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HHS/FDA RIN: 0910-AI64 Publication ID: Fall 2021 
Title: ●Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Certain Tobacco Products 

In 2019, the United States District Court for the District of Maryland ordered the U.S Food and Drug Administration (FDA) to require manufacturers of deemed new tobacco products, including electronic nicotine delivery system (ENDS) products; e.g., an electronic cigarette, that were on the market as of August 8, 2016, to submit applications for premarket review to FDA by September 9, 2020. Per the court’s orders, FDA may defer enforcement of premarket requirements for these tobacco products if an application was submitted by the September 9, 2020, deadline for up to one year, or until September 9, 2021. If a negative action is taken by the FDA on an application during that year, the product(s) must be removed from the market or risk FDA enforcement.

FDA proposes to amend 21 CFR 1.79 to add a requirement that an import filer submit the FDA premarket application number at the time of entry in the Automated Commercial Environment (ACE), operated by U.S. Customs and Border Protection (CBP), for an ENDS product. This rule, if finalized, will allow FDA to more effectively and efficiently determine the marketing authorization status of ENDS products offered for import, and thereby enforce the premarket authorization requirements of chapter IX of the FD&C Act. By reducing the time spent on import entry review, this rule, if finalized, will produce cost savings for FDA. Import filers of ENDS products will face costs to learn the rule and to retrieve Submission Tracking Numbers and enter them into ACE. The Federal Government will also face a cost to add a new ACE business rule for ENDS products.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 21 CFR 1, subpart D     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 21 U.S.C. 371    21 U.S.C. 381    21 U.S.C. 387j(c)(1)(A)(i)   
Legal Deadline:  None
Action Date FR Cite
NPRM  02/00/2022 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Federal 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Ann Marie Metayer
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Building 32, Room 4375,
Silver Spring, MD 20993
Phone:301 796-3324