FDA spreads confusion about nicotine and smoking

FDA has authorised 22nd Century to claim a reduced nicotine cigarette is a reduced risk product. This will spread confusion and divert smokers from better choices.

In one of its most ill-judged moves to date, the US Food and Drug Administration has today granted 22nd Century Group the right to market its VLN King and VLN Menthol King combusted, filtered cigarettes as modified risk tobacco products.

It has done this because these products are reduced in nicotine and, FDA concludes, anyone who is willing to smoke them will experience lower exposures to nicotine. But we have known for a long time that “people smoke for the nicotine but die from the tar” (Mike Russell). This is a product that reduces the nicotine but keeps the tar. What could possibly go wrong?

What has been announced?  

The MRTP (Modified Risk Tobacco Product) is the authorisation process for allowing companies to make marketing claims about reduced risk. The claims have to be assessed by FDA as “appropriate for the promotion of public health” under Section 911 of the US Tobacco Control Act. 

Here is the announcement press notice: FDA Authorizes Marketing of Tobacco Products that Help Reduce Exposure to and Consumption of Nicotine for Smokers Who Use Them. Here is the formal documentation: VLN King / VLN Menthol King.

This is the risk communication package authorised by FDA.

The MRTP allows certain reduced exposure claims regarding nicotine, including:

“95% less nicotine.”

“Helps reduce your nicotine consumption.”

“…Greatly reduces your nicotine consumption.”

When using any of the reduced exposure claims in the product label, labeling or advertising, the company must include, “Helps you smoke less.” The FDA also recommends that the labeling and advertising include the statement, “Nicotine is addictive. Less nicotine does NOT mean safer. All cigarettes can cause disease and death.”

FDA announcement 23 Dec 2021 [here] – also see appendix A for further permitted claims.

Update 18 January 2022. The company has announced that it will be marketing these products from March 2022: 22nd Century Launching the First Reduced Nicotine Cigarette Authorized by the FDA That Helps You Smoke Less. The company is positively gushing about the help it has had from FDA:

The FDA decision on VLN® is a major event for public health in the fight to reduce the harm caused by smoking. Not only did 22nd Century receive the MRTP authorization based on its application requests, the FDA proactively added an extra and incredibly valuable claim of “Helps You Smoke Less” mandated on every package to educate the consumer about the product’s benefit.

22nd Century Press release, 18 January 2022.

The problems with this – a quick thought experiment

If you want a quick route to understanding how bad this is: imagine taking the popular Juul product and modifying it to reduce the nicotine to a negligible level and then (somehow) increasing the toxicity of the aerosol to be equivalent to that of cigarette smoke.  Once you have created a new toxic but inadequate substitute for smoking, then it goes on the market with FDA approved claims saying that it will help you cut down on smoking and nicotine use. It couldn’t be more ridiculous – a super-toxic low-nicotine Juul would never even be allowed on the market in the first place, let alone blessed by FDA.

The problems with this – more detailed

I think there are four main problems with this: 

  1. A diversion from better options. The only real value these products have in public health terms is if smokers don’t use them because they are so unsatisfying, and switch to something with lower risk (that is the promise of a VLN rule). If they do use them, they are still exposed to thousands of toxins from smoke and no-one would be happy with vaping products that create the toxic exposures created by VLN cigarette products. However, the purpose of the marketing communication is precisely to encourage people to buy these products – that is what 22nd Century exists for. If people want to reduce their health risks, then they are far better advised to switch to a non-combustible vaping or heated tobacco products. So for health-conscious smokers, this is a diversion from a strategy that would actually help them. Instead, the authorised claims falsely promote reduced nicotine exposure as a health benefit, though with the sly disclaimer: “Nicotine is addictive. Less nicotine does NOT mean safer. All cigarettes can cause disease and death.” What, then, is the point?
  2. Not marketed for smoking cessation. This is not being marketed as a smoking cessation strategy. FDA and 22nd Century are not saying “use these as part of your journey to smoking abstinence“.  The claims relate to reduced exposures to nicotine arising from ongoing smoking, not a smoking cessation strategy. The 22nd Century products have not been evaluated by FDA as a smoking cessation strategy either for the PMTA or MRTP. I can’t think of anyone in public health that would suggest switching to these products to quit smoking – rather than tying Rx meds, NRT, or a non-combustible alternative to smoking (see What is the use case? below). FDA’s justification for the MRTP rests on the idea that people will use these products indefinitely, but just smoke less – and there will be some benefits from that.
  3. Misunderstands nicotine use. It’s almost as if FDA has no idea about smoking as a nicotine-seeking behaviour and the struggles that users would have with switching to these products (see rampant non-compliance in trials of VLNC cigs – see Benowitz et al. 2015). So where is the caution to smokers about the negative effects (withdrawal, craving) on them of reduced nicotine? Where is the consumer protection caution that “these products may not be as satisfying as your normal brand“. It implies that the drop in nicotine exposure just somehow happens as a result of using the product with no other impact on the user. 
  4. Making nicotine the problem. These claims strongly imply that nicotine is the problematic agent that needs to be cut out as far as possible. Yet that is not the case (or a gross over-simplification) and perceptions of nicotine risk are already wildly inaccurate among the public and professionals.  Only 21.4% of the US public (HINTS, 2019) disagrees that the nicotine in cigarettes is the substance that causes most of the cancer caused by smoking. How does this help Americans really understand and act accordingly?

What is the use case?

So, here is my question to FDA and to everyone who sees this as a positive development. If you were giving advice to a friend or if you were a health professional advising people who smoke, for what type of consumer and in what situation would you advise trying to use this product, given all the alternatives?

You have the option to advise people to try smoking cessation medications or NRT. You could advise counselling (what counselling services would advise switching to VLN cigarettes?). You could recommend trying some or all of vaping, heated tobacco, snus or nicotine pouches. You could even recommend a period of ‘dual use’ and gradual transition. But I can think of no circumstances where I would advise someone to go out and buy a packet of reduced nicotine cigarettes. It is not much different to advising them to just cut down their smoking, a strategy likely to fail.

So what is the use case? When would FDA officials or supporters of this measure advise users to switch to VLN cigarettes? Because that is exactly what they are doing by authorising or supporting these marketing claims. So I tweeted a reply to a prominent supporter of this measure. Still hoping for a reply.

Prediction

In my view, after an initial surge of interest, these products will bomb in the marketplace and 22nd Century will revert to its ongoing strategy of trying to sell these products to smokers under regulatory duress by pressing for a VLN rule (a prohibition on normal nicotine cigarettes).

The inimitable David Sweanor describes it as:

Removing the nicotine consumers seek in order to wean them off smoking might actually work for some people. But it looks a lot like an effort to end gun violence by marketing versions that cannot fire bullets. It is hard to imagine a significant number of those interested in either product finding such things to be acceptable options.

David Sweanor, by email, 23 December 2021

Does it help secure a ‘nicotine standard’?

Some supporters of this new MRTP authorisation see it as progress towards a greater goal: that would be imposing a ‘nicotine standard’ that requires rather than permits and promotes cigarettes with very low nicotine levels. I disagree with this strategy for many well-rehearsed reasons (see Twenty reasons to be sceptical about rules lowering nicotine levels in cigarettes – and what to do instead). But its only plausible rationale is that it forces people who smoke to either quit smoking or switch to a non-combustible reduced-risk product (in practice, they would also access illicit products). It works only because the VLN products are not a satisfactory alternative to smoking regular cigarettes.

That is not what is happening here. FDA’s MRTP authorisation stresses the public health value of actually using these products instead of regular smoking – not as a means to trigger smoking cessation or switching. It is offering this as a harm reduction strategy in its own right, rather than a device to move users on to a genuine harm reduction approach. 22nd Century will be promoting this product with a view to people using it as an alternative to smoking cessation or genuine harm reduction option. For this reason, it is a distraction from all the better options. This leads to the key challenge for FDA and those backing this authorisation: the use case.

What are MRTPs and PMTAs?

Under the US Tobacco Control Act, a new tobacco product requires a Pre Market Tobacco Application (PMTA). Under this process, FDA has to be satisfied that the product is appropriate for the protection of public health before it can be placed on the market. There are various exceptions for products that were already on the market in 2007 and derivatives of these products. Also, FDA is using enforcement discretion to allow many vaping products to remain on the market while it evaluates their PMTAs.

In contrast, the Modified Risk Tobacco Products (MRTPs) is about communication. The MRTP application is the process for making authorised marketing claims about reduced risk. FDA has to determine that such claims are “appropriate for the promotion of public health”.

22nd Century received its marketing order in 2019. FDA has so far granted PMTAs for five product sets: UST (Altria) Verve chewable tobacco disks (2021); Reynolds Vuse vaping product (2021); PMI iQOS (2020, 2019); 22nd Century reduced nicotine products (2019); Swedish Match General snus (2015). 

The 22nd Century cigarettes are the third product set to receive an MRTP – see Modified Risk Orders – the previous two were PMI’s iQOS (2020) and Swedish Match General snus (2019).

Multiple researchers used to support cigarette company claims

Another commentator points out that this is might as well be seen as FDA approving an MRTP to itself.

This is best seen as FDA awarding itself an MRTP. The only sales of these products are for research purposes and FDA has spent well over a hundered million dollars on researching these products. FDA has promoted the idea of reduced nicotine cigarettes for years and now it has waved the products through a process that is almost impossibly burdensome for others in record time. Yet the public health case for these products is very weak.

Private communicaton.

One of the quite insidious aspects of FDA granting an MRTP order to the 22nd Century very low-nicotine cigarette (VLNC) is the extent to which FDA/NIH has financially supported the company’s application by buying its cigarettes and using independent research organisations and investigators in the United States to provide the evidence to support its case. 

Any other tobacco or vape company would need to present extensive trials that it conducted itself and at its own expense, something that would be prohibitively expensive for most companies.  But not so for 22nd Century. 

The FDA’s decision summary explains… the application uses extensive “bridging”. Bridging is the use of evidence gathered from a very similar product for use in a commercial application to the FDA. 

Bridging from SPECTRUM NRC102/103 
Much of the evidence reviewed in these MRTPAs is based on studies of SPECTRUM NRC102 (nonmenthol) and NRC103 (menthol) very low nicotine cigarettes (VLNCs). The applicant stated SPECTRUM NRC102 is the same as VLN™ King, and SPECTRUM NRC103 is the same as VLN™ Menthol King. FDA found that the cigarette weight, cigarette length, cigarette diameter, and tipping paper permeability are the same between SPECTRUM and VLN™ cigarettes. SPECTRUM cigarettes and VLN™ cigarettes also share many identical components and materials including tobacco type, tobacco blend, cigarette paper, filter, seam adhesive, and tipping adhesive. The only material difference is that the SPECTRUM tipping paper has a silver line and the name SPECTRUM printed on it, whereas the VLN™ tipping paper does not have any markings. The base tipping paper for both SPECTRUM and VLN™ cigarettes has the same porosity of CU and is produced by the same manufacturer. Thus, FDA finds it appropriate to bridge data from studies of SPECTRUM NRC102/103 (referred to as “VLNCs”) to the proposed MRTPs. In this review, the terms VLNC cigarettes and SPECTRUM NRC102/103 are used interchangeably.  

FDA Decision summary

Of course, the SPECTRUM cigarette is the product used and paid for in most (all?) of the trials of VLNC so far. For example, the extensive (and impressive) trial by Donny et al 2015 published in the New England Journal of Medicine states “Investigational cigarettes were obtained from the National Institute on Drug Abuse“.  As the supplementary material makes clear, these were Spectrum cigarettes.  Hatsukami et al 2018, likewise. In fact, all the investigational cigarettes available to US research institutions are SPECTRUM cigarettes sourced from 22nd Century. See: 

FDA and NIH have been extraordinarily generous to this company. These public bodies account for almost all of 22nd Century’s reduced-nicotine cigarette sales (there is no significant market for these products other than for research purposes). Not only that, through extensive funding of VLNC research, FDA and NIH have paid for the research base for 22nd Century to make a commercial application, via bridging, for a modified risk claim that is specific to the company and its products (it is not a general claim for the VLNC category). This MRTP order allows it to make actual and implied reduced risk claims for ongoing use of this product.  These are set out on Page 1 and appendix A of the marketing order

We [FDA] authorize marketing of the tobacco products as modified risk tobacco products with reduced exposure claims, including:

• “95% less Nicotine
• “Helps reduce your nicotine consumption”
• “…greatly reduces your nicotine consumption”
• “VLN™ cigarettes are substantially lower in nicotine content than any other cigarettes currently available to smokers in the United States.VLN™ cigarette contain an average of just 0.27 mg of nicotine.”
• “Without exception, VLN™ cigarettes contain at least 95% less nicotine than the top 100 cigarette brands in the United States.”
• “22nd Century’s VLN™ cigarettes contain an average of 0.27 mg nicotine – -at least 95% less nicotine compared to conventional cigarettes.”
• “22nd Century’s VLN™ cigarettes feature the same nicotine content as the lowest nicotine style of the Company’s SPECTRUM research cigarettes.”
• “VLN™ cigarettes contain 0.27 ± 0.1 mg nicotine.”
• “As a result of our unique technology and plant breeding expertise, VLN™ tobacco grows with 95% less nicotine than conventional tobacco.”
• Graph depicting nicotine levels of VLN™ cigarettes compared to several other cigarette brands.

Where any of the reduced exposure claims listed in Appendix A are used in the product label, labeling, or advertising (LLA), under section 911(h)(1) and 911(h)(3)(B), this order requires that the LLA must also include the following condition of use: “Helps you smoke less.” Additionally, we recommend that the LLA include the disclaimer: “Nicotine is addictive. Less nicotine does NOT mean safer. All cigarettes can cause disease and death.”

FDA marketing order

As I have already argued in this blog, these claims are a complete muddle of factually true but profoundly misleading nonsense that adversely affects the perception of nicotine and crowds out other, far better, risk mitigation options for smokers for which FDA has not been so generous. It is also quite different to the impact of a VLNC rule.  In fact, the application uses a model that allows for VLN and conventional cigarettes to have equal market share (a risible assumption, but clearly not the intention of a VLNC rule either). See if you like the sound of this from the decision summary (p16)…

Additionally, the epidemiology review evaluated the applicant’s population model estimating the public health impacts of the proposed MRTPs. The model assumes that the market share of conventional cigarettes (CC) and VLN™ will be equalized at around 25% by year 2050, meaning that approximately 7.1% of CC smokers will initiate VLN™ smoking per year (i.e., if 7.1% of CC smokers switch to VLN™ cigarettes every year until 2050, then at least 25% of smokers will be using VLN™ cigarettes by 2050).

FDA Decision summary

I doubt that another company making a VLNC cigarette would be able to use ‘bridging’ to the Spectrum product unless they made their product virtually identical, which would be difficult and not even desirable. So all of that research effort is functioning as a direct subsidy for one cigarette company’s marketing claims. 

My impression is that the researchers in this field believe they have been doing something quite different to providing material for cigarette marketing claims. That is, they have been trying to assess the impact of a VLNC rule on the market as a whole, not providing free research to a single tobacco company to support official authorisation to make dubious and confusing claims. I must say, I feel uneasy about this.  Did these researchers expect to have their work used in this way? Do they agree with FDA’s findings based on their work?

I still come back to the basic ‘use case’ question – for what sort of person in what circumstances would a public health professional recommend someone tries a 22nd Century VLN cigarette, given the available alternatives?   Because this is what FDA is doing by allowing an MRTP claim for this product. 

 

44 thoughts on “FDA spreads confusion about nicotine and smoking”

    1. Hi Adam… yes, owning 22nd Century stock is not much more than speculation on regulatory announcements and sometimes these will be positive for the stock. But punters should recognise that no one wants to buy these products (other than researchers) in an open market. Even in a situation where 22nd Century gets its big win, an FDA imposed nicotine standard, very few will respond to the imposition by buying VLNC cigarettes given all the other available options. So in my view, there isn’t any underlying value in the stock (i.e. on a discounted cash flow basis), just promises that are boosted or thwarted by FDA announcements.

  1. Were I still smoking I have no doubt that if I smoked VLN cigarettes I would smoke more cigarettes – to reach a satisfactory nicotine level – and so do myself more harm. I would be confused by the reduced exposure claims and would probably infer that VLN cigarettes were somehow better for me – so if I smoked more that wouldn’t matter. I remember when we all thought “light” meant “healthier”, in relation to cigarettes. How is this different – how is it ethical?

    1. I actually don’t think smoking more is that likely. The proponents of VLNC cigarettes have realised that the whole enterprise would be scuppered by adversely lowering the nicotine to tar ratio and encouraging users to smoke more to get the nicotine they want. So their approach is to lower nicotine to levels so low and so abruptly that this compensatory smoking is impossible. The products would be reduced to, say, 0.4 mg nicotine per gram of tobacco. That would compare to 12-16 mg/g in normal tobacco cigarettes – so a 30-40-fold reduction. You would have to work very hard to get a nicotine hit from that. The more likely result is simply that no one will use these products on the same basis that few would wish to drink whiskey with 1% alcohol (about 1/40th the usual strength). The question is whether it is right to force them to switch to something other than cigarettes, and what they would actually switch to.

      1. “As the FDA also looks to ban menthol in highly addictive cigarettes, we fully expect the FDA will allow our VLN Menthol cigarettes, which offer little appeal for youth and former smokers because of their reduced nicotine content, to be allowed by the by the FDA to remain on the market to provide an off-ramp for adult smokers of menthol cigarettes”. James Mish, CEO. What’s so hard to understand about this concept and its purpose and mission? You attack without any depth of understanding. Before you condescendingly ask, I’m a proud, activist holder of 22nd Century stock.

      2. Hey Clive, right in your neck of the woods: The growing popularity of “nolo” drinks, also called as no and low-alcohol beer, among the 18–24-year-olds is emerging as the UK’s biggest trend. Drinking low ABV or switching to no alcohol substitutes as for entertainment purpose is observed to rise significantly among youngsters.

    2. Read some of the application. Read some of the studies. When you were previously getting your nicotine from regular smokes, if the cut the nicotine a little, you could get the same ‘hit’ by one more smoke. If they cut it by 50%, you might smoke 2 to get the same hit. You would need TWENTY of these to come close. Good luck with that. People don’t smoke more of these. They figure out real quick there is no return from another one. Please, just read some of the data.

  2. Mr. Clive Bates, “you’re spreading confusion ” and “you achieve little” by spreading falsehoods. Read up a little more on the science that backs the claim. Seems this is your way to mislead the public with false information. You consider yourself a highly respected journalist blogger ?, think again fool. Be honest with yourself, how much did they pay you ?. Everything has a price, even your soul. Happy rythmes.

    1. Perhaps you could clarify what it is you disagree with? Or what science you think I’m missing. Then we could debate your views. Also, please mention if you hold 22nd Century stock.

      Oh, and one more thing. My normal practice is to remove defamatory statements from the comments. But in your case, I’ll make an exception – I think it is revealing.

      1. Really now. I guess sir you may reach out to the FDA and ask for proof from their scientists. You certainty have that right. The real scientist can debate this with you. I am no scientist, and claim no glory as you claim to know more than the rest of us. This will save many lives by the harm caused by smoking by elimination of nicotine cravings. 22nd Century group were given the go ahead to this MRTP based on the science from many years of collaborative scientific studies. The first combustible ever to get an MRTP approval. Be well Mr. Clive, and Merry Christmas to you and yours.

  3. Quote : “Also, please mention if you hold 22nd Century stock.”. Yes, I proudly do. On another note, please be a respectful writer, regardless of what you believe in. Do remember, follow the science to measure the facts. Nothing is more irresponsible than to provide a narrative that is the contrary to the truth.

  4. “Our mission is to find ways to stop tobacco-related disease and death. We know that three out of four adult smokers want to quit and the data on these products show they can help addicted adult smokers transition away from highly addictive combusted cigarettes,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “Having options like these products authorized today, which contain less nicotine and are reasonably likely to reduce nicotine dependence, may help adult smokers. If adult smokers were less addicted to combusted cigarettes, they would likely smoke less and may be exposed to fewer harmful chemicals that cause tobacco-related disease and death.”

  5. I’m surprised Mr Bates’s critics here are so strenuously missing the point — the economic one, as well as the public health one.

    As Bates hints at, big companies bound up intimately with their regulators are less valuable than they appear. Investing in 22ndCent *is* “speculation on regulatory announcements” — it’s exactly that! And look how entwined with the FDA this corporation is; look at this little side deal where 22C gets to be the country’s *only* retailer of menthol smokes.

    Menthol smokes with the pleasure removed, mind you. Cigarettes, but without the enjoyability. Guns without bullets. 1% whiskey. Yeah. Mr Bates is a polite man, so let me paraphrase: these 22C cigs are farcically stupid products, absolute farts in the wind, which no one will ever willingly buy.

    So, my view — a nimble rent-seeking outfit like this one is probably not staffed by morons. Why are they proposing to make unsellable products? Surely the reason lies in the company’s relationship with the FDA.

    Here we can only speculate. Maybe it’s a burnt offering –an expensive symbolic gesture 22C is making in hopes of pleasing the regulatory gods. Maybe 22C thinks the public-health groups who will engage, for years, in the pointless study of these pointless products could themselves constitute a healthy market.

    But most likely, it’s a direction-of-travel thing. 22C probably suspects, or is calculating, or perhaps even *knows,* that the American government will soon launch a back-door, cack-handed attempt at tobacco Prohibition, New Zealand-style.

    You know how in Utah, you are allowed to buy beer, but it’s only 2.3 (3.2?) per cent alcohol? Maybe something like that is coming: you can technically buy cigarettes, it’s just that they’re horrible and you won’t want to. Thus your life will be saved.

    Eesh. I don’t normally buy into the notion that sellers of tobacco are Big Bad Evil Monsters, but this — this all looks kinda sleazy. Sinister too, like regulatory capture in reverse. Good on Mr Bates for bringing these escapades to light.

  6. It’s like saying whiskey is still whiskey if you lower its alcohol content to 0.5%. Technically, that may be correct, but not in any meaningful or useful sense. The essence of whiskey is its alcohol and the essence of a cigarette is its nicotine. In fact, the Federal Volstead Act 1920, the law that implemented the 18th Amendment prohibition of alcohol, defined a non-zero threshold for alcohol prohibition:

    The words “beer, wine, or other intoxicating malt or vinous liquors” in the War Prohibition Act shall be hereafter construed to mean any such beverages which contain one-half of 1 per centum or more of alcohol by volume

    So I think switching to VLNC cigarettes is about as likely as switching to 0.5% whiskey.

    1. The growing popularity of “nolo” drinks, also called as no and low-alcohol beer, among the 18–24-year-olds is emerging as the UK’s biggest trend. Drinking low ABV or switching to no alcohol substitutes as for entertainment purpose is observed to rise significantly among youngsters.

        1. Actually I’m banking on youth not becoming addicted to nicotine via smoking , no buzz VLN cigarettes, with the pending mandate. Smokers using vapes to quit seem to not be concerned that for every smoker that quits via vaping, many youths will become nicotine addicted because of easy accessibility and they quest for the attainable buzz, vapes provide.

  7. Hi Clive,

    A couple thoughts for you that might be benefical:

    1) You seem hung-up on the use cases, which I understand. What I would say though is this: not everyone’s journey to quit smoking is the same. Strategies that work from some don’t work for others. The ability for smokers to buy these VLN cigarettes should be viewed as 1 more tool that can be used. It may be very useful for some people. And if it’s not, guess what, they don’t sustain addiction. That is clear. While I agree with you that there likely won’t be a huge market for these, I do beleive they will be helpful to some. And like you say, if very little people will use them and of those that do try them they won’t create any new addiction…what’s the harm? No one is going to be smoking these thinking they are safe or light…those days are over.

    2) I wish you would have clarified the distinction between Modified Risk vs. Modified Exposure in your blog. This is an exposure claim, not a risk claim. Obvisouly these are not going to reduce your risk. They will allow you to control your nicotine exposure in hopes of smoking less.

    3) I’m not a shareholder, but honestly a bit confused why you are also very hung-up on that as well. Shareholders can have valid opinions. Many have done a lot of research on the company and the VLN product as they are putting their hard earned money at risk. As you seem to be concerned with, I’ll call it alternative motives, it probably should be asked of you as well: do you have a position long or short in the company?

    4) Your whiskey example doesn’t really make sense to me. There are non-alcholic beverages on the market. It’s actually a growing market. They are helpful for many people who want the taste of a beer or cocktail without having to bring alcohol into their system. They obviously are not harmful like a combustible cigarette, but like I said, it’s not a very good example to point to.

    Thanks for the write up, I think it’s valable to get the word out on these products (as they will soon be on the market regardless of what you think), and hopefully they can help some people.

    1. Daniel, many thanks for these thoughtful comments. Some responses:

      1. The use case. I wouldn’t say I am hung up on this (I’ve provided lots of other analysis), but I do think it is useful for public health people to think through the issues using this as a thought experiment. I’ve yet to find a case where someone can name the use case. Obviously, I have no objection to anyone using a product like this if it helps them but these products have never succeeded anywhere. The problem here is that FDA is putting its weight behind a reduced-risk claim and implying via the manufacturer that switching to this product would be beneficial in some way and a good path for a smoker to take. I cannot see a situation where a health agency would or should recommend that.

      2. Reduced exposure. I have discussed the interaction between a reduced exposure and reduce risk claim further along in the comments. But in short, FDA will only allow reduced exposure claims where it thinks there is likely to be a reduction in risk, but the data is not yet available to show that is the case (see TCA 911(g)(2)(A)(iv)). These products have not been evaluated for claims related to smoking cessation, so the claims must be related to sustained use. All FDA is really saying is that if you can use these products instead of smoking then there will be a benefit, but the problem is that these products are difficult to use for smokers for obvious reasons. It’s a bit like saying that if you can cut down from a pack a day to one every two days, there will be a benefit. The hard bit is doing it.

      3. Shareholders. I think it is helpful for people to disclose their interests, especially if (as in this case) they are casually throwing around untrue allegations about conflicts of interest related to me or others. Generally, I am happy to provide views on these matters regardless of the investment portfolio of my interlocutors.

      4. Whiskey. I agree the whiskey example is not a perfect analogy. My main point with this is that whiskey with very low levels of alcohol ceases to become what we would generally accept to be whiskey. And cigarettes with 0.4mg/g of nicotine (30-40x lower than typical cigarette tobacco) cease to be a cigarette as commonly understood. My point is that smoking is a nicotine-seeking behaviour and imposing a low threshold like 0.4mg/g as a market-wide standard is essentially a cigarette prohibition. While I can see the case for alcohol-free drinks (and I am an occasional user), I don’t really see why anyone in public health would recommend a smoking product for someone looking for a low/zero nicotine experience, when there is a large range of zero nicotine e-liquids to draw on. I’m not saying ban VLNC either, just that I doubt they will make much difference and that FDA should not be pumping up their potential.

      1. Thanks for the response Clive. I think we agree on most things. I could be wrong, but I just don’t see much downside in letting these on the market with the claims that were granted. I think the reward (it helps some people quit) out weighs the risk. I don’t beleive people will assume these are a safe cigarette. And even if they do, they will likely not use them for long. They definitely won’t get addicted to them! Anways, thanks again. This is such a small piece of the tobacco harm reduction puzzle, it’s hardly worth thinking much about. I firmly beleive that heat-not-burn products represent the most potential in the reduce risk category.

        Thanks again.

        1. I agree there is no reason to let prevent these products from having access to the market (though the FDA says that new tobacco products should be demonstrably ‘appropriate for the protection of public health’). I am not convinced these are APPH – not because they are worse than normal cigarettes, but that they are an officially-endorsed distraction from options that are better and for which the evidence is much stronger.

          The evidence review in the FDA Technical Project Lead Decision Summary is very weak. These ‘reduced exposure’ products would only be helpful if users continued to use them as alternatives to cigarettes for many years or they quit smoking. Yet the longest survey used is just 20 weeks. The problem is that these products amount to abrupt nicotine cessation without smoking cessation. The alternatives involve smoking cessation without nicotine cessation, in my view an inherently more stable proposition. Those options should be the appropriate comparator.

    2. Because there a better options that the FDA seems to eschew because of the false not in that kids use them because they are flavored.

      Nicotine with little to no harm. Not all the harm with little to no nicotine.

  8. The low nic cigarettes is one of the stupidest things they can push…

    Simply means people will smoke more to get their nic… thus inhaling more combustible toxins… all while making the tobacco company richer from increased cigarette sales

      1. Have you ever actually smoked a cigarette? iF you had you would know this is an absolutely ridiculous idea. Why not just use ecigs? Remove the majority of the risk right away. Why keep exposing yourself to and deprive yourself of the substance you are addicted to. It’s the worst of both worlds and literally makes zero sense. Dumb ass

    1. “Numerous independent scientific studies, funded largely by the FDA, the National Institutes of Health (NIH), and other U.S. federal government agencies, have demonstrated that using reduced nicotine content tobacco cigarettes helps smokers reduce their nicotine exposure and dependence, smoke fewer cigarettes per day, increase their number of smoke-free days, and double their quit attempts – all with minimal or no evidence of nicotine withdrawal or compensatory smoking.”

  9. No tobacco cigarettes on the market – anywhere in the world – have lower nicotine content than 22nd Century’s VLN cigarettes.

    As 22nd Century has explained in numerous press releases over the years, misconceptions abound regarding the definition of “Very Low Nicotine;” i.e. tobacco with nicotine CONTENT at minimally or non-addictive levels. Major tobacco brands that historically advertised “low nicotine” or “light” or “ultra light” cigarette styles were referring to the smoking machine-measured nicotine YIELD of cigarettes. However, these so-called “light” cigarettes Marloboro Filter Plus One, Camel One, Pall Mall Super Slims Silver, Winston Xsence white Mini, Virginia Slims Superslims, Davidoff One, etc.) actually have nicotine CONTENT that is virtually as HIGH as “regular” cigarette styles. According to the FDA, smokers of “light” cigarettes are easily able to obtain substantial doses of nicotine by altering their smoking behavior – covering the filter dilution holes with their fingers, drawing more deeply, and so on.

    Accordingly, a better measurement than “yield” – and the measurement that is supported by the FDA – is measurement of nicotine CONTENT. The nicotine content of a cigarette cannot be modified by smoking behavior.

    22nd Century produces Very Low Nicotine content tobacco cigarettes with nicotine levels as low as 0.5mg per gram of tobacco. In contrast, EVERY other manufacturers’ previously so-called “light” or “ultra-light” cigarettes have nicotine contents that are approximately 20 times higher (15-30mg nicotine per gram of tobacco).

    Dr. Neal Benowitz, a tobacco science expert and professor at University of California, San Francisco School of Medicine summarized a number of clinical trials when he explained that a nicotine content of 0.5 mg/g would “make it impossible to compensate by smoking cigarettes more intensively or smoking more per day.” With 22nd Century’s Very Low Nicotine Content Cigarettes, compensatory smoking is IMPOSSIBLE.Please understand, 22nd Century’s VLN cigarettes have 95% less nicotine in terms of nicotine content AND in terms of nicotine yields… But the FDA does not consider measures of nicotine yields to be an appropriate or reliable measure of nicotine that is ingested by real human smokers… and so the FDA (and by extension 22nd Century) only measure, compare, and evaluate nicotine CONTENT!!

    1. I agree with this. The level of nicotine has been set so low that compensatory smoking is impossible. It follows that a satisfactory nicotine experience is also impossible. And that is why these products will not be used in any substantial or sustained numbers by people who smoke. While they are an option, these products will fail in the marketplace. If there is a nicotine rule, they will still fail, because smokers will choose other options – vaping, heated tobacco, illicit cigarettes etc. .

      1. People who want to reduce or quit will use them. Many people with not use other ends products to aid their quit attempts. I was a long time smoker and think this is the best thing the FDA hS done in years. You think they ramped this to market think again at how long it took them to make the decision. Over two years just for the little marketing claim. I would like to know why you are so against something that believe me will help hundreds of thousands quit smoking.

  10. To the critics of Clive Bates: have you ever thought about the smokers as human beings? don’t they have human rights? And please spare me the tirade that “rights of non-smokers to smoke free environments have preference”, while this is true (and smokers know and accept it) it does not mean that we are entitled to harm them “for their own good” by the paternalistic argument of “releasing them from the misery of their addiction”. BTW: this argument was used by homophobic medics in the past when dealing with homosexuality as a mental disease from which homosexuals needed to be rescued.

    I see much harm to the welfare of many (if not most) current cigarette smokers if VLNC’s become their only option. However, VLNC’s would be OK if they are just an option with full nicotine cigarettes available. In such case it is very likely VLNC’s could be beneficial for some smokers. It could be an issue of trying them and either choosing or rejecting them.

    Making VLNC’s compulsory would cause less harm if smokers had legal access and veridic information on e-cigs, heated tobacco products and snus, but the current regulatory and mainstream public health technocracies in the US are at war with tobacco harm reduction products. Smokers mostly get misinformation and scare stories about vapor products. Unless this adverse environment changes this road is closed.

    Somebody criticized Clive’s analogy between VLNC’s and whisky with 0.5% alcohol. It is a very valid if VLNC’s become the only option, as in thsi case all cigarette brands would be VLN. The analogous case would be all whisky brands (glenfiddish, Johnny Walker) becoming 0.5% alcohol. Some posters mentioned the success of very low alcohol drinks, but these drinks are taking the brands of known whiskeys and are not replacing full alcohol ones (this case would be analogous to VLNC’s being optional).

    People juggle with the “addiction” term as if it was a universal feature, a sort of pharmacological destiny. It isn’t, dependence varies among smokers and among populations. The case of Mexico is illustrative (it holds in Central America and the Andean countries). From the one of lattest national polls (ENCODAT 2016-2017) only 38% of Mexican smokers smoke every day (7-8 cigarettes on average). The rest smoke occasionally, like only 5-6 cigarettes during a party of social gathering, some smoke flavored cigarettes. These smokers with weak nicotine dependence would be a likely niche for VLNC’s and could be beneficial for them by keeping their nicotine dependence low. However, for smokers who are strongly dependent VLNC’s as only option would be close to torture.

    Finally, herbal cigarettes and herbs for pipe smoking have been in the market for a long time (you can buy them in Amazon). These products satisfy a small niche of smokers. I tried them when I smoked and would occasionally smoke them. Part of the dependence of smoking is the ritual and socialization. But in the end, whether it is tobacco or harms or cannabis, smoke is smoke is smoke and we all know the effects of smoking the smoke. In the end, if VLNC’s become an option they would fare more or less as these herbal cigarettes.

  11. Who’s spreading confusion? Your opening sentence is a complete fallacy as to what the VLN MRTP allows 22nd Century to state about its products. “FDA has authorised 22nd Century to claim a reduced nicotine cigarette is a reduced risk product.” ??? Odd extrapolation.

    1. It has been granted a Modified Risk Order and is now a Modified Risk Tobacco Product. As I doubt it would have been successful with a risk modification that increases risk, then I think it is reasonable to assume the modified risk in question is meant to be a risk reduction.

  12. The FDA authorized the marketing of VLN® with the following MRTP claims:

    “Helps you smoke less.”
    “95% less nicotine.”
    “Helps reduce your nicotine consumption.”
    “…Greatly reduces your nicotine consumption.” Clive I don’t see reduced risk mentioned?🤷🏻

    1. As you point out in your comment, the product is now classified as a Modified Risk Tobacco Product (MRTP) and FDA’s announcement is that it has granted 22nd Century a Modified Risk Order for these products. That is what they are called. If you want to look it up, the Tobacco Control Act explains the definition at 911(b)(1 & 2).

      But if you would like to understand how FDA allows reduced exposure products to be considered a reduced risk, you have to go deeper into the Act. This is explained in 911(g) Marketing, in particular, paragraph 2(A & B), “Special Rule For Certain Products”. This is the section of the Act that has been used to justify the reduced exposure claim (you can look that up in the FDA’s letter). The point is that FDA only grants reduced exposure claims if the conditions in 911(g)(2)(A&B) have been met. In short, these conditions mean the reduced exposure will lead to reduced risk or reduced harm. I’m sure you can appreciate the logic… what is the point of allowing claims that are not expected to lead to reduced risk?

      So, to be more precise, the key condition for a reduced exposure product is at 911(g)(2)(A)(iv), which reads:

      the scientific evidence that is available without conducting long-term epidemiological studies demonstrates that a measurable and substantial reduction in morbidity or mortality among individual tobacco users is reasonably likely in subsequent studies.

      I would recommend anyone speculating on FDA announcements to become familiar with the Tobacco Control Act.

  13. Confusing? “ The FDA was clear in its press release that in no way does it approve the usage of combustible tobacco products nor are VLN cigarettes considered healthy or safe. The products may be advertised as containing less nicotine and as helpful in reducing nicotine exposure.”

    1. The problem is that FDA’s announcement is incoherent. It has issued a Modified Risk Order indicating that it thinks the reduced exposure is likely to meet this standard for reduced exposure claims:

      911(g)(2)(A)(iv) the scientific evidence that is available without conducting long-term epidemiological studies demonstrates that a measurable and substantial reduction in morbidity or mortality among individual tobacco users is reasonably likely in subsequent studies.

      But although it refers to the cigarettes as Modified Risk Tobacco Products, FDA states:

      Additionally, we recommend that the LLA [label, labelling, advertising] include the disclaimer: “Nicotine is addictive. Less nicotine does NOT mean safer. All cigarettes can cause disease and death.”

      I would say that is confusing, but maybe it’s just me.

      The issue for the public is that these are officially blessed risk communications. They are not just for general interest but are supposed to change behaviour to secure the user a reduced risk. The problem is that nicotine is not the exposure that causes the vast majority of the smoking-related risk, a fact already misunderstood by the vast majority of Americans. FDA plays right into that misunderstanding.

      The whole thing is beside the point. Hardly anyone will use these products because they have none of the advantages of vaping and none of the point of smoking.

  14. John Pritchard is Vice President of Regulatory Science of 22nd Century Group. He had written the following prior to FDA’s recent MRTP announcement. Certainly an opportunity awaits anyone here with an opinion to debate the science behind VLN ( Very Low Nicotine). Remember their mission remains the elimination of cigarette addiction everywhere.

    No Bull: Innovation by Buffalo’s 22nd Century Group, Inc. Century Group At Heart of New Zealand & US Plans To End Cigarette Addiction.

    This is not the first time that Buffalo will change the world. From cardiac pacemakers, skin grafts, first US daycare for working mums…and of course our beloved Buffalo wings.

    A short drive from the home of the inimitable Buffalo Bills is a small plant biotechnology company, 22nd Century Group, Inc. Working with experts around the US, the company developed the #science and #technology to grow tobaccos with a 95% reduction in nicotine content. No chemical extraction, no radiation; just tobacco with the nicotine slashed grown by #US #farmers

    From this, a cigarette product was then developed in coordination with health agencies in the #unitedstates to explore what had been theorised, hoped for, but not evaluated.

    After 10 years of largely FDA and NIH-funded, independent research at leading institutions including Johns Hopkins, The Mayo Clinic, Roswell Park, MD Andersen and dozens upon dozens of clinics and scientific investigations, the results are crystal clear.

    People who smoke these reduced nicotine content cigarettes, even those with no interest in quitting, reduce their nicotine consumption, reduce the number of cigarettes they smoke by up to half, have more #smokefree days and double their quit attempts. People do not smoke more and more to get nicotine (“compensatory smoking”) and report no or only minimal cravings and withdrawal.

    Applied nationally, #FDA has concluded that 8 million US lives would be saved if all cigarettes were required to have nicotine at these low levels ie non addictive; with 5 million people switching to lower-risk sources of nicotine or quitting altogether within 1 year. National smoking prevalence will tumble to around 1% over time. Future generations would be protected from ever being hooked on cigarettes.#awesome

    We currently await FDAs decision on our MRTP application for a modified exposure order, so that the product attributes can be communicated to consumers in the US. I am delighted to see the #leadership by #NewZealand #Aotearoa as well as the US FDA’s firm commitment and drive to enact similar product standards in the US.

    I’m deeply proud of what 22nd Century has already achieved and the great people I work with. As before, our primary mission remains the elimination of cigarette addiction. Everywhere. Watch this space. 🦬 💪🏻 🌎 🚭

  15. Whether or not theyre marketed as an alternative to quick smoking, thats exactly how theyll be used. Only a small population of people will smoke these just for the sake of smoking (think if people who smoke clove cigarettes). Its really surprising for you to suggest things like vaping, which has almost 0 long term effects known, or pharmaceuticals that carries risks like “may cause suicidal thoughts”. Those who wish to quit often fail because they get stuck on the actual act of smoking after an activity (eating, drinking, sex, whatever). This allows someone to “scratch that itch” while weaning themselves off. You seem to be hyper focused on technicalities and how theyre being marketed.

    All of this is obviously completely ignoring their cannabis section of the company, which has much larger potential anyways. Interesting blog, but it just seems to be obtusely negative.

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