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 The closely watched vote could pave the way for the first Food and
Drug Administration approval of a modified risk tobacco product and
set a precedent for companies seeking to make similar claims. The
two-day discussion will culminate in a vote on April 10th.
Snus is a moist smokeless tobacco product that users place
underneath the upper lip. It can be bought loose, or in small
teabag-like pouches. It does not involve chewing or spitting.
Swedish Match is asking permission to remove required warnings about
mouth cancer, gum disease and tooth loss from its product packaging,
saying there is no evidence to support a link between mouth disease
and Swedish snus. It proposes retaining the risk of nicotine
addiction.
The company also wants to replace a warning that smokeless tobacco
is not a safe alternative to cigarettes with one that acknowledges
no tobacco product is safe, but states its own products are
substantially less risky than cigarettes.
LEERY OF INDUSTRY PAST
The hurdles for winning approval are high.
In crafting the 2009 law giving the FDA authority to regulate
tobacco, Congress, leery of the industry's misleading marketing of
implicitly safer "light" and "low tar" cigarettes, set rigorous
standards for approving modified risk products.
Companies must show a product significantly reduces the risk of
disease for individual tobacco users. It must also show a health
benefit to the population as a whole, taking into account tobacco
and non-tobacco users.
Products such as snus and e-cigarettes are generally considered
safer than combustible cigarettes and may benefit a smoker who
switches. But if smokers use both products instead of switching, or
if the less risky products are taken up by people who otherwise
would not have used any tobacco product, the calculus might be
different.
Swedish Match believes it has a strong case.
Snus use in Sweden, particularly among men, has risen over the past
30 years. It is now the country's most popular tobacco product. At
the same time, smoking rates have plunged to the lowest in Europe.
Smoking related diseases, including lung cancer and heart disease,
have also fallen.
Azim Chowdhury, a partner at the law firm Keller and Heckman LLP,
said regulators should not ignore such statistics. If FDA were to
deny Swedish Match's application, Chowdhury said, "they would
basically be saying no-one will ever be approved."
Scott Ballin, a health policy consultant based in Washington, D.C.,
agrees. He sees a 60 percent chance the advisory panel will vote in
favor of Swedish Match but concedes opposition from public health
groups is strong.
"If the committee responds to pressure from tobacco control
advocates who believe that all tobacco is equally harmful then I
think we will see it punting and suggesting more research needs to
be done," he said.
WRANGLING OVER THE LAW
Opponents of approval argue FDA does not have legal authority to
permit changes to government-mandated warning labels. Moreover, they
say, the proposed label changes do not appropriately capture
potential risks associated with snus.
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"We don't know yet whether or not we are going to see people use
both products, or whether kids take up snus who would not otherwise
have smoked," said Erika Sward, an advocate with the American Lung
Association.
Critics also say it is unclear whether the population-level benefits
seen in Sweden would translate to the United States. Other factors,
including more restrictive bans on advertising, could be at play.
"The real question isn't whether a well done application for Swedish
snus could qualify for a modified risk claim, it is whether this
specific request should qualify," said Matthew Myers, president of
the Campaign for Tobacco-Free Kids.
Sandy Fowler-Jones, a Swedish Match spokeswoman, said the FDA "fully
vetted" the legal issue before the company filed its application.
The agency can permit changes to an individual product's warning
label, she said.
SMOKELESS TOBACCO
Adult smokeless tobacco use was 3.6 percent in 2012, according to
the Centers for Disease Control and Prevention, with the highest
rates among 18 to 25-year-old males.
The overall rate of snus use was 2.5 percent during the same period.
Among high school boys it was 3.9 percent.
U.S. smokeless tobacco products include Altria Group's Copenhagen,
Skoal and Red Seal brands.
Altria also sells Marlboro snus and Reynolds American Inc sells
Camel snus. These products would not be covered by any FDA decision
on the Swedish Match product, but some anti-tobacco groups fear that
consumers would not differentiate.
Swedish Match's products follow standards for reducing heavy metals
and other toxic substances that U.S. products are not bound by. In
an odd twist, Swedish snus is banned in Europe outside Sweden for
health reasons.
Cigarettes remain on the market.
(Reporting by Toni Clarke in Washington; Editing by David Gregorio)
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