The F.D.A. Rules Ignore Harm Reduction Benefits for Adult Smokers

By Kenneth E. Warner

(NY Times)

The Food and Drug Administration was right to assert their authority to regulate novel products containing nicotine and/or tobacco. They must use that authority wisely, however. Novel products such as e-cigarettes hold the potential to help thousands of Americans to quit smoking. Vaping is unquestionably less dangerous than smoking. The trick, then, is how to regulate e-cigarettes and other novel products to maximize their potential to reduce harm while simultaneously discouraging their use by young people who otherwise would never be exposed to nicotine.

The announced regulations target potential young smokers sensibly. But they fail to encourage the development of harm-reducing lower-risk products. To the contrary, the exacting demands for submitting a new tobacco product application, which will be required of the vast majority of novel products, including e-cigarettes, 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 as a consequence.

There is a better way. The F.D.A. should evaluate classes of products, like e-cigarettes. For those it determines are substantially less hazardous than smoking, the agency should establish basic standards, prohibiting or limiting exposure to toxic substances not essential to creating the products. Manufacturers would simply have to demonstrate that their products complied. The F.D.A. should also require product advertising to be directed only to adult smokers and to focus solely on harm reduction potential. It could even require advertising and packaging to inform consumers that while these products are not risk-free, they are significantly less dangerous than smoking and should be used instead of combusted tobacco products if smokers are otherwise unable to quit. Unfortunately, today e-cigarettes cannot legally make such health claims despite their self-evident truth.

The government’s current approach to e-cigarettes, as voiced by the Centers for Disease Control and Prevention and now the F.D.A., is hugely unbalanced, emphasizing the hypothetical risk to children while ignoring the potential harm reduction benefits for adult smokers. Even if products like e-cigarettes prove to impose a lasting risk on a small subset of kids – there is no good evidence to that effect to date – those kids will not experience the adverse consequences for the next four decades. During that period, more than 10 million adults will die prematurely from smoking, each losing on average 20 years.

The F.D.A.’s announced new product regulation is likely to squander an opportunity to hasten the demise of the enormous toll of combusted tobacco.


Kenneth E. Warner is the Avedis Donabedian distinguished university professor of public health and former dean of the School of Public Health at the University of Michigan.


One response to “The F.D.A. Rules Ignore Harm Reduction Benefits for Adult Smokers

  1. Pingback: The F.D.A. Rules Ignore Harm Reduction Benefits for Adult Smokers | Ecigvaporsonline·

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