Teens and electronic cigarettes are a combustible issue that’s been heating up the headlines lately.
By Sally Satel | April 11th, 2018
“‘I Can’t Stop’: Schools Struggle with Vaping Explosion,” blares the New York Times. The Wall Street Journal announces widespread concern: “Schools and Parents Fight a JUUL E-Cigarette Epidemic.” Meanwhile, CNN wonders whether vaping is the “health problem of the decade.”
It may (or may not) be a simple coincidence that the panicky coverage coincides with a recent lawsuit demanding that the Food and Drug Administration speed up regulation of vaping products. But, orchestrated or not, rushing the FDA to regulate puts smokers at risk.
The lawsuit, filed at the end of March by a coalition of seven anti-tobacco groups, including the Campaign for Tobacco-Free Kids, American Academy of Pediatrics, and five individual pediatricians, took aim at a key decision the FDA made last July. The agency pushed back the pre-market application submission deadline for e-cigarettes from August 2018 to 2022.
Plaintiffs want the original deadline re-instated, claiming that the regulatory delay is illegal. I believe that the delay is wise (and note that regulatory agencies routinely change compliance deadlines). The postponement gives the agency and Congress time to replace the burdensome and costly pre-market approval procedure, which would have crippled the vaping industry, with a more efficient regime. My preferred “standards-based” scheme would ensure product safety while allowing subsequent improvements in technology to reach the market efficiently.
Vaping products are already the most widely used quit-smoking tool. The FDA’s regulatory delay means longer access to a wide variety of vaping devices, including traditional e-cigarettes and the newer JUUL. This is good news for smokers as vaping products, which do not burn tobacco and thereby release dozens of carcinogens, are much safer than cigarettes. As a result, smokers who switch to vaping have improved lung function, blood pressure, cardiovascular health, and lowered risk of pneumonia. Nicotine, it must be emphasized at every opportunity, does not cause cancer.
The window of freedom created by the FDA’s regulatory delay has allowed JUUL, in particular, to blossom. The device’s technology is broadly similar to traditional e-cigarettes in that it produces nicotine-infused aerosol vapor. But, instead of heating nicotine liquid as classic e-cigarettes do, the sleek thin JUUL vaporizer heats pods containing propylene glycol, glycerol, flavoring, and nicotine salts. The salts enable JUUL to deliver high concentrations of nicotine that mimic a regular cigarette’s blood absorption pattern marked by a sharp peak and steep drop-off of nicotine levels. This pharmacologic profile holds special appeal for smokers.
Indeed, JUUL has rocketed to a 55 percent share of the US mass manufactured e-cig market (by dollar value) in a mere two years. At the same time, US cigarette sales volumes continue to decline to their lowest ever, strongly suggesting that such products have vast public health potential. CDC reports that the adult smoking rate hit 14.1 percent, another new record low, in the first nine months of 2017, down from a rate of 15.8 percent in 2016.
And it is not just an American phenomenon. “We are now seeing strong evidence in markets around the world that the substitution of non-combustion products is perhaps the most effective anti-smoking intervention we have ever had” says tobacco policy expert David Sweanor of the Center for Health Law, Policy and Ethics at the University of Ottawa.
But what about teens? It is the concern for their welfare that sparked the headlines in the first place, after all. Is vaping leading them to smoke? If indeed ”gateway effect” exists, the data strongly suggest that it is very small. For one thing, smoking among teens is at a historic low, dropping as vaping is rising. Notably, too, the 2015 National Youth Tobacco Survey found that only 0.3 percent of non-smoking adolescents regularly vape.
JUUL is too new to have been included in those data. And some questions surely need to be addressed. For example, how frequently are adolescents who haven’t first been regular smokers using JUUL on a routine basis? What, if any, are the delayed health risks of using JUUL (and other vaping products for that matter)? Is progression to smoking really as unlikely as appears to have been the case for traditional e-cigarettes? Is adult alarmism around JUUL backfiring and pushing kids to try it? Alternatively, is JUUL offering a path out of smoking for teens or diverting young people who were on their way to becoming smokers?
These and other questions should prompt rational discussion and data analysis. Instead, opponents of the FDA’s regulatory delay are posing a false choice between the well-being of teens and the wellbeing of smokers. Their tactic is simple: emphasize the theoretical downsides of safer nicotine delivery while ignoring its value as a way to help smokers quit.
A whiff of moral panic is in the air. FDA Commissioner Scott Gottlieb must be feeling pressure to renege on his welcome commitment to regulate according to a “continuum of risk,” tailoring each product’s regulation to the degree of harm that it poses.
The challenge for the agency is to see through this smoke screen, devise a thoughtful regulatory regime for non-combustibles, and resist the false choice between sacrificing smokers and protecting teens.