Going back to the nation’s founding, cigarette smoking has wreaked havoc on U.S. public health and contributed to an astronomical death toll. According to the Centers for Disease Control and Prevention, cigarette smoking causes about one of every five deaths in the United States each year.
Despite decades of anti-tobacco education and abstinence-promotion messaging, the problem persists, with an estimated 40 million adults currently who smoke cigarettes and thousands more teens who try their first cigarette each day. As many smokers and former smokers can attest, quitting is hard.
Since smoking remains an abiding and intractable problem, one would think public-health officials would welcome innovations that make quitting easier or reduce the associated harms. Yet the Food and Drug Administration (FDA) has taken the opposite approach when it comes to electronic cigarettes. Thanks to FDA bureaucrats, we could remember this past Monday as the beginning of the end of what was probably the most innovative and promising smoking-cessation industry ever to enter the U.S. market.
E-cigarettes are not risk-free, but research  by Public Health England has estimated they are at least 95 percent safer than traditional tobacco cigarettes. They’ve already proven an effective tool for many smokers seeking to quit, and their broader use has tremendous potential to improve public health. A recent study published in journal Nicotine & Tobacco Research estimated that e-cigarettes could reduce smoking-related deaths by 21 percent.
Since e-cigarettes are a relatively new technology, there remain important questions to be answered about their risks, especially when it comes to long-term use. Standards are needed to ensure quality control and consumer safety. But a sensible regulatory approach would recognize the relative safety of e-cigarettes and take care not to privilege deadlier forms of tobacco over the potentially life-saving alternatives.
The FDA’s final rule to regulate e-cigarettes does precisely the opposite. It would force manufacturers to comply with rules set out in 2009’s Tobacco Control Act, even though e-cigarettes are qualitatively very different from traditional cigarettes. It also erects barriers that will steer consumers toward the most harmful forms of nicotine delivery.
As of Aug. 8, some of the less-contentious parts of the regulations—a ban on selling to minors, identification requirements, prohibiting free samples, etc.—are immediately in effect. E-cigarette manufacturers now have two years to go through a long and expensive application process for each and every product that they wish to remain on the market after 2018. That is, unless they can prove “substantial equivalence” to a product that existed before the Tobacco Control Act’s arbitrary “deeming date” of Feb. 15, 2007—but that would be near impossible since e-cigarettes are such a new technology.
The FDA claims the applications will take 5,000 hours and cost $330,000 each, but some estimates put the cost at as much as $1 million for each product, which includes every potential combination of device, flavor and nicotine strength. It’s likely the biggest companies will be able to shoulder the costs and navigate the regulatory process, and a limited variety of generic vapor products will be on the market after 2018. But the smaller vape shops that offer a variety of customizable devices and liquids will inevitably fall victim to death-by-red-tape and be forced to close shop. Consumers can expect fewer choices and higher prices, and the e-cigarette industry as a whole will suffer from restricted competition and innovation.
Can the FDA’s illogical and harmful crusade against e-cigarettes be stopped? Fighting a regulatory giant is never easy, but it’s possible through a few avenues. First, there are legal challenges. At least five lawsuits have already been filed against the FDA’s regulations.
The FDA’s rules also have been challenged in Congress. There is already language in the Agriculture Appropriations bill – as well as a standalone bill, H.R. 2058 – that would push back the “deeming date” while still subjecting e-cigarettes to other FDA regulations. This would allow e-cigarettes introduced before this month to stay on the market without being forced into the costly application process.
To be clear, this regime would still favor existing products over new innovators and restrict future entry into the marketplace. But it’s a short-term fix that would preserve the market until the FDA develops a better regulatory scheme.
FDA officials and nicotine prohibitionists may think that they’re taking a “better safe than sorry” approach that will save consumers down the road from some yet-to-be-discovered dangers in e-cigarettes. In fact, they’re endangering millions of past, current and future smokers who are addicted to a product already known to be deadly and who may be able to make the switch to a lower-risk nicotine product if presented with desirable alternatives.
The FDA has a choice. They can continue their illogical moral crusade against e-cigarettes, which means that many Americans will continue to suffer from nicotine addiction and repeated failed attempts at quitting. Or they can work toward a new regulatory paradigm for e-cigarettes that ensures basic standards but clears the way for innovation in the potentially life-saving industry. If the FDA doesn’t reverse course before 2018, more lives will needlessly be lost and all of us who have to bear the public-health costs of tobacco-related deaths and illnesses will suffer.
- “research”: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/457102/Ecigarettes_an_evidence_update_A_report_commissioned_by_Public_Health_England_FINAL.pdf