FDA Extends Comment Period for Revised Substantial Equivalence Process to July 17

The U.S. Food & Drug Administration (FDA) has announced a 30-day extension to its current request for comments on how it should revise its substantial equivalence process, a key component of its regulation of tobacco products, including cigars.

Substantial equivalence is a process where a cigar company argues that a new product should be approved for sale because it is substantially equivalent in comparison to an already approved or grandfathered product. Eventually, substantial equivalence is expected to become the main mechanism by which virtually all new cigars are approved for sale by FDA.

A major issue with substantial equivalence is that it is not a form a manufacturer fills out, instead it’s a report that it creates and submits to FDA. The agency hopes that an updated process will help to ensure companies provide the correct information, ultimately reducing the amount of work by the agency.

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While manufacturers can apply for substantial equivalence now, few have applied for approval as the deadline for applying had been set for August 2021. That changed a month ago when a federal court threw out the 2021 deadline after a lawsuit brought on by anti-tobacco groups and pedestrians.

The process for a new deadline is still a pending legal matter. Today’s announcement likely has no bearing on it, though it does show FDA wants more time to continue to update its approval process.