Cigar News: Leaked Draft of FDA Cigar Deeming Rule Raises More Questions About FDA Rulemaking Process
10 Nov 2015
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.
While TVECA was focused on e-cigarette regulation aspects of the draft, included in the leaked table of contents was a line—”Regulation of Cigars and Selection of Option 1″—that caught the attention of cigar industry groups. The line was a strong indication that the FDA had transmitted to the OMB a deeming rule that included Option 1 for the regulation of cigars with no exemption for premium cigars.
Unlike Option 2, which exempted certain cigars that meet a definition of premium—including that they are handmade and have a retail price of at least $10—Option 1 would subject all cigars introduced after February 15, 2007 to an FDA approval process. It is a nightmare scenario that industry lobbying has been focused against since the FDA started the process of regulating cigars.
The OMB will now decide whether to proceed with the FDA draft of the rule or request more changes. Speculation is that it was the OMB that asked for Option 2 in the earlier stages of the process, so just because the FDA has moved forward with Option 1, that doesn’t guarantee Option 2 won’t be in the finalized rule.
The leak has raised other questions about the FDA process. Anti-tobacco politicians have already called for a probe of the leak, but the reality is the leak raises more fundamental questions about the FDA process.
Assuming they are authentic, the documents TVECA received could only have come from within FDA or OMB, meaning someone in the rulemaking process violated their confidentiality requirements. Contrary to the insinuations by those calling for a probe, it is the leaker who may have violated regulations, not the trade association that was within its rights to share the documents with the public or media. (Curiously, TVECA seems to have agreed not to disclose the full documents now, and has alluded to using what they have as leverage towards changes to the final document.)
If TVECA received the leaked documents others may have as well, and given that people within FDA and OMB tend to be pro-regulation, it is seems likely that anti-tobacco groups or politicians may have received leaked documents too. This might explain why anti-tobacco senators were so quick to call for OMB to accept FDA’s final version of the rule without changes or deliberations.
Either way, what is clear from the leak is at least one person with access to internal FDA documents is willingly disseminating those documents to people outside the agency. It makes you wonder how the agencies can be trusted with regulations that could determine the future of an industry that provides jobs for tens of thousands around the world, when they cannot even be trusted not to leak their own internal documents.
photo credits: Stogie Guys