The e-cigarette epidemic — recognizing Big Tobacco's Trojan horse

Nearly every authority agrees; we are in the midst of a public health epidemic.

In November, the American Medical Association, representing the nation’s physicians, called on the Food and Drug Administration (FDA) to take action against the “urgent public health epidemic” of skyrocketing e-cigarette use.

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In early December, then-Senator Hatch (R-UT) introduced the Smoke Free Schools Act, which — among other measures — called on the FDA to partner with the Centers for Disease Control (CDC) and U.S. Department of Education to discourage e-cigarette use among students and to study gaps in knowledge of the harms of e-cigarettes on youth, including injuries and poisoning.

The New England Journal of Medicine recently reported on urgent concerns of the impact of e-cigarettes on youth. Focusing on the extremely popular Juul (with 72 percent of the market as of August, 2018), they reported one pod is equivalent to approximately 20 combustible cigarettes — a full pack.

The article explained that Juul and similar products use “protonated nicotine formulations derived from nicotine salts” in tobacco, creating products with 2 to 10 times more nicotine than that found in most e-cigarettes. These higher concentrations are precisely what may make them so addictive.

An unprecedented advisory was issued by U.S. Surgeon General Jerome Adams in December about the dangers of e-cigarette use among U.S. teenagers, stressing that nicotine vaping among youth should be called “an epidemic.”

At that time, it looked as though there might be the will to press forward with stringent regulation, legislation or both, but, with the impact of January’s shutdown perhaps still being felt and a new Congress finding its way, that momentum seems to at least temporarily have dissipated.

What’s made this epidemic so dangerous — besides recent vape-pen malfunctions — is the soaring adoption rate by youth. For example, more than one in five U.S. 12th graders nicotine vaped in 2018. E-cigarette users claim that vaping decreases the risk of smoking combustible cigarettes, but a recent update on the Children’s Health Study in the journal Pediatrics found that e-cigarette use in youth who had never smoked increased their risk of smoking cigarettes: 40.4 percent became combustibles smokers within 16 months.

In addition, the idea that vaping is no more addictive than smoking tobacco has been dispelled by several studies. One, conducted by Stanford University, found that among test subjects — 700, 9th to 12th graders — 58.8 percent reported they had used Juul within the last 30 days, while they reported use of e-cigarettes and conventional cigarettes at 30.1 percent and 28.3 percent, respectively.

Researchers reported the higher rates of use were the most striking difference between Juul users and users of other e-cigarettes and conventional cigarettes and it raised concerns about higher rates of addiction.

Does vaping help confirmed adult smokers quit combustibles, which are much more harmful than e cigarettes, despite similar addictive effects? Yes, for some smokers, but no better than nicotine gum or patches

A recent study in the New England Journal of Medicine — featured in a Washington Post editorial this week — found that while a fifth of those smokers given e-cigarettes refrained from smoking cigarettes, they were still vaping a year later, while those who quit using patches and gum had mostly stopped using those nicotine replacement aids.

However, another study published last summer found no evidence that e-cigarette use helped adult smokers quit at rates higher than smokers who did not use these products and concluded that vaping among adult smokers is unlikely to drive quit rates.

In addition, “dual use” of cigarettes and e-cigarettes is troubling. In 2015, among adults, 58.8 percent of e-cigarette users also smoked cigarettes.

Among young adults the same year, 40 percent of e-cigarette users also smoked cigarettes. This suggests that some e-cigarette use may be supplementing smoking instead of replacing it.

Finally, a 2018 report from the National Academies of Sciences, Engineering and Medicine concluded there is “substantial evidence that e-cigarette use increases risk of ever using combustible tobacco cigarettes among youth and young adults,” suggesting that e-cigarette use itself is a risk factor, not just a correlation with smoking.

The two bills currently in committee (Sen. Hatch’s legislation, now sponsored by Sen. Udall [D-N.M.] — and another put forward by Sen. Durbin [D-Ill. ] earlier in 2018) are designed to address troubling impacts on teens and young adults. Yet, even if those bills are delayed, there is much that could be done and the regulatory body that could do it is the FDA.

It would be difficult to outlaw vaping, which could have the unintended effect of driving it underground. But, FDA commissioner Scott Gottlieb announced last September that the agency might consider banning some forms of e-cigarette to protect teens. This would be a critically important move, well within the FDA’s policy mandate. So far the FDA actions, cracking down on flavored e-cigarette cartridges and launching a vaping prevention campaign targeting teens who vape or are likely open to trying it, fall short of their potential.

Gottlieb said that the FDA will continue enforcement against retailers that sell to minors, but there is much more that the FDA could do, if it chose to. In May 2016, the agency finalized rules giving it authority to regulate e-cigarettes and anything meeting the definition of “tobacco product” under the Family Smoking Prevention and Tobacco Control Act. The FDA can now establish product standards and regulate manufacturing, importing, packaging, labeling, advertising, promotion, sale and distribution of e-cigarettes.

To stem the tide of the recognized epidemic that we face, the FDA could limit nicotine concentration in vaping fluids and set these below addicting levels, or at least at much lower levels, reducing the addictive nature of current products. Given this authority, why doesn’t the FDA lower the nicotine delivered by all combusted tobacco products as well?

Let’s hope the FDA takes decisive action to help control the e-cigarette epidemic. In July 2017, the agency delayed the compliance deadline for regulation of e-cigarettes to 2022, allowing the industry five years to assert that their products are safe alternatives to conventional cigarettes and that they aren’t targeting minors.

In light of teen use continuing to skyrocket, an addiction epidemic caused by nicotine products targeting our kids is irrefutable. The responsible move is for FDA to employ the precautionary principle: rescind the delay, issuing new regulations that could, if necessary, be modified in light of new evidence.

Delay only empowers the e-cigarette industry rather than protecting our children and their children.

Jonathan Fielding, M.D., is a professor of public health and pediatrics at University of California, Los Angeles.