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 Under a proposed FDA rule, almost all e-cigarette and vapor products
introduced after Feb. 15, 2007, would be required to meet regulatory
standards that the industry considers excessively stringent. The
House Appropriations Committee voted 31-19 on Tuesday in favor of
easing the process.
The amendment was offered by Republican Tom Cole of Oklahoma and
Democrat Sanford Bishop of Georgia. A vote by the full House of
Representatives on the spending bill has not yet been scheduled.
"What happened today is a big boost of momentum for the industry,"
said Arnaud Dumas de Rauly, treasurer of the Vapor Technology
Association, which represents manufacturers and businesses. "We're
happy to have bipartisan co-sponsors because up until now we only
had Republican buy-in. Now we have Democratic buy-in as well."
Public health advocates criticized the amendment, saying it benefits
industry at the expense of public health.
The 2009 Tobacco Control Act allows a new tobacco product to be
authorized for sale if it can be shown to be "substantially
equivalent" to a product already on the market before February 15,
2007. If no such product exists, the new product must undergo a much
more stringent review under the agency's "premarket tobacco
application" (PMTA) process.
The vapor industry says almost all its products would be subject to
PMTA review under the FDA's proposal because only one e-cigarette
was on the market in the United States before the grandfather date.
Since then, some 100,000 new e-cigarette and vapor products have
been introduced.
Moving or invalidating that grandfather date would allow some or all
of the products to act as "predicates" for future products,
something public health advocates say would allow e-cigarettes and
other tobacco products to escape a critical first-step review by the
FDA.
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The American Cancer Society Cancer Action Network said in a
statement changing the date would "make it easier for new products
to stay on the market before it is determined whether they attract
youth or otherwise harm public health."
A premarket tobacco application requires a company to prove, with
scientific data, that the new product will not harm the population
as a whole. So far only one company, Stockholm-based Swedish Match
AB, has cleared that bar. Last year the FDA authorized the sale of
eight of its smokeless snus products.
The FDA is expected soon to issue a final rule giving it authority
for the first time to regulate e-cigarettes and vapor products,
which generated $3.3 billion in U.S. sales last year.
The agency already has authority to regulate cigarettes, smokeless
tobacco and roll-you-own tobacco. The Tobacco Act gave it the option
of extending its authority over other tobacco products after issuing
a rule.
(Reporting by Toni Clarke in Washington; editing by Alan Crosby and
Bernard Orr)
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