OMB OIRA Publishes Fall 2023 Unified Regulatory Agenda

Dear Stakeholders:

Yesterday, the Office of Information and Regulatory Affairs published its Fall 2023 Unified Agenda outlining upcoming regulations that federal agencies plan to undertake. The report includes five proposed FDA actions directly affecting the premium cigar industry.

The following is a synopsis of those items:

Characterizing Flavors in Cigars

Next Significant Date: March 2024 - Final Rule will be released

The final rule aims to prohibit the use of non-tobacco flavors in cigars.  Lobbying on this rule and a related proposal to ban menthol cigarettes is intense and politically sensitive. The updated timeline reflects a substantial delay, which is not entirely unexpected, going into an election year.

Nicotine Levels for Certain Tobacco Products

Next Significant Date: April 2024 - Notice of Proposed Rule will be released

This proposed rule intends to set maximum nicotine levels for cigarettes and "certain tobacco products." The specific application of this rule to premium cigars remains to be seen. CRA is prepared to communicate our opposition to establishing a maximum nicotine level in premium cigars, as it could pose an existential threat. This proposed rule was originally expected in December, but has now been delayed until April.

Tobacco Product Manufacturing Practices

Next Significant Date: October 2024 - Final Rule will be released

The final rule establishes new standards for tobacco manufacturers, including those producing premium cigars. CRA has actively been engaged in the proposed rule, expressing concerns about potentially costly provisions that do not benefit public health. The organization continues to monitor the development of the final rule.

Administrative Detention of Tobacco Products

Next Significant Date: October 2024 - Notice of Proposed Rule will be released

This proposed rule grants the FDA the authority to seize and detain tobacco products suspected of having been adulterated or misbranded. While primarily targeted at vaping products, its potential impact on premium cigars is yet to be known, as premium cigars are not subject to FDA regulation. CRA, however, is concerned that if premium cigars are re-Deemed and become subject to FDA regulatory authority again, it will be important to ensure that FDA's detention powers do not impinge premium cigar imports.

Submission of Import Data

Next Significant Date: January 2024 - Notice of Proposed Rule will be released

This technical rule mandates the electronic submission of premarket authorization data for imported tobacco products. While this proposal is not likely to require active engagement, CRA will continue to monitor the rule's implementation for potential impact on premium cigars, were they to come back under FDA’s regulatory authority.

As always, CRA will continue to provide updates on all of these regulatory matters as they develop.

For questions regarding this update, please contact Cody Carden at cody.carden@cigarrights.org or Mike Copperman at mike.copperman@cigarrights.org.