Latest news with #Crosthwaite
The Hill
17-07-2025
- Business
- The Hill
FDA reverses ban on sale of Juul e-cigarettes
The Food and Drug Administration has authorized Juul Labs to keep its e-cigarettes on the market, a major reversal after the agency completely banned the company's products in 2022. The agency said Thursday it will allow the sale of Juul's original e-cigarette device as well as refill cartridges in tobacco and menthol flavors. The move followed 'an extensive scientific review' that showed the benefit to adult smokers outweighed the risk to young people or adults who don't smoke. FDA said Juul submitted evidence showing high rates of adults completely switched from cigarettes to either the tobacco- or menthol-flavored Juul products. 'While today's actions permit these specific e-cigarette products to be legally marketed in the U.S. to adults 21 and older, it does not mean these tobacco products are safe, nor are they FDA approved,' the agency said. FDA's decision marks the latest chapter for a company so popular it was once synonymous with vaping. But as more young people began using its fruit and candy-flavored products, federal scrutiny grew. Juul has denied allegations that it marketed its e-cigarettes to children and teens. The FDA in 2022 announced a ban on the sale of Juul e-cigarettes nationwide, saying the company did not prove that keeping its products on the market 'would be appropriate for the protection of the public health.' The agency suspended the order about two weeks later to conduct an internal review of 'scientific issues' in the company's application. Despite the pause, FDA's actions nearly bankrupted the company. It also subsequently paid $1.7 million billion to resolve thousands of lawsuits alleging the company aggressively marketed its e-cigarettes to young people and fueled a vaping crisis. The FDA considered Juul's appeal for two years and in 2024 formally rescinded the ban, putting the company's application back under scientific review. All electronic cigarette products are required by law to have FDA authorization to be legally marketed, and the companies must submit scientific evidence of public health benefits. 'Today's FDA authorization of JUUL products marks an important step toward making the cigarette obsolete,' K.C. Crosthwaite, Juul Labs' CEO said in a statement. 'We strongly support FDA's role in regulating tobacco and nicotine products,' Crosthwaite continued. 'Americans who use nicotine deserve an orderly, reliable market in which they can confidently choose from a wide array of smokefree nicotine products that are high-quality, innovative, backed by rigorous research, made in FDA-inspected manufacturing facilities, and marketed and sold responsibly.' Still, Juul is no longer the juggernaut it once was and has lost significant market share amid rising competition, including from e-cigarettes illegally imported from China. But anti-tobacco groups said they were dismayed by FDA's decision, saying it risks a reversal of recent progress in reducing youth e-cigarette use. 'It is a big step in the wrong direction to authorize sales of the product that was responsible for this public health crisis in the first place,' said Yolonda Richardson, president and CEO of the Campaign for Tobacco-Free Kids. 'There is no question that this crisis was driven by Juul's sleek, easy-to-hide products, which were sold in enticing flavors, including menthol, were marketed in ways that appeal to kids and delivered massive doses of nicotine that can quickly addict kids,' Richardson added. The American Lung Association (ALA) similarly blamed Juul for the spike in youth vaping. 'This is a serious misstep,' Ranjana Caple, senior manager of federal advocacy for ALA said in a statement. 'Juul is responsible for the youth vaping epidemic, and its products have hooked a generation of kids on nicotine. Authorizing these products signal a stunning failure to protect public health.'
Boston Globe
17-07-2025
- Business
- Boston Globe
Juul can continue selling its tobacco and menthol e-cigarettes, FDA says
Juul will be one of only two US companies authorized to sell menthol-flavored vapes, which many adults prefer to tobacco flavor. 'This is an important milestone for the company and I think we made a scientifically sound case for the role that menthol can play in e-vapor,' Juul CEO K.C. Crosthwaite told The Associated Press. Parents, politicians and antitobacco groups are certain to oppose FDA's decision. They have argued for years that Juul should be permanently banned from selling its products due to its role in triggering a yearslong spike in underage vaping Advertisement Juul was once valued at over $13 billion and its small, sleek e-cigarettes revolutionized the image and technology of the vaping industry. But the company has since been forced to slash hundreds of jobs and pay billions to settle lawsuits over its role in the rise of youth vaping. The FDA had ordered the company to remove its products from the market in June 2022. But then the agency abruptly reversed course days later and agreed to reopen its scientific review of Juul's application after the company pushed back in court. Advertisement Juul said that regulators had overlooked thousands of pages of scientific data critical to its submission. Thursday's announcement is not an approval or endorsement, and the FDA reiterated that people who do not smoke should not use Juul or any other e-cigarettes. The FDA determination indicates that smokers who switch completely to Juul can reduce their exposure to deadly carcinogens and other chemicals found in traditional cigarettes. The FDA decision applies to Juul's original product, which is now roughly a decade old. Crosthwaite said the company hopes to win authorization for its next-generation device and is also considering applying to FDA for more flavors. In recent years, the FDA has authorized a handful of e-cigarettes to help adult smokers cut back on traditional cigarettes, while rejecting more than a million other vaping products that failed to meet agency standards. Juul's main competitors, Vuse and Njoy, each previously received FDA permission to remain on the market. To meet FDA requirements, 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 or reduce their smoking, while teens are unlikely to get hooked on them. The brainchild of two Stanford University students, Juul launched in 2015 and within two years rocketed to the top of the vaping market. Juul quickly outpaced earlier brands with its high-nicotine, fruity-flavored cartridges, sold in mango, mint and creme brulé. The company's small, discrete devices provided a more potent, user-friendly alternative to older, bulkier devices. Advertisement But the company's rise was fueled by underage use, and e-cigarettes quickly became ubiquitous in U.S. schools. In 2019, the company was pressured into halting all advertising and eliminating most of its flavors, leaving only tobacco and menthol-flavored options. By then the company was already the target of multiple investigations and lawsuits by federal, state and local officials as well as class action attorneys. In 2022, the company paid $1.7 billion to settle thousands of lawsuits brought by families of Juul users, school districts, city governments and Native American tribes. The company separately agreed to pay $1.1 billion to settle lawsuits or investigations from most US states. Juul is no longer the top-selling e-cigarette brand and now trails Vuse, which is sold by Reynolds American. Teens have also shifted away from the brand amid a wider drop in vaping, according to the latest federal survey. The FDA reported last year that teen vaping dropped to a 10-year low, after stepped up enforcement against unauthorized brands imported from China, such as Elf Bar. Unlike Juul, disposable e-cigarettes like Elf Bar still come in fruit and candy flavors, despite efforts by regulators to block their use.
17-07-2025
- Business
Juul can continue selling its tobacco and menthol e-cigarettes, FDA says
WASHINGTON -- The Food and Drug Administration is allowing vaping brand Juul to keep its e-cigarettes on the market, providing relief to a company that has struggled for years after being widely blamed for sparking the teen vaping trend. FDA regulators said Thursday that studies from Juul show its e-cigarettes are less harmful for adult smokers, who can benefit from switching completely to vaping. The FDA decision applies to both tobacco- and menthol-flavored versions of the reusable product, which works with nicotine-filled cartridges sold in two different strengths. Juul previously discontinued several fruit and candy flavors that helped drive its popularity but were favored by teens. Juul will be one of only two U.S. companies authorized to sell menthol-flavored vapes, which many adults prefer to tobacco flavor. 'This is an important milestone for the company and I think we made a scientifically sound case for the role that menthol can play in e-vapor,' Juul CEO K.C. Crosthwaite told The Associated Press. Parents, politicians and antitobacco groups are certain to oppose FDA's decision. They have argued for years that Juul should be permanently banned from selling its products due to its role in triggering a yearslong spike in underage vaping Juul was once valued at over $13 billion and its small, sleek e-cigarettes revolutionized the image and technology of the vaping industry. But the company has since been forced to slash hundreds of jobs and pay billions to settle lawsuits over its role in the rise of youth vaping. The FDA had ordered the company to remove its products from the market in June 2022. But then the agency abruptly reversed course and agreed to reopen its scientific review of Juul's application after the company pushed back in court. Juul said that regulators had overlooked thousands of pages of scientific data critical to its submission. Thursday's announcement is not an approval or endorsement, and the FDA reiterated that people who do not smoke should not use Juul or any other e-cigarettes. The FDA determination indicates that smokers who switch completely to Juul can reduce their exposure to deadly carcinogens and other chemicals found in traditional cigarettes. The FDA decision applies to Juul's original product, which is now roughly a decade old. Crosthwaite said the company hopes to win authorization for its next-generation device and is also considering applying to FDA for more flavors. In recent years, the FDA has authorized a handful of e-cigarettes to help adult smokers cut back on traditional cigarettes, while rejecting more than a million other vaping products that failed to meet agency standards. Juul's main competitors, Vuse and Njoy, each previously received FDA permission to remain on the market. To meet FDA requirements, 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 or reduce their smoking, while teens are unlikely to get hooked on them. The brainchild of two Stanford University students, Juul launched in 2015 and within two years rocketed to the top of the vaping market. Juul quickly outpaced earlier brands with its high-nicotine, fruity-flavored vape cartridges, sold in mango, mint and creme brulé. The company's small, discrete devices provided a more potent, user-friendly alternative to older, bulkier devices. But the company's rise was fueled by underage use, and e-cigarettes quickly became ubiquitous in U.S. high schools and middle schools. In 2019, the company was pressured into halting all advertising and eliminating most of its flavors, leaving only tobacco and menthol-flavored cartridges for its device. By then the company was already the target of multiple investigations and lawsuits by Congress, state and local officials and class action attorneys. In 2022, the company paid $1.7 billion to settle thousands of lawsuits brought by families of Juul users, school districts, city governments and Native American tribes. The company has separately agreed to pay $1.1 billion to settle lawsuits with most U.S. states. Juul is no longer the top-selling e-cigarette brand and now trails Vuse, which is sold by Reynolds American. Teens have also shifted away from the brand amid a wider drop in vaping, according to the latest federal survey. The FDA reported last year that teen vaping dropped to a 10-year low, after stepped up enforcement against unauthorized brands imported from China, such as Elf Bar. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
San Francisco Chronicle
17-07-2025
- Business
- San Francisco Chronicle
Juul can continue selling its tobacco and menthol e-cigarettes, FDA says
WASHINGTON (AP) — The Food and Drug Administration is allowing vaping brand Juul to keep its e-cigarettes on the market, providing relief to a company that has struggled for years after being widely blamed for sparking the teen vaping trend. FDA regulators said Thursday that Juul's studies show its e-cigarettes are less harmful for adult smokers, who can benefit from switching completely to vaping. The FDA decision applies to both tobacco- and menthol-flavored versions of the reusable product, which works with nicotine-filled cartridges sold in two different strengths. Juul previously discontinued several fruit and candy flavors that helped drive its popularity but were favored by teens. Juul will be one of only two U.S. companies authorized to sell menthol-flavored vapes, which many adults prefer to tobacco flavor. 'This is an important milestone for the company and I think we made a scientifically sound case for the role that menthol can play in e-vapor,' Juul CEO K.C. Crosthwaite told The Associated Press. Parents, politicians and antitobacco groups are certain to oppose FDA's decision. They have argued for years that Juul should be permanently banned from selling its products due to its role in triggering a yearslong spike in underage vaping Juul was once valued at over $13 billion and its small, sleek e-cigarettes revolutionized the image and technology of the vaping industry. But the company has since been forced to slash hundreds of jobs and pay billions to settle lawsuits over its role in the rise of youth vaping. The FDA had ordered the company to remove its products from the market in June 2022. But then the agency abruptly reversed course days later and agreed to reopen its scientific review of Juul's application after the company pushed back in court. Juul said that regulators had overlooked thousands of pages of scientific data critical to its submission. Thursday's announcement is not an approval or endorsement, and the FDA reiterated that people who do not smoke should not use Juul or any other e-cigarettes. The FDA determination indicates that smokers who switch completely to Juul can reduce their exposure to deadly carcinogens and other chemicals found in traditional cigarettes. The FDA decision applies to Juul's original product, which is now roughly a decade old. Crosthwaite said the company hopes to win authorization for its next-generation device and is also considering applying to FDA for more flavors. In recent years, the FDA has authorized a handful of e-cigarettes to help adult smokers cut back on traditional cigarettes, while rejecting more than a million other vaping products that failed to meet agency standards. Juul's main competitors, Vuse and Njoy, each previously received FDA permission to remain on the market. To meet FDA requirements, 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 or reduce their smoking, while teens are unlikely to get hooked on them. The brainchild of two Stanford University students, Juul launched in 2015 and within two years rocketed to the top of the vaping market. Juul quickly outpaced earlier brands with its high-nicotine, fruity-flavored cartridges, sold in mango, mint and creme brulé. The company's small, discrete devices provided a more potent, user-friendly alternative to older, bulkier devices. But the company's rise was fueled by underage use, and e-cigarettes quickly became ubiquitous in U.S. schools. In 2019, the company was pressured into halting all advertising and eliminating most of its flavors, leaving only tobacco and menthol-flavored options. By then the company was already the target of multiple investigations and lawsuits by federal, state and local officials as well as class action attorneys. In 2022, the company paid $1.7 billion to settle thousands of lawsuits brought by families of Juul users, school districts, city governments and Native American tribes. The company separately agreed to pay $1.1 billion to settle lawsuits or investigations from most U.S. states. Juul is no longer the top-selling e-cigarette brand and now trails Vuse, which is sold by Reynolds American. Teens have also shifted away from the brand amid a wider drop in vaping, according to the latest federal survey. The FDA reported last year that teen vaping dropped to a 10-year low, after stepped up enforcement against unauthorized brands imported from China, such as Elf Bar. ___
The Hill
17-07-2025
- Business
- The Hill
Juul can continue selling its tobacco and menthol e-cigarettes, FDA says
WASHINGTON (AP) — The Food and Drug Administration is allowing vaping brand Juul to keep its e-cigarettes on the market, providing relief to a company that has struggled for years after being widely blamed for sparking the teen vaping trend. FDA regulators said Thursday that studies from Juul show its e-cigarettes are less harmful for adult smokers, who can benefit from switching completely to vaping. The FDA decision applies to both tobacco- and menthol-flavored versions of the reusable product, which works with nicotine-filled cartridges sold in two different strengths. Juul previously discontinued several fruit and candy flavors that helped drive its popularity but were favored by teens. Juul will be one of only two U.S. companies authorized to sell menthol-flavored vapes, which many adults prefer to tobacco flavor. 'This is an important milestone for the company and I think we made a scientifically sound case for the role that menthol can play in e-vapor,' Juul CEO K.C. Crosthwaite told The Associated Press. Parents, politicians and antitobacco groups are certain to oppose FDA's decision. They have argued for years that Juul should be permanently banned from selling its products due to its role in triggering a yearslong spike in underage vaping Juul was once valued at over $13 billion and its small, sleek e-cigarettes revolutionized the image and technology of the vaping industry. But the company has since been forced to slash hundreds of jobs and pay billions to settle lawsuits over its role in the rise of youth vaping. The FDA had ordered the company to remove its products from the market in June 2022. But then the agency abruptly reversed course and agreed to reopen its scientific review of Juul's application after the company pushed back in court. Juul said that regulators had overlooked thousands of pages of scientific data critical to its submission. Thursday's announcement is not an approval or endorsement, and the FDA reiterated that people who do not smoke should not use Juul or any other e-cigarettes. The FDA determination indicates that smokers who switch completely to Juul can reduce their exposure to deadly carcinogens and other chemicals found in traditional cigarettes. The FDA decision applies to Juul's original product, which is now roughly a decade old. Crosthwaite said the company hopes to win authorization for its next-generation device and is also considering applying to FDA for more flavors. In recent years, the FDA has authorized a handful of e-cigarettes to help adult smokers cut back on traditional cigarettes, while rejecting more than a million other vaping products that failed to meet agency standards. Juul's main competitors, Vuse and Njoy, each previously received FDA permission to remain on the market. To meet FDA requirements, 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 or reduce their smoking, while teens are unlikely to get hooked on them. The brainchild of two Stanford University students, Juul launched in 2015 and within two years rocketed to the top of the vaping market. Juul quickly outpaced earlier brands with its high-nicotine, fruity-flavored vape cartridges, sold in mango, mint and creme brulé. The company's small, discrete devices provided a more potent, user-friendly alternative to older, bulkier devices. But the company's rise was fueled by underage use, and e-cigarettes quickly became ubiquitous in U.S. high schools and middle schools. In 2019, the company was pressured into halting all advertising and eliminating most of its flavors, leaving only tobacco and menthol-flavored cartridges for its device. By then the company was already the target of multiple investigations and lawsuits by Congress, state and local officials and class action attorneys. In 2022, the company paid $1.7 billion to settle thousands of lawsuits brought by families of Juul users, school districts, city governments and Native American tribes. The company has separately agreed to pay $1.1 billion to settle lawsuits with most U.S. states. Juul is no longer the top-selling e-cigarette brand and now trails Vuse, which is sold by Reynolds American. Teens have also shifted away from the brand amid a wider drop in vaping, according to the latest federal survey. The FDA reported last year that teen vaping dropped to a 10-year low, after stepped up enforcement against unauthorized brands imported from China, such as Elf Bar. Unlike Juul, disposable e-cigarettes like Elf Bar still come in fruit and candy flavors, despite efforts by regulators to block their use. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
