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 On May 5, the FDA announced a final rule extending its tobacco
authority to include e-cigarettes, pipe tobacco, cigars and hookah.
The rule becomes effective in early August. Under the rule,
companies must seek marketing authorization for any tobacco product
introduced after Feb. 15, 2007.
The rule gives manufacturers a grace period of up to two years to
submit marketing applications, during which they can continue to
sell their products. They can sell them for an additional year while
the FDA completes its review.
As submitted by the FDA to the White House Office of Management and
Budget, the rule gave a grace period for flavored products of only
90 days after the rule became effective.
Public health advocates have long called for flavored tobacco
products to be banned, saying flavors such as bazooka Joe Bubble Gum
and Cotton Candy are designed to appeal to children.
The FDA provided pages of data and scientific studies in support of
its plan, noting "a dramatic rise in youth and young adult use of
typically flavored tobacco products, like e-cigarettes and waterpipe
tobacco, and continued youth and young adult use of cigars."
The OMB deleted both the FDA's planned policy and the rationale for
the policy.
A White House spokeswoman, Emily Cain, said the OMB "does not
comment on changes made during the interagency review process." The
FDA also does not comment, FDA spokesman Michael Felberbaum said.
In its originally submitted rule, the FDA said it recognized that
numerous flavored products would come off the market within 180 days
of the rule's publication "and that this will significantly impact
the availability of flavored tobacco products at least in the short
term."
But it said the move was important because tobacco products with
characterizing flavors, including menthol but excluding tobacco
flavor, were attractive to young people.
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"FDA made an overwhelming scientific case to OMB," Matthew Myers,
president of the Campaign for Tobacco-Free Kids, said in an
interview. "For reasons that are not articulated, those people
substituted their own judgment."
"We are deeply troubled that these important safeguards were
stripped in this way when FDA repeatedly demonstrated that the
science shows flavored products appeal to youth and young adults,"
Harold Wimmer, president of the American Lung Association, said in a
statement.
Proponents of e-cigarettes say the products can help people quit
smoking and that flavors are a crucial element of what makes them
attractive to adults seeking to quit. The FDA said in its original
rule that evidence supporting such claims "is thus far largely
anecdotal."
(Reporting by Toni Clarke; Additional reporting by Timothy Gardner
in Washington and Jilian Mincer in New York; Editing by Peter
Cooney)
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