(Recasts throughout; adds comment from analysts, e-cigarette
makers, public health advocates)
By Toni Clarke
WASHINGTON, April 24 The U.S. Food and Drug
Administration proposed rules on Thursday that would ban the
sale of e-cigarettes to anyone under 18, but would not restrict
flavored products, online sales or advertising, which public
health advocates say attract children.
The long-awaited proposal, which would subject the $2
billion industry to federal regulation for the first time, is
not as restrictive as some companies had feared and will likely
take years to become fully effective.
Bonnie Herzog, an analyst at Wells Fargo, said the proposal
is "positive for industry."
But public health advocates lamented the fact that the
proposal does not take aim at e-cigarette advertising or
sweetly-flavored products, which they say risk introducing a new
generation of young people to conventional cigarettes when
little is known about the long-term health impact of the
"It's very disappointing because they don't do anything to
rein in the wild-west marketing that is targeting kids," said
Stanton Glantz, a professor at the Center of Tobacco Control
Research and Education at the University of California, San
FDA Commissioner Margaret Hamburg said at a briefing on
Wednesday that the proposal represented the first "foundational"
step toward broader restrictions if scientific evidence shows
they are needed to protect public health.
That declaration worries some companies.
"The window is still open for a more draconian approach,"
said Jason Healy, president of Lorillard Inc's blu eCigs
unit, which holds roughly 48 percent of the market. "I think the
proposal shows a good science-based reaction here from the FDA,
but there is a lot we have to go through during the public
Lorillard, together with privately-held NJOY and Logic
Technology account for an estimated 80 percent of the market.
Other big tobacco companies, including Altria Group Inc
and Reynolds American Inc, are also entering the market.
E-cigarette advocates welcomed the FDA's light touch.
Dr. Michael Siegel, a professor of community health sciences
at Boston University, said a ban on flavorings would have
"devastated the industry, as the flavors are a key aspect of
what makes these products competitive with tobacco cigarettes."
Similarly, a ban on all e-cigarette advertising "would have
given tobacco cigarettes an unfair advantage in the
marketplace," he said.
NO FREE SAMPLES
A law passed in 2009 gave the FDA authority to regulate
cigarettes, smokeless tobacco and roll-your-own tobacco and
stipulated the agency could extend its jurisdiction to other
nicotine products after issuing a rule to that effect.
E-cigarettes use battery-powered cartridges to produce a
nicotine-laced inhalable vapor.
In the short term, the new rules would prohibit companies
from distributing free e-cigarette samples, forbid vending
machine sales except in adult-only venues and prohibit sales to
Companies would also be required to warn consumers that
nicotine is addictive, but no other health warnings would be
required. The addiction warning would have to be added no later
than two years after the rule is set and the e-cigarette
companies would not be allowed to make health claims in any
The proposal is subject to a public-comment period of 75
Vince Willmore, a spokesman for the Campaign for Tobacco
Free Kids, said the proposal "by no means does everything we
think needs to be done, but it starts the process. What is
critical now is that they finalize this rule and then move
quickly to fill the gaps."
He said the FDA should aim to establish the rule within a
year, but many are skeptical the agency will act that quickly.
"The reality of these things is that every step takes
years," said UCSF's Glantz. "By not addressing the
youth-directed marketing it means it won't be addressed for a
very long time."
Some e-cigarette companies that sell primarily through
convenience stores were surprised at the lack of restrictions on
online sales, since it can be difficult to verify a customer's
age over the Internet.
"The Internet thing is very surprising to me," said Miguel
Martin, president of Logic Technology. "It reduces the
visibility of the sales of the products and the type of products
that the government has awareness of."
The new rules would also require companies to submit new and
existing products to the FDA for approval. They would have two
years to submit applications from the time the rule goes into
effect. Companies may continue selling their products and
introducing new products pending the FDA's review.
In the meantime, e-cigarette companies would be required to
register with the FDA and list the ingredients in their
products. They would not be required to adhere immediately to
specific product or quality control standards. That could come
later, Hamburg said.
THE "VAPING" INDUSTRY
E-cigarettes and other "vaping" devices generate roughly $2
billion a year in the United States, and some industry analysts
expect their sales to outpace the $85 billion
conventional-cigarette industry within a decade.
Advocates of e-cigarettes claim they are a safer alternative
to conventional cigarettes, since they do not produce
lung-destroying tar, though long-term safety data is thin.
The FDA's proposal leaves many questions unanswered about
how new products would be regulated over the long run. One key
question relates to how products are approved.
Under current law, new tobacco products can be approved if
they are "substantially equivalent" to a product that was on the
market before Feb. 15, 2007. It is unclear whether any
e-cigarettes were on sale before then, to be used as a
Mitch Zeller, head of the FDA's tobacco division, said at a
briefing that the agency would be seeking more information
during the public-comment period on whether the "substantial
equivalence" pathway is even valid for e-cigarettes.
If it is not, e-cigarette companies would have to use a
different process, which would require them to prove their
products are appropriate for public health, a higher hurdle to
Also up in the air is the regulatory fate of some cigars.
The current proposal would include e-vaping products and other
tobacco products, but premium cigars may be excluded.
The FDA said it would seek public comment on whether all
cigars should be regulated equally. One option proposed by the
agency is to regulate them all. The other is to define a
category of premium cigars that would not be subject to the
Physicians said the possible exemption of premium cigars
from regulation was troubling.
"Any exemption for any kind of tobacco product proven to
cause lung and heart disease and cancer is unacceptable," said
Harold Wimmer, chief executive of the American Lung Association.
Cigar companies, backed by some members of Congress, had
lobbied heavily for a regulatory carve-out for premium cigars.
In a December 2013 letter to Hamburg and Sylvia Mathews Burwell,
director of the White House's Office of Management and Budget,
24 Republican lawmakers asked that premium cigars be exempt.
"As you know," they wrote, "premium cigars are a niche
product with an adult consumer base, much like fine wines. The
majority of people who enjoy a cigar do so occasionally, often
in social or celebratory settings."
Under the proposed rule, premium cigars are considered those
wrapped in whole tobacco leaf, made manually by combining the
wrapper, filler and binder, have no characterizing flavor, have
no filter, tip or non-tobacco mouthpiece and are relatively
(Editing by Larry King and G Crosse)