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FDA Extends PMTA to 2022

PMTA Delay Buys Vapers Some Breathing Space

Since the FDA first revealed its Deeming Regulations for e-cigarettes in April 2014, the looming threat of the new law has been the biggest worry for everyone involved with the US vaping scene – and, as Deeming is likely to wipe out hundreds of favorite juice flavors, it’s not that popular in the rest of the world either. So it’s no surprise that, when FDA Commissioner Scott Gottlieb announced a four-year delay this morning, there was widespread celebration.

The background to the delay is a 25-minute presentation Gottlieb delivered earlier today, outlining a new approach to nicotine addiction from the FDA. The aim is to radically cut the number of Americans who smoke, which of course isn’t a new goal. What is apparently new is a a willingness to look beyond the quit or die approach that American public health has been wedded to up to now.

 

Harm Reduction is in…

In his talk, Gottlieb highlighted the fact that nicotine is the reason people smoke, but it isn’t the reason they get sick and die. The FDA still seems to be taking a hardline position on how addictive nicotine actually is, but now Gottlieb has acknowledged, much more clearly than anyone at the agency has before, that there’s a spectrum of risk for nicotine-containing products.

One of the most alarming things that’s been happening over the last couple of years is the rising number of people who think vaping is as harmful as smoking. This has mostly been driven by tobacco controllers who’ve attacked anyone who says some nicotine products are safer than others. Now the FDA Commissioner has openly said exactly that, officially confirming what vapers have been saying all along.

While Gottlieb stopped short of actually saying that e-cigs are safer than smoking, that was a clear subtext of his speech. He referred several times to the unique risks of burning tobacco, and mentioned the potential for innovation to create safer products that have a satisfying amount of nicotine without the risks of cigarettes.

The bit that excited vapers was when Gottlieb, in what looked very like an admission that Deeming was rushed and not properly thought through, said that the agency needed time to implement its new nicotine strategy properly. To get that time, he said, he was telling the FDA’s Center for Tobacco Products to “reconsider” some aspects of Deeming. That was the cue for the announcement that the key deadline for manufacturers had been pushed back.

Few things about the Deeming Regulations are good news for vapers, but the worst was the November 8, 2018 deadline for Pre Market Tobacco Authorizations to be submitted. Any product that hadn’t had an expensive, time-consuming PMTA submitted by that date had to be immediately taken off the market. Gottlieb has now extended that deadline to August 8, 2022, gaining the industry almost another four years.

 

…but Deeming isn’t out

Of course it isn’t all good news. The extended deadline only applies to products that are already on the market; anything new still needs to be granted a PMTA before it can go on sale, so the entire US vape industry will be frozen in time for at least the next five years. There’s also no change to other deadlines – manufacturers will still have to submit health risk documentation next year, and add warning labels and ingredient lists to their products.

However, submitting the documentation should get a lot easier than it has been so far. A common complaint from manufacturers is that while the FDA want thousands of pages of PMTA paperwork for each product, they haven’t been very clear about what should be in it. Gottlieb says the agency will be releasing guidance to make the process less stressful and easier to navigate.

Another piece of good news is a revision of the “sunset policy”. Up to now the FDA has insisted that existing products which were under review would have to come off the market until the review was completed. That was annoying, because the review process isn’t quick and the agency is dealing with thousands of applications. Now, products can stay on the shelves until the review is finished.

The really bad news is that there’s still no change to the ridiculous 2007 grandfather date. The only products exempt from the PMTA process are ones that are “substantially equivalent” to products that were on the market on February 15, 2007. That basically means a handful of cigalikes loaded with low-grade synthetic tobacco flavor juice. Gottlieb has hinted that he thinks Mitch Zeller’s plan to review these to make sure they really are substantially equivalent is a waste of time, but he hasn’t changed the date. Bringing it forward to April 2014, when the Deeming Regs were published, would exempt a lot more products.

 

Other bad news also exists

A real worry in Gottlieb’s speech was how often he mentioned flavors, especially “kid-appealing” ones. Flavors are an easy target for anti-vapers, because a lot of people don’t seem to understand that all e-liquids are flavored – even tobacco ones. His focus on them is likely to encourage state and city efforts to push through flavor bans, and that’s already a worrying trend.

In fact vapers can expect to see a lot more attacks on their rights from states and cities. What Gottlieb said this morning is going to have annoyed a lot of people in public health and tobacco control, because he trashed a lot of what they’ve been saying about vaping. With their support at federal level suddenly looking a lot weaker they’re going to turn to state and local government as easier battlefields to attack us on.

Finally, there’s a real risk that Gottlieb’s whole nicotine plan could collapse. That’s because a key plank of it is rotten. While he’s identified the fact that the real problem is burning tobacco, not nicotine, his idea for getting people onto safer products has a real flaw in it. That flaw is the dumb idea of reduced-nicotine cigarettes.

Gottlieb seems to have fallen for the line, being pushed by some in public health, that reducing the amount of nicotine in cigarettes will make them less addictive and so smokers will stop smoking them. This sounds good, but it isn’t.

Unfortunately, we already know what happens when you reduce the amount of nicotine in cigarettes – people just smoke more. Ironically, tobacco controllers are still furious at the tobacco companies for doing this with light cigarettes, but now they want to try exactly the same thing.

 

So what now?

Today’s announcement is good news. While not perfect, it buys vapers and industry four years of desperately-needed breathing space. It’s not final victory, though; what we can’t afford to do is sit back and relax. There will still be state and local laws to resist, and the Deeming Regulations themselves still need to be amended or scrapped. What Gottlieb’s new plans do is take away some of the momentum that, yesterday, looked set to steamroller the regulations right over the top of us. Vaping advocates need to seize on this loss of momentum to push for more changes.

This might be a good time to remember that great Anglo-American statesman, Winston Churchill, as he announced that the British Army had routed the Germans at el Alamein in 1942. El Alamein didn’t change anything very important. It didn’t defeat the U-Boats in the Atlantic, or slow down the panzers advancing through Russia. But it did, for the first time, stop a German army in its tracks and throw it back to where it started from. It broke their momentum, just like the Deeming Regulations’ momentum was broken today, and Churchill knew what that meant:

“Now this is not the end. It is not even the beginning of the end. But it is, perhaps, the end of the beginning.”

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