What the FDA Gets Wrong About E-Cigarettes

(Bloomberg View) —

President Donald Trump’s nomination of Scott Gottlieb to be the next commissioner of the Food and Drug Administration is a hopeful sign that the FDA’s illogical tobacco product regulations may soon end.

The rules as they stand lump all nicotine-containing products in the same basket, regardless of what risks they pose, so that electronic cigarettes — which are orders of magnitude safer than tobacco cigarettes — cannot remain on the market unless their makers submit expensive and burdensome applications to the FDA. Combustible cigarettes, meanwhile, are free to keep killing more than 400,000 Americans a year, no paperwork required.

As a result, 99 percent of electronic cigarettes stand to be removed from the market, unburdening real cigarettes from the need to compete against safer products.

Gottlieb seems to realize that this doesn’t make sense. He has written of the “public health virtue” of helping move the market away from combustible cigarettes and toward safer products that deliver nicotine but without the enormous health risks associated with smoking.

The federal government’s current approach is described in last year’s Surgeon General’s report on electronic cigarettes, which characterizes vaping as a “form of tobacco use” and notes that electronic cigarettes are “the most commonly used form of tobacco among youth in the United States.” The report repeatedly emphasizes that all forms of tobacco use, including e-cigarettes, are dangerous.

There are two problems with these assertions. First, electronic cigarettes don’t contain tobacco, so vaping is not a form of tobacco use. Smokers who are concerned about their health but unable to quit nicotine use e-cigarettes in order to continue inhaling nicotine without the risks inherent in burning tobacco.

The Surgeon General’s report explains that “e-cigarettes are considered tobacco products because most of them contain nicotine, which comes from tobacco.”

But let’s be clear. If vaping is a form of tobacco use, then so is nicotine replacement therapy. And if “any form of tobacco use” is dangerous, then people who use nicotine gum and nicotine patches are also at risk. Obviously, it would be misleading to tell the public that the nicotine patch is a form of tobacco use. But the nicotine in a nicotine patch is derived from the same tobacco as is the nicotine in e-cigarettes.

The second problem with the report is its unwillingness to acknowledge any difference in risk among various products. How can a product that kills more than 400,000 Americans a year be compared with vaping products and nicotine patches?

The public relies on government health agencies to accurately communicate health risks. Vapers who read headlines suggesting that tobacco cigarettes and e-cigarettes are equal will be encouraged to return to smoking.

The report also criticizes the tobacco industry for historically misleading the public about the relative risks of different types of tobacco products (“light” vs. regular cigarettes), but then engages in its own form of deception by equating tobacco cigarettes, whose risks are well-known, with tobacco-free products, whose risks remain hypothetical. If there is any deficit in public understanding, it’s not in underestimating the risks of vaping, but in overestimating them, a recent survey shows.

The pitfall in exaggerating risks to scare children is that it doesn’t work. The risks associated with a behavior are part of what makes adolescents like it. Of course, grownups want to protect kids from risks. But the challenge is not to stop youth from ever taking them; it’s to create an environment in which risks are minimized. The priority should be to keep kids off of real cigarettes.

What’s more, efforts to scare kids away from vaping discourage many adults from quitting smoking. Many of my colleagues in medicine and tobacco control have been wrongly persuaded not to recommend e-cigarettes as an alternative for smokers who are unable to quit.

There is a way to regulate electronic cigarettes more sensibly: Congress should overturn the FDA e-cigarette regulations and substitute a framework that creates a separate category for e-cigarettes, with separate quality-control and safety standards; allows e-cigarette makers to innovate; and realistically communicates to the public the potential dangers of vaping.

When talking to people about risks to their health, honesty is always the best policy.

Siegel, a tobacco researcher, is a professor of community health sciences at the Boston University School of Public Health.

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