On Sept. 13, President Donald Trump tweeted, “While I like the Vaping alternative to Cigarettes, we need to make sure this alternative is SAFE for ALL! Let’s get counterfeits off the market, and keep young children from Vaping!” Although it is hard to disagree with the resident, it is not clear that the Food and Drug Administration (FDA) got the message.
Vaping is an alternative to combustible tobacco as a means of satisfying nicotine cravings. Rather than smoking, people “vape” nicotine-spiked solutions that are heated and aerosolized within “e-cigarettes.”
Cigarettes are deadly. They kill approximately 480,000 people each year and nearly half of all smokers. Vaping fluids do not contain the cancer-causing tars and benzenes found in cigarette smoke, and have far lower numbers and much smaller quantities of toxins. Therefore, although long-term studies are lacking, vaping nicotine-laced solutions is believed to be a much safer alternative to smoking.
In 2018, the National Academy of Sciences found “conclusive evidence that completely substituting e-cigarettes for combustible tobacco cigarettes reduces users’ exposure to numerous toxicants and carcinogens present in combustible tobacco cigarettes.” According to Public Health England, e-cigarettes probably inflict fewer than 5 percent of the harms of conventional cigarettes. Further, a study published in the New England Journal of Medicine last February found the e-cigarettes were almost twice as effective as other types of nicotine-replacement therapy like nicotine patches and gums.
Since their introduction into the United States in 2006, millions of people here and around the world have vaped nicotine-containing solutions without significant untoward effects. However, this year, approximately 1,500 people have developed severe lung disease, including 37 who died, in association with vaping.
The causes of these illnesses are not well-understood, but over 75 percent of affected individuals had been vaping cannabis-containing fluids. All affected individuals appear to have vaped unregulated, bootlegged, counterfeit solutions, many of which were produced in China. None of the injuries have been linked to legitimate manufacturers like market leader JUUL Labs — 35 percent owned by tobacco giant Altria — which accounts for 64 percent of U.S. e-cigarette sales in retail stores.
A common-sense first response to this crisis would be to try to get the illicit vaping products off the market. This will not be easy, but we need to try. A quick Internet search yields many websites selling counterfeit vaping products like “Dank Vapes,” a common packaging and delivery system for bootlegged vaping systems and solutions. Some sites have telephone numbers.
Education is critical. People must verify the sources of the solutions they vape are legitimate vendors; they should not vape cannabis-containing solutions.
Instead, the FDA’s response was to announce it is banning fruit, mint and menthol-flavored vaping solutions. According to the agency’s plan, it will only allow e-cigarettes that taste like tobacco to be sold.
FDA’s proposed action targets vaping products that are not known to have caused harm and will do little to remove the illicit, impurity-containing solutions that are making people sick. Moreover, by eliminating access to flavored products from legitimate vendors, the FDA risks driving greater numbers of flavor-preferring users — especially those who are young— to dangerous bootlegged e-cigarettes.
Removing flavored vaping products is also unjustified as a long-term policy. Proposed to address concerns about increased vaping among teens, the ban penalizes millions of adults who choose to use flavored vaping solutions. Although teens overwhelmingly prefer flavored vaping fluids, these solutions are also the most popular choice of former smokers who were successful in using vaping to quit tobacco.
Youth vaping and the possibility of hooking another generation on nicotine are vital concerns. Vaping must not become a gateway to cigarette smoking in those who would not otherwise have become smokers.
Fortunately, cigarette smoking rates among teens, like adults, have continued to drop and are at historic lows even while vaping has gained in popularity. Regulation should be tailored to preserving and enhancing these gains and keeping vaping products out of the hands of minors — especially those who would not otherwise use nicotine-containing products. Prohibition did not work with alcohol, and it won’t work with vaping.
Encouraging current smokers to switch to vaping could provide enormous public health benefits and save billions in tobacco-related health care costs. Banning flavored solutions or forcing manufacturers to perform costly studies in order to reintroduce them, risks keeping current smokers addicted to cigarettes and prompting former smokers to restart the habit. The FDA needs to get counterfeit solutions off the market and protect teens, but not deny adult smokers the benefits of flavored e-cigarettes.
• Roger D. Klein, MD JD (@RogerDKlein), is an expert with the Regulatory Transparency Project’s FDA and Health Working Group. He is a former adviser to the FDA, CDC, CMS and HHS.