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  1. Exemption from Substantial Equivalence

Review Process for Exemption from SE

How do I request an exemption from demonstrating substantial equivalence?

FDA issued a final rule on July 5, 2011 that describes the criteria and process for requesting an exemption. This rule also explains how a request for exemption will be reviewed.

The following steps outline the process to request an exemption from substantial equivalence:

  • Submit the information required in 21 CFR 1107.1.
  • Submit in an electronic format FDA can process, review, and archive. (The Technical Working Specifications describe the acceptable electronic format.)
  • FDA will review the request for exemption and determine whether to grant or deny an exemption request.
  • FDA will communicate the decision to the applicant in writing.

What do I do next?

If FDA notifies you in writing that it has granted your request for an exemption, you must still submit a report 90 days before you introduce the tobacco product to market. (see Section 905(j)(1)(A)(ii)). The report must include information demonstrating the following:

  • The product is in compliance with the Act
  • All modifications are covered by exemptions granted by FDA
  • The modifications are to a product that is commercially marketed
  • Actions taken by you to comply with the requirements under Section 907 of the FD&C Act which are applicable to the product

Note: You may not market your product until at least 90 days after the date that you submit the 905(j)(1)(A)(ii) report. However, you do not have to wait for FDA to complete its review of this report if FDA's review takes more than 90 days.

If FDA does not grant your request for an exemption, you must submit a Substantial Equivalent Report or a Premarket Tobacco Product Application and obtain a marketing order from FDA before you may market your product.

This web content highlights provisions of the Food, Drug and Cosmetic Act (FD&C Act). It is not intended to be comprehensive or reflect FDA's interpretation of the Act. For complete information, you must read the entire law. For your convenience, the section number of the FD&C Act is referenced and relevant sections are linked to throughout the web content.

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