| April 24
April 24 The U.S. Food and Drug Administration
proposed measures on Thursday that would ban the sale of
e-cigarettes to consumers younger than 18, but would not
restrict flavored products, online sales or TV advertising,
likely disappointing some public health advocates.
Electronic cigarette advocates lobbied against restrictions
on flavors and advertising, saying they would stifle innovation.
Critics argue flavors such as strawberry and butterscotch appeal
to youngsters, while unrestricted advertising threatens to make
the products glamorous and could act as a gateway to traditional
If finalized, the long-awaited proposal would subject the $2
billion e-cigarette industry to federal regulation for the first
time. 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.
FDA Commissioner Margaret Hamburg said at a briefing that
the proposal represented the first "foundational" step towards a
broader set of potential regulations that would establish
quality standards and include restrictions on flavoring and
The current proposal "lays the foundation for many more
actions and activities," she said.
In the short term, the rules 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 finalized. They would not be able to make health claims
in any advertising.
The proposal is subject to a public comment period of 75
If finalized, companies would be required to submit new and
existing products to the FDA for approval. They would have two
years to submit their 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, 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
see e-vapor sales outpacing the $85-billion traditional
cigarette industry within a decade.
Advocates of e-cigarettes, battery-powered cartridges that
produce a nicotine-laced inhalable vapor, claim they are a safer
alternative to smoking traditional cigarettes since they do not
produce lung-destroying tar. But there is little data about the
long-term safety of the products.
The FDA's proposal leaves many questions unanswered about
how new products would be regulated over the long run. One key
question relates to the mechanism by which products are
Under the current law, new tobacco products can be approved
if they can demonstrate they are "substantially equivalent" to a
product that was on the market before Feb. 15, 2007. It is
unclear, however, whether any e-cigarettes were on the market
before that date 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 additional information
during the public comment period on whether the "substantial
equivalence" pathway is even valid for e-cigarettes.
If it turns out not to be, e-cigarette companies would have
to apply through a different process that 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
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 Technology. The three account
for an estimated 80 percent of the market.
(Reporting by Toni Clarke in Washington; Editing by Michele
Gershberg and Andre Grenon)