> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Tobacco Product Substantial Equivalence Rule Withdrawn
- URL: https://www.fdaweb.com/tobacco-product-substantial-equivalence-rule-withdrawn/
- Published: 2021-01-25T12:00:00.000Z
- Updated: 2026-09-14T16:44:01.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5148512

*Federal Register* notice: FDA has withdrawn a 1/21-posted final rule that provided additional information on the content and format of reports intended to demonstrate substantial equivalence of a tobacco product (SE Reports). The rule also established general procedures FDA intends to follow when evaluating SE Reports, including procedures that address communications with an applicant and data confidentiality in a SE Report. The withdrawal is in response to an ongoing review by the Biden Administration of regulatory actions taken by the Trump Administration. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-01214.pdf?ref=fdaweb.com).