WASHINGTON -- While the U.S. Food & Drug Administration (FDA) considers new comments to the recently issued “Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions” guidance, the agency has announced its interim enforcement policy.
This interim policy is effective immediately and will continue until 30 days after the FDA issues a revised guidance or announces its intention to not issue one.
The interim enforcement policy states that for new tobacco products in which the only modification is a label change that creates a distinct product with identical characteristics to the predicate product, or new tobacco products in which the only modification is a change in product quantity, the FDA does not intend to issue any warning letters or take steps to initiate any judicial or administrative adversarial proceedings for these tobacco products that are marketed without required premarket authorization
Also, the FDA does not intend to issue any "not substantially equivalent" (SE) orders or preliminary finding letters for reasons of failing to provide sufficient information; however, the FDA does plan to issue other regulatory letters, including refuse-to-accept (RTA) letters and “not substantially equivalent” orders for those products that are not otherwise in compliance with the requirements of the Food, Drug & Cosmetic Act (FD&C).
In both instances, for the interim enforcement policy to apply, the change (whether to the label or in product quantity) must have been made from, and including, Feb. 16, 2007, through the end of this interim time period, it said.
During the interim enforcement period, if a company did not file an SE report for a tobacco product that meets the previously mentioned specifics, or if the company received an RTA for that submission, the FDA intends to provide a period of 30 days from the date it issues a revised guidance, or announces that it will not issue such a revised guidance, for companies to file an SE report, it said.
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