April 18, 2014

Stanton A. Glantz, PhD

Obama Administration should release draft FDA e-cig rule to level the playing field between the tobacco industry and the public

Just when you thought the Obama Administration's (non) handling of e-cigarettes could not get any more dysfunctional, the FDA posted this announcement on its website on Friday afternoon April 18, 2014:

A Special Statement from CTP [FDA Center for Tobacco Products]
Updates from the Center for Tobacco Products
The FDA has not issued its proposed rule regarding what additional tobacco products should be regulated by the agency. We are aware that the Tobacco Vapor Electronic Cigarette Association has indicated publicly that they have a copy of our proposal. The proposal is still in draft form and under review. As a matter of policy, the FDA does not share draft rules with outside groups while a rule is still under review.

Also on Friday, TVECA, the Tobacco Vapor Electronic Cigarette Association, an industry trade group, announced on its website, "The TVECA has had informal discussions with the FDA today, 4/18/2014, and we all decided that it the best interest of the regulatory process as well as the industry and the public, not to post the coument on Tuesday." 
So, It is clear that someone (my guess, based on no particular inside information, is that it was in the White House) leaked the draft to TVECA.  After all, if TVECA did not have a copy of the draft why would the FDA be negotiating with them and putting out its bizarre statement on the FDA website?
In any event, it is rediculous for the FDA to work with industry too keep a draft of its deeming rule secret from the public when industry clearly has a copy.  That fact that the industry thinks it is in "the best interest ... [of] the industry and the public" thinks keeping the draft secret from the public is also strong evidence that the proposal will effectively prioritize industry needs over public health.  In addition to the fact that TVEA effectively said so in its statement, they would be aggressively screaming about the draft proposal if it was not going their way.
The net result is to have an even more one-sided process than we have seen so far:  Industry has detailed indications of what the FDA is thinking while the public and health interests are being kept in the dark.
At this point, the FDA should immediately release the draft that the Administration leaked to TVECA so that we can all have the same information.
Lately I have been getting a lot of calls from reporters asking for my prediction of what the FDA was going to propose in the deeming rule.  My accurate answer is, "I don't have any inside information."  But, just based on the overall drift in the FDA's behavior and the fact that TVECA seems happy with the proposal, here is my guess:

  • The FDA will embrace the industry's "harm reduction" agenda
  • The FDA will say that it is willing to tolerate high levels of "dual use" of cigarettes and e-cigarettes as a "transition" away from combusted tobacco
  • The FDA will say that further research is needed before it can make any statements about health effects
  • The FDA will establish some quality standards for e-cigarettes (a good thing and something that the big companies want)
  • The FDA will impose restrictions on sales to youth (a good symbolic thing to do, but something that will have little practical effect other than reinforcing the industry's "we're socially responsible" agenda)
  • The FDA will impose some ineffectual restrictions on marketing directed at kids of the kind that the cigarette companies have long suggested as part the industry's ineffectual voluntary advertising codes
  • The FDA will not restrict e-cigarette advertising on television and radio
  • The FDA will not ban flavors
  • The FDA will not impose any prohibitions on the claim that e-cigarettes are safe
  • The FDA will not impose any prohibitions on the "no secondhand smoke" and "smoke anywhere" claims the industry makes
  • The FDA will not prohibit claims that e-cigarettes are effective for smoking cessation
  • The cost-benefit analysis will include a large "consumer surplus" discount (that considers depriving vapers of the pleasure of nicotine addiction is a cost of regulation) that will lead to the conclusions that regulation has little net benefit, which will make reasonable regulation all but impossible.

In other words, I expect something that will be a boon to the industry.

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