12
TOBACCO BUSINESS INTERNATIONAL
JULY/AUGUST 2014
NEWS & TRENDS
JULY/AUGUST 2014
I
n April, the U.S. Food and Drug
Administration released its long-
awaited proposal to extend the
agency’s tobacco authority to cover
additional tobacco products. Prod-
ucts that would be deemed subject
to FDA regulation are those that meet
the statutory definition of a tobacco
product, including currently unregu-
lated marketed products, such as
electronic cigarettes (e-cigarettes),
cigars, pipe tobacco, nicotine gels,
waterpipe (or hookah) tobacco, and
dissolvables not already under the
FDA’s authority. The FDA currently
regulates cigarettes, cigarette to-
bacco, roll-your-own tobacco, and
smokeless tobacco.
“This proposed rule is the latest
step in our efforts to make the next
generation tobacco-free,” says Health
and Human Services Secretary Kath-
leen Sebelius.
Under the proposed rule, makers
of newly deemed tobacco products
would be required to:
• Register with the FDA and report
product and ingredient lists;
• Only market new tobacco prod-
ucts after FDA review;
• Only make direct and implied
claims of reduced risk if the FDA
confirms that scientific evidence sup-
ports the claim and that marketing
the product will benefit public health
as a whole; and
• Not distribute free samples.
In addition, the new rule would ap-
ply the following provisions to newly
deemed tobacco products:
• Minimum age and identification
restrictions to prevent sales to under-
age youth;
• Requirements to include health
warnings; and
• Prohibition of vending machine
sales, unless in a facility that never
admits youth.
“This is an important moment for
consumer protection and a significant
proposal that if finalized as written
would bring FDA oversight to many
new tobacco products,” explains FDA
Commissioner Margaret A. Hamburg,
M.D. “Science-based product regula-
tion is a powerful form of consumer
protection that can help reduce the
public health burden of tobacco use
on the American public, including
youth.”
“The proposed rule would give the
FDA additional tools to protect the
public health in today’s rapidly evolv-
ing tobacco marketplace, including
the review of new tobacco products
and their health-related claims,” adds
Mitch Zeller, director of the FDA’s
Center for Tobacco Products.
The proposal includes a provision
that would give all regulated entities,
including small businesses, “adequate
time” to comply with the new require-
ments, says a spokesperson for the
agency. The proposal will be available
for public comment for 75 days. While
the FDA has pledged to consider all
comments, the agency has specified
certain areas where it is particularly
interested in input on cigars and e-cig-
arettes. The FDA’s original requests to
that effect are as follow:
• “The FDA recognizes that different
tobacco products may have the poten-
tial for varying effects on public health
and is proposing two options for the cat-
egories of cigars that would be covered
by this rule. The FDA specifically seeks
comment on whether all cigars should
be subject to deeming, and which other
provisions of the proposed rule may be
appropriate or not appropriate for differ-
ent kinds of cigars.”
• “The FDA seeks answers to the
many public health questions posed
by products, such as e-cigarettes,
that do not involve the burning of to-
bacco and inhalation of its smoke, as
the agency develops an appropriate
level of regulatory oversight for these
products. The FDA seeks comment
in this proposed rule as to how such
products should be regulated.”
FDA Proposes Extending Authority
Agency looks to oversee currently unregulated marketed products,
including e-cigarettes, cigars and pipe tobacco.
Swedish Match Seeks Modified-Risk Designation
Company hopes to free General snus from warning label requirements.
Swedish Match has applied for FDA ap-
proval to market its General snus product
line as a modified-risk tobacco product
(MRTP). If approved, the company will
be able to deviate from the warning label
requirements that apply to all tobacco
products.
In the application, Swedish Match cites
research showing that snus has health ben-
efits for the public. “Swedish snus is very
well scientifically documented and our
application consists of more than 100,000
pages,” says Lars-Erik Rutqvist, senior vice
president of scientific affairs at Swedish
Match. “As an industry leader, we must
properly apply the evidence to demon-
strate the potential public health benefit of
our snus tobacco products.”
In keeping with FDA recommendations,
the company has been proactive in en-
gaging with the agency on its submission,
meeting with FDA representatives to dis-
cuss the format and data requirements for
its MRTP application.
Swedish Match’s corporate headquar-
ters are located in Stockholm, Sweden and
its U.S. division is in Richmond, Virginia.
