World Report

Will Trump snuff out e-cigarettes? President Trump promised to ban flavoured e-cigarettes, but 11 weeks later, they are still on the shelves. Susan Jaffe reports from Washington.

When US President Donald Trump reviewed proposed rules and policies at horrible”, Trump said. “That’s the announced a plan on Sept 11 to prohibit the Office of Management and Budget one problem I can’t seem to forget… the sale of most flavoured electronic (OMB) for more than a decade. The ban instead of having a flavour that’s at cigarettes, more than 450 people cleared the OMB on Nov 4. least safe, they’re going to be having in the USA had a mysterious lung “The policy making process is a flavour that’s—that’s poison.” In disease associated with vaping, and not stalled—it continues to move response, an industry repre­sentative six had died, according to the Centers forward”, said White House spokesman noted that counterfeits are already for Disease Control and Prevention Judd Deere, shortly before Trump available and that most of the (CDC). The ban would be finalised convened a meeting on Nov 22 that people who became sick were using within 30 days, said Health and Human e-cigarettes containing additives such Services Secretary Alex Azar. “‘He has shown he is more as tetrahydrocannabinol (THC) and The number of cases of the lung swayed by the tobacco industry vitamin E acetate. disease has since soared to 2290, as of and politics than by our In September, Juul—the company Nov 20, in 49 states, Washington, DC, children’s health’...“ with the largest share of e-cigarette and the US Virgin Islands. 47 e-cigarette sales—voluntarily took all but its smokers (vapers) have died, according brought together nearly two dozen menthol-flavoured and tobacco- to the CDC. However, as this report public health advocates supporting the flavoured products off the market. went to press, officials from the Trump ban and the conservative groups and However, another manufacturer told administration would not disclose industry representatives who oppose it. Trump that flavoured Juul products are when the promised ban would be Trump questioned both sides for an still available in some stores. issued. hour, but more than once the discus­ Matthew Myers, president of The ban reportedly stalled after sion descended into a shouting match. the Campaign for Tobacco-Free Trump met with industry lobbyists One of the few points of agreement Kids, reminded Trump: “We have earlier this month, who warned that centred on raising the minimum age 5·3 million kids who are addicted, and such a decision would lead to the loss for e-cigarette purchasers from 18 years it’s separate from the lung disease… of thousands of jobs, according to to 21 years. a million kids a day are using these news sources. They also said a ban “21, we’re going to be doing that”, products repetitively with addiction.” would probably cost him votes in Trump said, according to a meeting Banning the flavours would make battleground states he needs to win transcript. Despite the current age e-cigarettes less appealing to re-election next year. limit of 18 years, e-cigarette use by children, Myers said. His group Trump’s apparent willingness to delay middle school and high school students would allow only tobacco-flavoured or block the policy ignited protests increased from 3·6 million in 2018 products to be sold. “What we’re from public health groups, medical to 5·3 million in 2019, according to talking about doing is removing associations, and members of Congress. the CDC. In 2018, 67% of high school “He has shown he is more swayed students and 49% of middle school by the tobacco industry and politics students who used tobacco products than by our children’s health”, Senator in the past 30 days reported using a Patty Murray of Washington state said flavoured tobacco product. The flavours last week at a hearing of the Senate include mango, bubblegum, cherry and Committee on Health, Education, Labor melon, and mint. and Pensions, where she is the senior However, Trump worried that a Democrat. blanket ban of most candy-flavoured The delay in the ban proposed by or fruit-flavoured e-cigarettes would the US Food and Drug Administration increase the risk of counterfeit (FDA) is “unusual”, said Bridget e-cigarettes being sold on the black Dooling, a research professor at market. George Washington University’s “They’re going to be selling stuff

Regulatory Studies Center, who also on a street corner that could be Jose Luis Magana/AFP/Getty Images

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For more on Scott Gottlieb’s the flavours that have fuelled the The FDA declined to comment on and the secretary reports to the resignation see World Report epidemic among our kids.” how much time the companies will president. FDA policies are de facto Lancet 2019; 393: 1086–87 Nevertheless, others are concerned have to withdraw those products or policies of the Executive Branch, so if For the article on the Food and Drug Administration’s that nicotine-addicted smokers who how long the review process will take. the HHS secretary or president chooses independence see https://www. use fruit-flavoured or candy-flavoured Although the lung disease that to do so, they can intercede.” healthaffairs.org/doi/ e-cigarettes will switch to the tobacco- has affected some vapers has been Califf was one of seven former abs/10.1377/ hlthaff.2018.05185?rfr_dat=cr_ flavoured products. The only way to associated with certain additives, FDA commissioners who published pub%3Dpubmed&url_ prevent more young people from “we still don’t know which flavours an article in Health Affairs in January ver=Z39.88-2003&rfr_ becoming addicted is to ban all are associated with these substances, recommending that the FDA separate id=ori%3Arid%3Acrossref. e-cigarettes, countered Patrice Harris, which particular products or brands”, from HHS and become an independent org&journalCode=hlthaff president of the American Medical said Peter Briss, medical director for federal agency. Association, which last week adopted the CDC’s National Center for Chronic Yet independence is exactly what a resolution supporting an immediate Disease Prevention and Health members of a Senate committee ban on all e-cigarette products except Promotion. “There are hundreds of expected last week when they held a those approved by the FDA as smoking different e-cigarette or vaping devices hearing on Trump’s nominee for FDA cessation aids. The FDA has yet to and there are thousands or perhaps commissioner, Stephen Hahn. He is approve any e-cigarettes for that tens of thousands of different liquid a radiation oncologist and the chief purpose. brands that may contain more than executive officer at the University of Manufacturers and retailers at one compound or substance.” Texas MD Anderson Cancer Center. the meeting also told Trump that a Some products use prefilled, dispos­ “Is the FDA under your leadership total ban would force 10 000 small able, flavoured cartridges or pods able and willing to take action which e-cigarette shops to close, and could containing flavoured nicotine, such as will protect our kids whether or not the also put the companies that make the those made by Juul. Other e-cigarettes White House wants you to take that flavours and the devices out of business. require users to fill the device with a action?” asked Senator Mitt Romney, a The industry representatives estimate nicotine liquid purchased separately, Utah Republican. Hahn said the policy that as many as 160 000 direct and and vape shops can mix in preferred was still under consideration and he related jobs would be lost. Furthermore, flavours. Both types use a rechargeable did not have all the facts. “But I can tell they say a total ban would take away a battery that plugs into a computer. you this for sure, sir, I will use science safer alternative from former smokers When 29 patients from ten different and data to guide the decisions if I’m of tobacco cigarettes, since e-cigarettes states had fluid from their lungs tested, fortunate enough to be confirmed”, may contain less nicotine. all had evidence of vitamin E acetate, Hahn said. “If e-cigarettes, in fact, help adults Briss said. CDC investigators suspect it Hahn would be the first FDA quit smoking, then the manufacturers might be used as a thickening agent for commissioner in 30 years who has should submit the evidence to FDA”, e-cigarettes containing THC. However, almost no previous government Harris said in a statement after the “the evidence is not yet sufficient to experience. He would succeed meeting. “Until then, we are asking rule out other chemicals of concern”, Scott Gottlieb, who championed the government to ban flavours, which Briss said. a package of measures aimed at has everything to do with placing In the absence of federal action, e-cigarettes, including lowering the another generation at risk of nicotine seven states have enacted temporary nicotine content to minimally addictive dependence.” emergency bans on the sale of flavoured or non-addictive levels, enforcing the Even if a ban on flavours or all e-cigarettes, and Massachusetts bans ban on sales to minors, and supporting e-cigarettes was put in place, they the sale of all e-cigarettes. Legislation restrictions on sales of flavoured could be back on the market if the pending in Congress would take similar e-cigarettes to adults. Gottlieb resigned FDA approves them. The FDA had set steps. in April. a deadline of 2022 for applications The decision to replace this At the end of the White House with safety studies, but the deadline patchwork of rules with a nationwide meeting last week, Trump was asked was brought forward to May 12, 2020, ban is up to President Trump. “It is a if he would go back to his “initial following a successful lawsuit against chain of command”, said Robert Califf, instinct” in September to ban flavoured the FDA by the American Academy of a professor of cardiology at Duke e-cigarettes. “We did have an instinct…” Pediatrics, the Campaign for Tobacco- University School of Medicine and the he replied. “It’s going to be very Free Kids, and other organisations. FDA commissioner under Trump and interesting. We’ll let you know pretty Companies that miss the deadline must former President Barack Obama. “The soon.” take their products off the market or commissioner reports to the Secretary else face enforcement action. of Health and Human Services [HHS] Susan Jaffe

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