Document Containing FDA Option 1 Leaked, Is It Valid? *UPDATE*

Last night the Tobacco Vapor Electronic Cigarette Association shared a message stating they had obtained a copy of the FDA Deeming Regulations as proposed to the OMB. Since that message from TVECA there have been conflicting reports to the validity of the document.

The document which proposes Option 1 would be the worst possible news for the cigar industry and would put all brands that have come in to the marketplace after 2007 in jeopardy.

This is what we know….

  1. TVECA released the TOC of the purported document claiming to be the FDA Proposal to the OMB.
  2. This morning IPCPR held a conference call with its members stating that nothing new has been released.
  3. A major player in the cigar news community shared the TVECA post which has still not been verified.
  4. Cigar Rights of America sends out an email stating,”We would like to emphasize that this is (allegedly) a DRAFT from FDA and that the rule is currently under OMB Office of Information and Regulatory Affairs review, and that it is very possible that the policy could change while under review.
  5. IPCPR informs its board that they received a copy of the TOC. and are waiting for the full document to be released before offering an analysis.
  6. When The Cigar Authority confronted TVECA asking if the document they shared was from FDA-2014-N-0189, they confirmed this was the case.
  7. Screen Shot 2015-10-27 at 1.52.02 PM
  8. Despite a promise to post the entire FDA document at 2pm, the site in question instead opted to publish an e-cig industry guidance document

It is important to note that as of now this alleged leaked document has yet to be verified, and if you visit the TVECA website it appears at first glance to be a marketing ploy to gather the names and addresses as well as phone numbers to those interested in seeing the full document.

We will post the FDA Document when and if it has been verified but until then we will not. We at The Cigar Authority have all our members in touch with various sources that we consider reputable and will report back as needed but for now we will treat this as rumor that has yet to be proven accurate.

Update: The FDA has issued a statement on this alleged leak as follows….

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 rule making.”