4/28/2020 F.D.A.

Delays Rules That Would Have Limited E-Cigarettes on Market - The New York Times

F.D.A. Delays Rules That Would Have Limited E-Cigarettes on

Market
nytimes.com/2017/07/28/health/electronic-cigarette-tobacco-nicotine-fda.html

Sheila Kaplan July 29, 2017

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Electronic-cigarette makers won a major reprieve on Friday when the Food and Drug Administration
delayed regulations that could have removed many of their products from the market and opened the
door to endorsing e-cigarettes as a means to get smokers to quit.

The F.D.A. commissioner, Dr. Scott Gottlieb, announced the delay as part of a broad plan to reduce
tobacco deaths in the United States, which now number about 480,000 a year. That strategy will
include steps to push makers of tobacco cigarettes to reduce the levels of nicotine in their products to
make them less addictive, he said. Federal law gives the agency the authority to require lower levels
of nicotine in tobacco products, F.D.A. officials said, and the announcement was a step toward that.

Dr. Gottlieb, in a conference call with reporters, said the F.D.A. would encourage e-cigarette
companies to talk to the agency about gaining approval of their products as smoking cessation aids if
that is their intent.

In a later interview with The New York Times, Dr. Gottlieb sounded notably more open to e-cigarettes
than many other federal public health officials, who have opposed the devices as a gateway to
nicotine addiction and eventually to the smoking of tobacco cigarettes. Although Dr. Gottlieb said he

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was concerned about children’s use of e-cigarettes and would consider regulating flavors designed to
appeal to them, he also noted the potential benefits to addicted cigarette smokers of products
capable of delivering nicotine without having to burn tobacco.

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“We do think there’s a potential opportunity for e-cigarettes to be a lower-risk alternative to smokers
who want to quit combustible cigarettes,” he said. “We still have to figure out if they are a way to get
people off combustible cigarettes. We don’t fully understand.”

The announcement thrilled the e-cigarette industry, which was facing a deadline of next year for
makers to seek approval to sell any product that entered the market after Feb. 15, 2007.

“Without this delay, over 99 percent of vaper products available on the market today would be
banned next year,” said Greg Conley, president of the American Vaping Association, which is an
advocate for the industry, in a statement that was almost certainly an exaggeration.

The Tobacco Vapor Electronic Cigarette Association posted the commissioner’s remarks on its
website. “Absolutely, it’s a good thing,” said Ray Story, the chief executive and founder of the
organization. “When you look at harm reduction, it’s a no-brainer.”

Makers of tobacco cigarettes were warier because the F.D.A. said it would seek public input on a
move to lower nicotine levels in combustible cigarettes to nonaddictive levels. Shares of cigarette
makers tumbled after the morning announcement, but the companies issued careful statements in
support of the F.D.A.’s move.

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Shares of Altria, the maker of Marlboro and other brands, fell about 19 percent, its biggest decline
within a trading day in 18 years, before partly recovering. The company called the F.D.A.’s
announcement “an important evolution in the agency’s approach to regulating tobacco products and
a meaningful step forward in developing a comprehensive regulatory policy that acknowledges the
continuum of risk.”

Shares of another cigarette maker, British American Tobacco, fell. The company, which owns R. J.
Reynolds, said it looked forward to “participating in a thorough process to develop a comprehensive
plan for tobacco and nicotine regulation.”

Tobacco is the leading cause of preventable deaths in the United States. E-cigarettes are less
harmful than tobacco cigarettes because they do not contain deadly tar. They instead provide the
nicotine fix smokers crave through a liquid that is heated into vapor and inhaled. Although it is the
nicotine that hooks the smoker, it is the other chemical compounds in tobacco and tobacco smoke
that pose direct health hazards.

The F.D.A. will encourage companies to reduce nicotine levels in tobacco products to less addictive
levels, Dr. Gottlieb said.

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“The science of nicotine regulation, and understanding what the addictive level is, is well
established,” Dr. Gottlieb said. “There is a threshold level below which cigarettes probably wouldn’t
be addictive.’’

Whether tobacco companies will come aboard, and when, is hard to say. “It’s important to understand
that any proposed rule such as a nicotine product standard must be based on science and evidence,
must not lead to unintended consequences and must be technically achievable,” Altria said in an
email. It added, in a remark that will surely please tobacco industry lobbyists, “We intend to be fully
engaged throughout this process.”

While granting e-cigarette makers a reprieve from some regulations, Dr. Gottlieb said, the F.D.A. will
redouble its efforts to protect children from products that contain nicotine, including e-cigarettes, and
will pursue regulations of flavored tobacco products designed to appeal to them. E-cigarettes come in
many fruit and alcohol flavorings to appeal to “vapers” of all ages, with names like Tutti Frutti and
Cupcake.

Public health advocates were cautiously optimistic. Matthew L. Myers, the president of the Campaign
for Tobacco-Free Kids, called Dr. Gottlieb’s agenda a “bold and comprehensive vision, with the
potential to accelerate progress in reducing tobacco use and the death and disease it causes.’’

At the same time, Mr. Myers criticized the delay given to e-cigarette and cigar companies for
complying with previously released rules. In a statement released Friday afternoon, Mr. Myers added,
“This long delay will allow egregious, kid-friendly e-cigarettes and cigars, in flavors like gummy bear,
cherry crush and banana smash, to stay on the market with little public health oversight. There is no
reason to allow these products to stay on the market while developing and implementing the strategy
Dr. Gottlieb outlined today.”

Dr. Gottlieb said he was prepared for criticism from people in the public health field. He said the
F.D.A. needed time to develop solid regulations, rather than just guidance, on how the agency would
use its oversight to regulate tobacco and e-cigarette products.

“I’m hopeful that people who follow this issue closely and might have a particular point of view are
going to recognize what we are trying to do, to have a significant public health impact,’’ he said. “I
wouldn’t say we are encouraging people to use e-cigarettes, but certainly we’d like to see smokers
use F.D.A.-approved cessation packages like gums and patches.’’

Dr. Neal Benowitz, a professor at the University of California, San Francisco, School of Medicine, has
had many discussions over the years with the F.D.A.’s tobacco chief, Mitchell Zeller, about trying to
reduce the nicotine levels in tobacco. He said he was pleased to read Friday’s announcement, but
felt cigarette makers would not move willingly to reduce nicotine.

“Philip Morris, many years ago, did try to market a low-nicotine cigarette, and there was no
commercial market for it,” Dr. Benowitz said.

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