On this page:
- Substantial Equivalence Overview
- Recommended steps to prepare an SE Report for a new tobacco product
- Submit an SE Report
- Help with SE Reports
- Response to SE Reports
A substantially equivalent tobacco product is one that has been found by FDA to have either the same characteristics as a predicate product or has different characteristics than the predicate tobacco product but the Substantial Equivalence Report (also known as a 905(j) Report) submitted by the manufacturer demonstrates that the new product does not raise different questions of public health. A predicate tobacco product is one that was commercially marketed in the United States (other than in a test market) as of Feb. 15, 2007, or is a product previously found to be substantially equivalent by FDA and in compliance with the requirements of the Food Drug & Cosmetic Act (FD&C Act).
A tobacco product that is modified by adding or deleting a tobacco additive, or increasing or decreasing the quantity of an existing tobacco additive, may qualify to apply for an exemption from demonstrating substantial equivalence (known as an Exemption Request).
Note: *New tobacco products commercially marketed after February 15, 2007 but before March 22, 2011 with an SE Report submitted by March 22, 2011 are known as provisional SE tobacco products— these may continue to be marketed unless FDA issues an order that the new product is not substantially equivalent.
Learn more about the FDA’s process for reviewing substantial equivalence reports.
- Determine a predicate product.
- FDA's standalone grandfathered submissions database includes information on potential predicate products. The database contains grandfathered determination information from voluntarily-submitted requests for a grandfathered status review of a tobacco product.
- Reviewing Decision Summaries for previously issued Substantial Equivalence Marketing Orders may provide helpful information.
- If the predicate product you’ve selected is eligible for grandfather status, it may be helpful to Submit a standalone grandfather submission
- SE Reports typically include the following information:
- Cover letter
- Listing of design features
- Listing of ingredients
- Listing of materials
- Description of heating source
- Description of composition
- Harmful and potentially harmful constituents (HPHCs)
- Laboratory accreditation
- Storage conditions of products (both the predicate and new)
- Health information
- Final summary or closing statement
- Prepare an environmental assessment (EA) per National Environmental Policy Act (NEPA) requirements.
- Request, in writing, an Industry Account Manager (IAM) account for CTP Portal, if your company does not already have an IAM.
- Prepare your submission electronically using the FDA's eSubmitter software and the eSubmitter template “CTP Transmittal Form.”
- Submit online via the CTP Portal.
Note: The CTP Portal provides more functionality than the ESG, and CTP recommends using the CTP Portal. However, if you already have an ESG WebTrader account, you may use it to submit documents to CTP.
Submit by Mail:
If you are unable to submit online, mail submissions to CTP's Document Control Center.
- Rules and Guidance for Substantial Equivalence: FDA has issued several documents that provide information for those submitting SE Reports, including FDA’s interpretation of the statutory sections related to substantial equivalence, recommendations on form and content, and whether a change to the product quantity in the package renders a product “new” and thus subject to premarket review.
- Proposed rule: Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports
- Guidance: Section 905(j) Reports- Demonstrating Substantial Equivalence for Tobacco Products
- Guidance: Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions.
- SE Report Appendices: Common Issues
To help manufacturers prepare an SE Report for submission and avoid common deficiencies that might result in an unfavorable application decision, the FDA has posted appendices organized by product type. The information included in these appendices reflects deficiencies frequently seen in previous SE Reports that FDA has reviewed.
- Other Resources
- The Office of Small Business Assistance can answer questions about requirements of small businesses and how to comply with the law.
- Watch webinars focused on substantial equivalence regulations and requirements.
- Read questions and answers on SE.
- Submit or reference Tobacco Product Master Files (TPMFs).
TPMFs are voluntary submissions to the FDA that contain trade secret and/or confidential commercial information about a tobacco product or component. TPMFs are a beneficial tool for manufacturers, component suppliers, ingredient suppliers, and researchers, and can assist applicants in the tobacco product submission process.
- SE Presentations from Tobacco Product Application Review Public Meeting (Oct 2018)
- Deficiency Letter: FDA may ask for specific additional information that is needed or will be helpful in making a substantial equivalent decision. Applicants have 180 days to respond to this type of letter.
- SE order: If FDA determines that a new tobacco product is substantially equivalent and is in compliance with all other legal requirements, a written SE order will be issued to legally market the product in the United States. See issued SE Marketing Orders to date.
- Not substantially equivalent (NSE): If FDA determines that the new tobacco product does not have either the same characteristics as the identified predicate tobacco product or that the new product raises different questions of public health, FDA will issue an order stating that the product is not substantially equivalent (NSE). An NSE tobacco product may not be legally marketed unless it receives a marketing order via one of the premarket application pathways.
Learn more about the FDA's review process for SE Reports.
- Statement from FDA Commissioner Scott Gottlieb, M.D., on actions to advance our comprehensive plan to reduce tobacco-related disease and death, through new efforts to improve the tobacco product application review process, including a newly proposed rule
- Common Issues Found in Substantial Equivalence Reports
- April 2018: FDA Update on Provisional Substantial Equivalence (SE) Review Process
- SE Marketing Orders
- SE Performance Measures
- Small Business Assistance for Tobacco Product Industry
- Section 905(j) of the Tobacco Control Act