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.
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.

Tyler Olhorst is a Contributing Editor at The National Digest based in New York. You can reach him at inquiries@thenationaldigest.com.