FDA Firms Up SE Process for Tobacco Makers

Agency establishes requirements, format for ‘substantial equivalence’ reports
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WASHINGTON The process by which tobacco makers can get the U.S. Food and Drug Administration’s (FDA's) blessing on a large number of products has received another degree of clarity, with the agency releasing requirements for the content and format of reports sent in for what’s known as “substantial equivalence,” or SE.

As the FDA further defines how it will regulate tobacco products, one of its decisions was to create a class of products that would fall into the SE class for approval. These products would have come to market after Feb. 15, 2007, or the “predicate” date. The 2009 Tobacco Control Act grandfathered in any tobacco product on the market before the predicate date, allowing retailers to continue selling those products without the need for further FDA approval.

Tobacco products that went on the market after the predicate date, but were similar to products that were grandfathered in, could apply for FDA approval via the SE applications. Supposedly, SE applications would be easier to obtain than approvals for products that were completely new.

In a press release sent March 28, the FDA said it also posted six SE appendices on its website to help manufacturers create their reports.

The quality of SE reports sent to the FDA has improved, the statement said, but they still range widely in the level of detail included. For example, some had very little information on the comparison of the new tobacco product with a predicate tobacco product, while other SE reports were much more detailed, the release said.

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