Latest news with #K.C.Crosthwaite
New York Times
17-07-2025
- Health
- New York Times
F.D.A. Approves Juul Vapes After Yearslong Delay
The Food and Drug Administration authorized Juul e-cigarettes for the U.S. market on Thursday, ending a lengthy standoff with regulators and lawmakers who accused the company of spurring an epidemic of e-cigarette use among youths. The company was required to prove that the products were 'appropriate for the protection of public health' under agency rules. Juul said in a statement that it met the bar, in part, by showing that its products had helped about two million adults quit smoking cigarettes. The F.D.A. authorized both the e-cigarette system and menthol- and tobacco-flavored cartridges. Though concerns about the health effects of e-cigarettes are mounting, they are still widely viewed by experts as safer than cigarettes. 'Today's F.D.A. authorization of Juul products marks an important step toward making the cigarette obsolete,' K.C. Crosthwaite, the company's chief executive, said in a statement. Mr. Crosthwaite said underage use of Juul products was 'down 98 percent since 2019, to one-half of 1 percent of youth.' At least one lawmaker panned the decision. Senator Dick Durbin, Democrat of Illinois, recounted in a statement Thursday that Juul had 'ignited' an epidemic of vaping among youths and 'lied about the harms of their vapes.' Want all of The Times? Subscribe.
NBC News
17-07-2025
- Health
- NBC News
Juul can continue to sell e-cigarettes, FDA says
Juul Labs can continue to sell its e-cigarettes and refill cartridges per a decision Thursday by the Food and Drug Administration. According to an announcement on Juul's website, the FDA determined that its e-cigarette device and pods — which come in tobacco and menthol flavors — are 'appropriate for the protection of public health.' Thursday's authorization, first reported by The Wall Street Journal, marks the long-awaited conclusion to a multiyear FDA review that placed the products in regulatory limbo. An FDA spokesperson said the authorization does not mean the products are safe or 'FDA approved'; rather, Juul provided evidence demonstrating that its e-cigarettes met the legal standard for marketing new tobacco products in the U.S. The spokesperson said the FDA must consider the risks and benefits to the U.S. population as a whole, including the benefits to adults who currently smoke cigarettes. Juul submitted robust data to show that high rates of adults switch from cigarettes to menthol- or tobacco-flavored Juul products, the spokesperson said. 'This is good news for the millions of Americans who still smoke cigarettes,' Juul Labs said in an online statement. The company has positioned its products as an alternative to traditional cigarettes, which contain tobacco. Juul's e-cigarettes are tobacco-free. However, they contain nicotine, the active ingredient in tobacco, which can be addictive. The chemicals in e-cigarettes have also been linked to lung and heart disease. The FDA in 2022 ordered Juul to stop selling its e-cigarettes, citing a lack of evidence needed to assess their potential health risks. The decision followed a nearly two-year review of Juul's application seeking FDA authorization, which is required by law for companies to market e-cigarettes. At the time, the FDA under the Biden administration said there was 'insufficient and conflicting data' about 'potentially harmful chemicals leaching from the company's proprietary e-liquid pods.' But the FDA suspended the ban less than two weeks later, telling Juul it could continue to sell its products while the agency carried out a review. In June 2024, the FDA formally rescinded the ban and gave Juul's application a 'pending status,' opening the door for a potential authorization. 'We strongly support FDA's role in regulating tobacco and nicotine products. Americans who use nicotine deserve an orderly, reliable market in which they can confidently choose from a wide array of smokefree nicotine products,' K.C. Crosthwaite, CEO of Juul Labs, said Thursday in a statement. Many anticipated that the Trump administration would be more lenient with vaping regulations, given President Donald Trump's comment on Truth Social during his second presidential campaign that he would 'save vaping.' The Washington Post reported that the comment followed a private meeting with a leading vaping lobbyist. Juul has faced controversy over its early marketing practices, which critics say targeted young consumers under 21. In 2021, the company settled a lawsuit over allegations that it marketed its wares to teens, agreeing to pay $40 million to the state of North Carolina. But Juul has denied that it deliberately tried to market its products to young people. The use of e-cigarettes by U.S. middle and high school students has declined significantly in recent years. However, more than 1.6 million students still reported using them as of 2024. Yolonda Richardson, CEO of the Campaign for Tobacco-Free Kids, said the FDA's decision on Thursday is 'a big step in the wrong direction' and could reverse recent progress with reducing e-cigarette use. '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,' she said.
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.
