12
TOBACCO OUTLET BUSINESS
MAY/JUNE 2013
NEWS & TRENDS
MAY/JUNE 2013
Rather than continue a losing fight to implement its current
proposed graphic warning labels, the FDA has announced
plans to revisit the design. Announcing the agency’s de-
cision to not request that the U.S. Supreme Court review
an appeals court decision on the matter, Attorney General
Eric Holder wrote a letter to House Speaker John Boehner
stating: “In light of these circumstances, the Solicitor Gen-
eral has determined...not to seek Supreme Court review
of the First Amendment issues at the present time.” The
nine warning labels under contention portrayed a mixture
of graphic images and text that cigarette makers R.J. Reyn-
olds Tobacco Co., Lorillard Inc., Commonwealth Brands
Inc. and Liggett Group LLC protested were in violation of
the free speech clause of the First Amendment.
As reported in
TOB
over the past year, the tobacco com-
panies fought the warning labels in court, charging that
it was unconstitutional for the FDA to force them to dis-
seminate the government’s anti-smoking message. In re-
sponse, the FDA argued that the public interest in convey-
ing the dangers of smoking outweighed the companies’
free speech rights and that Congress had given the agency
the authority to require the new labels because the existing
health warnings were not proving effective.
After a prolonged court battle, the tobacco companies
prevailed when the new graphic cigarette warning labels
were blocked by U.S. District Judge Richard Leon’s tem-
porary injunction and then were struck down as unconsti-
tutional.
The FDA now says it will “undertake research to sup-
port a new rulemaking consistent with the
Tobacco Control
Act.
” The agency has not provided a timeline for the re-
lease of revised labels.
FDA Scraps Graphic Labels
In a concession to opposition and courtroom losses, the Food and Drug Administration is going
back to the drawing board on cigarette label requirements.
The FDA has announced that mak-
ers of nicotine replacement products
may change their product labels to
inform consumers that they may use
over-the-counter nicotine gum, patch-
es and lozenges longer than the cur-
rent labels suggest. Labels on nicotine
replacement products have been di-
recting consumers to stop use after 12
weeks at most, but the FDA has autho-
rized manufacturers to let consumers
know they can use the products for
longer periods as long as they are talk-
ing to their doctor about the usage.
The agency has also suggested re-
moving the warning that consumers
should not use a nicotine replace-
ment product if they are still smoking,
chewing tobacco, using snuff or any
other product that contains nicotine—
including another nicotine replace-
ment product.
Designed to help people quit smok-
ing cigarettes by supplying controlled
amounts of nicotine to ease the with-
drawal symptoms, nicotine replace-
ment products were first approved
as a prescribed medication about 30
years ago. Since then the products
have been approved for over-the-
counter use, but because little reliable
data existed on the safety of long-term
use for more than one product con-
taining nicotine at the same time, the
FDA required labeling that would safe-
guard consumers from potential risks.
However, pressure from the pub-
lic health arena against restrictive la-
beling has increased over the years,
as health officials increasingly ex-
pressed concern that the current
labels might be preventing smokers
from trying to quit, since they were
likely to relapse after the suggested
time period elapsed. In response to
those concerns, the FDA is changing
its labeling requirements in hopes of
allowing “more people to use these
products effectively for smoking
cessation and that tobacco depen-
dence will decline,” according to
FDA Commissioner Margaret Ham-
burg.
The label change is likely to take
some time, as individual makers must
seek FDA approval to make the chang-
es. However, nicotine replacement
product manufacturers are encour-
aged by the news. As a spokesperson
for GlaxoSmithKline, which makes
Nicorette and NicoDerm CQ brands,
noted, the action is viewed as “a posi-
tive step to help more smokers quit.”
FDA Softening on Nicotine Replacement
The Food and Drug Administration will be allowing a label change on nicotine gum and other
nicotine replacement products.
