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July 28, 2017

FDA-CTP New deadline

A partial reprieve from the Nov 18th deadline-

July 28th Statement from FDA

6th paragraph down:

“…the agency intends to extend timelines to submit tobacco product review applications for newly regulated tobacco products that were on the market as of Aug. 8, 2016. This action will afford the agency time to explore clear and meaningful measures to make tobacco products less toxic, appealing and addictive. For example, the FDA intends to develop product standards to protect against known public health risks such as electronic nicotine delivery systems (ENDS) battery issues and concerns about children’s exposure to liquid nicotine. It also will provide manufacturers additional time to develop higher quality, more complete applications informed by additional guidance from the agency.

“…applications for non-combustible products such as ENDS or e-cigarettes would be submitted by Aug. 8, 2022. Additionally, the FDA expects that manufacturers would continue to market products while the agency reviews product applications.

11th paragraph down:

“…Among other things, the FDA intends to issue regulations outlining what information the agency expects to be included in Premarket Tobacco Applications (PMTAs), Modified Risk Tobacco Product (MRTP) applications and reports to demonstrate Substantial Equivalence (SE). The FDA also plans to finalize guidance on how it intends to review PMTAs for ENDS. The agency also will continue efforts to assist industry in complying with federal tobacco regulations through online information, meetings, webinars and guidance documents.”

 All other deadlines including health documents and ingredient listings are still in full effect. All previous deadlines are still in full effect as well including no new products (except for china) cannot be released without approval.

Scott Gottlieb was sworn in as FDA Commissioner on May 11, 2017 and is making progress where Mitch Zeller was issuing (IMO ham-fisted) instructions and directions causing no shortage of problems and uncertainty for the vaping industry and more confusion to the public.

Time will tell if Dr Gottlieb will get painted into a corner, too.

Meanwhile, the battle on local and State levels combating prohibition, taxation, and age 21 ordinances and laws continues.

 

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