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Cole-Bishop Amendment defeated

FDA E-Cig Regulations: Democrats Have Killed a Key Amendment (Cole-Bishop), But it Isn’t Over Yet

An amendment to a government funding bill that could have saved the vaping industry from it’s imminent destruction was shot down by democrat leaders last week. The Cole-Bishop amendment would have changed the all-important “predicate date” on the FDA e-cig regulations, and in the process, would have meant all vaping devices on the market as of August 8th 2016 would have been “grandfathered” in and allowed to remain on the market. The death of the amendment is bad news for the industry, but there has been a more positive development too. As well as some other avenues to try to accomplish the same thing, the vaping industry also got an unexpected gift from lawmakers.

 

Why the Cole-Bishop Amendment Is Needed

 

The FDA e-cigarette regulations are a disaster for the industry. The “slow motion ban” works like this: in 2018, all e-cigarette companies that want to continue selling products will have to submit an application to the FDA to and be granted permission to market them. This all sounds fine, but there are some huge issues.

 

First, you have to send in separate applications for every product, even if there is little difference between them. For example, if you have one e-liquid flavor available in four nicotine levels, this means you’ll need to send four applications in, and you’ll have to do that for every single flavor you offer. Secondly, it’s expected to cost $1 million or even more per application. Finally, there’s no guarantee of success even if you do cough up.  

 

The end result of this has been almost unanimously predicted. Vaping companies are largely small businesses, and most won’t be able to afford to even submit the applications, much less do a good enough job of it to be granted permission. The companies in the best place to do it would be those owned by tobacco companies. The rules could hand the industry to Big Tobacco if there aren’t some crucial changes.

 

The amendment was really simple. Instead of forcing the inappropriate “predicate date” – February 2007, when basically no e-cigarettes were on the market – the bill aimed to modernize the date. When the rule was first enacted, cigarettes got a free pass because they had valid products from long before 2007, so they could easily be “grandfathered” in. This creates a perverse situation where potentially life-saving products have a harder time staying on sale than the product responsible for the lost lives. Ending this made sense, but apparently not enough to win over lawmakers.

 

The Failure of the Budget Rider

 

The attempt to save the industry worked through what is technically called a “rider,” which is a rule that “rides along” with a much bigger piece of legislation. In our case, the Cole-Bishop rider was attached to the budget bill. However, democrats in particular screwed up and crushed the rider along with 159 others.

 

This isn’t the end of the line for this type of legislative action. There is another budget in September, which offers another opportunity to try the same basic approach. More importantly, there is also a stand-alone Cole-Bishop bill, HR 1136, which is still gaining support but needs a lot more to really make a dent.

 

The crucial point is that this isn’t the end of the line for the vaping industry. There are many more opportunities to change things for the better, and as CASAA’s blog post points out, even the process of trying to get this amendment passed has drawn attention to the issue. Members of Congress are starting to understand why the issue is important, and that in itself is a positive outcome.

 

Good News for Vaping: FDA Delays Implementation of Deeming Rule  

 

So the FDA e-cigarette regulations aren’t unstoppable, but as things stand the industry is still set to be crushed on August 8th, 2018. However, there has been a piece of good news for vaping: all remaining deadlines have been pushed back by three months. It doesn’t change anything (aside from moving doomsday to November 8th, 2018), and with changes in leadership at the FDA, a delay isn’t such a big surprise, but it’s still a positive sign. In particular, the explanation given by a policy analyst at the FDA is promising:

 

“This extension will allow new leadership at the FDA and the Department of Health and Human Services additional time to more fully consider issues raised by the final rule that are now the subject of multiple lawsuits in federal court”

 

We all know there really is a lot that needs to be considered about the regulations, and with Trump’s FDA pick being against “red tape” in general, vapers may have cause for cautious optimism. There are also signs that the FDA is starting to understand the vaping issue more in general.

 

But we should be wary of expecting anything too positive. There is a lot of pressure from various groups to “protect the children” by restricting vaping as much as possible, and any move favorable to vaping will undoubtedly be met with a lot of resistance. The new administration could genuinely change things, but it’s important to remember that so far, nothing has changed. The deadlines have been extended but they still exist. To stop the destruction of the industry, we need to keep fighting.

 

Two Bills That Could Save Vaping

 

The best hope for improving the situation for vaping is HR 1136, also known as the FDA Deeming Authority Clarification Act of 2017.

 

As well as changing the predicate date, this provides some actual regulation in terms of product standards, suggests advertising restrictions and more. Overall, the bill is intended to save the vaping industry by moving the predicate date, but also to appeal to as many politicians as possible to give it the best chance of success. It might not be ideal for vaping in every way, but it’s the most realistic prospect for saving the industry.

 

At the moment, the bill is gaining co-sponsors but needs more to really stand a chance in making it through the legislative process. The more vape shop owners, manufacturers and ordinary vapers get involved and encourage politicians to support the legislation, the better chance it will have.

 

The other bill (HR 2194) is a lot more ambitious, called “The Cigarette Smoking Reduction and Electronic Vapor Alternatives Act of 2017.” This comes from the vaping congressman Rep. Duncan Hunter and focuses on the issue of comparative risk – legally acknowledging that some nicotine-containing products are safer than others and regulating them accordingly. It also proposes reasonable regulations for product quality (for example, it suggests following the American E-liquid Manufacturing Association’s guidelines), and prohibits marketing to kids.

 

The big issue is that HR 2194 just isn’t a realistic option in the current climate. We’re fighting to keep the market from being completely crushed, and while the proposals set out by Hunter are exactly the sort of thing we need for vaping, finding support for them isn’t going to be easy. It simply reaches too far to really pick up a lot of support from ordinary politicians and the public.

 

HR 1136 isn’t ideal, but it’s a much better prospect because it cedes plenty of ground to broaden its base of support. If everyone was informed about vaping, HR 2194 would be more widely-supported and a better choice for how to regulate vaping, but that’s not the world we live in.

 

We Need to Keep Fighting

 

The tiny piece of good news and the substantial bit of bad news are both important reminders that this fight isn’t over. The deeming regulations are not unstoppable, and although everything appears to be going ahead as planned, the new administration, the legal challenges to the regulations and some more sensible pieces of legislation could change everything. Vapers and advocates need to stay loud, stay positive and stay active. The industry’s doomsday is drawing ever-closer, but it can still be averted.

Lee Johnson is a writer and vaper from the UK. He started vaping in 2012, and since then has contributed to E-Cigarette Reviewed, E-Cigarette Direct’s Ashtray Blog and Vaping360. He strongly believes smokers need accurate information about vaping and other reduced-harm alternatives to smoking. He has a degree in physics from the Open University and a passion for all forms of science.

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