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FDA Regulations

July 28, 2017

Today, FDA Commissioner Gottlieb announced a stunning shift in the US Government’s approach to regulating tobacco products. Dr. Gottlieb announced that FDA is embarking on a new and comprehensive approach to regulating nicotine – and reducing addiction. This initiative will create a multi-year roadmap that will cause greater public awareness that nicotine is not the cause of death and disease, and nicotine products exist on a continuum of risk. That’s right, FDA has finally recognized the continuum of risk and that “cigarettes are the most harmful form of nicotine delivery.” AND, THAT SWITCHING TO LOWER RISK PRODUCTS CAN PROVIDE PUBLIC HEALTH BENEFITS! Here’s the headline: FDA will extend the PMTA deadlines for marketing newly regulated non-combustible products to August 8, 2022!

They will also allow marketing to continue after that new PMTA submission deadline date in 2022 as long as your PMTA application is under review! (previously, you only had a year... even if they had not even looked at your application yet). So, that means we have nearly 5 years to complete PMTA applications, but applications will still be required and those applications may be in a very different form than what the assumptions have been thus far. This extra time is significant for vapor manufacturers and retailers, alike. It means we can now see a future for our businesses we didn’t see yesterday. Here is an example of testimony that came in from SFATA member companies immediately after the announcement this morning. SFATA members Michael and Carla Bowers first words were, "I guess we can renew our leases now.”

FDA issues extension for Product Registration Filing Deadline!

December 9, 2016

Today, the FDA issued the revised guidance, “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.” In the initial revised guidance issued in July of this year, U.S. manufacturers of newly regulated products faced a deadline of December 31, 2016 for compliance with the registration and product listing requirements of section 905 of the Tobacco Control Act. The guidance has been revised again to clarify that for U.S. manufacturers of newly regulated tobacco products who first manufactured those products prior to August 8, 2016, the FDA does not intend to enforce the submission deadline for establishment registration and product listing as long as submissions are received by the FDA on or before June 30, 2017. However, companies which begin manufacturing newly regulated tobacco products in a domestic establishment on or after the August 8 effective date of the deeming rule must register and list immediately with the FDA. The FDA is currently accepting submissions and encourages companies to register and list their products in advance of the new compliance date.

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