FDA Failed to Act on E-Cigarette Regulations

The F.D.A. is a longstanding American institution which is trusted to ensure that the products available to the American consumer are safe and effective. But the recent emergence of more than a thousand lung illnesses related to e-cigarette and vape pen use has raised questions about the organization’s effectiveness in ensuring the safety of the new category of products. While e-cigarettes have been around for more than ten years, they have long been presumed to be safe despite a lack of thorough scientific research, and in recent months this presumption of safety has been called into question. In response to the outbreak of vaping-related illnesses, some of which have been deadly, journalists have conducted interviews with current and former government officials and public health experts to reveal a myriad number of factors, from lobbying to fears of political ramifications to excessive bureaucracy, that paralyzed the F.D.A. and enabled the beginning of what may very well become a long-lasting public health crisis.

Though the general public has only recently come to understand the serious health complications posed by vaping, public health officials have warned of this risk as early as 2013, with limited success. Dr. Thomas R. Frieden, former director of the F.D.A., issued a public warning that year about the rise of vaping, the fact that potential health issues were as-of-then unknown, and in particular the risk of developing nicotine addiction vaping posed to adolescents. The F.D.A., however, was unable to regulate the burgeoning industry, as two e-cigarette companies successfully sued the F.D.A for treating the devices as drugs rather than as tobacco products, which are subject to less stringent regulations. At the time, the Obama administration was more focused on the rollout of the Affordable Care Act than on other regulations, and in Obama’s last year in office, his administration rejected an F.D.A. proposal to ban flavored e-cigarettes, amidst intense lobbying from the industry.

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President Trump’s director of the F.D.A., Dr. Scott Gottleib, who had previously served on the board of a chain of vaping lounges, granted a four-year extension to e-cigarette companies before they had to prove that the public benefits of their products outweigh their risks, creating an opportunity for companies like Juul to flourish. Dr. Frieden described this extension as “public health malpractice,” as the addictive potential of nicotine and e-cigarettes’ appeal to young people was by then already well-known. Unlike most public health experts, Dr. Gottleib saw e-cigarettes as having potential to become valuable smoking cessation tools, rather than as a gateway to nicotine addiction and other tobacco products. And when it comes to vaping T.H.C., the active ingredient in marijuana, the F.D.A. is virtually silent, as the drug is still illegal at a federal level, and the rise in popularity of this method for getting high has been rapid.

In the aftermath of the spate of vaping-related illnesses, the F.D.A. has finally announced an intention to ban flavored e-cigarettes, but faces an uphill battle in doing so, as the industry vehemently opposes this sort of regulation. However, a federal judge recently overturned Dr. Gottleib’s four-year extension, meaning e-cigarette companies will have to demonstrate the public benefit of their products sooner than they previously thought. Though e-cigarette companies claim their products offer a less harmful alternative to cigarettes, the continuing rise of e-cigarette use among teenagers threatens to undermine this argument, as regulators are likely to believe the risk of developing deadly lung illnesses outweighs the benefits of the technology as a smoking-cessation tool. But for now, e-cigarettes remain on the market, in most states largely unregulated, even as they continue to pose a serious risk to health and life, which is sure to get worse as time goes on unless action is taken.

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Health Scares Spell Trouble for Vaping Industry

Recently, a string of vaping-related hospitalizations made headlines and led to growing concerns about the safety of e-cigarettes marketed as healthier alternatives to cigarettes and other tobacco products. In the aftermath of this news, a number of states have moved to ban flavored vaping products, and the federal government even contemplated the idea of banning all flavors of vapor except tobacco nationwide. This sudden spike in concern has led to problems for the vaping industry, as blame is being placed squarely on the manufacturers of nicotine-containing products for the public health epidemic, and as the growing popularity of vaping among teenagers and young people threatens to undo the work of several decades of public campaigns aimed at curbing nicotine addiction.

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Juul, a brand which has become synonymous with vaping as it controls roughly 70% of the e-cigarette market, recently saw a change of leadership as it replaced its CEO with a former tobacco executive. A sudden change in leadership is never a good sign for a company, particularly one as large as Juul, and this news comes amidst other troubling developments for the company. Recently, the F.D.A. claimed that Juul broke the law by implying that e-cigarettes were safer than traditional cigarettes despite the lack of scientific evidence concerning the long-term health effects of using the products. Even more disconcertingly, the F.D.A found that Juul was marketing their products to teenagers in high schools as part of a campaign ostensibly targeted at reducing tobacco use by young people. Juul has said that it intends on fully cooperating with the F.D.A.’s regulations, and has announced it will not fight a proposed ban on flavored nicotine cartridges. Next year, e-cigarettes are scheduled to be banned in San Francisco, and Juul is considering whether or not they should abandon a ballot initiative to overturn the ban.

In order to stay on the market in the United States, Juul and other similar companies have to be able to prove that their products promote public health more than they harm it, which is growing increasingly difficult as the news reports of vaping-related hospitalizations and an epidemic of nicotine addiction in young people. While initially envisioned as a tool to help people quit smoking, vaping has instead become a fashionable trend, and many who are addicted to nicotine have no history of smoking cigarettes. The rise in popularity of e-cigarettes has been explosive, and while F.D.A. regulations concerning the sale of nicotine products have long been in effect, regulatory bodies have yet to catch up with the specific public health problems that e-cigarettes in particular pose. 

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Health professionals across the country are in virtual consensus in advising against the use of e-cigarettes, except as replacements for cigarettes as smoking cessation devices. Even then, there are nicotine delivery systems, such as chewing gum and patches, that are likely safer than vaping as they do not involve any inhalation of chemicals. The director of the National Institute on Drug Abuse, Dr. Nora Volkow, said that e-cigarettes should be clinically tested to determine whether they are effective as smoking cessation tools, and if they are they should only be available by prescription, which is the same standard to which other potentially dangerous drugs are held.

While recent develops certainly don’t bode well for the e-cigarette industry, it’s difficult to make any concrete predictions about the fate of affected companies. Famously, the tobacco industry spent millions of dollars lobbying against the notion that cigarettes cause cancer and other health problems, and were very successful in doing so for several years. Vaping has become so widespread that its popularity perhaps even eclipses that of the tobacco products that preceded it, and as a result, the industry has a lot of money to spend on resisting regulatory efforts. However, the government has fought Big Tobacco before, pioneering widespread public health campaigns in an attempt to stop tobacco use, and as such has plenty of relevant experience to apply to fighting Juul and similar companies. Meanwhile, a meaningful segment of an entire generation of young people who otherwise would not have been exposed to nicotine are addicted to vaping, and only time will tell how they will be able to get their nicotine fix in the years to come.