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FDA Oversight is Key to Minimizing Risks of E-Cigarettes, Especially to Kids, and Realizing Potentia

October 24, 2015


An abridged response was published as a letter to the editor in The New York Times on October 23, 2015.

In his October 16, 2015, column in The New York Times (“Can E-Cigarettes Save Lives?”), Joe Nocera asserts that the use of e-cigarettes will “dramatically reduce” the dangers of smoking. He also excoriates all who say that we don’t yet know whether the emergence of e-cigarettes will reduce the number of Americans who die from tobacco use or whether it will encourage a new generation of tobacco users. He is so certain about his conclusion that he says it is time to “forget about the FDA” in regulating these products.

If there is a public health benefit to the emergence of e-cigarettes, it will only come if they are effective at helping smokers end the use of cigarettes and if they are marketed in a way that prevents the re-glamorization of smoking among young people. Addicted smokers who switch completely to e-cigarettes in all probability reduce their risk of disease, but those who continue to use cigarettes gain little health benefit.

Nocera is wrong when he advises to “forget the FDA”: These goals can be achieved only through effective oversight by the Food and Drug Administration, not by circumventing it. The answer isn’t to ignore the protections in current law; it is to press the Obama Administration to quickly issue rules designed to regulate e-cigarettes in a way that will minimize deaths from tobacco.

The concern about youth use is serious. From 2013 to 2014, past-month e-cigarette use among high school students tripled to 13.4 percent. We’re also seeing high prevalence of e-cigarette use among youth who have never used cigarettes. In 2013, over a quarter of a million youth who had never smoked a cigarette used e-cigarettes.

For more than 75 years, the Food, Drug and Cosmetic Act has required drug manufacturers, including manufacturers of products that claim to help people quit smoking, to present their scientific evidence to objective, independent, expert scientific review by the FDA. It is the only way to protect consumers from irresponsible, dangerous claims. Not one e-cigarette manufacturer has produced that kind of evidence or applied to the FDA to make such claims.

When it comes to claims that cigarette smokers will reduce their risk if they switch to an e-cigarette, the 2009 law giving FDA jurisdiction over tobacco products sets out a common-sense standard that weighs the product’s impact both on current tobacco users and on the population as a whole.

No other manufacturer of products regulated by the FDA is allowed to make claims about the safety of their products without first conducting the science to demonstrate the accuracy of their statements; neither should e-cigarette makers.

The Obama Administration has taken too long to finalize its proposed rule asserting authority over e-cigarettes, but e-cigarette manufacturers also bear significant responsibility for the delay. Even before the 2009 law was passed, they sought to exempt their products from FDA oversight. Then they fought the FDA’s initial efforts to regulate e-cigarettes in court. Subsequently, they have lobbied heavily to delay and/or weaken action by the FDA.

Without thoughtful new government action, the incentives are upside down. Manufacturers have little incentive to spend the money to make products that will be most effective at helping cigarettes smokers quit or switch and, if they do so, aren’t able to tell consumers which products are most effective at doing so. The current situation rewards those whose marketing reaches the widest audience, including kids, whether or not they help adult cigarette smokers looking to reduce their risk of disease by switching completely to e-cigarettes.

Finalizing the proposed rule asserting jurisdiction over e-cigarettes is a long-overdue first step. There is an equally critical next step. Claims that a product is effective at helping cigarette smokers quit are drug claims overseen by FDA’s Center for Drug Evaluation and Research (CDER), not by FDA’s Center for Tobacco Products. Without CDER’s review and approval, no such claims can be made.

When the AIDS epidemic swept across the nation, the FDA and CDER worked with stakeholders to expedite the process of bringing to market products that could make a difference quickly without compromising public safety. FDA recognized that there was a huge cost to “business as usual.”

Today, close to half a million Americans die every year from tobacco use. We don’t know whether some form of e-cigarette technology could make a fundamental difference. But we do know that the FDA and CDER could play a critical role that they are not now playing by providing incentives and a path forward to those who produce products, backed up by sound science, that help cigarette smokers reduce their risk of disease by switching completely to e-cigarettes and who market those products in a way that does not make them appealing to our nation’s youth.

The emergence of e-cigarettes calls out for urgent and decisive action by the Obama Administration. Until the Administration acts, there will continue to be more questions than answers with potentially tragic consequences.