Benjamin Mateus
The Trump administration announced Wednesday that it is seeking to ban all flavored e-cigarettes. This comes in reaction to the developing epidemic that has seen more than 450 people develop severe lung illnesses attributable to the inhalation of vapor from e-cigs, or “vaping.” There are now six confirmed deaths reported.
The cause of these illnesses remains unknown. Medical officials speculate that a new toxin or adulterated vaping product may be the inciting factor. However, Juul, the most brand of e-cigs among children, has not been implicated in the epidemic.
Contributing to this furor over the developing lung illness epidemic is the acknowledgment of the epidemic of teenage nicotine addiction associated with the wide prevalence of e-cigarette use among middle- and high school-aged people.
According to the Centers for Disease Control and Prevention (CDC), the use of e-cigarettes among adolescents in the US climbed to 3.6 million in 2018, up from 2.1 million in 2017. The Federal Drug Administration (FDA) and US congressional members are under pressure from anti-vaping advocates to address these striking statistics. At the forefront has been the grassroots organization called Parents Against Vaping E-cigarettes.
The FDA has been working on a “guidance document” that would ban all e-cigarette flavors in the next few weeks. Health and Human Services Secretary Alex Azar told reporters, “Once the FDA would finalize this guidance, we would begin enforcement actions to remove all such products from the marketplace …we will not stand idly by as these products become an on-ramp to combustible cigarettes or nicotine addiction for a generation of youth.”
The FDA explained that once the proposed ban on flavored e-cigarettes takes effect, only tobacco-flavored products would be allowed on the markets and producers would have until May 2020 to submit their applications for their “new tobacco product.”
FDA’s regulations on e-cigarettes went into effect on August 8, 2016. According to their rules, companies that produced e-cigarettes had two years to file “new tobacco product” applications with the FDA. An additional year of manufacturing was granted while the FDA reviewed the application. According to NPR, “Without such applications on file, e-cigarette products currently on the market are technically illegal and subject to government action.”
In the face of such seemingly bold and decisive action by the FDA, the admission by former commissioner of the FDA, Scott Gottlieb, in an NPR interview earlier this year is astonishing. He said, “[T]hese products are on the market out of an exercise of enforcement discretion by the FDA. They [manufacturers] don’t have these applications in. They haven’t submitted them. No company has submitted an application for an e-cigarette.”
It is worth highlighting a section from the FDA’s 2016 section on Rules, Regulations and Guidance on e-cigarettes which stated, “Before this rule, there was no federal law to stop retailers from selling e-cigarettes, hookah, or cigars to youth under age 18.” They also noted then the alarming rise in e-cigarette use by high school students. These regulatory measures and concerns were merely rhetorical in nature.
On May 16, 2019, the American Lung Association posted an article on their web site titled, “Federal Judge Rules FDA Acted Illegally in Delaying Required Review of E-Cigarettes, Cigars.” Despite its own regulations, the FDA was allowing e-cigarettes to remain on the market until 2022 before producers had to apply for “new tobacco product” authorization. Furthermore, they would permit products to remain on the market indefinitely during the FDA’s review.
On May 15, Judge Paul W. Grimm of the US District Court for the District of Maryland found that the FDA had exceeded its legal authority. According to his Memorandum Opinion, “FDA’s delay gave manufacturers responsible for the public harm a holiday from meeting the obligations of the law. Instead of addressing public health concerns associated with tobacco use by minors and others, the August 2017 Guidance [which delayed the product review requirement] exacerbated the situation by stating, in essence, that manufacturers can continue to advertise and sell products that are addictive and that target a youth market … at a time when minors’ use of tobacco products like e-cigarettes is at an epidemic level and rising.”
This provides significant context to the current frenzy that has taken hold of congressional busybodies and FDA officials. They are furiously trying to cover for their criminal negligence and culpability in the present epidemic attributed to the vaping crisis as well as for the nicotine addiction that is placing these young people at risk to turning to combustible tobacco.
No comments:
Post a Comment