Commonly asked questions about CTP and FDA's new regulations for e-cigarettes, cigars, and all other tobacco products.
www.fda.gov
On
page 94 (Table 14) of the "deeming" Regulatory Impact Analysis (RIA), the FDA has estimated the average cost for each premarket review pathway for newly regulated tobacco products to be:
- an SE exemption report = around $1,500
- an SE report = anywhere from around $3,500 to around $22,700
- a premarket tobacco application (PMTA) = in the low to mid hundreds of thousands of dollars (around $117,000 to around $466,000), not in the millions of dollars described by some others
Each tobacco product application is a unique situation. However, generally speaking, a manufacturer could submit one premarket application for multiple tobacco products with a single, combined cover letter and table of contents for each product. However, when FDA receives a premarket submission that covers multiple, distinct new tobacco products, we intend to consider information on each product as a separate, individual PMTA. Where the same information applies to multiple products, it should be noted.
FDA considers each ENDS product with a differing flavoring variant or nicotine strength to be a different product
My comments below.
I have trouble believing that the above post saying 80 PMTA apps will hold up. At the low end of the PMTA cost estimate that is over 9 million dollars!
Yep filing is cheap pursuing thru to completion is EXPENSIVE.
yes as things get passed it can become lots cheaper by riding on the backs of things that have passed. But so far nothing vape has passed PMTA.
About Sweedish Snus. Not vaping but something that actually passed the PMTA process.
Swedish Match, the sole company that has received approval through the PMTA pathway (for eight General Snus products), says the process is more expensive, more time-consuming and requires more resources than the FDA predicted:
- Costs: Swedish Match didn’t keep a running tally of the costs, but Teller says, “it was a lot more than the [FDA] estimate,” and resulted in a 100,000-page-plus application.
- Time: The FDA gave manufacturers two years from the August 8, 2016, implementation of the deeming rule to submit to PMTA. “If companies hadn’t already started on this process before the law was announced, who knows if there’s enough time to get it all done,” Teller warned.
- Resources: PMTA requires significantly more research, data and information than the SE pathway. “Only so many entities can do that research,” Teller said. “There’s probably been a mad scramble to find these companies.”
For anyone in the tobacco business, 2016 will likely go down as the “Year of Deeming.” On May 5, 2016, the U.S. Food and Drug Administration (FDA) announced its long-awaited deeming rule for cigars, electronic cigarettes, vape, pipe tobacco—and more—with the first wave of the regulations going...
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