On March 8, the Food and Drug Administration announced that it is proposing a long-awaited rule on so-called “tobacco product manufacturing practices.”  Here are some preliminary thoughts on the proposed rule:

• The timing of the proposed rule was a bit of a surprise. Although the proposed rule had been listed as a priority on FDA’s regulatory agenda for some time, nothing indicated that this proposal was imminent. And FDA has identified a number of other rulemaking priorities for 2023, including the proposed ban on menthol cigarettes, the proposed ban on characterizing flavors in cigars and a proposed standard on nicotine levels in cigarettes. It is becoming more and more clear that new leadership at FDA and the Center for Tobacco Products will be working aggressively to impose new requirements on industry.

• The proposed rule is quite comprehensive and would entail significant changes for most manufacturers, and particularly for smaller ones. Some elements of the proposed rule, such as requirements to address adverse experiences and to ensure that products are not adulterated, are not a surprise. However, the breadth of the proposed rule dwarfs more modest approaches that the industry had previously proposed. It is likely that the rule would entail substantial new costs for manufacturers, and it is not clear that FDA has adequately considered those costs.
• The proposed rule would apply to all manufacturers, both domestic and foreign. It is noteworthy, however, that foreign manufacturers still are not subject to establishment registration requirements or regular inspections. In light of this, it is not clear how FDA would enforce these requirements for foreign manufacturers.
• FDA may be biting off more than it can chew. It is a well-known fact that FDA is having trouble enforcing the existing requirements under its jurisdiction. FDA should first consider its wherewithal to enforce existing requirements before it undertakes new enforcement obligations.
• There will be time to comply with the proposed rule. It is important to note that this is only a proposal by FDA. Rules of this magnitude usually take a couple of years to finalize, so we do not expect the proposed rule to be finalized until 2025. If and when the proposed rule is finalized, most manufacturers will have two years to comply, with smaller manufacturers (those with fewer than 350 employees) having four years to comply.
• The proposed rule ups the ante in the pending litigation between the premium cigar industry and FDA. The open question is whether FDA regulation of premium cigars is vacated altogether. If the deeming rule is not vacated as to premium cigars, all manufacturers of premium cigars would be subject to the new manufacturing requirements if and when the proposed rule is finalized.
• All stakeholders should engage on the proposed rule.  Stakeholders have the opportunity to comment on the proposed rule, and FDA is legally obligated to consider all relevant comments before it finalizes the rule. Comments on the proposed rule are due by September 6, 2023, and FDA intends to hold a virtual hearing on the proposed rule on April 12, 2023.

Please let us know if you would like our help understanding the contours of the proposed requirements or in commenting on the proposed rule.