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.
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.
