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WASHINGTON — ELECTRONIC cigarettes, battery-powered devices that convert a solution of nicotine and other chemicals into a vapor that can be inhaled, or “vaped,” have the potential to wean a vast number of smokers off cigarettes. No burned tobacco leaves, no cancer-causing tar: a public health revolution in waiting.

The problem is, not enough smokers are switching to e-cigarettes, despite their relative safety — and understandably so. Smokers are barraged with news about inaccurate labeling, shoddy counterfeits and poorly made e-cigarettes that emit toxins and cancer-causing chemicals in vapor. And to the frustration of smokers, public health experts and, yes, manufacturers, the Food and Drug Administration, which has not yet set up sensible regulations, is making the situation worse.

There’s no doubt that the initial public enthusiasm over e-cigarettes is waning: A report last year in the American Journal of Preventive Medicine showed that while nearly 85 percent of smokers believed that e-cigarettes were safer than cigarettes in 2010, that number had dropped to 65 percent in 2013.

Quality concerns are likely to keep rising: This year Chinese manufacturers, the most frequent culprit in safety oversight, are expected to ship more than 300 million e-cigarettes to the United States and Europe. Many of these products will be perfectly safe; the issue is that, so far, we lack an effective regulatory regime to distinguish the good from the bad.

It’s not that the F.D.A. has been idle. Last year it proposed a “deeming rule” — in effect, a blueprint for a regulatory framework for e-cigarettes. But given the avalanche of public comments (more than 135,000) and the importance of getting it right, a regulatory pathway will not be cleared anytime soon.

Consider the complexity. The proposal has some useful provisions, such as a ban on sale to minors and a requirement to disclose ingredients. But the proposal would also push e-cigarettes into the hugely burdensome regulatory framework that Congress set up for any new tobacco product.

That would be a mistake. To appreciate the extent of the unnecessary burden, consider “pre-market review.” Companies would have to demonstrate not only that each specific product was beneficial to intended users (adult smokers), but they would also have to show the consequences to teens and nonsmokers. Gathering these data would be vastly time consuming and expensive: According to the agency’s own estimates, conducting the necessary scientific investigations and preparing a pre-market application would take on average more than 5,000 hours and cost more than $300,000.

Only the large tobacco producers would be able to shoulder these costs, driving many of the 450 or so small e-cigarette makers from the market. This would suppress the innovation that’s crucial to expanding, refining and enhancing the safety and appeal of e-cigarettes.

Pre-market review is commonly used to prove that very risky products, like drugs, medical devices, pesticides and aircraft engines, aren’t harmful. But the point of e-cigarettes is not that they are safe, but that they are significantly safer than cigarettes.

Instead of waiting years to develop burdensome regulations, the F.D.A. should act now by setting interim safety guidelines. These guidelines would not carry the force of law, but they could go far to bolster smokers’ confidence that a safer way to inhale nicotine exists.

The agency should start by focusing on a few basic steps. It should outline basic good-manufacturing practices for the devices and liquids, including limits on the amount of chemicals, like formaldehyde, and metals, like nickel, that can be present in the aerosols. It should disallow outright some contaminants in the nicotine solution and flavorings.

It should require manufacturers to ensure that all batches of chemicals are traceable and that all sources of hardware are known. The guidelines should also require makers to verify that e-cigarette batteries can be charged safely and that they will operate safely in the course of normal use. Interim guidelines should require manufacturers to use childproof packaging that carries a warning: “This product contains nicotine, which is addictive and is intended for adult smokers only.” Also, a mechanism for reporting adverse effects is needed.

Finally, the F.D.A. should allow companies to tell smokers about the benefits of switching to vaping products. Labels could read: “While more research is needed, it is likely that e-cigarettes meeting F.D.A. interim safety guidelines are much safer than smoking.”

Such minimal standards are overdue. The longer it takes the F.D.A. to set them, the longer smokers risk confusion about the virtues of switching — and keep inhaling deadly smoke.

Sally Satel is a resident scholar

at the American Enterprise Institute.

Will the F.D.A. Kill Off E-Cigs?,
NYT,
JAN 18, 2015,
https://www.nytimes.com/2015/01/19/
opinion/will-the-fda-kill-off-e-cigs.html

Wise Controls on E-Cigarettes

APRIL 25, 2014

The New York Times

The Opinion Pages

Editorial

By THE EDITORIAL BOARD

The rapidly growing electronic-cigarette business would finally be brought under regulatory supervision under long-delayed rules proposed by the Food and Drug Administration on Thursday. If the rules go into effect substantially as written, they will lay the foundation to protect the public from devices whose risks and benefits are largely unknown.

Sales of the devices have risen sharply and are poised to skyrocket now that big tobacco companies are entering the market once dominated by small firms. Use of e-cigarettes among middle and high school students doubled from 2011 to 2012, calls to poison control centers linked to e-cigarettes have increased sharply, and the number of victims referred to hospitals tripled from 2012 to 2013.

These battery-powered devices turn liquid nicotine into a vapor that the smoker inhales. Proponents say they are much safer than ordinary cigarettes because they don’t contain the tars and toxic chemicals generated by burning tobacco. But regulators say so little is known about e-cigarette use that, as a public health matter, they can’t definitively say the product is safer.

Some heavy smokers, for example, could actually be deterred from quitting if they used e-cigarettes to satisfy their nicotine craving where smoking was prohibited and then returned to their tobacco habit. Some nonsmokers might become addicted to nicotine after smoking e-cigarettes and move on to regular cigarettes. And young people who smoke only e-cigarettes can still suffer damage to the developing brain. Nobody knows what the net impact of all this would be on the nation’s health. Dozens of studies are underway to find out.

The proposed rule is a good, if incomplete, first step. It prohibits sales to children under 18, requires retailers to verify age by photo identification and penalizes those who sell to minors. It restricts vending machine sales to adult-only facilities, and it prohibits free samples.

Manufacturers would for the first time have to tell the F.D.A. what ingredients and toxic chemicals are in their products, and the agency would decide, based on scientific evidence, whether the product could be marketed. Nicotine-containing e-cigarettes would have to bear warning labels that they could be addictive. And companies could not claim that their e-cigarettes are less harmful than regular cigarettes without submitting scientific proof to the F.D.A.

Some desirable restrictions were not included in the new rule, but they could be added in separate rule-making later. The agency should surely ban flavors and colorful packaging that appeal to youngsters. It should also move judiciously to restrict television marketing on shows watched by young people. And it ought to limit the concentration of nicotine in vapors generated by e-cigarettes.

The European Parliament voted to limit concentrations to 2 percent, similar to ordinary cigarettes, which is well below levels that can be bought on the Internet. It makes no sense to allow e-cigarettes to be more addictive than the cigarettes they are supposedly replacing.

It has been four years since passage of a law that gave the F.D.A. authority to regulate cigarettes and certain other tobacco products and three years since the agency began grappling with alternatives like e-cigarettes and hookahs. The agency ought to move quickly to issue the final version of these proposed rules, and then proceed to develop the other needed safeguards.