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.
As a matter of policy, the FDA does not share draft documents or negotiate with outside groups while they are under review. The FDA is committed to maintaining the integrity of the regulatory process. It is important to note that the rule is still in draft form and was submitted to the Office of Management and Budget (OMB) on Oct. 19, 2015. OMB is required to review all significant regulatory actions.
The FDA remains committed to an open dialogue with all interested parties, including industry, consumers and the public health community – and looks forward to the completion of this important rulemaking.