From: Winston-Salem Journal
Dr. Michael Siegel, a professor at the Boston University School of Public Health, expressed concern that the FDA’s goal with the pathway requirement will drive most small businesses, vape shops and e-cigarette companies out of business due to the high regulatory cost combined with a lack of resources and scientific expertise.
“It might be the case that not even the largest manufacturers – such as the tobacco companies – could be able to technically complete a successful application under the FDA deeming regulations and guidance,” Siegel said.
Cigar News: Leaked Draft of FDA Cigar Deeming Rule Raises More Questions About FDA Rulemaking Process
From: Stogie Guys
Two weeks ago, e-cigarette trade group Tobacco Vapor Electronic Cigarette Association (TVECA) said it was in possession of a copy of the the deeming rule sent from the Food and Drug Administration (FDA) to the Office of Management and Budget (OMB) for final review before publication and implementation. Initially, the group leaked a copy of the table of contents and promised to leak the full document soon after.
Although the documents were never fully authenticated, every indication points to the document being legitimate. The FDA even took the unusual step of issuing a statement acknowledging the leak and stating they had an understanding that no more of the document would be made public.
The FDA has not yet issued its final rule and other documents related to extending the agency’s authority to other currently unregulated tobacco products. We are aware that the Tobacco Vapor Electronic Cigarette Association (TVECA) has indicated publicly that it has a copy of the draft final rule. We cannot confirm if TVECA has a copy of the most recent version of the draft final rule, or even if their copy is authentic. It is our understanding based on recent conversations between the FDA and TVECA, that the group will not be releasing the document in question.