The long and winding road which led to 2009 s Family Smoking Prevention and Tobacco Control Act (FSPTCA, or TCA), which bestowed regulatory authority over tobacco products to the FDA, had many bizarre twists
The long and winding road which led to 2009 s Family Smoking Prevention and Tobacco Control Act (FSPTCA, or TCA), which bestowed regulatory authority over tobacco products to the FDA, had many bizarre twists and unintended perhaps consequences. Considering that it was crafted over several years and had midwives of such diverse provenance as Sen. Ted Kennedy and Philip Morris s Steve Parrish (among many others), it isn t surprising that it does indeed resemble a typical committee-produced law in its complexity.
One of its worst features (again, among many) is its requirement that any tobacco product allowed on the market after Feb. 15, 2007 undergo an evaluation process to be deemed substantially equivalent (SE) to a product on the market prior to that date (Why that date? Don t ask). While pretty bad, the law requires an onerously expensive and lengthy assessment for products ineligible for the SE designation, i.e. not analogous to anything available prior to that date. So oppressive, in fact, that most (nearly all) of the current e-cig makers would likely go bankrupt or be swallowed up by Big Tobacco if made to comply with that requirement (termed PMTPA, pre-market tobacco product application) rather than the SE category.
Here s the thing: how many current e-cig devices are actually substantially equivalent (or even vaguely equivalent) to something on the market during the Bush administration? Answer: zero. Thus, absent some change in the TCA, all of the current e-cig/vapor products would be forced off the market, at best for some years, at worst, forever, killing arguably the best chance for smokers to get effective help in quitting.
Into this bleak scene, a hero has appeared: Rep. Tom Cole (R-OK) has proposed an amendment to the TCA, HR2058, The FDA Deeming Authority Clarification Act. Elegant in its simplicity, it would simply change the grandfather date for the SE qualification to whatever date the FDA s deeming regulations (which would officially deem e-cigs as tobacco products, subject to FDA regulation) go into effect. This would at least allow the current hundreds or thousands of e-cig/vapor products to remain on the market while assembling the data required by the FDA.
Sadly, even if enacted, the regulations would still kick in for those products in development, possibly to be available after that future date, which will chill the development of ever-more-effective harm reduction products. This bar to effective new products to help smokers quit was probably one intended effect of the TCA, thanks to the anti-competitive drive of Philip Morris s participation in the creation of the TCA. The new proposed amendment to the TCA would be a significant boon to public health, while still far from an ideal situation. Will it pass, needing of course to get through the House and the Senate and then having to be signed by the President? I believe the odds are against it, but let s keep hope alive. Certainly, anyone with a real devotion to public health should support it.