Tobacco Ingredient and Nicotine Reporting

The Federal Cigarette Labeling and Advertising Act (FCLAA), 15 U.S.C. §1335a(a), Public Law 89–92, in part requires that each person who manufactures, packages, or imports cigarettes annually submit to the Department of Health and Human Services (HHS) a list of ingredients added to tobacco in the manufacture of cigarettes (Ingredient Report). The Centers for Disease Control and Prevention (CDC), Office on Smoking and Health (OSH), has been delegated the responsibility of implementing these provisions. The Ingredient Report must include all additives and flavors. Submissions are due to CDC, OSH by March 31; and for importers, the Ingredient Report is also due upon initial importation into the United States. The report submitted by March 31st each year must represent the ingredients added to tobacco in the manufacture of cigarettes during the previous calendar year.

Under FCLAA, one may submit information which does not identify the company that uses the ingredients or the brand of cigarettes that contain the ingredients. A person or group of persons required to provide the ingredient list may designate an individual or entity to provide the list. In the event that another individual or entity, such as an attorney or counsel, is designated to submit this information on your behalf, this individual or entity should clearly state the name(s) of the importer(s) or company(ies) for whom they are submitting the information.

The Comprehensive Smokeless Tobacco Health Education Act (CSTHEA), 15 U.S.C. §4403(a)(A), Public Law 99–252, in part requires each manufacturer, packager, or importer of smokeless tobacco products to annually submit to HHS the list of ingredients added to tobacco in the manufacture of smokeless tobacco products (Ingredient Report). CSTHEA, 15 U.S.C. §4403(a)(1)(B), further requires the submission of the quantity of nicotine contained in each smokeless tobacco product (Nicotine Report). CDC, OSH has been delegated the responsibility of implementing these provisions. Submissions are due to CDC, OSH by March 31; and for importers, the Ingredient Report is also due upon initial importation into the United States. The reports submitted by March 31st each year must represent the ingredients added to tobacco in the manufacture of smokeless tobacco during the previous calendar year; and the specification of the quantity of nicotine contained in smokeless tobacco products manufactured or imported during the previous calendar year.

Under CSTHEA, one may submit information which does not identify the company that uses the ingredients or the brand of smokeless tobacco that contains the ingredients. A person or group of persons required to provide the nicotine data and ingredient list may designate an individual or entity to provide the list. In the event that you designate another individual or entity, such as an attorney or counsel, to submit this information on your behalf, this individual or entity should clearly state the name(s) of the company(ies) for whom they are submitting the information.

United States Code Main Page

• Federal Cigarette Labeling and Advertising Act, 15 USC §1331–1341
• Comprehensive Smokeless Tobacco Health Education Act, 15 USC § 4401–440
• Collection of State Cigarette Taxes, 15 USC § 375–378
• Trafficking in Contraband Cigarettes Act, 18 USC § 2341–2346
• Requirements Applicable to Imports of Certain Cigarettes, 19 USC § 1681–1681b
• Alcohol, Tobacco, and Certain Other Excise Taxes, 26 USC § 5701–5708
• Qualification Requirements for Manufacturers and Importers of Tobacco Products and Cigarette Papers and Tubes, and Export Warehouse Proprietors, 26 USC § 5711–5713
• Restriction on Importation of Previously Exported Tobacco Products, 26 USC § 5754, 5761

Code of Federal Regulations Main Page

• Regulations Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, 16 CFR 307–307.12
• Manufacture of Tobacco Products and Cigarette Papers and Tubes, 27 CFR 40.1–40.478
• Importation of Tobacco Products and Cigarette Papers and Tubes, 27 CFR 41.1–41.228
• Removal of Tobacco Products, and Cigarette Papers and Tubes, without Payment of Tax, for Use by the United States, 27 CFR 45.1–45.51

• In 1998, the Attorneys General of 46 states signed the Master Settlement Agreement (MSA) with the four largest tobacco companies (Phillip Morris, RJ Reynolds, Brown and Williamson, and Lorillard) in the United States to settle state suits to recover costs associated with treating smoking-related illnesses.
• The Attorney General of each state are responsible for enforcing the provisions of this agreement.
• The National Association of Attorneys General Tobacco page includes a summary of the agreement and amendments, an application to join, and more.
• Four states—Florida, Minnesota, Texas, and Mississippi settled their tobacco cases separately, prior to the MSA.

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.

CDC requests all submissions be on letterhead of the manufacturer, packager, importer, respective counsel, or designated individual or entity.

Electronic mail submissions are not accepted at this time given the inability to ensure the confidentiality of information submitted. CDC no longer accepts submissions transmitted on CD, 3-inch floppy disk, and/or thumb drive.

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

The reporting status of manufacturers, packagers, and importers will be coded by CDC as either “compliant,” “noncompliant,” or “inactive.”

The FCLAA, Public Law 89–92, is a statute that was designed to “establish a comprehensive federal program to deal with cigarette labeling and advertising with respect to any relationship between smoking and health.” In 1984, this Act was amended by PL 98–474, the Comprehensive Smoking Education Act, 15 U.S.C. § 1335a(a) to in part provide the Department of Health and Human Services with a list of the ingredients added to tobacco in the manufacture of cigarettes.

The CSTHEA, Public Law 98–252, was passed in 1986 to inform the public of any dangers to human health resulting from the use of smokeless tobacco products. CSTHEA requires, in part, that each person who manufactures, packages, or imports smokeless tobacco products to annually submit to the Department of Health and Human Services the list of ingredients added to tobacco in the manufacture of smokeless tobacco products as well as a specification of the quantity of nicotine contained in each smokeless tobacco product.

FCLAA defines a cigarette as “any roll of tobacco wrapped in paper or in any substance not containing tobacco, and any roll of tobacco wrapped in any substance containing tobacco which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette. . .”

CSTHEA defines smokeless tobacco as “any finely cut, ground, powdered, or leaf tobacco that is intended to be placed in the oral cavity.”

FCLAA and CSTHEA do not apply to cigars or cut rag tobacco unless the cut rag tobacco is packaged as a final product for consumption (i.e., no further manipulation is required in order to be consumed). Other items not covered by FCLAA or CSTHEA include little cigars; or roll-your-own, hookah, or pipe tobacco.

Manufacturers, packagers, and importers of cigarettes and smokeless tobacco products.

Both FCLAA and CSTHEA require manufacturers, packagers, and importers to annually report ingredients added to tobacco in the manufacture of cigarettes and smokeless tobacco to the Secretary of Health and Human Services. In turn, the Secretary has delegated this responsibility to the Centers for Disease Control and Prevention, Office on Smoking and Health (OSH), as stated in 50 FR 49617, December 3, 1985 [PDF–51.4 KB]; 59 FR 4717, February 1, 1994 [PDF–59.7 KB], respectively.

• Contact information for submissions to OSH

Both FCLAA and CSTHEA require manufacturers, packagers, and importers to annually report ingredients added to tobacco in the manufacture of cigarettes and smokeless tobacco.

However, CSTHEA additionally requires manufacturers, packagers, and importers of smokeless tobacco products to annually report on the specific quantity of nicotine in these products by submitting data on total nicotine, unionized nicotine, total moisture, and pH.

• Recommended Formats for Reporting

The Nicotine Report is a specification of the quantity of nicotine (total nicotine, un–ionized nicotine, total moisture, and pH) contained in smokeless tobacco products from the previous calendar year. A uniform analytical protocol was developed that consists of standard laboratory methods to measure nicotine, moisture, and pH in smokeless tobacco products, and an equation to calculate un–ionized nicotine. It includes standardized parameters for pH, moisture, and nicotine determination (sample size, sample preparation, quantity and purity of standards and reagents, instrumentation, measurement time and conditions, etc.). It is the responsibility of the manufacturer, packager, or importer to submit the Nicotine Report according to the specifications set forth in the protocol.

For detailed information on the protocol for testing smokeless tobacco products and the recommended format for reporting total nicotine, amount of unionized nicotine, and percentage of unionized nicotine, total moisture, and pH for each smokeless product, please review the following:

• Notice Regarding Requirement for Annual Submission of the Quantity of Nicotine Contained in Smokeless Tobacco Products Manufactured, Imported, or Packaged in the United States (1999)
• Recommended Formats for Reporting

All submissions are due annually by March 31 and upon initial import. These submissions reflect ingredients added to cigarettes and smokeless tobacco products which are manufactured, packaged, or imported in the previous calendar year; as well as a specification of the quantity of nicotine contained in smokeless tobacco products manufactured or imported during the previous calendar year.

Electronic mail submissions are not accepted at this time given the inability to ensure the confidentiality of information submitted. In addition, CDC no longer accepts submissions transmitted on CD, 3-inch floppy disk, and/or thumb drive. Reports may also be submitted via facsimile, but all faxed lists should be followed-up with a mailed original.

Each chemical compound has a unique CAS number for purposes of identification, assigned by the American Chemical Society. A CAS registry is available from the National Institutes of Health National Library of Medicineexternal icon.

Initially natural additives and flavors were not given CAS registry numbers; however, because these ingredients are now regularly used in manufacturing, many have been assigned CAS registry numbers.

Flavors made of multiple chemicals will have a separate CAS registry number for each chemical in that compound.

CAS numbers are required to properly identify and reduce ambiguity among ingredients used in tobacco products. This is particularly important, as an ingredient with a common name may have different chemical names and thus, different CAS assignments. An example of this is sugar, whose chemical names can be fructose, glucose, or sucrose.

Yes, the U.S. Congress gave full weight and consideration to the sensitive nature of tobacco ingredients in drafting FCLAA and CSTHEA. The list of ingredients added to tobacco in the manufacture of cigarettes and smokeless tobacco products and the specification of the quantity of nicotine contained in each smokeless tobacco product received by CDC, OSH under 15 U.S.C. Section 1335a(a) of FCLAA and 15 U.S.C. Section 4403(a)(1)(A) and (B) of CSTHEA are generally trade secret or confidential information subject to section 552(b)(4) of Title 5external icon. However, 15 U.S.C. Section 1335a(2)(B) of FCLAA and 15 U.S.C. Section 4403(b)(2)(B) of CSTHEA do not authorize the withholding of the list of ingredients from any duly authorized subcommittee or committee of the Congress. If a subcommittee or committee of the Congress requests the Secretary of HHS to provide it such a list, the Secretary of HHS or a representative of CDC will make the list available to the subcommittee or committee and shall, at the same time, notify in writing the person who provided the list of such request.

A limited number of staff has access to confidential information [PDF–117 KB]. Each of these persons has signed a pledge of confidentiality and these statements along with a list of their names are located in a locked safe. Additionally, the list of ingredients and the specification of the quantity of nicotine are secured in a locked safe located in a locked office. Electronic information is stored on a removable hard drive also kept in the safe. Further, OSH redacts privileged, proprietary, and confidential information from public files.

CDC requests all submissions be provided on letterhead of the manufacturer, packager, importer, or designated individual or entity. They may be mailed or faxed; however, a faxed copy should be accompanied by a mailed original. Because CDC cannot ensure the confidentiality of information submitted via E-mail, this is not an acceptable format. In addition, CDC no longer accepts submissions transmitted on CD, 3-inch floppy disk, and/or thumb drive.

• Contact information for submissions to OSH
• Recommended Formats for Reporting

Yes. Under 15 U.S.C. Section 1335a(a) of FCLAA and 15 U.S.C. Section 4403(a)(2) of CSTHEA a person or group of persons required to provide a list of ingredients and a specification of the quantity of nicotine may designate an individual or entity to provide the above-referenced lists required by these federal laws. In the event that another individual or entity is designated to submit the required information, such as an attorney acting on behalf of a manufacturer or importer; or a manufacturer acting on behalf of an importer, that individual or entity should clearly state the name of the company for whom the information is being submitted.

If there have been no changes to the ingredient list in the previous calendar year, the manufacturer, packager, importer, or designated individual or entity as addressed above may submit a letter stating that there have been no changes in the list of ingredients added to the tobacco products along with a copy of the original submission.

In order to confirm whether or not a manufacturer, packager, or importer is compliant with FCLAA or CSTHEA, a statement should be submitted in writing if no ingredients are added to tobacco in the manufacture of cigarettes or smokeless tobacco.

The manufacturer of the tobacco product or of the flavoring added to the tobacco products may submit a list of ingredients and/or a specification of the quantity of nicotine contained in the smokeless tobacco product directly to CDC on behalf of the importer. As with any submission, the list of ingredients and the specification of the quantity of nicotine shall be treated as trade secret or confidential information [PDF–117 KB] subject to section 552(b)(4) of Title 5, United States Code and “shall not be revealed… to any person other than those authorized by the Secretary in carrying out their official duties under this section.”

• Contact information for submissions to OSH
• Recommended Formats for Reporting

Once the accuracy of the submitted information is verified, CDC will issue a certificate of compliance for that calendar year. If missing data or errors are noted (e.g., an invalid or missing CAS registry number), a letter will be sent requesting clarification of the submission within 60 days.

The process of verifying an Ingredient Report and providing a response may take several weeks. Frequently, however, this process only takes a few days, although this can vary depending on the complexity and completeness of submissions. If the Ingredient Report contains many errors, the process may become more lengthy.

Yes. While this is not an exhaustive list of federal agencies that are responsible for tobacco-related matters, the Federal Trade Commission’s (FTC) Division of Advertising Practices is responsible for reviewing and approving health warning label plans for all cigarette and smokeless tobacco products, whether manufactured domestically or abroad, that enter the U.S. stream of commerce.

Yes. While this is not an exhaustive list, other agencies with whom you may need to interact include the Federal Trade Commission (FTC); the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF); Alcohol and Tobacco Tax and Trade Bureau (TTB); and U.S. Customs.

Yes. According to 15 U.S.C. §1338 [PDF–121 KB] “Any person who violates the provisions of this chapter shall be guilty of a misdemeanor and shall on conviction thereof be subject to a fine of not more than $10,000.” 15 U.S.C. Section 4404 has a similar penalty provision.

Yes, both laws contain some preemptive provisions, however they do not preempt stricter state-level requirements regarding the submission of ingredient information. 15 U.S.C. 1334(a)-(b), of FCLAA reads:

(a) Additional statements

No statement relating to smoking and health, other than the statement required by section 1333 of this title, shall be required on any cigarette package.

(b) State regulations

No requirement or prohibition based on smoking and health shall be imposed under State law with respect to the advertising or promotion of any cigarettes the packages of which are labeled in conformity with the provisions of this chapter.

And the CSTHEA, 15 U.S.C. §4406(a)-(c), states:
(a) Federal action

No statement relating to the use of smokeless tobacco products and health, other than the statements required by section 4402 of this title, shall be required by any Federal agency to appear on any package or in any advertisement (unless the advertisement is an outdoor billboard advertisement) of a smokeless tobacco product.

(b) State and local action

No statement relating to the use of smokeless tobacco products and health, other than the statements required by section 4402 of this title, shall be required by any State or local statute or regulation to be included on any package or in any advertisement (unless the advertisement is an outdoor billboard advertisement) of a smokeless tobacco product.

(c) Effect on liability law

Nothing in this chapter shall relieve any person from liability at common law or under State statutory law to any other.

CAS is the acronym for the Chemical Abstract Service registry number. Each chemical compound has a unique CAS number for purposes of identification, assigned by the American Chemical Society. A CAS registry is available from the National Institutes of Health National Library of Medicine.

CAS is the acronym for the Chemical Abstract Service registry number. Each chemical compound has a unique CAS number for purposes of identification, assigned by the American Chemical Society. A CAS registry is available from the National Institutes of Health National Library of Medicine.

A manufacturer, packager, or importer has successfully submitted an Ingredient Report that lists each ingredient with their proper chemical name and CAS registry number, and, as applicable, a specification of the quantity of nicotine in smokeless tobacco products.

The Comprehensive Smokeless Tobacco Health Education Act (CSTHEA), Public Law 98–252, was passed in 1986 to inform the public of any dangers to human health resulting from the use of smokeless tobacco products. CSTHEA requires, in part, that each person who manufactures, packages, or imports smokeless tobacco products to annually submit to the Department of Health and Human Services the list of ingredients added to tobacco in the manufacture of smokeless tobacco products as well as a specification of the quantity of nicotine contained in each smokeless tobacco product.

The Federal Cigarette Labeling and Advertising Act (FCLAA), Public Law 89–92, is a statute that was designed to “establish a comprehensive federal program to deal with cigarette labeling and advertising with respect to any relationship between smoking and health.” In 1984, this Act was amended by PL 98–474, the Comprehensive Smoking Education Act, 15 U.S.C. § 1335a(a) to in part provide the Department of Health and Human Services with a list of the ingredients added to tobacco in the manufacture of cigarettes.

A company that, to our knowledge, is no longer manufacturing, packaging, or importing tobacco products.

A list of ingredients and their corresponding CAS numbers that are added to tobacco in the manufacture of cigarettes and smokeless tobacco products during the previous calendar year.

A specification of the quantity of nicotine (total nicotine, un-ionized nicotine, total moisture, and pH) contained in smokeless tobacco products from the previous calendar year.

A manufacturer, packager, or importer has failed to provide the annual Ingredient Report (and as applicable, Nicotine Report for smokeless tobacco) by the March 31 deadline or upon initial import, and/or failed to correct inadequacies or errors in a submission within 60 days of notification of these errors.

The Comprehensive Smokeless Tobacco Health Education Act (CSTHEA), 15 U.S.C. §4408, defines smokeless tobacco as “any finely cut, ground, powdered, or leaf tobacco that is intended to be placed in the oral cavity.”