The final rule also addresses a major issue with the FDA premarket application process: transparency on how applications will be accepted, reviewed and how companies can submit amendments to already submitted applications. Because of the finalized rule, the FDA has withdrawn its September 2011 draft guidance.
In terms of the Substantial Equivalence (SE) process, the final rule issued this week defines the minimum requirements for the content and format of the SE Reports. The FDA states that it believes SE will be the most common pathways manufacturers of cigarettes, smokeless tobacco, hookah tobacco, roll-your-own tobacco and cigars will use to keep certain tobacco products on the market. The final rule issued brings uniformity and consistency to SE Reports and better defines what information the agency is looking for to help it determine whether a new product is truly substantially equivalent to a product that was commercially marketed in the U.S. as of Feb. 15, 2007, as required by law. The final rule also reveals how the FDA will communicate with applicants, how records supporting SE Reports will be retained, the confidentiality surrounding submitted SE Reports, how SE Reports can be amended or withdrawn, how applications can be transferred between owners, and how reports can be submitted electronically.
The FDA is continuing to review premarket applications it received on or before Sept. 9, 2020 for deemed new tobacco products and intends to provide a more detailed update on its progress since that deadline in the coming weeks. The agency is currently prevented by court order from enforcing premarket requirements for premium cigars. The FDA is also continuing to work on a separate rule for MRTP applications which gives manufacturers the ability to market a tobacco product as modified or lower risk.
For the FDA’s “Premarket Tobacco Product Applications and Recordkeeping Requirements,” click here. For the “Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports,” click here.
For all the latest legislation and FDA news impacting the tobacco industry, click here.
