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Supervisory Review/Appeal Process for Tobacco Product Decisions

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What is Supervisory Review? 

Supervisory review (otherwise known as a supervisory appeal) is a process where an FDA decision may be appealed, in writing, to the next supervisory level in the chain of command within the agency. 

Federal regulation 21 C.F.R. 10.75 provides that an employee, supervisor, or any interested person outside the agency may request supervisory review of a FDA decision, other than decisions made by the Commissioner. Additionally, 21 C.F.R. 10.75 may be used as required by delegations of authority.

A request for supervisory review does not:

  • Automatically stop the effect of the decision that is being appealed
  • Delay the effective date of the decision that is being appealed
  • Generally result in enforcement discretion during consideration of the supervisory review
    • For provisional tobacco products*, should FDA receive a request for supervisory review of a Not Substantially Equivalent (NSE) order from the applicant within 30 calendar days from the issue date of the NSE order, FDA does not intend to take enforcement action based on the order until FDA makes a decision on that request.

*A provisional tobacco product is a product first introduced or delivered for introduction into interstate commerce for commercial distribution after February 15, 2007, and prior to March 22, 2011, and for which a 905(j) (or substantial equivalence) report was submitted no later than March 22, 2011.

When Might Industry Request a Supervisory Review? 

Supervisory reviews related to tobacco products may be submitted to the Center for Tobacco Products (CTP) for decisions, such as: 

Submitting a request for supervisory review might be appropriate when the applicant believes that CTP has made an error during application review, such as:

  • Missed information in the application
  • Incorrectly interpreted information in the application
  • Incorrectly interpreted scientific information

Supervisory review is intended to determine whether a procedural or substantive error was made with regard to a decision. This determination must be based on information in the administrative file related to that decision.

However, submitting a request for supervisory review may not be appropriate when the request is not based on a procedural or substantive error, such as when: 

  • The applicant received an RTA letter for failure to include required information (such as a required form) in their application, and that information was, in fact, not included.
  • The applicant wants to submit new information 
    • NOTE: published scientific literature not solely related to the products in the application is not considered “new information” in this context
  • The applicant is solely seeking FDA’s enforcement discretion to delay enforcement of FDA’s actions while preparing a new product application for submission.
  • The appeal is based on business or operating needs such as number of employees; expense of, or difficulty with, complying with statutory or regulatory requirements; or difficulty with obtaining or conducting necessary research.

How Do I Submit a Supervisory Review Request?

If an interested person outside the agency wishes to request supervisory review of a decision, the request should be made in writing, preferably within 60 days of the decision. 

Step 1: Prepare a Supervisory Review Request

  • A Supervisory Review Request should include: 
    • A cover letter
      • Subject line: “REQUEST FOR SUPERVISORY REVIEW of [brief description of the decision and CTP Submission Tracking Number (STN) if applicable]
    • The decision being appealed
    • If applicable, include any previous attempts to resolve or address concerns with Office of Science 
    • Identification of a proposed outcome to resolve any issue 
    • A request to meet with reviewing official (if applicable) 
    • Rationale and/or clarifications to explain why the submitter believes the decision is incorrect
  • Published scientific studies that are not solely related to data in the application being appealed may be considered in the supervisory review.

Step 2: Submit a Supervisory Review Request

  • A supervisory review request should be sent as a single submission.
  • The review request should be submitted through the CTP Document Control Center (DCC), either in hard copy at the address below or electronically via CTP Portal or Electronic Submission Gateway (ESG). FDA does not currently accept review requests via email.

Center for Tobacco Products
Food and Drug Administration
Document Control Center
10903 New Hampshire Avenue
Building 71, Room G335
Silver Spring, MD 20993-0002

  • It is in the submitter’s best interest to both track the request and follow-up with the CTP Ombuds Team to ensure the request has been received.

Can I Include New Information in a Supervisory Review Request?

No. When submitting a request for supervisory review, do not include new information. 

New information could include any information, data, or analysis which was not part of the administrative file that was the basis for the decision, with the exception of minor clarifications.

The best method of submitting new, different, or missing information for an application for the premarket review of a new tobacco product is to submit the application again, not to submit a request for supervisory review.

What Are My Options if I Do Not Agree with the Outcome of the Supervisory Review? 

CTP is committed to addressing scientific, procedural, and other disputes with parties as quickly and amicably as possible. 

If a request for supervisory review fails to resolve the dispute, please contact the CTP Ombudsman’s office to discuss the next steps. 

Who Can I Contact If I Have Further Questions about Supervisory Review?

For further information on CTP’s Supervisory Review process, you may contact the CTP Ombuds Team:

Additional Resources

CTP’s Freedom of Information Act (FOIA) 

Applicants may consider requesting documents from CTP's Freedom of Information Act (FOIA) via a written or online FOIA request to FDA.

Frequently requested records and more information about these requests are available on CTP’s Freedom of Information Act page.
 

 
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