24
TOBACCO BUSINESS
JULY/AUGUST 2013
TPSAC that would start the 60-day clock for TPSAC to make
its recommendations?; (2) What materials should FDA provide
TPSAC with to make its recommendations?; and (3) What
report format should TPSAC use for its recommendations? Go
to
for the webcast video and related documents.
…In letters sent to all members of the U.S. House and
Senate, the American Association for Cancer Research (AACR)
urged them to oppose the
Traditional Cigar Manufacturing
and Small Business Jobs Preservation Act of 2013,
proposed
legislation that
would exempt traditional large and premium
cigars
from FDA regulation.
…A
New York Times
editorial said while cigarette packs
are unlikely to carry
graphic warning labels
anytime soon
given the D.C. Circuit Court of Appeals’ August 2012 ruling
rejecting the FDA’s proposed graphic labels and the FDA’s
decision not to appeal that ruling, the delay is perhaps only a
temporary setback “for the federal government’s campaign
to reduce the health damage caused by this highly lethal
product” as the U.S. Supreme Court’s April 22 refusal to hear
the major cigarette makers’ appeal of a separate ruling by the
6th Circuit Court of Appeals, upholding the TCA’s mandate
for large graphic warnings, leaves intact a host of provisions
in the law that should help discourage smoking.
…In a letter to FDA Commissioner Margaret Hamburg,
US Sens. Dick Durbin (D-Illinois), Frank Lautenberg (D-New
Jersey), Richard Blumenthal (D-Connecticut), Sherrod Brown
(D-Ohio) and Jack Reed (D-Rhode Island) urged the agency to
issue
“deeming regulations”
asserting regulatory authority
over e-cigs, noting that even though the number of U.S.
adults who have tried the device has doubled since 2010,
they are currently not required to be evaluated or approved
by the FDA.
…As required by the
Food, Drug & Cosmetic Act,
the FDA
posted onto the Drugs section of its website a copy of its
Section 918 Report
to Congress on “Innovative Products
and Treatments to Achieve Abstinence from Tobacco Use,
Reductions in Consumption of Tobacco, and Reductions
in the Harm Associated with Continued Tobacco Use,”
discussing the agency’s actions and policies relating to
NRT products and the regulation of “innovative products
and treatments,” having taken into account input from the
December 17, 2012 public hearing though part (c) of the
statute addressing “reductions in the harm associated with
continued tobacco use” was given short shrift, in spite of the
5,000+ comments on eCigs recorded on the docket
associated with the December 17 FDA workshop, as
the report focused almost uniquely on providing “Big
Pharma’s” NRT products with more opportunities to
market and sell their products. The report is available
on the home page of
.
…In what may be a first step towards
unified
regulation of all nicotine delivery,
CTP announced
a new Department of Health and Human Services’
website entitled BeTobaccoFree.gov, described as a
“one-stop shop” for tobacco-related information from
across its agencies.
…US-H.1578, introduced April 16 by Rep. Pallone
(D-NJ), would
raise the federal cigarette excise
from January 1, 2014 through December 31, 2023
by 4 cents per pack to 104.66 cents a pack, with the
increased revenue used for more individuals to join
the Pre-Existing Condition Insurance Program of the
Affordable Care Act.
…The World Health Organization set the theme of
this year’s
World No Tobacco Day,
to be observed on
May 31, 2013, as “Ban tobacco advertising, promotion
and sponsorship,” which is a requirement that all
parties at the WHO’s Framework Convention for
Tobacco Control must fulfill within five years of entry
into the treaty.
TB
TMA REPORT
On Other tOBaccO neWS…
