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Tobacco Ingredient and Nicotine Reporting Instructions | OSH | CDC

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Smoking & Tobacco Use
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

http://www.cdc.gov/tobacco/tobacco_industry/instructions.htm

12/6/2007

Tobacco Ingredient and Nicotine Reporting Instructions | OSH | CDC

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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:
z

The submission clearly states on whose behalf the submission is made.

z

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
z

The submission is signed and certified as correct by the submitter.

z

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.

http://www.cdc.gov/tobacco/tobacco_industry/instructions.htm

12/6/2007

Tobacco Ingredient and Nicotine Reporting Instructions | OSH | CDC

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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

1Reporting

of nicotine applies to smokeless tobacco only.

Page last updated 02/28/2007

http://www.cdc.gov/tobacco/tobacco_industry/instructions.htm

12/6/2007