FDA Extends Comment Period for Tobacco Manufacturing Standards Proposal

The U.S. Food & Drug Administration (FDA) has extended the deadline to comment on its proposed rules for Requirements for Tobacco Product Manufacturing Practice. The original deadline was set at Sept. 6, the new deadline is Oct. 6, 2023.

FDA formally announced the proposed rule in March, though it has not finalized what exactly these rules will entail. Broadly, the plan is to require facilities that manufacture regulated tobacco products to implement safety and quality control practices and document how those self-created programs are implemented and adhered to. In a document published by the agency in March, eight categories were specifically outlined:

1. General Provisions
2. Management System Requirements
3. Buildings, Facilities, and Equipment
4. Design and Development Controls
5. Process Controls
6. Packaging and Labeling Controls
7. Handling, Storage, and Distribution
8. Record Keeping and Document Controls

At least initially, FDA seems like it will allow the companies that operate these facilities to create their own rules and practices. For example, one factory could choose to have employees use gloves, while another factory might decide to require regular handwashing. These rules will cover the cleanliness and safety of the buildings, the materials stored inside buildings and the finished products themselves. Under the current proposal, facilities would need to establish not only a way for consumers to report defective products but also a system that shows how those complaints are addressed.

Perhaps, most jarring: factories based outside the U.S. would be subject to inspections.

The March proposal indicated that there would be a two-year compliance period for larger facilities and a four-year compliance period for facilities with less than 350 employees, meaning the rules are unlikely to go into effect until 2026 or 2030 at the earliest.

---

For the premium cigar industry, it’s possible that some factories will not have to worry about these rules, at least for the moment. Earlier this month, Judge Amit P. Mehta vacated the deeming regulations for “premium cigars” as part of Cigar Association of America et al. v. United States Food and Drug Administration et al., a seven-year-old lawsuit that was filed by the Cigar Association of America (CAA), the Cigar Rights of America (CRA) and the Premium Cigar Association (PCA), three cigar trade groups.

As such, the deeming regulations introduced in 2016 by FDA do not apply to cigars that meet the definition of “premium cigars,” which would include most large, unflavored cigars.

While a factory like Padrón’s Tabacos Cubanica S.A., which likely produces only cigars that would meet the definition of “premium cigar,” might not have to comply with the rules, many cigar factories would because they produce flavored cigars, machine-made cigars or other cigars that won’t meet the definition of “premium cigars.” Most, if not all, of the large suppliers in the industry will need to comply with at least some of the rules as FDA has proposed supplier-compliance as part of the new rules.

Furthermore, while some premium-only factories may not be subject to the program right now, those same factories could be subject to these rules in the future. Mehta’s ruling does not prevent the agency from regulating premium cigars in the future, rather, it prevents FDA from regulating premium cigars until after the agency properly follows the rulemaking process. Ironically, Mehta found FDA failed to properly consider comments as part of the 2014-2016 rulemaking process.

Additionally, the Department of Justice has until early October to file an appeal of Mehta’s decision.

To leave a comment, click here.