By Sally Satel
Yesterday, the New York Times published an editorial titled “Big Tobacco Attacks Sensible F.D.A. Vaping Rules.”
Two points for debate surface immediately.
First is the question of just how sensible those rules really are. Second is the insinuation that tobacco companies should play no role in developing nicotine products that are far less hazardous than cigarettes.
By conflating products with their makers, the editorialists miss a crucial point about public health: that smokers are best served when safer alternatives to cigarettes are developed and available without needless delay.
What’s important is that appealing quality products exist, not who makes them.
Confusion over that key principle may have set the stage for the myriad assumptions, aspersions, and half-truths contained in the editorial.
Here is a point-by-point review.
Editorial: “As smokers turned to electronic cigarettes to reduce the health risks of smoking, big tobacco companies started buying e-cigarette makers and producing and selling their own.” (Point #1)
“Now those companies are lobbying Congress to prevent the Food and Drug Administration from regulating electronic cigarettes and cigars, as it does conventional cigarettes.” (Point #2)
“If the [tobacco companies] succeed, they will be able to sell and market addictive nicotine products to young people with few restrictions.” (Point #3)
Response to #1: Yes, tobacco companies are in the harm reduction business: they want to sell vaping devices and other reduced risk products that allow smokers to consume nicotine more safely. Why is this bad? Altria, Reynolds, and Philip Morris International (PMI) have product lines that are intended to appeal to smokers who want to quit conventional combustible cigarettes.
Safer products can only be a win for public health.
E-cigarettes don’t combust tobacco and thus they do not release tar, carbon monoxide, and scores of other cancer-causing toxins. According to the Royal College of Physicians, they are 95 percent less risky than cigarettes.
E-cigarettes contain nicotine, an addictive substance that poses negligible health risks to otherwise healthy people. Even smokers with asthma or hypertension who have switched completely or partly to vaping products enjoy improved lung function and blood pressure. (The effects, if any, on long-term inhalation of propylene glycol and glycerin, components of e-liquid, remain to be seen and must be studied post-market.)
More good news. The CDC just reported that e-cigarettes are the most popular device used for smoking cessation (35.3%), more popular than both nicotine gum and patch combined (25.4%).
Response to #2: Makers of vaping products are not avoiding regulation. They want it. They need it. What they want is sensible regulation and this is where the F.D.A. fails. The “deeming regulations” impose massive regulatory burdens.
For example, manufacturers of electronic cigarettes and vaping devices must spend between $300,000 and $2 million to prepare and file a “pre-market application” with the F.D.A. for approval. Now, multiply these demands by a factor of 10s to 100s, to account for an entirely new assessment for each device or e-liquid flavour that a company makes. This extends to details such as improving battery safety to guard against overheating or even changing the concentration of nicotine in an e-liquid.
The F.D.A. will also need to create a vast bureaucracy of scientists and evaluators to process the 6-7,000 applications it anticipates receiving. Under section 910c of the Federal Drug and Cosmetic Act, the FDA is required to review these applications “no later than 180 days after the receipt of an application.” It’s anyone’s guess how they can do so.
In the short run, F.D.A.’s rules will drive hundreds of small and medium-sized vaping companies out of business. In the long run, the chilling effect of F.D.A. policy on innovation will keep smokers inhaling lethal tar.
Response to #3: Tobacco companies would not be able to “sell to young people with few restrictions.” There would remain restriction on sales to minors; in no way would adolescents be given access via new legislation. Sellers would be required to certify, face-to-face, that a buyer is at least 18 years old and if they want to sell online, they would need to obtain a permit.
Editorial: “The tobacco lobby wants Republicans to amend a vital appropriations bill (point #1) to exempt products that were introduced before May 2016 from F.D.A. review (point #2).”
Response to point #1: The amendment to which the editorial refers is the F.D.A. Deeming Authority Clarification Act of 2017, also called the “Cole-Bishop amendment.” The amendment would not “exempt” products from regulation.
The Cole-Bishop amendment would allow e-cigarette products and other newly deemed products that were already on the market before August 2016 to remain on the market without applying to the F.D.A. for marketing approval, the same freedom enjoyed by the numerous combustible cigarettes that were on the market before February 2007.
But, the amendment would not exempt the products from F.D.A. regulations. They would be subject to regulations regarding batteries, product standards, labelling rules, advertising guidelines, and registration requirements for retailers and manufacturers. Companies would be penalized if they violate any of these. Unfortunately, new products introduced after August 2016 would still have to undergo the existing (and overbearing) F.D.A. marketing approval.
Response to point #2: The editorial says that the “tobacco lobby” wants to revise the current approval process. Indeed. And they are not alone. In the name of harm reduction, public health experts want more sensible regulation too.
Among them are Kenneth E. Warner, the Avedis Donabedian distinguished university professor of public health and former dean of the School of Public Health at the University of Michigan. As he writes, “the [F.D.A.’s] exacting demands … will impose a production and financial cost that few manufacturers will be able to meet. As these firms and their products disappear, smokers will be afforded fewer low-risk alternatives to smoking and some will pay the ultimate price.”
Amy Fairchild, now Associate Dean of Academic Affairs and Professor at Texas A and M School of Public Health, echoes Warner’s concerns. “If there is to be a future for e-cigarettes, it is critical not to limit their potential to seriously challenge traditional cigarettes, she says. After evaluating the F.D.A.’s deeming rules, Fairchild concluded, “the [agency’s] final rule may be so burdensome that it effectively prohibits e-cigarettes.” Of the overly risk-averse posture held by so many in the tobacco control community, she and two colleagues from the Mailman School of Public Health aver, “an unwillingness to consider e-cigarette use until all risks or uncertainties are eliminated strays dangerously close to dogmatism.”
Editorial: “Another government report found that 16 percent of high-school students said they had used e-cigarettes in 2015, up from just 1.5 percent in 2011.”
Response: Experimentation is presented as if a problem. And, on its face, it does seem worrisome. Yet unmentioned in the editorial is the fact that youth are not progressing from vaping e-cigarettes to smoking real ones. If such a “gateway effect” were to manifest, it would be troubling. But evidence has yet to emerge in the five years the Centers for Disease Control has tracked teen vaping.
Teens do experiment with e-cigarettes (although less than one percent use them on a daily basis) but as more try them, smoking rates in that group are the lowest ever and falling fast. This suggests, but does not prove, that would-be teen smokers don’t go beyond vaping and/or that they are using e-cigarettes to quit. Whatever the explanation, it is clear that increased experimentation is not leading to more teen smokers.
Editorial: The F.D.A. is simply doing its job by protecting public health.
Response: The F.D.A. will do its job when it accepts that some adults will always want to use nicotine. This demands new rules that enable innovation, efficient approval, and access of smokers to an array of vaping products and other non-combustibles. The current regulations are the opposite of sensible. They protect no one and will kill many.