Guidance for Industry
Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007
Comments may be submitted at any time for Agency consideration. Electronic comments may be submitted to http://www.regulations.gov. Alternatively, submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD, 20852. All comments should be identified with Docket No. FDA-2011-D-0125.
For questions regarding this guidance, contact the Center for Tobacco Products at (Tel) 1-877-CTP-1373 (1-877-287-1373) Monday-Friday, 9 a.m. – 4 p.m. EDT.
Additional copies are available online at http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm. You may send an e-mail request to [email protected] to receive an electronic copy of this guidance. You may send a request for hard copies to U.S. Food and Drug Administration, Center for Tobacco Products, Attn: Office of Small Business Assistance, Document Control Center, Building 71, Room G335, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993-0002.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Tobacco Products
[Date]
OMB Control No. 0910-0***
Expiration Date: *****
See additional PRA statement in Section VI of this guidance.
Table of Contents
A. What is a tobacco product? 1
B. What is a new tobacco product? 2
C. What is a grandfathered tobacco product? 2
III. ADMINISTRATIVE INFORMATION 3
A. Who may request a grandfathered status review? 3
B. How should a request for a grandfathered status review be submitted to FDA? 3
C. How will FDA review the Grandfathered Submission? 4
IV. RECOMMENDED CONTENT OF A REQUEST 4
A. Description of the Tobacco Product 4
B. Evidence Demonstrating the Grandfathered Status of the Tobacco Product 4
Guidance for Industry1
Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007
This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
This guidance provides information on how a manufacturer may establish that a tobacco product was commercially marketed in the United States as of February 15, 2007. The guidance includes a description of the types of evidence recommended to demonstrate that a tobacco product was commercially marketed in the United States as of February 15, 2007. The guidance also includes definitions and administrative information, such as who may submit a request for a grandfathered status review and how to submit a request.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
This section provides the definitions of certain terms used in this guidance document.
A tobacco product is “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product)” (section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)).2 This term does not include an article that is a drug, a device, or a combination product as defined in the FD&C Act (see section 201(rr) of the FD&C Act). The term is not limited to products containing tobacco, but also includes components, parts, or accessories of tobacco products, whether they are sold for further manufacturing or for consumer use. For example, tobacco, papers, and filters are tobacco products, whether they are sold to consumers for use with roll-your-own tobacco or are sold for further manufacturing into a product sold to a consumer, such as a cigarette.
A new tobacco product is defined in section 910(a)(1) of the FD&C Act3 as:
any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007; or
any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007.
In general, a tobacco product manufacturer must obtain an order under section 910(c)(1)(A)(i) (order after review of a premarket application) before the manufacturer may introduce a new tobacco product into interstate commerce (section 910 of the FD&C Act). An order under section 910(c)(1)(A)(i) is not required, however:
• if a manufacturer submits a substantial equivalence report under section 905(j) of the FD&C Act4 (a 905(j) report) and obtains an order under section 910(a)(2)(A)(i);
or
if FDA has granted a substantial equivalence exemption request submitted under 21 CFR 1107.1 and the manufacturer submits the required report under section 905(j).
For the purposes of this guidance, FDA refers to tobacco products that were commercially marketed (other than exclusively in test markets) in the United States as of February 15, 2007, as grandfathered tobacco products. Grandfathered tobacco products are not considered new tobacco products and thus are not subject to the premarket requirements of the FD&C Act (section 910 of the FD&C Act).
A grandfathered tobacco product may serve as the predicate tobacco product in a 905(j) report (intended to be used toward demonstrating substantial equivalence) for a new tobacco product (section 905(j)(1)A)(i) of the FD&C Act, 21 U.S.C. 387e(j)(1)(A)(i)). As discussed earlier, under section 201(rr) of the FD&C Act,5 a product made or derived from tobacco that is intended for human consumption is not a tobacco product if it fits the definition of a drug, device, or combination product under the FD&C Act. Such products, even if they were on the market as of February 15, 2007, may not be grandfathered tobacco products and cannot serve as predicate tobacco products for a 905(j) report.
We interpret the phrase “as of” February 15, 2007, as meaning that the tobacco product was commercially marketed (other than exclusively in test markets) in the United States on February 15, 2007. If your tobacco product had been commercially marketed in the United States before February 15, 2007, but was not commercially marketed on that date, it is not a grandfathered product and may not be commercially marketed unless you comply with the premarket requirements of section 910 of the FD&C Act and obtain a marketing order. Section IV.B describes how you can demonstrate that a tobacco product was commercially marketed (other than exclusively in test markets) in the United States as of February 15, 2007.
If you believe that your tobacco product should be considered a grandfathered tobacco product and would like an Agency determination on the status of your product, you may submit a request for review as described in section III.B below.
At this time, FDA intends to limit its review of grandfathered status to finished, regulated tobacco products. These finished, regulated tobacco products include the tobacco products named in section 901(b) of the FD&C Act (i.e., cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco) and tobacco products deemed by regulation to be regulated under Chapter IX, as well as the component parts of regulated tobacco products sold or distributed for consumer use (e.g., cigarette rolling papers, filters, or filter tubes sold separately to consumers or as part of kits). FDA does not intend to review grandfathered status for component parts of regulated tobacco products that are sold or distributed solely for further manufacturing into finished tobacco products because at this time the Agency does not intend to enforce the requirements of sections 910 and 905(j) of the FD&C Act for these components.6
For the purposes of this guidance, a submission requesting a grandfathered status review is referred to as a Grandfathered Submission. Each tobacco product should be submitted in a separate Grandfathered Submission.7 Grandfathered Submissions can be submitted electronically via the FDA’s Electronic Submissions Gateway8 (ESG) using FDA’s eSubmitter tool9. Although electronic submission is not required, FDA strongly encourages electronic submission for efficient and timely data submission and management. Alternatively, submissions can be mailed to:
Food and Drug Administration
Center for Tobacco Products
Document Control Center
Building 71, Room G335,
10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
FDA will review the Grandfathered Submission to determine whether the tobacco product is a grandfathered tobacco product (i.e., the tobacco product was commercially marketed (other than exclusively in test markets) in the United States as of February 15, 2007). FDA will notify you of its determination in writing. If FDA is unable to determine the grandfathered status of your product, the Agency may contact you to request further information.
FDA recommends that you specifically identify the product (e.g., name) and provide a brief description of the tobacco product that will allow FDA to review your request in context. For example, the description could include a list of components that comprise the product, a basic description of the materials, and how the product is used by the consumer. In addition, to better assist our review of your request, the description should include a legible photograph or schematic diagram of the tobacco product.
FDA recommends that you provide adequate information to demonstrate that the tobacco product was commercially marketed (other than exclusively in test markets) in the United States as of February 15, 2007. As stated in section II.D, we interpret “as of” to mean “on.” Accordingly, the information submitted should demonstrate (individually or collectively) that the tobacco product was commercially marketed (other than exclusively in test markets) in the United States on February 15, 2007. If you cannot provide documentation specifically dated on February 15, 2007, FDA suggests you provide documentation of commercial marketing for a reasonable period of time before and after February 15, 2007.
Examples of such information may include, but are not limited to, the following:
dated copies of advertisements
dated catalog pages
dated promotional material
dated trade publications
dated bills of lading
dated freight bills
dated waybills
dated invoices
dated purchase orders
dated customer receipts
dated manufacturing documents
dated distributor or retailer inventory lists
any other document you believe demonstrates that the tobacco product was commercially marketed (other than exclusively in test markets) in the United States as of February 15, 2007
FDA will consider and evaluate all of the information provided on a case-by-case basis.
Your Grandfathered Submission may include nonpublic trade secret or confidential commercial information. Several laws govern the confidentiality of information submitted under the FD&C Act, including section 906(c) of the FD&C Act (21 U.S.C. 387f(c)), the Trade Secrets Act (18 U.S.C. 1905), and the Freedom of Information Act (FOIA) (5 U.S.C. 552), as well as FDA’s regulations implementing these laws. FDA’s general regulations concerning the public availability of FDA records are contained in 21 CFR part 20.
This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
The time required to complete this information collection is estimated to average 2 hours per response, including the time to review instructions, search existing data sources, gather the data needed, and complete and review the information collection. Send comments regarding this burden estimate or suggestions for reducing this burden to:
Food and Drug Administration, Center for Tobacco Products, Document Control Center, Building 71, Room G335, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this information collection is 0910-xxxx (expires xxxxxxx).
1 This guidance was prepared by the Office of Compliance and Enforcement and the Office of Regulations in the Center for Tobacco Products at FDA.
2 21 U.S.C. 321(rr)
3 21 U.S.C. 387j(a)(1)
4 21 U.S.C. 387e(j)
5 21 U.S.C. 321(rr).
6 See the Guidance for Industry and FDA Staff, Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products (January 2011), available on the Internet at http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.
7 These procedures pertain specifically to Grandfathered Submissions. The procedures related to grandfathered evidence submitted as part of a 905(j) report are not within the scope of this guidance document.
8 The FDA ESG system requires users to apply for a free account before submitting data, a process which can take one to three weeks. Once approved, the user can send all submissions to CTP using the eSubmitter tool and FDA ESG. Instructions on obtaining an ESG account are available at http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ucm188949.htm.
9 The FDA eSubmitter tool is an electronic application designed to streamline the process for regulatory submissions. Users of the eSubmitter tool first download and install the computer application and then enter all data. The eSubmitter tool is available at http://www.fda.gov/ForIndustry/FDAeSubmitter.
| File Type | application/msword |
| File Title | Action Letter Type |
| Author | CDRH |
| Last Modified By | Colburn, Christopher |
| File Modified | 2014-07-15 |
| File Created | 2014-07-15 |