• August 9, 2020

Improving transparency

The US Food and Drug Administration says that it is taking steps to improve the efficiency and transparency of its ‘tobacco product application review process’.

‘Specifically, the agency is improving transparency regarding applications for a subset of tobacco products – known as “provisional substantial equivalence (SE) tobacco products,” the FDA said in a note issued yesterday through its Center for Tobacco Products (CTP).

‘As part of this process improvement, starting this week, a copy of the summary review (TPL Review) and the final cycle primary discipline reviews that serve as a basis for the NSE decision will be made available to companies concurrent with issuance of NSE orders for these provisional SE applications,’ the note said. ‘Companies previously obtained such documents by filing a Freedom of Information Act (FOIA) request. Any review document other than those issued with an NSE order may still be obtained by submitting a FOIA request.

‘Under the Family Smoking Prevention and Tobacco Control Act, tobacco products introduced into interstate commerce after February 15, 2007 – but before March 22, 2011 –could remain on the market legally if an SE Report was submitted no later than March 22, 2011, unless FDA issued an NSE order. To receive an SE order, the manufacturer must demonstrate that the new tobacco product has the same characteristics as a valid predicate tobacco product, or if it has different characteristics, that those changes do not cause the new tobacco product to raise different questions of public health.

‘Earlier this month, FDA Commissioner Scott Gottlieb, M.D. and CTP Director Mitch Zeller co-authored a blog outlining new efforts and initiatives under the Comprehensive Plan for Nicotine and Tobacco Regulation, including today’s action. FDA plans to announce additional process improvements ahead of the tobacco product application review public meeting on October 22-23, 2018.’

More information is available at: https://www.fda.gov/NewsEvents/Newsroom/FDAInBrief/ucm616785.htm?utm_source=Eloqua&utm_medium=email&utm_term=stratcomms&utm_content=FDAinbrief&utm_campaign=CTP%20News%3A%20Provisional%20NSE%20-%2081318.