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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After String of Vaping-Related Hospitalizations, Walmart Ends E-Cigarette Sales

On Friday, Walmart said that it would stop selling all e-cigarettes after their inventory runs out, citing “the growing federal, state, and local regulatory complexity and uncertainty regarding e-cigarettes.” The announcement comes in the midst of a number of reports linking use of e-cigarettes, or other electronic vapor inhalation devices, to health issues, including hospitalizations and in a few cases death. Walmart joins Rite-Aid, Costco, and Dollar General in retailers who have decided to stop selling electronic nicotine delivery systems. And Target, Walmart’s biggest competitor, has never sold e-cigarettes and stopped selling cigarettes in 1996. That being said, Walmart is the largest retailer in the country, and other retailers tend to follow Walmart’s lead, as Walmart Chief Executive is the chairman of the Business Roundtable, an influential lobbying organization that includes among its members some of the biggest companies in the world.

While the exact causes of the recent string of vaping-related health scares are as of yet unknown, many affected individuals reported vaping THC products, including some which were acquired illegitimately, and some patients reported using nicotine products. Nevertheless, Walmart’s decision reflects a rapidly-rising anti-vaping sentiment, as e-cigarette use among adolescents has skyrocketed, owing in part to the success of Juul, a company that manufacturers nicotine cartridges and diffusers which can easily be mistaken for USB drives. 

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The Trump administration had seriously considered banning all flavored vape products in an effort to curb their appeal among young people, but abruptly changed course. Other ways of fighting the popularity of vaping among youth, such as ultra-sensitive vapor detectors which can be installed in schools and other public places, have been proposed. And while manufacturers like Juul claim their products are intended as smoking cessation aids, to allow nicotine addicts to gradually reduce their intake of the drug, these manufacturers profit tremendously off of the sales of e-cigarettes to people who have no intention of quitting, particularly young people. The National Institute on Drug Abuse this week released survey results indicating that the prevalence of vaping among teenagers has doubled since 2017.

Walmart’s action will likely have little impact, as there’s no end in sight for the resilient and centuries-old tobacco industry, which now has more loyal customers than ever before.

It should be noted that Walmart continues to sell regular cigarettes, which have been found definitively to cause major health problems, including cancer, lung disease, and early death, whereas the long-term negative health effects of vaping are still unknown. Additionally, Walmart continues to sell assault-style weapons even in the aftermath of a string of mass shootings in the United States, though the company has imposed limits on the sale of ammunition and discourages open carry of guns in stores. Three major television stations, CNN, CBS, and Viacom have also said they’d stop airing advertisements from e-cigarette companies on their networks in response to fear about illnesses. Additionally, several politicians have returned donations that they received from e-cigarette companies like Juul, unwilling to be associated with companies that have the potential to become the face of a public health epidemic in this country. 

Some fear that Walmart’s decision will drive people who ordinarily vape to take up smoking cigarettes instead, as the retailer still offers the latter nicotine product. Others criticize the view that flavored e-cigarettes should be banned, noting that adults also enjoy flavored e-cigarettes, and banning flavors would negatively impact those who use e-cigarettes as a smoking cessation tool. Regardless of Walmart’s decision to no longer sell e-cigarettes, the nicotine products are easy to find and acquire, even for teenagers, as they continue to be featured in gas stations, convenience stores, and smoke shops. As such, Walmart’s action will likely have little impact, as there’s no end in sight for the resilient and centuries-old tobacco industry, which now has more loyal customers than ever before.

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