Substantial Equivalence: The Review Process
FDA oversees the manufacture, sale, and distribution of tobacco products, including detailed review of Substantial Equivalence (SE) Reports, one of the three premarket application pathways for marketing a new tobacco product. Learn more about what happens once an SE Report is submitted, how the FDA reviews it, and current timelines for different phases of review.
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Processes related to the review of substantial equivalent reports have been updated to help manufacturers develop higher quality, more complete applications in a timely manner. Beginning Oct. 1, 2018, FDA has been:
- Sending an Appendix of Common Issues for the specific tobacco product categories/subcategories with every notification letter and acknowledgement letter
- Allowing 180 days for applicants to respond to an FDA deficiency letter (previously known as Preliminary Finding or Advice/Information Request letters)
- Providing 180 days for applicants to amend applications before scientific review begins
Because manufacturers now have additional time – and new helpful information – to respond, FDA no longer intends to grant requests for extensions of time in response to deficiency letters as a result of these updates.
FDA is also making publicly available all Appendices of Common Issues, organized by specific tobacco product categories/subcategories.
Industry can provide input on appropriate timelines for review of SE Reports, including the updates above, as part of the public comment period for the proposed rule: Content and Format of Substantial Equivalence Reports; FDA Actions on Substantial Equivalent Reports. When final, this rule will set formal minimum timeline requirements for submitting SE Reports and related information.
START: Application Submission
PHASE 1: Receiving, Acknowledging, Checking for Completeness
PHASE 2: Grandfathered Determination (if Applicable) and Reviewer Assignment
PHASE 3: Scientific Review and Issuance of Decision
You decide that you want to commercially distribute a new tobacco product in the United States that you believe is substantially equivalent to a predicate* tobacco product.
You then submit an application for Substantial Equivalence to FDA
At least 90 days before you want to commercially distribute the new tobacco product.
Submit online through the CTP Portal, an alternative to the existing FDA Electronic Submissions Gateway (ESG) WebTrader tool. If you are unable to submit online, you can mail your submission to CTP's Document Control Center.
*A predicate tobacco product is one that was commercially marketed (other than exclusively in a test market) as of February 15, 2007, or one previously found to be substantially equivalent by FDA and in compliance with the requirements of the Food, Drug & Cosmetic Act.
When we receive an application for substantial equivalence, we:
- Stamp the date on it.
Applications which are received after business hours are stamped the next business day.
- Give it a Submission Tracking Number and put it in an internal tracking system.
- Assign a Regulatory Health Project Manager (Project Manager) within the CTP’s Office of Science to review it. [top]
2. The Project Manager reviews the application to be sure that it is complete and that it describes a product under CTP’s jurisdiction.
If the application is under CTP’s jurisdiction and contains statutorily mandated items, then FDA sends an acknowledgment letter to the applicant.
If the application is not under CTP’s jurisdiction, missing statutorily mandated items, ora combination of the aforementioned, then FDA sends a Refuse to Accept letter. [top]
The acknowledgement letter includes:
- Name of applicant
- Full product identification
- Date we received the application
- Our submission tracking number
- Contact information for the Project Manager
- A general note from the Office of Compliance and Enforcement that the applicant may be contacted about grandfathered status (if applicable) [top]
TRIGGER ACTION | Completion of Phase 1 with an acknowledgment letter issued
Steps 4 & 5 are concurrent.Who is appropriate as a reviewer depends on the contents of the application and on the results of earlier reviews.
4. CTP begins review to determine if the predicate product can be considered grandfathered (if applicable).
- The Project Manager in the Office of Science sends a formal request to the Office of Compliance and Enforcement to begin reviewing the predicate tobacco product to determine if it can be considered grandfathered (GF).
- Determination of the predicate’s GF status is done either through the substantial equivalence (SE) report itself or by reference to a stand-alone GF submission.
- Stand-alone GF submissions are submitted and reviewed separately from SE reports. If an SE report relies upon a stand-alone GF submission, the SE report should include the GF number associated with the stand-alone GF submission.
- A submission for GF determination under SE review requires the same information that is needed for a stand-alone GF submission.
- The Office of Compliance and Enforcement may ask the applicant for more information to determine grandfathered status.
A grandfathered tobacco product is a tobacco product that was commercially marketed (not exclusively in test markets) in the United States as of February 15, 2007.
If you have any questions regarding your applications, please contact your assigned regulatory health project manager. [top]
Reviewers may come from these disciplines:
- Environmental Science
- Social Science
- Medical [top]
TRIGGER ACTION | Completion of Phase 2
6. Reviewers determine if more information is needed. If so, Project Manager sends appropriate letter:
We ask for specific information that we need or that would be helpful in making a decision about substantial equivalence. (Applicants have 60 days to respond to this type of letter.)
We give a preliminary finding that the application does not support a substantial equivalence order. We list the deficiencies in the application and inform the applicant that if the deficiencies are not corrected, we will likely issue a not substantially equivalent order.
If no additional information is needed from the applicant, CTP determines if the product is substantially equivalent (SE) or not substantially equivalent (NSE). [top]
Substantially Equivalent Order
We tell the applicant that the product is substantially equivalent (SE) and the manufacturer is authorized to sell or distribute it in interstate commerce.
Not Substantially Equivalent Order
We tell the applicant that the product is not substantially equivalent (NSE), and the manufacturer is not authorized to sell or distribute it in interstate commerce.* In order for the product to be sold, the manufacturer would need to apply for and receive authorization through one of the marketing pathways.
Applicants may withdraw an application at any time. If they withdraw the application, the Project Manager sends a letter acknowledging that withdrawal. That ends the process, no matter what phase the application is in.
*Any currently marketed product that receives an NSE order may no longer be sold or distributed in interstate commerce.
This resource is intended to provide a high-level overview of the major steps that occur during review of an SE application. [top]