Enforcement of General Tobacco Standard Special Rule for Cigarettes, 48974 [E9-23144]
Download as PDF
<![CDATA[
48974
Federal Register / Vol. 74, No. 185 / Friday, September 25, 2009 / Notices
best assured of having their full effect if
received within 60-days of the date of
this publication.
Dated: September 17, 2009.
Joe Ellis,
Director, OPERA, OER, National Institutes of
Health.
[FR Doc. E9–23078 Filed 9–24–09; 8:45 am]
BILLING CODE 4140–10–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0449]
Enforcement of General Tobacco
Standard Special Rule for Cigarettes
AGENCY:
Food and Drug Administration,
HHS.
jlentini on DSKJ8SOYB1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Federal Food, Drug, and
Cosmetic Act (the act), as amended by
the Family Smoking Prevention and
Tobacco Control Act (FSPTCA),
establishes a tobacco standard special
rule for cigarettes. This special rule for
cigarettes prohibits a cigarette or any of
its component parts (including the
tobacco, filter, or paper) from
containing, as a constituent (including a
smoke constituent) or additive, an
artificial or natural flavor (other than
tobacco or menthol) or an herb or spice,
including strawberry, grape, orange,
clove, cinnamon, pineapple, vanilla,
coconut, licorice, cocoa, chocolate,
cherry, or coffee, that is a characterizing
flavor of the tobacco product or tobacco
smoke. The Food and Drug
Administration (FDA) is providing this
notice to remind regulated industry that
as of the effective date identified in the
FSPTCA, cigarettes that contain certain
characterizing flavors are considered
adulterated under the act. FDA is also
providing in this notice contact
information to which individuals who
observe violative products after the
effective date of the tobacco standard
special rule may report their
observations to FDA.
DATES: Effective September 22, 2009.
ADDRESSES: To report tobacco products
that fail to comply with section
907(a)(1)(A) of the act after September
22, 2009, please contact the Center for
Tobacco Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850–3229, 877–287–
1373 or https://www.fda.gov/flavored
tobacco.
FOR FURTHER INFORMATION CONTACT:
Michele Mital, Center for Tobacco
Products, Food and Drug
VerDate Nov<24>2008
18:52 Sep 24, 2009
Jkt 217001
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850–3229, 877–287–
1373, Michele.Mital@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Smoking
is the leading preventable cause of death
in the United States. An important way
to reduce the death and disease caused
by smoking is to prevent children and
adolescents from starting to smoke.
Congress has stated that flavors make
cigarettes more appealing to youth and
often result in exposure to additional
carcinogens and other toxic
constituents. The removal from the
market of cigarettes that contain certain
characterizing flavors is an important
step in FDA’s efforts to reduce the
burden of illness and death caused by
tobacco products.
The FSPTCA provides FDA with
regulatory authority over the
manufacture, marketing, and
distribution of tobacco products.
Specifically, section 907(a)(1)(A) of the
act, as amended by the FSPTCA,
establishes a tobacco product standard
special rule for cigarettes that states in
part: ‘‘* * * a cigarette or any of its
component parts (including the tobacco,
filter, or paper) shall not contain, as a
constituent (including a smoke
constituent) or additive, an artificial or
natural flavor (other than tobacco or
menthol) or an herb or spice, including
strawberry, grape, orange, clove,
cinnamon, pineapple, vanilla, coconut,
licorice, cocoa, chocolate, cherry, or
coffee, that is a characterizing flavor of
the tobacco product or tobacco smoke.’’
This standard applies to all tobacco
products that meet the definition of a
‘‘cigarette’’ in section 900(3) of the act,
as amended, even if they are not labeled
as ‘‘cigarettes’’ or are labeled as cigars or
as some other product.
As of the September 22, 2009,
effective date, cigarettes and their
component parts that fail to comply
with the special rule established under
section 907 of the act, as amended, are
deemed adulterated under section 902
of the act, as amended. Under the act,
adulterated products sold or held for
sale in the United States may be subject
to seizure under section 304 of the act
(21 U.S.C. 334). In addition,
manufacturers, distributors, and
retailers may be subject to injunction
actions, civil money penalties, and/or
criminal prosecution for violating the
requirements of the act (sections 301,
302, and 303 of the act (21 U.S.C. 331,
332, and 333, respectively)). FDA
intends to use the full range of
enforcement tools within the agency’s
authority to ensure compliance with the
new requirement.
FDA encourages individuals who
observe violative products after
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
September 22, 2009, to report their
observations to FDA. This collection of
information was approved under OMB
control number 0910–0647 and expires
on March 31, 2010. Individuals may
report products in violation of this
standard to FDA through the contact
information provided in the ADDRESSES
section of this document.
Dated: September 21, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–23144 Filed 9–22–09; 11:15 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–2487–FN]
Medicare and Medicaid Programs;
Application by the American
Osteopathic Association for Continued
Deeming Authority for Ambulatory
Surgical Centers
AGENCY: Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final notice.
SUMMARY: This final notice announces
our decision to approve the American
Osteopathic Association (AOA) for
continued recognition as a national
accreditation program for ambulatory
surgical centers (ASCs) seeking to
participate in the Medicare or Medicaid
programs.
DATES: Effective Date: This final notice
is effective on October 23, 2009 through
October 23, 2013.
FOR FURTHER INFORMATION CONTACT:
Cindy Melanson, (410) 786–0310.
Patricia Chmielewski, (410) 786–6899.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Medicare program, eligible
beneficiaries may receive covered
services in an ambulatory surgical
center (ASC) provided certain
requirements are met. Sections
1832(a)(2)(F)(i) of the Social Security
Act (the Act) establishes distinct criteria
for facilities seeking designation as an
ASC. Under this authority, the
minimum requirements that an ASC
must meet to participate in Medicare are
set forth in regulations at 42 CFR part
416, which determine the basis and
scope of ASC covered services, and the
conditions for Medicare payment for
facility services. Regulations concerning
provider agreements are at 42 CFR part
489 and those pertaining to activities
E:\FR\FM\25SEN1.SGM
25SEN1
]]>Agencies
[Federal Register Volume 74, Number 185 (Friday, September 25, 2009)]
[Notices]
[Page 48974]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-23144]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0449]
Enforcement of General Tobacco Standard Special Rule for
Cigarettes
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Federal Food, Drug, and Cosmetic Act (the act), as
amended by the Family Smoking Prevention and Tobacco Control Act
(FSPTCA), establishes a tobacco standard special rule for cigarettes.
This special rule for cigarettes prohibits a cigarette or any of its
component parts (including the tobacco, filter, or paper) from
containing, as a constituent (including a smoke constituent) or
additive, an artificial or natural flavor (other than tobacco or
menthol) or an herb or spice, including strawberry, grape, orange,
clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa,
chocolate, cherry, or coffee, that is a characterizing flavor of the
tobacco product or tobacco smoke. The Food and Drug Administration
(FDA) is providing this notice to remind regulated industry that as of
the effective date identified in the FSPTCA, cigarettes that contain
certain characterizing flavors are considered adulterated under the
act. FDA is also providing in this notice contact information to which
individuals who observe violative products after the effective date of
the tobacco standard special rule may report their observations to FDA.
DATES: Effective September 22, 2009.
ADDRESSES: To report tobacco products that fail to comply with section
907(a)(1)(A) of the act after September 22, 2009, please contact the
Center for Tobacco Products, Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850-3229, 877-287-1373 or https://www.fda.gov/flavoredtobacco.
FOR FURTHER INFORMATION CONTACT: Michele Mital, Center for Tobacco
Products, Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850-3229, 877-287-1373, Michele.Mital@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Smoking is the leading preventable cause of
death in the United States. An important way to reduce the death and
disease caused by smoking is to prevent children and adolescents from
starting to smoke. Congress has stated that flavors make cigarettes
more appealing to youth and often result in exposure to additional
carcinogens and other toxic constituents. The removal from the market
of cigarettes that contain certain characterizing flavors is an
important step in FDA's efforts to reduce the burden of illness and
death caused by tobacco products.
The FSPTCA provides FDA with regulatory authority over the
manufacture, marketing, and distribution of tobacco products.
Specifically, section 907(a)(1)(A) of the act, as amended by the
FSPTCA, establishes a tobacco product standard special rule for
cigarettes that states in part: ``* * * a cigarette or any of its
component parts (including the tobacco, filter, or paper) shall not
contain, as a constituent (including a smoke constituent) or additive,
an artificial or natural flavor (other than tobacco or menthol) or an
herb or spice, including strawberry, grape, orange, clove, cinnamon,
pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or
coffee, that is a characterizing flavor of the tobacco product or
tobacco smoke.''
This standard applies to all tobacco products that meet the
definition of a ``cigarette'' in section 900(3) of the act, as amended,
even if they are not labeled as ``cigarettes'' or are labeled as cigars
or as some other product.
As of the September 22, 2009, effective date, cigarettes and their
component parts that fail to comply with the special rule established
under section 907 of the act, as amended, are deemed adulterated under
section 902 of the act, as amended. Under the act, adulterated products
sold or held for sale in the United States may be subject to seizure
under section 304 of the act (21 U.S.C. 334). In addition,
manufacturers, distributors, and retailers may be subject to injunction
actions, civil money penalties, and/or criminal prosecution for
violating the requirements of the act (sections 301, 302, and 303 of
the act (21 U.S.C. 331, 332, and 333, respectively)). FDA intends to
use the full range of enforcement tools within the agency's authority
to ensure compliance with the new requirement.
FDA encourages individuals who observe violative products after
September 22, 2009, to report their observations to FDA. This
collection of information was approved under OMB control number 0910-
0647 and expires on March 31, 2010. Individuals may report products in
violation of this standard to FDA through the contact information
provided in the ADDRESSES section of this document.
Dated: September 21, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-23144 Filed 9-22-09; 11:15 am]
BILLING CODE 4160-01-S
