The U.S. Food & Drug Administration (FDA) has announced proposed regulations that would allow it to, amongst other things, inspect factories outside of the U.S. that manufacture tobacco and/or vaping products sold in the U.S.
As with many proposals from the FDA, it is described as a way to help combat the sales of illegal e-cigarettes and vaping products, a cause that has the support of both anti-tobacco groups and Big Tobacco companies. While some cigar factories might not be affected by the change, it would impact many factories and also the tobacco suppliers for the cigar industry.
The FDA describes the rule as a way to increase parity between domestic and foreign factories. Currently, domestic factories are subject to many additional requirements, such as inspections by the FDA and more rigorous product listings. The agency says that the proposed rule would extend these requirements to foreign factories and suppliers, which would level the playing field and also improve the FDA’s tobacco regulatory mission.
Per the FDA:
Because FDA has not issued such regulations, foreign owners or operators are not currently required to register their establishments or list their tobacco products that are imported or offered for import into the United States, unlike domestic owners or operators who are subject to the already effective, self-implementing registration and listing requirements of section 905 of the FD&C Act (21 U.S.C. 387e). This discrepancy creates gaps in information for FDA to perform its public health mission. This proposed rule would therefore extend registration and listing requirements to foreign establishments that engage in the manufacture, preparation, compounding, or processing of a tobacco product. Registered foreign establishments would be subject to inspection under section 905(g) and 905(h) of the FD&C Act (21 U.S.C. 387e(g) and 387e(h)). FDA believes that issuing this regulation to apply these requirements to foreign owners and operators would bring parity between foreign and domestic owners and operators and in doing so improve FDA’s understanding of the types of tobacco products being manufactured, the tobacco products sold in the United States, and the location of all establishments engaged in manufacturing them. For example, FDA does not have registration and listing information from establishments that manufacture ENDS outside of the United States that are imported or offered for import into the United States; having that information would help FDA more efficiently identify commercially marketed tobacco products in the United States that do not comply with the law and keep abreast of the marketplace. Accordingly, FDA is proposing registration and listing requirements for foreign tobacco product establishments.
If this rule were to become finalized, it would not apply to all cigar factories. Due to the cigar industry’s success in a decade-long lawsuit against the FDA, the agency currently does not regulate cigars that meet a definition of “premium cigars,” i.e. most handmade cigars that do not have any added flavors. Because of this, it seems unlikely that a factory that only produces cigars that meet this definition would be affected by these rules.
Somewhat curiously, a footnote in the proposed rule describes the lawsuit as “pending.” The 60-day deadline for the Department of Justice to appeal the April 15 ruling expired in mid-June. It seems likely that this is a discrepancy related to when the proposed rule was drafted. A listing from the White House Office of Management and Budget indicates that the proposed rule was at one point on the calendar to be published in May.
The FDA has given some examples of the types of information companies would need to turn over. That includes information on the types of tobacco used, the size of the cigar, the type of packaging used and what kind of characterizing flavor(s) that a product has. However, it’s also given a specific example for a tobacco grower or supplier of cigar tobacco filler.
In a June 16 meeting with the government regarding the proposal, the Cigar Association of America (CAA), an industry trade group whose members include companies that make billions of machine-made small cigars as well as handmade cigar producers like AJ Fernandez, advocated for streamlined regulations, especially around private label cigars. However, the organization said it was supportive of the move.
“CAA is supportive of a rule to have formal requirements for tobacco product manufacturing establishment registration for both domestic and foreign establishments, as long as the rule is thoughtfully crafted to account for (i) the current legal realities of re-labeled and private label products, and (ii) the complicated, unique industry relations between/among manufacturers, brand owners, and importers, and (iii) the very clear practical differences between domestic and foreign establishments,” said the CAA in a Powerpoint presentation.
The prospect of FDA inspectors visiting cigar factories overseas is not a new one.
In 2023, the agency announced a different proposed rule that would have gone multiple steps further, not only introducing inspections but also creating a variety of health and safety standards for the manufacturing operations. This would have included requirements for operating procedures about things like safety and hygiene, as well as more extensive record-keeping. Ultimately, that proposal has not come to fruition.
The 2026 proposal is nowhere near as strict, though it would still result in the monumental step of the FDA establishing foreign factory inspections.
While the FDA is highlighting many of the same benefits of the 2023 proposal, it has made parity a much more prominent talking point.
“All companies selling tobacco products in the United States should play by the same rules,” said Bret Koplow, acting director of the FDA’s Center for Tobacco Products, in a press release. “The FDA is working hard to close the gap between domestic and foreign companies, level the playing field for American businesses, and ensure that all manufacturers are held to the same standards.”
That quote was just one of two Koplow made in the agency’s press release.
Today’s announcement is part of a legally required process for the agency to introduce new rules. As part of this process, the FDA must announce the proposed rule and give people and businesses the opportunity to submit comments about the proposal.
That comment window will run from June 29 to Sept. 14, 2026. After that, the agency is required to review the comments, and, if it would like to proceed with the rule, must respond to those comments.
Overall Score
FDA
U.S. Food & Drug Administration
