Tobacco Ingredient and Nicotine1 Reporting
Instructions
The requirements for submission and the format for submitting the Ingredient
Report for cigarettes and the the Ingredient and Nicotine Reports for smokeless tobacco, and a specification of the
quantity of nicotine for smokeless tobacco, are available in the
Federal
Register.
Certification
Deadline:
As detailed in
64 FR 14086, March 23, 1999; and
66 FR 17559, April 2, 2001, all submissions required under
the Federal Cigarette Labeling and Advertising Act (FCLAA)
and Comprehensive Smokeless Tobacco Health Education Act (CSTHEA) for cigarettes and smokeless tobacco are due upon initial
importation and annually thereafter by March 31. Submissions to
CDC's Office on Smoking and Health
are reflective of ingredient information required by FCLAA
and CSTHEA during the previous calendar year.
Once an accurate submission of an Ingredient Report and
Nicotine Report (where applicable) have been received,
CDC will issue a Certificate of Compliance valid until March 31
of the following year.
Note: All faxed submissions should be immediately followed with
a mailed original.
Report Format:
CDC requests all submissions be on letterhead of the manufacturer,
packager, importer, respective counsel, or designated individual
or entity.
Because CDC cannot ensure the confidentiality of information
submitted via e-mail, that is not an acceptable format. However,
submission of data by way of mailing a CD, 3-inch floppy disk, or thumb drive
is acceptable.
Reports may also be submitted via facsimile, but all faxed lists should
be followed-up with a mailed original.
To the best of our knowledge, laboratory analysis is not available
that will provide a complete representation of the ingredients added
to tobacco in the manufacture of cigarettes or smokeless tobacco.
Laboratory analysis in lieu of the Ingredient Report is not acceptable.
Note: If no ingredients are added to tobacco in the manufacture
of cigarettes or smokeless tobacco, a statement to that effect must
be submitted in writing.
Recommended Formats for
Reporting
Contact information for
submissions to OSH
Categories:
The reporting status of
manufacturers, packagers, and importers will be coded by CDC as
either “compliant,” “noncompliant,”
or “inactive.”
Compliant
Importers of cigarettes and smokeless tobacco products must submit
a list of ingredients added to tobacco in the manufacture of the
product upon initial importation of said product. Additionally,
all manufacturers, packagers, and importers must annually submit
by March 31 a list of ingredients added to tobacco in the manufacture
of cigarettes and smokeless tobacco products during the previous
calendar year.
A Certificate of Compliance will be issued for submissions that
meet all of the following requirements:
- The submission clearly states on whose behalf the submission
is made.
- The list of ingredients, including chemical names and corresponding
Chemical Abstract Service (CAS) registry numbers, added to tobacco
in the manufacture of cigarettes and/or smokeless tobacco products
is complete and without error.
Example:
Chemical Name: Menthol
CAS Number: 89–78–1
- The submission is signed and certified as correct by the
submitter.
- The submission for smokeless tobacco products contains a
specification of the quantity of nicotine through the reporting
of the amount of total nicotine, amount of unionized nicotine
and percentage of unionized nicotine, total moisture, and pH
for each smokeless product.
Noncompliant
Failure to provide the annual Ingredient Report and Nicotine
Report (for smokeless tobacco) by the March 31
deadline and failure to correct inadequacies or errors in a submission
within 60 days of notification will result in CDC deeming the manufacturer,
packager, or importer noncompliant.
In addition, if a report is submitted by a designated individual,
the manufacturer, packager, or importer on whose behalf the report
is submitted must be identified with the submission. Otherwise,
the company will be deemed noncompliant.
Noncompliant status will be changed upon receipt of required
information.
Inactive
Companies are encouraged to inform CDC if they are no longer
manufacturing, packaging, or importing tobacco products. CDC communicates
with other federal agencies involved in the regulation of tobacco
products and will share the information of a company’s status as
appropriate.
Other Requirements
In addition to the requirements detailed here, manufacturers,
packagers, and importers of tobacco products may have additional
legal obligations to consider. Although not an exhaustive list,
other federal agencies that may have applicable laws include the
Alcohol and Tobacco Tax and Trade Bureau (TTB), U.S. Customs (Customs),
and the Federal Trade Commission (FTC).
Contact Information
Page last reviewed 02/28/2007
Page last modified 02/28/2007