Commenting on the Deeming Proposed Rule
On April 25, 2014, FDA published a proposed rule, Tobacco Products Deemed To Be Subject to the Food, Drug & Cosmetic Act (Deeming), to regulate additional tobacco products that meet the definition of a tobacco product. Proposed newly deemed products would include e-cigarettes, cigars, pipe tobacco, certain dissolvables that are not “smokeless tobacco,” gels, and waterpipe tobacco.
Recently, we extended the comment period for the proposed rule to August 8, 2014. We understand there may be some confusion surrounding how to submit comments.
Here’s all you need to know:
Learn more and submit your comments before August 8.
FDA Issues Draft Guidance on SE Report Requests
Today, FDA published draft guidance titled “Substantial Equivalence Reports: Manufacturer Requests for Extensions or to Change the Predicate Tobacco Product” in the Federal Register. Once finalized, this draft guidance will represent FDA’s current thinking on manufacturer requests for:
- Extensions of time to respond to CTP-identified deficiencies in Substantial Equivalence (SE) reports; and
- Change of predicate tobacco products in submitted SE reports.
During the review of an SE report, CTP may issue a scientific advice/information letter or preliminary finding letter to a manufacturer describing deficiencies of the SE report. In response to those letters, some manufacturers have requested an extension of time to respond to the deficiencies, or have requested to change the predicate tobacco product identified in the SE report. This draft guidance states that CTP will no longer grant extensions, except in very limited instances. Because CTP no longer has a backlog of regular SE reports awaiting review, and CTP is starting review on regular SE reports as they are received, there is no longer a delay when manufacturers withdraw their application and resubmit it when they have gathered the appropriate information.
Additionally, this draft guidance states that, because the comparison of the new and predicate products is the basis for the determination of substantial equivalence, manufacturers should not change the predicate tobacco product once scientific review begins.
Beginning today, comments regarding this draft guidance may be submitted for 60 days at Regulations.gov. CTP also plans to post a webinar discussing this draft guidance on its website soon. A link will be sent out in This Week in CTP when it is posted.
To learn more about the SE process, please visit our Substantial Equivalence webpage.
