– Sally Satel, 5/10/19
The Food and Drug Administration (FDA) is actually doing too much to regulate e-cigarettes. While concern over youth use is indeed warranted, the agency’s overall strategy threatens access to e-cigarettes for adult smokers.
E-cigarettes are a great public health advance, intended for smokers who cannot or will not give up nicotine. Vapers inhale nicotine via a propylene glycol-based and/or glycerin-based aerosol estimated to be at least 95 percent less hazardous than conventional cigarettes, which burn tobacco and release carcinogens and carbon monoxide. A recent, rigorous study reported that “vaping” was twice as effective as FDA-approved nicotine replacements (patches, gum, lozenges) in helping smokers quit cigarettes for one year.
Unfortunately however, the FDA’s premarket regulations are needlessly burdensome. They require every electronic cigarette product on the market (the devices and the liquids that give them taste and vapor) to be accompanied by a separate application to the FDA showing that the product is beneficial to the public’s health.
To do this successfully, a company must show that its e-cigarette product is safer than regular cigarettes; that it helps smokers to quit; and that the above benefits won’t be outweighed by the adoption of the product by nonsmokers, including young people. To satisfy this last requirement alone — the so-called population effects — long-term clinical and epidemiological studies are likely to be required.
According to the FDA itself, the cost of processing these applications — dozens to hundreds from each company — will take more than 5,000 hours to complete and cost a minimum of $330,000 per product. This extremely high cost will almost surely limit applicants and thereby protect actual cigarettes upon which the agency, per congressional mandate, can impose no approval requirements.
A far better approach would entail product quality standards, reminiscent of the United Kingdom’s approach. A compendium of agency-issued rules should establish prudent vapor battery and electrical standards that prevent overheating of the charger, explosion, etc., along with restrictions that ban potentially harmful ingredients.
Recently, the FDA has devoted enormous attention to the rise in youth use of Juul, a vaping device. Doubtless, teen use is an unwanted development, but the agency has fomented alarm, absent meaningful evidence of harm to date (including convincing data on a net “gateway-to-smoking” effect or compromised cognitive functioning), regarding the impact of vaping on teens.
There is wide agreement that e-cigarettes should not be available to minors who do not smoke and that the government should restrict marketing to them. But the intense focus on teen use has diverted almost all attention from the importance of adult access.
Availability and product innovation for adult smokers should be encouraged. The FDA has lost perspective when it comes to the adult side of this policy challenge.