Don’t Let FDA Kill Vaping

Published May 11, 2016

Legislators have long attempted to reduce the negative health impacts of smoking through taxes, bans, and regulations. Some have tried to extend these same policies to electronic cigarettes or “e-cigarettes,” even though they contain no tobacco and are substantially less harmful than traditional cigarettes. This week, the Food and Drug Administration (FDA) unveiled new regulations placing electronic cigarettes under an avalanche of new rules requiring that they be approved as a new type of tobacco product — effectively treating them like traditional cigarettes. 

E-cigarettes have quickly become a popular tobacco-replacement product, with the total market expected to hit $50 billion by 2030. Evidence suggests that they are effective at helping smokers reduce their cigarette use or even quit altogether, which is why many experts — including, most recently, the Royal College of Physicians — argue that e-cigarette use will result in significant public health benefits, to say nothing of the economic advantages.

FDA’s deeming regulations extend the agency’s regulatory authority to include cigars and other tobacco-like products, in addition to e-cigarettes. The main issue posed by these regulations is the process these products will have to go through to receive FDA approval. Any new tobacco product that does not meet the standard of “substantial equivalence” to another product currently on the market is required to go through a lengthy and expensive process known as “premarket tobacco application” (PMTA).

The PMTA process is so arduous that only one product in the past six years has successfully made it over this large regulatory hurdle, according to the Tax Foundation. This is especially concerning for new vaping products such as e-cigarettes because few will be able to qualify as “substantially equivalent” to an existing tobacco product, meaning they will likely need to go through the PMTA process. PMTA is estimated to cost businesses $3 million to $20 million per application.

Linked to the approval issue is the problem of the predicate date, which is the grandfather date used by FDA as the starting point for tobacco products to receive enhanced review and regulation. The date used previously, February 15, 2007, was chosen for regulated products because it is the date the Tobacco Control Act was introduced. In effect, using this date for all tobacco and tobacco-like products will place nearly all vaping products, including e-cigarettes, under PMTA review. This could constrict or even eliminate the current market. 

Protecting the vaping market from overregulation is important. According to many in the public health community, e-cigarettes are far safer than combustible cigarettes, and several studies show that they remain one of the most successful methods used by smokers to stop their consumption of tobacco. For instance, the American Association of Public Health Physicians concluded that e-cigarettes “could save the lives of 4 million of the 8 million current adult American smokers who will otherwise die of a tobacco-related illness over the next 20 years.”

Many opponents of e-cigarette use say they act as a “gateway” product to cigarettes, especially for younger users. But the evidence suggests otherwise. According to Health Day, in 2013 researchers at the University of Oklahoma Health Sciences Center studied 1,300 college students with an average age of 19. Only 43 of the students told researchers their first nicotine product was an e-cigarette, and only one of those 43 later switched to traditional cigarettes. In a follow-up survey, most of the students were not using nicotine or tobacco at all.

Without changing the predicate date, most of these innovative products will never make their way to the marketplace, limiting the options of those who are looking for a less-harmful alternative to smoking. E-cigarettes and other vaping devices have far fewer negative consequences than traditional tobacco products for both users and bystanders, and many smokers use e-cigarettes to stop smoking, thereby reducing the likelihood of suffering from serious tobacco-related illnesses such as lung cancer. Vaping is not the same as smoking tobacco products; they should not be treated in the same way.

[Originally published at Real Clear Policy]