FDA Publishes Finalized Substantial Equivalence Rule, Impact for Cigars Unclear

Today, the U.S. Food & Drug Administration (FDA) announced finalized rules for companies wishing to get FDA approval for tobacco products through the substantial equivalence or premarket tobacco product application approval pathways. Both updates are aimed at trying to help companies get approval and FDA more quickly process applications by producing better quality applications.

However, it’s also unclear what any of this means for premium cigars, at least for now.

Because of an August 2020 court ruling, cigars that are considered “premium cigars”—a definition that likely includes just about every cigar sold in a humidor except for flavored cigars—are not currently subject to the current substantial equivalence rule. FDA is waiting on a panel formed by the National Academy of Sciences to deliver a report about whether the agency should apply the current set of rules for premium cigars or use a different set of rules. The agency does not expect the panel to deliver its findings until next year, meaning today’s announcement currently does not apply to most cigars that are sold in humidors.

FDA has said that it will update its rules once it makes a decision about premium cigars.

This is the second time this year FDA has announced plans for a finalized substantial equivalence rule. In January, the agency announced the updated rules in the waning days of the Trump administration; as is often customary when a new administration takes over—particularly from an opposite party—the Biden administration quickly announced a regulatory freeze that included the updated substantial equivalence rules.

Now, FDA is publishing the updated rules again and it seems quite similar to the rules it proposed in January.

These new rules are FDA’s attempts to try to get companies to provide the agency with more complete reports, meaning FDA can avoid looking at reports that are missing critical pieces of information, something that wastes the agency’s time. Furthermore, it will also mean that the companies themselves should have a clearer idea of what information the agency wants, meaning the companies can focus on producing relevant information.