Dr. Michael Siegel op/ed in Wall St. Journal: The FDA’s vaporous thinking about e-cigs
The Food and Drug Administration on Thursday finally released its regulations on electronic cigarettes. The rules, intended to sharply restrict the use of e-cigarettes—which deliver nicotine via a propylene glycol and/or glycerin-based smokeless aerosol—were immediately lauded by many health groups. But these new FDA regulations will actually protect tobacco-cigarette sales at the expense of the public’s health. They will also destroy thousands of small businesses and effectively hand the e-cigarette market over to a small number of large companies, including the tobacco companies.
Why? Because the regulations require every electronic-cigarette product on the market (the devices and the liquids that give them taste and vapor) to submit a premarket application to the FDA demonstrating that the product is beneficial to the public’s health. To do this successfully under the statute, 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.
It is a test that the agency cannot expect the e-cigarette makers to pass. I happen to disagree with those public-health experts who believe that “vaping” e-cigarettes may be more dangerous than smoking, and that vaping may make it harder to quit tobacco or even induce young people to start smoking. But if some public-health professionals don’t believe that electronic cigarettes are beneficial for the public’s health, how can an e-cigarette company expect to convince the FDA that its products are beneficial?
The FDA itself has acknowledged that the premarket applications are a burdensome requirement that will take more than 5,000 hours to complete and will cost a minimum of $330,000 per product. Since few of the e-cigarette-product makers—most of which are small businesses—can afford to stay in business and pay for this level of resources or expertise, the majority of these companies will shut down. That will leave the market open only for e-cigarette products made by the largest of companies, some of which have already begun buying what once were small-company e-cigarette brands. For example, R.J. Reynolds now owns Vuse.
Even worse, by creating a huge preapproval barrier to product innovations, the new regulations remove the incentive to pursue e-cigarette improvements that are the most effective in getting people to quit smoking tobacco by better mimicking the experience of smoking, such as the taste and the sensation of puffing, and improvements to make e-cigarettes even safer. Some tobacco financial analysts have predicted that such innovations could result in a 50% decrease in cigarette consumption over the next decade. Instead the FDA seems bent on blocking what might have been one of the most substantial public-health victories of our lifetimes.
And if improving public health is the goal, why is the FDA regulating e-cigarettes more stringently than the real tobacco cigarettes that are killing more than 400,000 people each year—while e-cigarettes have helped hundreds of thousands of smokers quit over the past five years? Because cigarette-makers don’t have to submit burdensome and expensive applications to stay on the market, the FDA has in effect protected them from competition from a product that could have cut their cigarette sales in half.
But what is by far the most shameful aspect of these regulations is that the new regulations will do nothing to actually help make e-cigarettes safer. For instance, the FDA isn’t banning the use of a kind of battery used in some brands that has a small but proven risk of exploding. The new regulations don’t ensure that e-liquids cannot be overheated in a way that can produce carcinogens like formaldehyde—another rare but documented risk. And they don’t ban potentially harmful ingredients in some brands, such as diacetyl, a chemical once used in popcorn-butter flavoring that has been associated with “popcorn lung” disease.
The only way out of this mess is for Congress to take matters into its own hands and enact legislation that would force the FDA to change its regulations in a way that will actually protect, rather than harm, the public’s health. This could be done by requiring the FDA to set safety standards directly for vaping products instead of requiring premarket applications that create a huge federal bureaucracy while destroying small businesses and doing nothing to protect the public’s health.
Michael Siegel Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 25 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.