability play in choosing an ink supplier? Sustainability is increasingly important. Suppliers offering low-VOC, heavy-metal-free, and recyclable ink options help printers meet environmental standards and align with eco-conscious brand values. Q5. Why should I consider Vanguard Inks and Coatings as my supplier? Vanguard Inks and Coatings offers high-quality, custom-formulated flexographic inks with quick delivery, expert support, and a strong focus on sustainability—making them a top choice for US printers. TIME BUSINESS NEWS
Indian Express
an hour ago
- Health
- Indian Express
Substandard edible oil found in Nandurbar: Minister warns of action
Several edible oil samples collected in Nandurbar district have failed to meet food safety standards, and action will be taken against the guilty, Food and Drug Administration (FDA) Minister Narhari Zirwal informed the Maharashtra Legislative Assembly during Question Hour on Monday. The matter was raised by MLA Aamshya Padvi, with follow-up questions from members Sameer Kunawar and Hiraman Khoskar. Responding to the question in the Lower House, Minister Zirwal said that on March 10, the FDA inspected the Gopal Provision Store in Akkalkuwa. During the inspection, samples of Mahika brand refined soybean oil and Kamla brand groundnut oil were collected for testing. Preliminary reports indicated that the samples were substandard as per food safety norms. Following an appeal by the vendor, the samples were sent for further analysis to the Central Food Technological Research Institute (CFTRI) in Mysuru. Zirwal added that in the financial year 2024–25, 12 edible oil samples were tested in the district, of which five were found to be of inferior quality. 'Out of these, legal action has been initiated in two cases under the Food Safety and Standards Act, 2006. The remaining three are awaiting final reports from referral laboratories,' the minister said. Zirwal told the House that strict measures will be taken against those found violating food safety norms.
