Anyone remember when the United States was all about the entrepreneur? How many sought their fortunes, the “American Dream” (including the white picket fence) and so forth?
It seems that modern day America is now home to the corporations (very Continuum-like). So who better to look after the health and wellbeing of the population, than profit-driven mega-entities eh?
You’ll remember that, around this time last year, the newly appointed FDA Commissioner Scott Gottlieb made an interesting, and somewhat controversial, announcement. Controversial for the likes of Campaign for Tobacco-Free Kids anyway. So controversial in fact, that they filed a lawsuit urging the FDA to apply the new rules.
I said at the time:
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?
Y’see, there has been a slew of PR on the very low nicotine cigarettes debacle. Followed, naturally, by an increase in the demands for flavour bans (or extensive regulation at least) – most notably, Senator Durbin. Never mind that VLNC is a ridiculously stupid idea, the US believes it is the cause of all evil. So, after a year, what’s happening?
Thanks to the illustrious Puddlecote for highlighting the latest announcement, a whole host of shenanigans are going on.
Through the U.S. Food and Drug Administration’s comprehensive framework for regulating nicotine and tobacco, we’re developing policies that support the possibility of a world where combustible cigarettes could no longer create or sustain addiction.
Can’t really argue with the stated aim, even if I believe it is misguided.
Y’see, the title of the press release highlights a few of the concerns I had last year:
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps the agency is taking to support the development of novel nicotine replacement drug therapies to help smokers quit cigarettes
Gottlieb also reiterated his point from last year:
Part of this work requires that we recognize that nicotine, while highly addictive, is delivered through products posing a continuum of risk – with combustible cigarettes at one end, to nicotine replacement therapy (NRT) products at the other. We’re working on multiple fronts to recognize the role that more novel forms of nicotine delivery could play in achieving our public health goals, as part of an appropriately regulated marketplace.
Y’see, as I said at the time, this is an indication that the FDA is looking at the “EU Model” to enforce limits on ‘consumer’ products while allowing for higher limits on ‘medicinal’ products. It would appear, therefore, that I was – at least partially – right, considering the recent announcement.
This not only includes encouraging innovation of potentially less harmful tobacco products for those adults who still seek to use nicotine (such as e-cigarettes), but also taking a closer look at our overall approach to the development and regulation of NRT products that are regulated as drugs, and designed to safely reduce withdrawal symptoms, including nicotine craving, associated with quitting smoking.
The development of novel NRT products, regulated as new drugs, is a critical part of our overall strategy on nicotine.
Novel NRT products. This includes e-cigarettes, and no doubt Heat-not-Burn too. It is quite clear from the announcement that Gottlieb isn’t talking about free market products available from vape shops. Instead, he is talking about this.
Today, and as a result of this work, we’re releasing the first of two draft guidances aimed at supporting the development of novel, inhaled nicotine replacement therapies that could be submitted to the FDA for approval as new drugs, similar to current over-the-counter pharmaceutical NRT products. The guidance, “Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products,” focuses on data recommended to evaluate potential toxicities associated with orally inhaled nicotine-containing drug products. This includes products such as electronic nicotine delivery systems like e-cigarettes that are intended for smoking cessation and other long-term uses that would make them subject to regulation as drugs.
There’s much in that one paragraph to discuss. First up, “orally inhaled nicotine-containing drug products”. There is already a few of those, so why on earth would an e-cigarette need to be included in this category, considering many have been using them for years with few – if any – negative effects.
The “other long-term uses” caught my eye for that very reason. Many vapers enjoy vaping as much, if not more than, smoking and are quite happy in continuing the use of their favoured product for as long as possible. The concern I have here is that the FDA will look to impose a scaling limit on how long one of these “nicotine-containing drug products” can be used for.
This draft guidance, when finalized, is aimed at providing sponsors with recommendations on the nonclinical information appropriate to support development and approval of orally inhaled nicotine-containing drug products. It recognizes that a great deal of toxicity information is available for nicotine. But such information may not be available for other compounds contained in e-liquids and delivered by these products. These include the flavorings and heat-generated chemicals. These products can be used for six months or more over the course of a lifetime. So, it’s important to understand the risks to humans from these exposures, including developmental and reproductive toxicity and carcinogenicity.
Now then, dear reader, what other product range can you think of that is generally used for six months or more over the course of a lifetime?
If you said “NRT”, give yourself a gold star. Y’see, when you look at the guidance itself, it is rather clear what industry this is aimed at.
The sponsor can rely on the exposure to nicotine in an approved drug to inform the nonclinical toxicity evaluation for this purpose. If the sponsor references a relevant approved drug, that drug should provide equal or higher exposure than the exposure anticipated from the proposed orally inhaled nicotine-containing drug product, considering the conditions of use proposed in labeling. For example, a relevant approved drug is one that has similar conditions of use to the proposed orally inhaled nicotine-containing drug product, including the dose, duration, route of administration, and the indicated population.
This is guidance for a therapeutical product, which doesn’t exist. Meaning that any company that decided to have a go at this would need to have really, really, really deep pockets. It is entirely designed with pharmaceutical companies in mind in the same way that the Tobacco Products Directive references the relevant medicinal products directives (2001/83/EC and 93/42/EEC).
A medicalised e-cig, as we know, would be bland, flavourless and above all, not fun to use. It’s reasonable to say the Tobacco Industry has the cash to follow this kind of route, after all, BAT did receive an MA for the eVoke – which never saw market.
It is interesting to note that Gottlieb states this guidance is the first of two, with the second due sometime in Autumn:
This second guidance will help lay out a framework for new potential clinically relevant outcomes for smoking cessation products, such as reducing the chance of a smoker going back to using cigarettes long term and showing a positive impact on certain measures of cardiovascular health.
That future guidance also is expected to address potential alternative treatment regimens like pre-treatment before quit day, quitting by gradual reduction (reduce-to-quit), or using two NRT drug products together.
It seems that by 2022 when the predicate date really bites, the only e-cig product a consumer could potentially get would be a joyless, soulless, and flavourless medical drug delivery system. There is no mention of guidance being developed for the independent sector to allow for an actual consumer product.
It is remarkable how this is being handed over so blatantly to an industry that wants the independent sector gone, while still insisting on rules that will effectively remove competition from anything recreational that is currently on sale.
As Puddlecote notes:
It is, to all intents and purposes, a co-ordinated effort to make e-cigs a medical product and one which should only be used as a means to quit nicotine entirely. It is basically handing the entire market to the pharmaceutical industry. In other words – and especially considering the parallel regulations to take the good nicotine out of cigarettes and leave the harmful elements in – ‘quit or die’ on steroids.