FDA Plans Updated Substantial Equivalence Process for Tobacco Products

One of the many complaints cigar companies have with the FDA and the agency’s regulations on tobacco products is a lack of clarity. Nowhere is that lack of clarity been a larger complaint than when it comes to the process of substantial equivalence.

Today, the U.S. Food & Drug Administration (FDA) announced that it would be seeking public comments on a proposal to update its substantial equivalence process.

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.

FDA explains the process in brief:

In order for a new tobacco product to be substantially equivalent, the FDA must find that it either has the same characteristics as a valid predicate tobacco product; or that it has different characteristics than the predicate tobacco product but the information submitted demonstrates that the new product does not raise different questions of public health.

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. Today’s proposal would help to clarify what the agency is and is not looking for in order to grant approval, including establishing a list of minimum requirements that would need to be included in order for the agency to grant approval.

You can view the current FDA guidance for how to submit a substantial equivalence report for cigars here.

“Over the past few years, the quality of SE Reports sent to the FDA has improved, but the reports submitted to the agency still range widely in the level of detail included,” said Scott Gottlieb, FDA commissioner, in a press release. “For example, some have very little information on the comparison of the new tobacco product with a predicate tobacco product while other SE Reports are much more detailed in describing how the new tobacco product compares to the identified predicate tobacco product and provide supporting information.”

Today’s announcement is a 171-page document that outlines the additional guidance FDA plans on adding to its official substantial equivalence guidance. In addition, FDA will seek comment on the proposals within the document as well as other issues beginning April 2. As of now, there has been no official change to FDA’s substantial equivalence process.

While the changes would apply to cigars, there are less than a dozen mentions of cigars within the document. In fact, today’s announcement includes a blanket statement asking for more guidance from industry and the public on cigars and ENDS, i.e. e-cigarettes.

“For tobacco products not specifically identified (e.g., ENDS, cigars) FDA invites
comments and information on the parameters that may be needed to support an SE Report.”