FDA Extends Comment Period for Substantial Equivalence

Requests from public prompt agency to push deadline to July 17
Photograph: Shutterstock

WASHINGTON The U.S. Food and Drug Administration (FDA) has announced a 30-day extension of its public comment period for its substantial equivalence process, which determines if tobacco products coming to market are essentially the same as ones already on store shelves. The designation allows those products a less complex pathway to U.S. consumers as compared to completely new-to-market ones.

On June 12, the FDA announced the extension to July 17 of the comment period for the proposed rule “Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports.” The proposed rule was originally published April 2, with a public comment period that was originally scheduled to end in June.

When finalized, the rule would establish requirements for the content and format of reports manufacturers must send to the agency to demonstrate the substantial equivalence of a new tobacco product, the agency said in a press release. This proposed rule would also provide information on how the agency intends to evaluate these submissions.

The extension was the result of requests from the public. “The agency believes the extension is appropriate and would help ensure that interested persons have time to fully consider the proposed provisions, as well as to fully consider and develop responses to the agency’s specific requests for comment,” officials said in the release.

The public may submit either electronic or written comments through July 17.

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