FDA Announcement: What Does it Mean?

FDA Announcement: What Does it Mean?

When I finally finished reading all the articles on the announcement from the FDA, I found it difficult to tally what I’d read with the celebrations of vapers. Don’t get me wrong, there’s a lot to be hopeful for from the announcement. But that’s all it is. Hope.

We’ve had that before haven’t we? Just recently the lawsuit against the FDA brought by Nicopure Labs went against Nicopure. That was probably one of the main attempts – recently – to challenge the Deeming Rule and maybe give the industry some much needed breathing room. It wasn’t to be.

Vapers were disappointed in the lack of support for Cole-Bishop last year, along with the exclusion of an amendment in the budget, the vaping industry in the US seemed to be doomed. To an extent, perhaps it still is.

The course set by the previous FDA Commissioners - Robert Califf and Margaret Hamburg - with regards to the vapour industry seems as though it might be facing, if not a u-turn but a significant course change in the approach to regulating the industry.

The goal is to ensure the FDA has the proper scientific and regulatory foundation to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act. To make certain that the FDA is striking an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes, the agency is also providing targeted relief on some timelines described in the May 2016 final rule that extended the FDA’s authority to additional tobacco products.

We know that the expanding evidence base surrounding vapour products has been largely ignored at best, or cherry picked at worst, by the FDA; so to have an affirmation that the agency will at least make more of an effort to be evidence based is one of the few positives I can take away from Goettlieb. Maybe he listened to Clive Bates?

The key lies in taking a new and comprehensive approach to the regulation of nicotine.

This is where it gets interesting.

Because nicotine lives at the core of both the problem and, ultimately, the solution to the question of addiction, and the harm caused by combustible forms of tobacco.

Both the problem, and ultimately, the solution. As most of you will know, the act of smoking involves combustion. Burning tobacco, while pleasurable for many, increases the risk of various diseases - how much of an increase is open for debate. However, with Goettlieb now saying that nicotine is both the problem and the solution, that does leave the FDA in a quandary.

Regular readers will know that I don’t believe nicotine is as “astonishingly addictive” as is claimed by the anti-smoking crowd. It does have some reinforcing properties, but they are akin to the properties of caffeine, yet no-one bothers to worry about folk ordering the extra large, double-shot latte.

There are many misconceptions surrounding nicotine, so it is no real surprise that many of them end up in Goettlieb’s speech, yet in almost the same breath he says (emphasis mine):

But the nicotine in cigarettes is not directly responsible for the cancer, lung disease, and heart disease that kill hundreds of thousands of Americans each year. Yes, it got them all addicted and kept them addicted for the long term. And it got most of them addicted when they were still teenagers. But it’s the other chemical compounds in tobacco, and in the smoke created by setting tobacco on fire, that directly and primarily cause the illness and death, not the nicotine.

So there is a slight change there. Then we see:

The bigger problem is the delivery mechanism - how the nicotine gets delivered. Attach it to smoke particles created by burning cigarettes and the mechanism is deadly. But attach the very same nicotine to a medicinal product without the other chemicals found in tobacco products and these therapeutic products have been found to be safe and effective by FDA in helping smokers quit.

It’s a hint that FDA are maybe going to look at a medicinal route for vapour products, just as the EU has done with the TPD. Maybe it’s a sign of a possible dual-route approach. At this point, anything is possible.

we must acknowledge that there’s a continuum of risk for nicotine delivery. That continuum ranges from combustible cigarettes at one end, to medicinal nicotine products at the other.

This is the other sign that FDA might look at a medicinal route for vapour products, maybe they’ll follow the EU in having a “consumer limit” of 20mg/ml with anything over that having to be medicalised. It’s not entirely without basis, considering Goettlieb has a past with the Pharmaceutical industry. This’ll be an avenue to watch carefully.

Armed with the recognition of the risk continuum, and the reality that all roads lead back to cigarettes as the primary cause of the current problem, we need to envision a world where cigarettes lose their addictive potential through reduced nicotine levels.

This is, of course, regarding the Very Low Nicotine Cigarettes, which I have talked about before. It is interesting, in the broader context to see this is an idea that still carries water with the FDA, and Goettlib in particular; especially considering the self-titration evidence available. The idea that smokers will smoke more of the lower nicotine cigarettes to reach their desired intake (which no smoker can consciously acknowledge with any accuracy).

I’m directing our Center for Tobacco Products to develop a comprehensive nicotine regulatory plan premised on the need to confront and alter cigarette addiction.

Why not, as was once mooted in the UK once before, develop an entirely separate nicotine regulatory framework, instead of bundling nicotine under a tobacco ruling. Don’t bother with medicalisation or any of that nonsense. But then, that would be too easy wouldn’t it?

This is all before Goettlib even mentions vapour products; or “Electronic Nicotine Delivery Systems” in his speech:

Among other things, we will advance rules that will lay out what needs to be in applications for Substantial Equivalence, Modified Risk Tobacco Product, and Pre-Market Tobacco Product applications; whether and how we would exempt premium cigars from regulation; how to possibly regulate kid-appealing flavors in products like Electronic Nicotine Delivery Systems, or ENDS; and whether we should ban menthol in cigarettes and flavors in cigarillos – factors that we know are a leading driver of youth smoking.

Can we expect significant changes to the equivalence rules? Possibly. Exclusion of vapour products - and other reduced risk products including Heat not Burn - from MRTP and PMTA applications? Open ended question. Though given how the speech has been received by the usual suspects, they believe that vapour products aren’t going to be subject to a PMTA. I doubt that is the case.

Interestingly, Goettlieb specifically mentions “kid-appealing flavours” with regards to vapour products. Clive has mentioned this before, as have several others. Flavours are a large part of why vaping works for so many. Yes, there are likely to be some flavours, and associated packaging/design that could be considered being “kid-appealing”; but frankly, another aspect open to wide interpretation.

We will re-double our efforts to protect kids from all nicotine-containing products.

The current raft of Tobacco 21 rulings spreading through the US would seem to nullify this line. There is already a minimum age for purchase, set at 18; like the rest of the world. We know that if a kid wants to get something age-restricted, they are going to find a way to get it. Be it marijuana, alcohol or tobacco. Increasing the age restriction is only going to make it all the more enticing to the little bastards. Unless there is adequate enforcement of existing rules, this will always be the case.

As is known, many smokers start long before they are legally allowed to purchase tobacco. I most certainly did. I had that beat by the best part of 5 years.

As we move forward, I also hope we can all see the potential benefits to addicted cigarette smokers, in a properly regulated marketplace, of products capable of delivering nicotine without having to set tobacco on fire. The prospective benefit may be even greater for the subset of current cigarette smokers who find themselves unable or unwilling to quit.

Yet again, a government agency is holding reduced risk products, and in this case vapour products specifically, as both a stick and carrot. How much stick they turn out to be remains to be seen. We’ve already seen in the UK that vapour products are touted as mostly a cessation option rather than the lifestyle product they are. I suspect that in many ways, the US is now going to try, in a roundabout way, to follow the UK; although they are a good few years behind.

To give ourselves time to implement this framework, including through notice and comment rule-making, I’m directing CTP to reconsider the various compliance policies associated with the deeming regulation. This includes the policies relating to the compliance periods for premarket submissions for products on the market at the time the deeming rule took effect and for FDA’s review of those submissions. Specifically, CTP will consider the language in the preamble that set forth timelines for submissions and raised concerns about products coming off the market before FDA had reached a decision.

We now know that the deadline has been shifted from 2018 to 2022. Aside from that, nothing much has fundamentally changed. No new products can be brought to market since 8/8 and, unless anything drastically changes, vapour products will still be subject to the lengthy, and costly, PMTA process. It’s just been delayed four years.

In addition, we’ll also be revising the so-called “sunset policy” through additional guidance so that existing products under review remain on the market. The current policy could have forced existing products off the market.

Another small positive. At least the US market will still have something. For now at least.

While there are indications that, finally, the FDA are at least turning towards the right direction with regards to embracing harm reduction the speech, and the associated releases might just be making too much noise over what could be little change.

After all, the FDA has just granted the vapour industry four years breathing space, which in reality is just an extension on PMTA submissions while we nervously await any new rulings. It also means that all sorts of bans, including the usual public place (and in some bizarre cases - _open space_) bans, along with flavour bans (like the one being challenged in San Francisco) and the inclusion of vapour products in Tobacco 21 ordinances will continue, and likely increase in number.

We’ll also see the usual bullshit science published from the usual suspects trying (and in most cases succeeding) to spread doubt among the public; who already believe vaping is as bad as smoking. A perception that has been on the rise over the last two years.

Finally, we’ll see the usual suspects calling for FDA to do something to “protect our kids”.

By all means, celebrate the fact that the industry execution has been delayed by four years. But tomorrow, and the next day, and the day after that, and the day after that, we’ll be countering bullshit stories and junk science with increasing frequency. If you thought the last two years was bad in the US, you’ve not seen anything yet. We’ve got another four to get through, and at the end of it?

Well, no-one really knows. What I do know, or specifically, what I suspect is there’ll be a whole slew of “very low nicotine cigarette” science published, most of it will probably be junk. While simultaneously, we’ll continue to see “science” dedicated to finding ‘harms’ of vapour products.

It still isn’t about health.