Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

        Market and Distribute a Tobacco Product

Exemption from Substantial Equivalence

                        
                Questions & Answers on Exemption from SE Home
          Tobacco Products
          Products, Guidance & Regulations
          Market and Distribute a Tobacco Product
          Exemption from Substantial EquivalenceMarket and Distribute a Tobacco Product Exemption from Substantial Equivalence
  	
        Share
    Post
    Linkedin

    Email
    Print**On this page:**

Overview of Exemption Requests (EX REQ)
	Preparing an Exemption Request (step 1) and Abbreviated Report (step 2)
	Exemption Request Review Process
	Exemption Request Decisions
	Exemption Request ResourcesOverview of Exemption Requests (EX REQ)

An EX REQ can be submitted by the original manufacturer for any new tobacco product seeking an FDA exemption order, under section 905 (j)(3) of the Federal Food, Drug, and Cosmetic (FD&C) Act.  A new tobacco product may be considered for an exemption from Substantial Equivalence (SE) if FDA determines that:

The new tobacco product is modified by adding or deleting a tobacco additive or increasing or decreasing the quantity of an existing tobacco additive;
	The proposed modification is minor and to a legally marketed tobacco product;
	An SE Report is not necessary; and
	An exemption is otherwise appropriatePreparing an Exemption Request (step 1) and Abbreviated Report (step 2)

**Step 1: Prepare an EX REQ**

An EX REQ includes (as required by21 CFR 1107.1): 

	The manufacturer's address and contact information
		Identification of the tobacco product
		A detailed explanation of the purpose of the modification
		A detailed description of the modification, including a statement as to whether the modification involves:
		adding a tobacco additive;
			deleting a tobacco additive;
			increasing the quantity of an existing tobacco additive; or
			decreasing the quantity of an existing tobacco additive
		A detailed explanation of why the modification is a minor modification of a tobacco product that can already be sold under the FD&C Act.
		A detailed explanation of why an SE Reportis not necessary to ensure that permitting the tobacco product to be marketed would be appropriate for protection of the public health.
		A certification signed by a responsible official of the manufacturer summarizing the supporting evidence and providing the rationale for the official’s determination that the modification does not increase the tobacco product’s: 
		appeal to or use by minors;
			toxicity;
			addictiveness; or
			abuse liability
		Other information justifying an exemption
		An environmental assessment prepared in accordance with the requirements of § 25.40
		Submission in electronic format (unless previous waiver was granted)
		Additional applicable required items per the final rule Refuse to Accept Procedures for Premarket Tobacco Submissions
	We recommend the following structure:
	Cover letter and Administrative Information
		Table of contents
		Summaries
		Product Description and Manufacturing (as applicable)
		Nonclinical (if applicable)
		Clinical -- Product Impact on Individual Health (if applicable)
		Clinical -- Product Impact on Population Health (if applicable)
		Environmental Impact**Did you know?**

FDA regulations require individual environmental assessments to be submitted for each individual tobacco product.


How to Submit an EX REQ 
	Request an Industry Account Manager (IAM) to establish a CTP Portal account, if your company does not already have an IAM.
		Prepare your submission electronically using 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.
		Applicants may request a waiver from FDA to submit a EX REQ in a format other than electronically. Waivers will be granted if use of electronic means is not reasonable for the applicant.Submit by Mail:
		If you are unable to submit online, mail submissions to CTP's Document Control Center
	Amendments
	Amendments can be submitted using the above instructions.  The amendment should include a cover letter that includes the submission tracking numbers of the EX REQ in the subject line.  If responding to a deficiency (including requests), follow the instructions as outlined in your deficiency letter.**Step 2: Submit an Abbreviated Report**

Abbreviated Report: Step Two in the exemption process, the Abbreviated Report must be prepared after an Exempt Order is issued and is required to legally market a new tobacco product. It should include information demonstrating that:
	The product is in compliance with the FD&C Act.
		All modifications are covered by exemptions granted by FDA (Exempt order letter was issued).
		The modifications are to a product that can be commercially marketed.
		Actions taken by the manufacturer to comply with the requirements under section 907 of the FD&C Act, as applicable.To assist FDA in the review of the Abbreviated Report, we recommend you utilize the format provided within the appendix of your Exempt Order.

EX REQ Review Process

Exemption from Substantial Equivalence
**Acceptance Review:** An administrative review that ensures the product falls under the Center for Tobacco Products jurisdiction and confirms that the statutory and regulatory requirements of an application are met based upon sections 910 and 905(j)(3) of the FD&C Act, criteria set forth in  § 1107.1, and the criteria set forth in § 1105.10.

	Output
		Acceptance letter or
			Refuse to accept (RTA) letter
	**Notification:** FDA review process when manufacturer proposes to modify a tobacco product legally marketed under a pending provisional SE Report or RFR status.
	Output
		Notification letter: Notification of intent to review provisional product (e.g., pull from RFR), and suspend review of EX REQ until final determination of SE Report. Applicants have 14 days to withdrawal the EX REQ if they do not want to initiate this process.
	**Substantive Review:** FDA evaluation of the scientific information and data in an application.
	Output
		Deficiency letter: Additional information is needed to make a found exempt decision. Applicants have 30 days to respond to this type of letter.
			Environmental information request letter: FDA made a scientific decision to support a marketing order; however, the applicant is required to provide information for environmental considerations before a marketing order can be issued.
	**Action:**
	Output
		Exempt order letter 1 or
			Not exempt order letter**Abbreviated Report Review Process (Step Two of the EX REQ process)**

Exemption from Substantial Equivalence
**Acceptance Review:** An administrative review that ensures the product falls under Center for Tobacco Products jurisdiction and confirms that the statutory and regulatory requirements of the Abbreviated Report are met.

	Output
		Acceptance letter 2
			General correspondence letter: Provides detail if information provided does not allow for an EX REQ to be established
	**Notification:**  
	Output
		None required
	**Review:**  FDA evaluation of the information in the Abbreviated Report.
	Output
		None required
	**Action:**
	Output
		None required – If the manufacturer has not received additional correspondence from FDA within 90 days, they may commercially market the new tobacco product within the United States.**Exemption Request Decisions**

Found Exempt Orders
	Tobacco Product Marketing OrdersExemption Request Resources

Rule
	Exemptions from Substantial Equivalence Requirements
	Tobacco Compliance Webinars for Manufacturers and Importers
	Reference Tools
	2021 Deemed Product Review: A Conversation with the Center for Tobacco Products Office of Science
		2019 Deemed Tobacco Product Applications Public Meeting includes many presentations relevant to PMTA preparation, submission, and review
		2018 Tobacco Product Application Review Public Meeting has many presentations relevant to PMTA preparation, submission, and review
		Refuse to Accept Procedures for Premarket Tobacco Product Submissions
		National Environmental Policy Act; Environmental Assessments for Tobacco Products
		Establishing that a Tobacco Product was Commercially Marketed in the United States as of February 15, 2007 (Evidence to establish pre-existing tobacco product status)
		Submit and Reference Tobacco Product Master Files (TPMF)
		Scientific Policy Memoranda about FDA ReviewReferences
	1. In order to legally market, the applicant must (1) submit an Abbreviated Report; and (2) ninety days must pass since FDA’s receipt of the Abbreviated Report.
2. The Acceptance letter contains the notification of the 90-day timeline that must elapse prior to introduction.

                                                                                  Content current as of:
      01/12/2022
                  
                   
Regulated Product(s)
		 TobaccoExemption from Substantial Equivalence                
                          

                        Questions & Answers on Exemption from SE
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop