Fda

President Joe Biden's administration on Tuesday announced it would develop a policy requiring cigarette makers to reduce nicotine to non-addictive levels -- a move that would substantially cut nicotine levels in cigarettes and deal a powerful blow to the tobacco industry. If successful, the new US. standard could save millions of lives by the end of the century and shape a future in which cigarettes are no longer responsible for addiction and debilitating disease. The initiative requires the Food and Drug Administration to develop and then publish a rule that would likely be contested by industry. "The goal of the potential rule would be to reduce youth use, addiction and death," the FDA said. "Nicotine is powerfully addictive," said FDA Commissioner Robert Califf. "Making cigarettes and other combusted tobacco products minimally addictive or non-addictive would help save lives. "The U.S. Surgeon General has reported that 87 percent of adult smokers start smoking before age … [Read more...] about FDA to seek drastic cut in cigarettes’ nicotine content

The U.S. Food and Drug Administration ( FDA ) is poised to ban Juul Labs’ e-cigarettes from the market, according to a Wednesday report from The Wall Street Journal . “The marketing denial order would follow a nearly two-year review of data presented by the vaping company, which sought authorization for its tobacco- and menthol-flavored products to stay on the U.S. market,” the outlet reported, noting that the agency’s decision could come as soon as Wednesday. Juul — which markets itself as an alternative to cigarettes for adult smokers — sells nicotine capsules smoked through a small device. Sales surged nearly 800% between 2017 and 2018, causing Juul to gain a 68% market share in the e-cigarette category. The FDA’s move to ban Juul products comes months after President Biden’s Department of Health and Human Services planned to implement a $30 million grant program which allegedly would have involved handing out crack pipes to drug addicts as part of safe smoking … [Read more...] about Months After Crack Pipe Controversy, Biden’s FDA To Ban Popular E-Cigarette Products: Report | The Daily Wire

Millennials and hipsters beware: big government wants to come for your e-cigarettes if teenagers do not stop using them. On Wednesday, the Food and Drug Administration threatened to remove from the market some of the popular vaping products of five top-selling national brands unless they submit plans to prevent minors from using their products. “The agency is asking each company to submit to FDA within 60 days plans describing how they will address the widespread youth access and use of their products,” the FDA said in a statement. “If they fail to do so, or if the plans do not appropriately address this issue, the FDA will consider whether it would be appropriate to revisit the current policy that results in these products remaining on the market without a marketing order from the agency. This could mean requiring these brands to remove some or all of their flavored products that may be contributing to the rise in youth use from the market until they receive premarket … [Read more...] about The FDA Threatens To Ban Vaping Products Due To Teenage Use | The Daily Wire

THE FDA has announced that it was notified of another baby formula-related infant death, bringing the total casualties to ten, new documents show. This comes after an increasing number of infants have died since early 2021 due to the formula possibly being contaminated at a Michigan factory. Abbott began a recall of its formula product in February and closed the Michigan plant. The FDA previously reported that two children had died and two were sick due to the formula, but the number continues to grow. Over a week ago, the FDA said more reports were received of several children who had died or become sick after drinking the formula that allegedly has a dangerous bacteria. The formula from the Sturgis plant has contained the bacterium cronobacter sakazakii, experts believe. read more sun stories STRANGER THINGS I was the Pentagon’s UFO scientist - I’ve seen countless mystery objects KING'S HAUNTING WORDS Elvis made … [Read more...] about Baby formula warning after FDA investigates TENTH infant death linked to Abbott Laboratories

The US Food and Drug Administration is gearing up to ask Juul Labs to take its e-cigarettes off of US shelves. A decision could be announced as soon as Wednesday, according to a report in the Wall Street Journal . The FDA has been investigating the company over the past two years, as the company argues their products benefit public health. The verdict will decide whether they are effective in getting smokers to quit, and if so, whether that benefits the health damage caused to new users, many of whom are teenagers who never smoked previously. Juul has been on the FDA’s radar after their e-cigarettes became popular in 2017, particularly its fruity flavored cartridges. The brand came under scrutiny by the FDA over concerns that its product was targeting minors and had caused the number of young people vaping to spike. As a result, the FDA banned the sale of fruity and sweet flavors of e-cigarettes, hoping to deter minors from vaping. In the past, the agency … [Read more...] about FDA ‘set to ban Juul e-cigarettes in the US’

A federal court on Friday granted a request by Juul Labs to temporarily block an order by the Food and Drug Administration to stop selling its electronic cigarettes in the U.S. The e-cigarette maker had asked the U.S. Court of Appeals for the D.C. Circuit to stay what it calls an "extraordinary and unlawful action" by the FDA that would require it to immediately halt its business. The company, which is partly owned by tobacco giant Altria, filed an emergency motion with the appeals court as it prepares to appeal the FDA's decision. The FDA said Thursday that Juul must stop selling its vaping device and its tobacco and menthol flavored cartridges. The action was part of a sweeping effort by the agency to bring scientific scrutiny to the multibillion-dollar vaping industry after years of regulatory delays. To stay on the market, companies must show that their e-cigarettes benefit public health. In practice, that means proving that adult smokers who use them are likely to quit … [Read more...] about Federal court blocks FDA ban on Juul e-cigarette sales in U.S.

Juul Labs said Tuesday that the U.S. Food and Drug Administration ( FDA ) “overlooked” 6,000 pages of data the company says show its e-cigarette products led to less exposure to toxic chemicals. Last week, the regulatory agency issued a marketing denial order for Juul products after a two-year review of data presented by the company. However, the U.S. Court of Appeals for the D.C. Circuit approved a halt to the order on Friday after Juul argued that the FDA’s decision was “extraordinary and unlawful.” According to a report from The Wall Street Journal , Juul submitted court documents on Tuesday alleging that the FDA neglected to consider all of Juul’s evidence. Among other things, the agency told Juul that it failed to produce data on aerosols. Juul responded by saying that “the data is right there” in its original submission to the FDA, but regulators “simply overlooked the aerosol data it claimed it needed.” Juul said in the filings that its e-cigarettes contained … [Read more...] about ‘The Data Is Right There’: Juul Says The FDA ‘Overlooked’ Key Information Before Banning The Product | The Daily Wire

Published 19 August 2015 Share close Share page Copy link About sharing The US Food and Drug Administration has approved a libido-enhancing drug for women dubbed the "female Viagra". Flibanserin, a drug produced by Sprout Pharmaceuticals and marketed as Addyi, recently passed an FDA advisory committee meeting. It has been criticised as having only marginal benefits. Unlike Viagra, which affects blood flow to the genitals, Addyi is designed to help women regain their sex drive by boosting levels of brain chemicals. Sprout said trials had shown an increase "in the number of satisfying sexual events", although experts suggest the test results were modest. Versions of the pill have been submitted for approval in the past but never passed. It was rejected by the FDA twice for lack of effectiveness and side effects like nausea, dizziness and fainting. What is … [Read more...] about ‘Female Viagra’: Libido pill Addyi approved by FDA

Government advisers debated Tuesday if Americans should get a modified COVID-19 booster shot this fall -- and exactly how best to update it to fight a virus that surely will change even more by then. “That’s the problem -- we’re being asked to more or less have a crystal ball today,” said Dr. Arnold Monto of the University of Michigan, who heads the Food and Drug Administration’s vaccine advisory committee. Current COVID-19 vaccines have saved millions of lives globally and those used in the U.S. still offer strong protection against hospitalization and death -- especially after a booster dose. But their ability to block infection markedly dropped when the super-contagious omicron mutant emerged. Pfizer and Moderna tested shots updated to better match the omicron that surged over the winter, but that first mutant has disappeared -- replaced by its genetically distinct relatives. The two newest omicron cousins, called BA.4 and BA.5, now make up about half of U.S. … [Read more...] about FDA advisers debate updating COVID booster shots for fall

This week's train strikes, involving 40,000 workers and three days of disrupted travel, are the worst in three decades. Members of the RMT (Rail, Maritime and Transport Workers) union are calling for a 7% pay rise - which is below the latest inflation rate of 9.1% - but far above the 3% that has been offered so far. Such wide scale industrial action has seen other public sector workers threaten to walk out - including teachers, doctors, and nurses. Train and Tube delays and disruption continues - follow live updates They say that if the current cost of living crisis is not factored into this year's pay deals, it will lead to further disruption across multiple sectors and even more staff leaving their professions. Advertisement Here Sky News looks at what different public sector roles are paid, how they have fared with inflation, and what their demands are. How is public sector pay decided? Around 5.4 million people work in the public sector … [Read more...] about Rail strikes: How much are public sector workers paid – and how do recent pay deals compare to what train staff want?