The FDA on Wednesday threatened to take popular vapers off the market if their makers can’t prove within 60 days that they can keep them away from minors. The leading maker of e-cigarettes is Juul, a startup that’s said to be valued at $15 billion and has captured almost 70 percent of the market in three years, according to research firm Nielsen. The startup is based in San Francisco, which along with other cities in the Bay Area has banned sales of flavored tobacco products and vaping liquids. “I’m disturbed by an epidemic of nicotine use among teenagers,” said FDA Commissioner Scott Gottlieb in a statement Wednesday. He said e-cigarettes “may still pose health risks, including possibly releasing some chemicals at higher levels than conventional cigarettes, and these potential risks require closer scrutiny.” So the FDA is launching what Gottlieb called the “largest coordinated tobacco compliance effort in FDA’s history,” which includes going after Juul and its competitors, such as Vuse, MarkTen, blu e-cigs and Logic. The agency is investigating their marketing practices, plus their online sales and distribution. The FDA is also cracking down on those who sell e-cigarettes to minors, such as convenience stores and other retailers. “Let me be clear: Everything is on the table,” Gottlieb said. “This includes the resources of our civil and criminal enforcement tools.” Juul is no stranger to the FDA. In April, the agency asked the company to turn over information about its technology and marketing practices in an effort to find out if Juul was deliberately marketing its products to children. A day later, Juul announced a $30 million investment to try to keep its vaping devices out of children’s hands. When reached Wednesday, a Juul spokeswoman sent the following statement: “JUUL Labs will work proactively with FDA in response to its request. We are committed to preventing underage use of our product, and we want to be part of the solution in keeping e-cigarettes out of the hands of young people.” Related Articles San Francisco’s Juul to invest $30M to fight underage vaping US warns retailers not to sell Juul e-cigarette to kids The Juul’s so cool, kids smoke it in school Juul’s vaping products are flash drive-like devices that dispense liquid — usually containing nicotine — with flavors such as mango, cool cucumber and creme brulee. Anti-cigarette advocates complain that the FDA has been slow to act, and that it could do more. “The FDA has broad authority to eliminate candy flavors, all flavored products to protect kids,” said Erika Sward, the American Lung Association’s national assistant vice president for advocacy, Wednesday. She added that the FDA should require all new nicotine products to go through a pre-market review process. “What we have seen for years under the Obama administration and now the Trump administration is a continual kicking of the can down the road,” Sward said. “Kids are becoming big tobacco’s next generation.” On the other hand, any federal action on the issue is welcome, said Bob Gordon, co-chair of the San Francisco Tobacco-Free Coalition. “Locally, we have taken action to end the sale of candy-flavored tobacco,” he said Wednesday. “If the FDA is going to take similar action, we certainly applaud them.” Besides San Francisco, other Bay Area cities and counties that have either banned or limited the sale of flavored tobacco include Santa Clara County, Oakland, Hayward, San Leandro, Berkeley and Contra Costa County. The FDA said it will also announce next week a new campaign to warn children and teens of the dangers of nicotine and using e-cigarettes. In California, vaping is illegal for people under 21 years of age. Other states’ legal vaping age is 18.<doc-sep>WASHINGTON/LOS ANGELES (Reuters) - The U.S. Food and Drug Administration is considering a ban on flavored e-cigarettes from Juul Labs and other companies as it grapples with an “epidemic” of youth e-cigarette use that threatens to create a new generation of nicotine addicts, the agency’s head said on Wednesday. In a speech at FDA headquarters, Commissioner Scott Gottlieb said the agency would also revisit a policy that extended the dates for some manufacturers of flavored e-cigarettes to get FDA approval before selling their products. That could lead to removal of some major flavored e-cigarette brands, including the popular products made by Juul Labs Inc., if they do not address the issue to the agency’s satisfaction. “We see clear signs that youth use of electronic cigarettes has reached an epidemic proportion,” Gottlieb said. Manufacturers offer and market e-cigarette flavors that clearly appeal to minors, including candy and bubble gum flavors. The FDA said more than 2 million middle school and high school students used e-cigarettes in 2017. The FDA is giving the five top-selling e-cigarette brands - Juul, Vuse, MarkTen XL, Blu and Logic - 60 days to provide plans for how they will mitigate sales to minors. Juul owns about 72 percent of the U.S. market for e-cigarette sales, according to Wells Fargo. “Juuling,” along with “vaping,” has become a common term for e-cigarette use by teenagers on social media and at U.S. high schools. Investors in Juul’s competitors appeared to welcome the FDA announcement. Shares of British American Tobacco, which owns the Vuse brand, closed up nearly 6 percent, while shares of cigarette-maker Imperial Brands PLC, which owns Blu, rose more than 3 percent. Shares of traditional cigarette maker Altria Group , which also owns the MarkTen brand, closed 6.6 percent higher, while Philip Morris International shares ended up 3.4 percent. Wells Fargo analyst Bonnie Herzog, in a research note, said Juul appears “most at risk” from the crackdown because of its “strong appeal to youth and the FDA’s comments on flavors.” Slideshow ( 4 images ) She said Altria could be well positioned because it has a long history of dealing with youth access to its products and has “limited/mature flavor profiles relative to Juul.” MENTHOL VERSUS FRUIT MEDLEY AND CREME BRULEE MarkTen’s flavors, for example, include “menthol,” “classic,” and “summer blend,” while Juul’s flavors have included “fruit medley” and “creme brulee,” recently shortened to “fruit” and “creme.” Gottlieb announced a number of steps the agency plans to take as part of a broader crackdown on the sale and marketing of e-cigarettes to minors. The agency issued 12 warning letters to companies that it says have deceptive marketing labels on e-liquids. “We cannot allow a whole new generation to become addicted to nicotine,” he said. Juul Labs said it would work with the FDA and is committed to preventing underage use of its product. But spokeswoman Victoria Davis said “appropriate flavors play an important role in helping adult smokers switch.” The FDA moves come as it seeks to balance its approach on e-cigarettes, which can be used to wean lifelong smokers onto less harmful nicotine products, but also risk drawing a new generation to nicotine addiction. “While we remain committed to advancing policies that promote the potential of e-cigarettes to help adult smokers move away from combustible cigarettes, that work can’t come at the expense of kids,” Gottlieb said. Slideshow ( 4 images ) The other companies also said they would work with the FDA on youth prevention efforts. “We welcome FDA’s action today and look forward to sharing our thoughts about how to prevent and reduce youth use, an issue we have focused on for decades,” Altria spokesman George Parman said in a statement. Imperial Brands unit Fontem Ventures said it would work to further strengthen youth access prevention policies and procedures. British American’s R.J. Reynolds Vapor Company, said it will comply with the FDA request, adding that “youth tobacco prevention is a priority for our companies.” Logic Technology Development, owned by Japan Tobacco Inc, said it will demonstrate to the FDA “that Logic markets its products only to adults.” As part of its broader enforcement efforts, the FDA said it issued more than 1,300 warning letters and fines to retailers who illegally sold e-cigarette products to minors.<doc-sep>"Tank" e-cigarettes are becoming increasingly popular. Heavily stylized and modifiable, they contain a larger cartridge of e-liquid and a battery pack that can be recharged, some by USB. Smoking deveces by the inventor of the electronic cigarette, Hon Lik are seen in Beiijng on May 25, 2009. Also known as an 'e-cigarette', the battery-powered devices are designed as an alternative to cigarettes, cigars and pipes, and provide inhaled doses of nicotine by delivering a vaporized propylene glycol/nicotine solution, while also providing the physical sensation and flavors similar to inhaled tobacco smoke. With 350 million tobacco smokers nationwide, China will join the world in observing World No Tobacco Day on May 31. AFP PHOTO/Frederic J. BROWN (Photo credit should read FREDERIC J. BROWN/AFP/Getty Images) Story highlights FDA announces new action on e-cigarettes to stop youth epidemic in the US Action will be taken against on five major manufacturers and more than 1,300 retailers (CNN) — The head of the US Food and Drug Administration took aim Wednesday at Juul and other e-cigarette manufacturers, warning that they must show in the next two months how they’ll keep the devices out of the hands of young people. Noting an “epidemic” surge in teen use of e-cigarettes, FDA Commissioner Dr. Scott Gottlieb warned the FDA might require companies to change their sales and marketing practices; stop distributing products to retailers who sell to kids; and remove flavored e-cigarette products from the market. “I use the word epidemic with great care,” Gottlieb said. “E-cigs have become an almost ubiquitous – and dangerous – trend among teens. The disturbing and accelerating trajectory of use we’re seeing in youth, and the resulting path to addiction, must end. It’s simply not tolerable.” Juul, MarkTen, Vuse, Blu and Logic control 97% of the e-cigarette market, the FDA said. In the next 60 days, the FDA plans to investigate the five e-cigarette companies’ marketing and sales practices, with possible “boots on the ground inspections,” Gottlieb said. The agency will also be increasing federal enforcement actions on e-cig sales to minors in convenience stores and other retail sites, Gottlieb said. On Wednesday, it announced “historic action” against more than 1,300 retailers who illegally sold Juul and other e-cigarettes to minors during a crack down on retailers this summer. Gottlieb called the action the largest coordinated enforcement effort in the agency’s history. The FDA will also look closely at “straw purchases,” in which adults visit web-based stores and buy in bulk to resell to minors. Federal law prohibits the sale of e-cigarettes to people younger than 18. “If young adults go online and buy 100 units of a product to sell to teens, that activity ought to be easy for a product manufacturer to identify,” said Gottlieb. If manufacturers aren’t willing to do the research, he said, the FDA will do it for them, with appropriate consequences. “Let me be clear: Everything is on the table,” said Gottlieb. “This includes the resources of our civil and criminal enforcement tools.” A generation addicted? E-cigarette makers argue the devices help adult smokers give up cigarettes – potentially saving them from related illnesses – by giving a nicotine fix without the smoke and smell of combustible cigarettes. The scientific consensus, however, is still out on the long-term health effects of vaping. The FDA recognized the impact its actions might have on adults trying to stop smoking, Gottlieb said, but emerging research on how flavored products encourage excessive use by young people shows action must be taken. More than 2 million middle and high school students were current users of e-cigarettes in 2017, the FDA said, and e-cigarettes were the most commonly used tobacco product by youth. Youths are more likely than adults to vape, according to the US Centers for Disease Control and Prevention. “I’ll be clear. The FDA won’t tolerate a whole generation of young people becoming addicted to nicotine as a tradeoff for enabling adults to have unfettered access to these same products,” Gottlieb said Wednesday. “We’re especially focused on the flavored e-cigarettes. And we’re seriously considering a policy change that would lead to the immediate removal of these flavored products from the market.” Juul Labs, which controls about 70% of the market, said in its statement that “appropriate flavors” play a role in adults changing their smoking habits, but added that they “are committed to preventing underage use of our product, and we want to be part of the solution in keeping e-cigarettes out of the hands of young people.” Several other manufacturers targeted by the FDA – MarkTen, Vuse, Blu and Logic – also issued statements agreeing with the need to limit access to minors and announcing their willingness to work with the FDA to reach a solution. The Vapor Technology Association, which says it represents over 600 vaping manufacturers and distributors, also supports limiting teen access, but added that the new actions by the FDA ventured “into dangerous territory” by not being in the best interest of public health. In a statement, VTA Executive Director Tony Abboud asked: “Does FDA really want millions of Americans to return to smoking cigarettes?” A change of plan Last year, the FDA announced that it would delay regulations that could have halted the sales of many e-cigarettes. Instead, the agency gave extensions till August 2022 to new and existing vaping products. The agency said it allowed the extra time to strike an appropriate balance between regulation and encouraging the development of innovative tobacco products that may help older smokers quit. At that time of the extension, Gottlieb said Wednesday, the agency didn’t foresee the “epidemic‘“of adolescent use that has become one of the plan’s biggest challenges. “Today we can see that this epidemic of addiction was emerging when we first announced our plan last summer,” said Gottlieb. “Hindsight, and the data now available to us, reveal these trends.” Get CNN Health's weekly newsletter Sign up here to get The Results Are In with Dr. Sanjay Gupta every Tuesday from the CNN Health team. Since Wednesday’s action did not change the current 2022 timeline for regulatory review, some said the agency’s action fell short. “We need to go further,” said Michael Bloomberg, the billionaire philanthropist who has worked for years to reduce tobacco use. “The FDA should immediately move to regulate flavored e-cigarettes, instead of waiting until 2022, as it is currently planning to do,” Bloomberg said in a statement. The Campaign for Tobacco-Free Kids also called for stronger action. In a statement, Matthew Myers, the campaign’s president, said the FDA’s action would only represent a turning point if it “reverses its policy and requires that all of these products undergo agency review now, not four years from now.” The American Medical Association’s Dr. Barbara McAneny also said the FDA could do much more, pledging that the association would “continue to advocate for more stringent policies.” U.S. Senate Democratic Whip Dick Durbin and Republican Sen. Lisa Murkowski also asked the FDA to end delays. In a statement, they called for support for their bipartisan legislation, introduced in July, which would ban flavored cigars and place stringent controls on e-juice flavorings. FDA actions so far In April the agency launched a Youth Tobacco Prevention Plan, designed to address some of the known public health risks, such as flavors, that contribute to adolescent use of e-cigarettes. Shortly after the launch, the FDA cracked down on e-liquids marketed to resemble kid-friendly foods like juice boxes, candy and cookies. As part of today’s action, the agency sent an additional 12 warning letters to another 12 companies that continue to sell the products. The FDA also targeted Juul retailers this spring, issuing 56 warning letters and six civil monetary penalties. Today’s effort notches up that action, becoming, said Gottlieb, the “largest ever coordinated initiative against violative sales in the history of the FDA.” The agency said it plans to unveil a new e-cigarette public education campaign targeted to youth next week, and will soon announce wider access to new nicotine replacement therapies to help more adult smokers quit cigarettes.’ CNN’s Roni Selig contributed to this report.<doc-sep>
Federal regulators are threatening to pull e-cigarettes from shelves if manufacturers do not control teen use, which officials say has reached epidemic levels. The Food and Drug Administration was prepared to embrace e-cigarettes as a way to wean adult smokers from cigarettes, but the agency is rethinking its approach after seeing scores of teens vaping. The crackdown by the FDA includes historic action against more than 1,300 retailers and five major manufacturers for their roles in "perpetuating youth access," the agency said. "E-cigs have become an almost ubiquitous — and dangerous — trend among teenagers," FDA Commissioner Scott Gottlieb said in a statement. "The disturbing and accelerating trajectory of use we're seeing in youth, and the resulting path to addiction, must end. The FDA cannot tolerate a whole generation of young people becoming addicted to nicotine as a trade off for enabling adults to access these products." The e-cigarette craze has driven what's arguably the largest uptick of teen nicotine use in decades after years of driving cigarette smoking rates to record lows. Teens who would have never smoked cigarettes are happily inhaling fruity flavors, sometimes without realizing it is packed with nicotine, an addictive substance. Middle school and high school students sneak the devices into schools and flaunt pictures of their vapes or of themselves performing tricks on Instagram. FDA order targets five brands The FDA is specifically ordering five brands — Juul, British American Tobacco's Vuse, Altria's MarkTen. Imperial Brands' Blu E-cigs and Japan Tobacco's Logic — to submit plans within 60 days detailing how they will prevent teens from using their products. The agency may require the companies to revise their sales and marketing practices, to stop distributing products to retailers who sell to kids and to stop selling some or all of their flavored e-cigarette products until they clear the application process. Between now and the 60-day mark, the FDA will investigate manufacturers' marketing and sales practices, including holding "boots on the ground inspections." A Juul spokeswoman said the company will work proactively with the FDA in response to its request. "We welcome the FDA's actions today, and we look forward to sharing our thoughts about how to prevent and reduce youth usage, an issue we've focused on for decades," an Altria spokesman said. Fontem Ventures, a subsidiary of Imperial Brands, said in a statement it's "evaluating today's request and statement from the FDA," but it welcomes "the opportunity to demonstrate and work with the FDA to further strengthen" its youth access prevention policies and procedures. A Logic spokesman said the company has received the agency's request and will "continue to work with the agency to demonstrate" that it "markets its products only to adults." BAT will provide the agency with a comprehensive plan in 60 days, as requested, a spokesman for R.J. Reynolds Vapor, a unit of BAT, said in a statement. Tobacco stocks surged on news of the FDA's action. As part of the FDA's largest-ever coordinated action against illegal sales, the agency has sent warning letters to more than 1,100 retailers that are selling e-cigarettes to teens despite a federal ban on sales to minors. It has fined 131 retailers, with fines ranging from $279 to $11,182. These actions come after the agency conducted a blitz of both brick-and-mortar and online retailers between June and the end of August. The FDA warned and fined more than 60 retailers in that first retail effort. Across the entire e-cigarette category, the FDA is considering restricting manufacturers from selling flavored nicotine liquid or making the products undergo an agency review. Products that were on the market before Aug. 8, 2016, were supposed to start undergoing review this year until Gottlieb extended the deadline until Aug. 8, 2022, so manufacturers would have more time to file complete applications. Anti-tobacco groups applauded the idea but said the FDA's actions didn't go far enough. They want to see the agency to stick to the original deadline of this year and restrict the use of flavors. Looking for 'straw' purchases Additionally, the agency is investigating whether manufacturers' online shops are being used for "straw" purchases, where buyers resell products to minors. If the FDA identifies problems, it can take both civil and criminal actions. "Let me be clear: Everything is on the table, including all our civil and criminal enforcement tools," Gottlieb said. "If the companies don't know, or if they don't want to know, that these straw purchases are occurring, we'll now be helping to identify it for them."