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 The long-awaited proposal would subject the $2
billion e-cigarette industry to federal regulation for the first
time.
FDA Commissioner Margaret Hamburg said at a briefing that the
proposal represented the first "foundational" step towards broader
restrictions if scientific evidence shows they are needed to protect
public health.
Critics of e-cigarette advertising say it risks introducing a new
generation of young people to conventional cigarettes when little is
known about the long-term health impact of the products. And they
lamented the fact that limits were not included in the proposed
rule.
"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 Francisco. "They should not have
been so timid."
Hamburg said the current proposal "lays the foundation for many more
actions and activities."
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."
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 rule would prohibit companies from
distributing free e-cigarette samples, forbid vending machine sales
except in adult-only venues and prohibit sales to minors. Companies
would be required to warn 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. The
companies would not be allowed to make health claims in any
advertising.
The proposal is subject to a public-comment period of 75 days.
Willmore said the FDA should aim to establish the rule within a
year.
Some are skeptical that restrictions on marketing or flavors will
come any time soon.
"The reality of these things is that every step takes years," said
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, one of the biggest e-cigarette
manufacturers. "It reduces the visibility of the sales of the
products and the type of products that the government has awareness
of."
The rules would 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.
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In the meantime, they 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.
EVOLVING "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. But there is little data about their long-term safety.
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 February 15, 2007. It is unclear whether any e-cigarettes
were on sale before then, to be used as a benchmark.
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 clear.
Also unclear is the 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 FDA's
authority.
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 expensive.
Tobacco company Lorillard Inc, owner of the blu e-cigarette brand,
is the dominant player in the field, followed by privately held NJOY
and Logic. The three account for an estimated 80 percent of the
market.
(Editing by Larry King)
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