aims to develop e-cigarette standards; nicotine policy
Send a link to a friend
[June 12, 2014]
By Toni Clarke
WASHINGTON (Reuters) - The
U.S. Food and Drug Administration is working to develop
strong product standards for electronic cigarettes and
other nicotine delivery devices that will protect public
health and enable the agency to withstand legal
challenges, its tobacco chief said on Wednesday.
Mitchell Zeller, director of the FDA's Center for Tobacco Products,
said the agency is exploring potential product standards in the
areas of addiction, toxicity and product appeal as it prepares to
gain regulatory authority over electronic cigarettes and other
The establishment of product standards is one of five priorities for
the division over the next few years, Zeller said, outlining them
publicly in the most comprehensive manner to date.
They include putting in place regulations for approving new products
and monitoring them after they reach the market, ensuring that the
agency has in place a strong compliance and law enforcement presence
in every state, public education and the formulation of an FDA-wide
nicotine policy that recognizes some products are less risky than
The agency is formulating product standards at a time when the
benefits and risks of e-cigarettes remain the subject of intense
"It's not the nicotine that kills half of all long-term smokers, its
the delivery mechanism," he said at a lunch in Washington, D.C.
organized by the American Legacy Foundation, an anti-tobacco group.
. "We have to recognize some of these realities and figure out how
they can impact regulatory policy.".
The 2009 Tobacco Control Act gives the FDA authority, as long as it
has scientific evidence to support the policy, to ban or restrict
ingredients and compounds in a particular product, though the agency
will need to issue a new rule to act on its authority.
In April the FDA proposed rules that would ban the sale of
e-cigarettes to people under the age of 18 and subject the $2
billion industry to federal regulation for the first time. The
proposal would not restrict flavored products, online sales or
advertising, disappointing public health advocates who argue they
[to top of second column]
Zeller said that while it is never a good thing for a young person
to inhale nicotine, further research is needed to assess the net
impact of e-cigarettes on the overall health of the population and
that it is important to have "an open mind" about the potential
benefits of emerging technologies.
"We share the concerns about the marketing of e-cigarettes to kids,"
he said, "We share the concerns that flavors certainly look like
they would be appealing to kids; but let's not lose sight of the
bigger picture here--tobacco use remains the leading cause of
preventable death and disease principally because of the ongoing use
of products that burn tobacco.
The FDA is also considering regulating menthol, but Zeller said he
could not estimate how long it will take to formulate a proposal.
The agency received 176,000 comments from the public on the matter.
"We are seriously considering all the comments as we consider our
regulatory options," he said. "We can only go as far as the science
will take us."
(Reporting by Toni Clarke in Washington; editing by Andrew Hay)
[© 2014 Thomson Reuters. All rights
Copyright 2014 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.