The US Food and Drug Administration is in the final stages of announcing regulations for electronic cigarettes and other vaping products. In their current form, they would almost certainly wipe out 99% of the market, leaving the industry in the hands of Big Tobacco, and it seems only Congress has the power to stop this from happening. Will they do it?
According to a number of sources, the only thing holding the FDA from finally announcing its final regulations on e-cigarettes is the controversial grandfather date. Adopted in the Tobacco Control Act of 2009, this mandate requires any nicotine-delivery device released after February 15, 2007, to apply retroactively for approval. The grandfather date was designed as a roadblock to the introduction of new tobacco cigarette products and to that end, it has proven very effective, as only a handful of review applications have been submitted by tobacco companies since 2009.
That’s because even with their deep pockets and well oiled lobby machine, cigarette companies are finding the required investigations for approval incredibly burdensome. The applicants need not only demonstrate the safety of their products, but also provide evidence that they are beneficial to public health by showing that it has a negligible effect on non-smokers. They must also present scientific findings on the impact of their products on the general population (the likelihood of former smokers re-initiating tobacco use with the products and the likelihood of smokers switching to these products instead of quitting completely or attempting to quit with FDA-approved medication).
Achieving all of the above is not only ridiculously difficult, it’s also obscenely expensive. The FDA suggests that the review application will cost around $300,000 for a single product, but sources from inside the industry believe the cost will actually reach into the millions. Considering that most companies have multiple products already on the market, it’s easy to see why experts believe the vast majority of businesses will be unable to sustain the cost. And that’s not even considering that some applications will be rejected.
At the moment, the only way to bypass the application for review is to submit a substantial equivalence application, to prove that the product you are trying to launch is substantially similar to one that was already on store shelves before February 15, 2007. That’s easy to do for Big Tobacco, as cigarettes really haven’t evolved very much since then, but it’s a different story of e-cigarettes. In 2007, we only had ineffective pen-style devices – you know, the ones tobacco companies are still selling – but technology has come a long way since then, and we now have advanced vaporizers that not only deliver nicotine more effectively, but are highly customizable and have improved battery life. The only problem is they are nothing like the cigalikes of 2007 and would have to be reviewed by the FDA. So while combustible cigarettes get a free ride for remaining unchanged (tar, carbon monoxide and thousands of carcinogens), modern e-cigarettes have to go through a roadblock. That sounds fair…
So what can be done about this absurd situation? The only viable option seems to be pushing the grandfather date from Feb. 15, 2007 to the date on which the FDA’s final rule takes effect, so that products on the market at that time and new ones substantially equivalent to them wouldn’t have to be submitted for review. That sounds easy enough, and quite necessary, considering the fundamental differences between analog cigarettes and technologically-advanced e-cigs, only it is anything but.
Faced with pressure from the e-cigarette industry and the vaping community, the FDA declared itself helpless to do anything about this issue, saying that it does not have the authority to change the grandfather date, even if it wanted to. But that last part is very important, because if it really wanted to, the FDA could at least help solve the problem. As Joe Kasper, chief of staff for U.S. Rep. Duncan Hunter (R-CA) – who actually worked on legislation to change the date and ensure e-cigarettes are not regulated as traditional tobacco products – said “if [the FDA] signaled support, this would be done by now and so many small businesses nationwide wouldn’t have the anxiety that they do.” But the FDA has shown anything but support to electronic cigarettes.
Today, the House Appropriations Committee is scheduled to take up an agriculture spending package, and e-cigarette supporters and harm reduction advocates are hopeful that they will also pass an amendment to the bill to push the grandfather date forward for vapor products. This would not interfere in any way with the FDA’s ability to set quality and manufacturing standards and introduce any of it other regulations. It would simply allow modern e-cigarettes and other vaping products to be used, instead of forcing people to go back to the obsolete products of 2007 or, even worse, take up smoking again. You would think that is a no-brainer.
And yet, Congress probably won’t pass the amendment. Why would they do that when the current grandfather date fits the agenda of Big Tobacco and Big Pharma, two of the strongest lobby groups in Congress? Because it’s in the best interest of public health? Let’s not kid ourselves.
Tobacco companies have invested heavily in e-cigarettes during the last few years, either developing their own products or acquiring already popular e-cig brands, but they have been focusing almost exclusively on cigalike products, which, incidentally, are very similar to the products that were around in 2007. Pharmaceutical giants, on the other hand, have been seeing their profits drop as the increasing popularity of e-cigarettes started affecting nicotine gum and patches sales, so they will definitely welcome FDA regulations with the original grandfather date included.
Not to mention that the increase in e-cigarette use all over the United States, smoking rates are dropping faster than expected and that is affecting state budgets. Introducing e-cigarette taxes is may help, but simply killing e-cigarettes is bound to be more effective.