The Office of Information and Regulatory Affairs recently published the Spring 2021 Unified Agenda of Federal Regulatory and Deregulatory Actions. This year’s Department of Health and Human Services’ agenda addresses 8 topics directly related to tobacco and electronic nicotine delivery systems (ENDS), summarized below:

Final Rule Stage

• Premarket Tobacco Product Applications and Recordkeeping Requirements: The pre-publication version of this final rule was initially published on January 19, 2021, but withdrawn as part of the new administration’s regulatory freeze. This rule will establish content and format requirements to ensure that premarket tobacco product applications (PMTAs) contain sufficient information for FDA to determine whether the marketing of a new tobacco product should be authorized. Additionally, the rule will set forth the basic procedures for premarket tobacco product application review and require applicants receiving marketing authorization to establish records and make post-market reports to FDA. The rule will also require tobacco product manufacturers to keep records to support legal marketing of certain tobacco products, such as documents showing that a tobacco product does not need to undergo premarket review. The agenda indicates that a final rule was slated for May 2021, but no final rule has been published as of this date.

• Format and Content of Reports Intended to Demonstrate Substantial Equivalence: The pre-publication version of this final rule was also initially published on January 19, 2021, but withdrawn as part of the new administration’s regulatory freeze. This rule will establish the format and content of reports intended to demonstrate substantial equivalence (SE) in tobacco products and will provide information as to how the Agency will review and act on these submissions. The agenda indicates that a final rule was slated for May 2021, but no final rule has been published as of this date.

• Prohibition of Sale of Tobacco Products to Persons Younger Than 21 Years of Age: As required by Section 603 of Further Consolidated Appropriations Act, 2020, Pub. L. 116-94, FDA is issuing a final rule to make conforming changes to its regulations to: reflect the increased minimum age of sale for tobacco products from 18 to 21 years of age; increase the minimum age for verification from under the age of 27 to under the age of 30; and increase the minimum age for facilities that maintain vending machines that sell tobacco products from 18 years to 21 years of age. The agenda indicates that a final rule was slated for May 2021, but no final rule has been published as of this date.

Proposed Rule Stage

• Requirements for Tobacco Product Manufacturing Practice: The rule proposes to establish tobacco product manufacturing practice (TPMP) requirements for manufacturers of finished and bulk tobacco products. This proposed rule, if finalized, would set forth requirements for the manufacture, pre-production design validation, packing, and storage of a tobacco product. This proposal would help prevent the manufacture and distribution of contaminated and otherwise nonconforming tobacco products. This proposed rule provides manufacturers with flexibility in the manner in which they comply with the proposed requirements while giving FDA the ability to enforce regulatory requirements, thus helping to assure the protection of public health. A NPRM is scheduled for October 2021.

• Modified Risk Tobacco Product Applications: This proposed rule would establish content and format requirements to ensure that modified risk tobacco product applications contain sufficient information for FDA to determine whether it should permit the marketing of a modified risk tobacco product. Additionally, the proposed rule would set forth the basic procedures for modified risk tobacco product application review and require applicants receiving authorization to market a modified risk tobacco product to establish and maintain records, conduct post-market surveillance and studies, and submit annual reports to FDA. A NPRM is schedule for November 2021.

• Administrative Detention of Tobacco Products: The FDA is proposing regulations to establish requirements for the administrative detention of tobacco products. This action, if finalized, would allow FDA to administratively detain tobacco products encountered during inspections that an officer or employee conducting the inspection has reason to believe are adulterated or misbranded. The intent of administrative detention is to protect public health by preventing the distribution or use of tobacco products encountered during inspections that are believed to be adulterated or misbranded until FDA has had time to consider the appropriate action to take and, where appropriate, to initiate a regulatory legal action. A NPRM is scheduled for December 2021.

• Tobacco Product Standards Prohibiting Characterizing Flavors in Cigars and Menthol in Cigarettes: These proposed rules are separate tobacco product standards that would ban characterizing flavors in all cigars and menthol cigarettes. Notices of proposed rulemakings are scheduled for August 2021 for the flavored cigar ban, and April 2022 for the menthol cigarette ban.

Cathie Chen contributed to this article.