When e-cigarettes burst onto the market about a decade ago, manufacturers enjoyed a long period of no regulation. The market boomed, and so did e-cigarette use among Americans.
Now that may change. Last week, the Food and Drug Administration finally was granted authority over the e-cigarette market (as well as other previously unregulated tobacco products such as cigars and hookah) under a new federal rule. In three months, the agency will begin banning the sale of these products to minors, and will require all manufacturers of products that hit the market after February 15, 2007, to register with the FDA and submit their products for approval — disclosing ingredients, safety and emissions data, and manufacturing processes.
Many public health advocates are calling the new regulations a win for health and safety. But there's plenty of grumbling about them, too. Some who favor e-cigarettes as safer alternatives to traditional tobacco products have argued that heavy-handed laws could stall innovation and use by smokers of these potentially lifesaving devices. The American Vaping Association has gone so far as to call the laws a form of prohibition and a gift to the cigarette industry. Others say the new regulations are too costly. (Each application for approval, advocates estimate, will cost manufacturers upward of $1 million. The FDA estimates a more modest cost of several hundred thousand dollars.)
To learn more about the decision-making behind the new rule, I talked to Mitch Zeller, director of the FDA's Center for Tobacco Products. A veteran of the agency's war on tobacco, he's been leading the effort to regulate e-cigarettes for several years now. This conversation has been edited for length and clarity. Mitch Zeller: The main news here is that finally e-cigarettes, cigars, hookah, and pipes will be regulated by the FDA, which is a milestone in consumer protection. Congress told the agency, "You're in the business of regulating tobacco products to reduce disease and death from tobacco." But the original grant of authority only covered cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.
The most immediate change that's going to be seen in coming months is enforcing a prohibition that makes it illegal to sell these products to young people. Over time, other regulations will kick in. If a company wants to introduce a new product, it must file an application [with the FDA] first. [Our] scientific experts will make an assessment on whether the new product should be marketed or not. Going forward, if an e-cigarette maker wants to make a health claim, it's going to have to submit an application to FDA first. [Other] requirements that will kick in over time: reporting ingredient information to us, registering with us. With each of these applications, important information will be submitted on an application-by-application basis, about the ingredients or additives we are concerned about.
In the absence of this authority, we can't tell the public what's in the aerosol of e-cigarettes. There was no requirement for companies to register with us, give us information about [their products], and that's all going to change over time. That's bedrock consumer protection.
JB: You've described having to make the new tobacco regulations with insufficient scientific data about e-cigarettes. What are the biggest uncertainties in your view?
MZ: You could divide it into two buckets: things we know and things we don't know. What we know, when it comes to young people's use of e-cigarettes, is that there's a huge public health concern. From 2011 to 2015, there was a 900 percent increase [from 1.5 percent in 2011 to 16 percent in 2015] in use of e-cigarettes by kids of high school age. That's a huge problem.
What we don't know is about dual use of both e-cigarettes and cigarettes. We know 70 percent of all adults who use e-cigarettes continue to smoke regular cigarettes. What we don't know, at a population level, is whether it's simply a transition away from cigarettes, which would be a benefit for public health, or dual use [of both products] leading to a diminished interest in quitting, which would have an adverse impact on public health. We'll get answers over time.
JB: 900 percent! That's a big jump in use among adolescent use of e-cigarettes. What's the greatest health concern there?
MZ: The lungs were not designed to inhale nicotine and the other chemicals that are in e-cigarettes. Nicotine is not a benign and safe compound. It has known cardiovascular effects. It can be very harmful to the developing fetus.
Young people's lungs shouldn't be exposed to the aerosol and vapor that contains nicotine. But, there is a continuum of risk — there are more harmful ways to deliver nicotine and less harmful ways to deliver nicotine.
JB: Yes, even people who don't like e-cigarettes acknowledge that the evidence appears to show they are safer than traditional cigarettes — and that encouraging use of these devices among smokers could be smart harm reduction. What do you think about that argument for these devices?
MZ: For products regulated by FDA, the most harmful and deadly [nicotine delivery system] is cigarettes. When used as intended, cigarettes kill half of all users. The brains of addicted smokers don't know where the nicotine is coming from. They're just craving the next dose.
A currently addicted cigarette smoker is already putting the residue of 7,000 chemicals of tobacco smoke into [his] lungs. We have to ask ourselves some tough questions when it comes to dealing with the leading cause of preventable death, which is disproportionately cigarette use. What if we can safely transition currently addicted nicotine users to safer forms of nicotine delivery? But what if they need to stay on these products for life? How do we feel about, as a society, permanent long-term use?
JB: So how did you balance those uncertainties in making this new rule?
MZ: It's FDA's job to do the best possible job we can in addressing what are the net population–level public health impacts. A lot of people are trying to simplify the e-cigarette debate into black and white: Either they're terrible or they're the greatest thing since sliced bread.
The reality is that e-cigarettes have both a positive and negative impact on public health.
JB: Much has been made about the seeming contrast between America's approach to e-cigarettes and England's. Public Health England, for one, declared e-cigarettes 95 percent safer than regular cigarettes, and the Royal College of Physicians endorsed e-cigarettes to help smokers quit. These groups are not regulatory agencies like the FDA — but their messages signify pretty diverging views from those coming out of public health in the US, where the harms of e-cigarettes have been emphasized.
MZ: One huge difference between e-cigarettes there and here is that, for whatever reason, [middle and high school–age] kids' use of e-cigarettes there is much much lower than it is in the US.
To me, it's a little too black and white to say with such certainty that this is a technology that's 95 percent safer than cigarettes. The reason is that you can't make an assessment of relative safety or risk of these technologies in the abstract.
If I were a pack-a-day smoker who was unable or unwilling to quit, and I substituted my cigarettes for e-cigarettes, there's no question I'd be significantly reducing my risk. But as a regulatory agency, we have to make decisions at the population level.
That's where it gets complicated. E-cigarettes have a positive and negative impact. In the US, that kids' use of e-cigarettes is way [up] is a negative. When it comes to adults, we have a disproportionate percentage of adults using e-cigarettes and cigarettes together.
By Julia Belluz - Vox/May 9, 2016