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issues were “particularly interesting”: 1)
The 4-4 vote on whether “The evidence
support[s] the statement that health
risks to individual users from using
snus products are ‘substantially lower’
than the health risks from smoking
cigarettes,” with comments from two
dissenters opposed to the use of the
word “substantially,” suggesting they
may have voted differently had it
been omitted; 2) A unanimous vote
that the proposed warning statement
is inadequate to communicate the
potential health risks to individual users
of SMNA’s snus products, saying that
the “wording of any health claim will be
heavily scrutinized”; and 3) The 6-0 vote,
with two abstentions, that modified-risk
information should not be included in
the required warning label, which Stifel
said is a “negative for future modified-
risk products” as the “marketing power
of an MRTP is somewhat undercut” if
companies cannot use modified-risk
claims in an FDA-approved warning label.
…Reporting on a recent presentation
by
FDA Center for Tobacco Products
Director Mitch Zeller,
Stifel said that 1)
FDA is sorting through 135,000 public
comments on deeming regulations and
is expected to “soon” release the final
rule, which could be different from the
originally proposed rule, and could be
followed by increased regulation in the
future; 2) Zeller wants to establish a
continuumof risk across nicotine delivery
products and create a nicotine policy that
involvesmultiple federal agencies; 3) FDA
is conducting studies to help it develop
scientific evidence to support product
standards, including restrictions on the
level of certain ingredients; and 4) FDA
is conducting its Population Assessment
of Tobacco and Health (PATH) study to
gather long-term data on consumers,
their ability to quit, polyuse, and youth
consumption.
…In April, Dr. Stephen Ostroff, the
acting commissioner of FDA, said that
the agency is moving “full speed ahead
on the proposed deeming rule” to bring
currently unregulated tobacco products,
including
e-cigs, under FDA regulation.
He mentioned that data released on
April 17 from the National Youth Tobacco
Survey, which showed an increase in
e-cig use among middle and high school
students, is a “cogent reminder of just
how important the deeming rule is.”
…
CTP’s former director of policy Eric
Lindblom
, now at Georgetown University
Law Center’s O’Neill Institute for National
and Global Health Law, wrote a 37-
page treatise published in the
Food and
Drug Law Journal
entitled “Effectively
Regulating E-Cigarettes and Their
Advertising—and the First Amendment.”
It addressed how FDA should regulate
e-vapor
products,
arguing
that
government already knows enough to
regulate these products, the current use
of which are “at least somewhat less
harmful to users and nonusers than
smoking.”
…U.S. Rep. Tom Cole’s (R-Oklahoma)
FDA Deeming Authority Clarification Act
of 2015 would make technical changes
to the FSPTCA to allow FDA to choose
a
new grandfather/predicate date
for
newly regulated products as a result
of the deeming regulations, instead of
the now proposed February 15, 2007
date. Cole noted that adhering to this
original date “will make it costly and
create significant barriers for the industry
and the FDA to bring innovative new
products that may significantly reduce
the harms associated with tobacco to
market, and could force the withdrawal of
many products that have come to market
since February 2007.” He also pointed
out that newly deemed tobacco products
“would be treated much more harshly
than immediately regulated products”
because the “look back” period for
grandfathered products was only two-
plus years from June 22, 2009 when the
FSPTCAwas signed in February 2007, but
the newly deemed products would have
eight-plus years, assuming CTP meets its
June 2015 target (June 2015 to February
2007), and longer if the final rule is not
published by then. Rep. Cole proposed
that CTP make the predicate date for
newly deemed products the effective
date of the final rule and give the new
products the same 21-month transition
period provided for currently regulated
products, which were given until March
22, 2011 from June 22, 2009.
…In an April 28 letter, representatives
of 31 public health and medical groups
urged
President Obama to finalize
the deeming rule
to bring currently
unregulated tobacco products under
FDA’s regulatory authority, noting that “In
the absence of regulation, we have seen
irresponsible marketing of unregulated
products such as cigars and electronic
cigarettes, often using tactics and sweet
TMA REPORT