Frequently Asked Questions
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, 1985pdf icon [PDF–51.4 KB]; 59 FR 4717, February 1, 1994pdf icon [PDF–59.7 KB], respectively.
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.
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:
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.
Because CDC cannot ensure the confidentiality of information submitted via E-mail, this 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.
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 5pdf iconexternal 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 icon[PDF–117 KB]external icon. 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. However, submission of data by way of mailing a CD, 3-inch floppy disk, or thumb drive is acceptable.
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 icon[PDF–117 KB]external icon 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.”
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 Practicesexternal icon 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)external icon; the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) external icon; Alcohol and Tobacco Tax and Trade Bureau (TTB)external icon; and U.S. Customsexternal icon.
Yes. According to 15 U.S.C. §1338 pdf icon[PDF–121 KB]external icon “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.