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 The bill, from Republican Representative Duncan Hunter of
California, would reverse the Obama administration's "Deeming Rule"
which deems e-cigarettes to be tobacco products, subject to the same
strict regulations governing traditional cigarettes. E-cigarettes
heat nicotine-laced liquid into vapor but do not contain tobacco.
Hunter's bill, which was reviewed by Reuters, would exempt vaping
devices from many of those rules, including a requirement that new
products be reviewed and authorized by the FDA before being sold.
E-cigarette makers say the process is too expensive and would
prevent smokers from gaining access to the products.
The bill adds momentum to a series of legal and legislative efforts
by tobacco and vaping companies to derail the FDA rule, though it is
unclear how much support it will garner.
The move comes as President Donald Trump's administration is cutting
regulations across the board and as Congress is poised to confirm
Dr. Scott Gottlieb to lead the FDA. Gottlieb, who held a financial
interest in the vape shop Kure, said e-cigarettes in certain
circumstances may be a good alternative for smokers.
A separate plan from Republican Representative Tom Cole of Oklahoma
and Democrat Sanford Bishop of Georgia would exempt thousands of
vaping devices currently on the market from FDA approval. The
Cole-Bishop proposal is expected to be attached as a rider to
Trump's spending plan, which could be voted on as early as this
week.
Hunter's bill would go further, bringing the entire regulatory
process to a halt.
"Cole-Bishop is like gaining the inch, and Hunter's legislation the
yard," said Joe Kasper, Hunter's chief of staff.
The FDA rule, which went into effect on Aug. 8, requires that any
product introduced after Feb. 15, 2007, be submitted to the FDA for
review within two years. Products that were on the market prior to
that date are grandfathered and do not require premarket
authorization.
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The FDA said it does not comment on proposed or pending legislation.
Big tobacco companies such as Altria Group Inc and Reynolds American
Inc see vaping products as a promising business line and have
lobbied alongside their smaller e-cigarette counterparts against the
rule.
"We believe that regulation should promote innovation of potentially
less risky tobacco products," said David Sutton, a spokesman for
Altria.
To that end Hunter's bill would formally incorporate the concept of
harm reduction into the FDA's mission by requiring it to support
less-dangerous nicotine delivery products. Those philosophically in
favor of harm reduction argue that by promoting products considered
less harmful than cigarettes, the overall public health will
benefit.
Opponents fear that e-cigarettes are dangerous products that could
be used by tobacco companies to addict a new generation of children
to nicotine, and, they fear, to cigarettes.
"While we're always going to have some concerns about kids accessing
either cigarettes or vaping pens, that should not motivate the
federal government to go in the complete opposite direction and say
nobody can have them," Kasper said.
(Reporting by Toni Clarke in Washington and Jilian Mincer in New
York; Editing by Lisa Shumaker)
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