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FDA announces comprehensive plan for tobacco and nicotine regulation (fda.gov)
68 points by happy-go-lucky on July 28, 2017 | hide | past | favorite | 86 comments


It seems like targeting the cancer-causing agents in tobacco would be more important than targeting nicotine. With less nicotine, some smokers will inevitably smoke more, thereby consuming more cancer-causing chemicals than before this move by the FDA.


Cigarette companies have been tinkering with nicotine levels for decades. The available evidence suggests that while smokers may alter their smoking behaviour to some extent (taking longer and deeper puffs), their overall cigarette consumption does not significantly change.

As stated in the announcement, this decision is in the context of the widespread availability of reduced-harm nicotine delivery devices, namely e-cigarettes. Reducing nicotine levels in conventional cigarettes is hoped to push existing smokers towards e-cigarettes, whilst reducing the appeal and the addictive potential of cigarettes to young people.

I would hope that this decision will be backed up by pilot studies and long-term surveillance, but it seems quite reasonable prima facie.

https://www.ncbi.nlm.nih.gov/pubmed/25277253


>With less nicotine, some smokers will inevitably smoke more, thereby consuming more cancer-causing chemicals than before this move by the FDA.

Yes, this is exactly what will happen as happens with any addictive drug. The solution causes the problem to be worse. The government really needs to get out of the drug war business.


I agree in principal, but realistically I'm not sure that you can reduce the cancer-causing agents because some of them are the result of burning plant matter not additives. I think the idea they are working on is to make the product less addictive and thereby easier to quit using.


Well, for starters vapes/ecigarretes entirely avoid the cancer-causing agents of tobacco while still having nicotine. So it's pretty possible to do that for very cheap.


Except that when that liquid does hit the vaporizing bit it does create some carcinogens. Too early to tell if less/same/more carcinogenic. also,... popcorn lung.


>Too early to tell if less/same/more carcinogenic

Absolutely not. There is a substantial body of evidence showing that e-cigarette vapor is vastly less carcinogenic than tobacco smoke if the coil temperature is kept below ~220°C. Fortunately, the market is now awash with devices that have accurate temperature control.

The issue of diacetyl was potentially significant, but is now mostly fixed. Reputable manufacturers are aware of the toxicity of diacetyl and have overwhelmingly removed it from their products. Diacetyl is expected to disappear completely from e-cigarette products under the new regulatory regimes in the US and the EU. Cigarette smoke contains far greater concentrations of diacetyl than even the worst e-cigarette products tested.

This announcement by the FDA shows a clear intention to transition current smokers from combustible cigarettes to alternative nicotine delivery systems; this reflects the overwhelming body of evidence for the greatly reduced harms associated with e-cigarettes.

http://journals.plos.org/plosone/article?id=10.1371/journal....

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5377270/

http://www.sciencedirect.com/science/article/pii/S1438463916...

http://onlinelibrary.wiley.com/doi/10.1002/tox.20153/abstrac... https://academic.oup.com/ntr/article-abstract/17/2/168/28580...


Popcorn lung was a great example of the industry self regulating IMO. Reputable vendors all removed the problematic ingredient. Also, wasn't that whole thing overblown? I didn't follow it to closely so take this with a heap of salt, but I remember reading that the amount was way below problematic amounts even for heavy vapers.


Nicotine on its own is a highly addictive substance which provides no health benefits. It should be targeted just as well.


It's not though. It's a mild stimulant, with similar benefits to caffeine. (Not health benefits per se; it helps some people focus).

> Wikipedia summarizes Guillem et al 2005 as "Technically, nicotine is not significantly addictive, as nicotine administered alone does not produce significant reinforcing properties" - the addictiveness coming from MAOIs (eg. Khalil et al 2000, Khalil et al 2006) & possibly other compounds present in tobacco; while there don’t seem to many human studies aside from the Amsterdam et al 2006 review on the observed inhibition in smokers (consistent with the MAOIs playing a role in addiction), there are a number of significant animal studies:

https://www.gwern.net/Nicotine

Not to say it's not addictive at all, I'm mildly addicted to nicotine gum, to about the same extent I'm addicted to caffeine (if it's available I'll certainly take it, but if I run out, I'm not rushing to the store to buy more).


Perhaps the FDA should regular sugar and the amounts of it which make it into our drinks, bread, prepared sauces, etc.


One of the first things you notice when coming to America from Europe is just how damn sweet everything is. Even your eggs seem too sweet, let alone your drinks and actual sweets.

Maybe regulation is a good idea.


So the threshold is "provides no health benefits"? Should we also target coffee in the same way (nicotine being in the same classification as caffiene)?

How about we only regulated things which are proven to be harmful?


Nicotine is not that addictive. Coffee is just as physically addictive in my opinion. And I've actually managed to quit using nicotine several times whereas I've only successfully quit coffee once (and I'm back on it). Also, it does have health benefits, if alertness, relaxation, and mental clarity are health benefits, which are some of the effects of alcohol and coffee. Why does everything have to have a health benefit? I think some people would just lose it if they didn't have nicotine. Anyway, what's the harm to you?


You could say the same about sugar.


nootropic


Nicotine has several health and mental benefits and is not at all addictive if taken apart from cigarettes.

https://www.scientificamerican.com/article/is-nicotine-all-b...


Er, nicotine itself is absolutely addictive, regardless of the delivery mechanism. From the article you linked: "Scientists don't doubt nicotine is addictive".


Scientists also don't doubt that caffeine is "addictive." Anything can be "addictive."

Let's put it this way: are there any scientific studies with results indicating that nicotine, by itself, has significantly stronger self reinforcing properties in comparison to caffeine.

The answer is no: there are none. Quite the opposite. Nicotine has pretty weak self reinforcing properties for all the hype. The magic is in tobacco smoke and various other drug interactions that result in the strong self reinforcing properties of tobacco smoke. So, when many people bring up nicotine's addictive properties they're really talking about tobacco smoke.

There's also the hand-mouth habit, but I digress.


"A key piece of the FDA’s approach is demonstrating a greater awareness that nicotine – while highly addictive – is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes."

"Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts – and we believe it’s vital that we pursue this common ground.”

This seems like exactly the right approach to me and it is super exciting to see the FDA saying this stuff. I hope they stick with it.


Ignoring the politics as it distracts from the article.

It looks like the FDA is going.to regulate new tobacco products such as e cigarette's nicotine levels down to non addictive levels. While opening public dialogue as to whether the same should apply to cigarettes.


Why should it not apply to cigarettes as well?


From the announcement: "Importantly, the anticipated new enforcement policy will not affect any current requirements for cigarettes and smokeless tobacco, only the newly-regulated tobacco products such as cigars and e-cigarettes."


I smoked a lot for about 15 years. Every time I tried to quit it was cold-turkey and I don't remember ever feeling like I needed the nicotine, I just wanted to get away from whatever it was I was supposed to be doing, or what I was doing was so mindless I needed something to preoccupy myself (e.g. driving, walking, sitting around). I'm not sure nicotine is the problem for a lot of people. If it is, lowering it is just going to cause them to smoke more. I'm not sure what ultimately worked for me but I don't really think about it anymore and I can have a few while partying without getting sucked back in to the habit completely. NYS prices may have played a big role.


Why have I read a few comments saying lowering nicotine would cause people to smoke more? I've not smoked before so I don't really get it.


In my case, I don't think lower nicotine would have increased my smoking because I believe it was the act of smoking I was addicted to, not the drug. I'm sure nicotine had some effect on my quitting, I doubt I'm a special snowflake, immune to the addictive qualities of a substance. However, if nicotine is the only reason someone smokes, they're going to smoke whatever it takes to get their fix. Even without nicotine, the act of smoking anything is harmful. The more of that they do, the worse off their lungs will be. If anything, I think more nicotine per cigarette would be better.


It is like saying that if people need X amount of calories and you decide to put them on a diet by just giving them smaller portions, they will simply eat more portions to hit the calorie level they need.

If they smoke for the nicotine, they will smoke until they get the amount they crave. If they smoke because they like something else about it, then they won't. But most people smoke for the nicotine, or they would have some other habit instead.


People are used to a given amount of nicotine. If each unit of tobacco product has less nicotine, they will consume more units to achieve the amount of nicotine they are used to.


Nicotine is pleasant, it's a nootropic. If there's less in your chosen method of absorption, you will try to compensate.


Think of it in terms of lowering the oxygen levels in a sealed room. You body will gasp for air in a survival reaction.


There are a lot of comments about smoking more to make up for reduced nicotine levels, but this is a little bit misguided. Keep in mind the time it takes to consume nicotine. If you have a 5-minute smoke break at work you can't hang out for 15 minutes to smoke 3 because each cigarette is less potent. I'm sure there's a better term for it, but smoking isn't a zero sum game, you don't always have the option of increasing the quantity to make up for reduced concentration, if for no other reason than time and financial constraints.


Is smoking more to get the same buzz considered a win?


I believe the technical term is EBITDA-accretive.


I would not consider it to be one. Nicotine is not the most harmful part of tobacco use, the smoke is.

Nicotine is a helpful drug that enhances focus and working memory. Forcing tobacco to be sold with lower nicotine content seems to be throwing out the baby, and keeping the bathwater. Completely the opposite of what is good.


Cigarettes have NO medicinal value. Why are they not schedule one right up their with marijuana which research has indicated has many many medicinal uses?


With tobacco use already on a rapid decline, here comes to FDA, late to the party. But they're going to claim credit for it later, rest assured.


The tobacco branch was added in 2009.

NCTR research or any scientific research is not going to come out super fast.

https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalP...

disclaimer: my view is my personal view and not that of FDA.


That lag time is unfortunate. At this point I'd want to see research on regulating and stigmatizing marijuana use.

(One of the first things Canada did when making marijuana legal was to make "no smoking" zones extend to marijuana, too.)


Depending on the demographic it may not be in decline at all.


It seems like a lot of my younger friends are using a "juul", which has a ton of nicotine in it. I'm kind of scared for them.


Nicotine by itself is not dangerous. There's a VERY common misconception that nicotine itself is carcinogenic, while there is actually insufficient evidence for that. It's the tobacco, tar, and carbon monoxide that are responsible for most of the adverse effects of nicotine products.

The only concern with vapes like the juul is that while their base components are safe to vape, sometimes they use flavors which are not very well studied (and which, when heated, may degrade into carcinogenic chemicals).


While nicotine itself may not be a carcinogen, there's evidence it encourages the growth/spread of cancer and and increases the likelihood of recurrence. It might be inhibiting antitumor immune responses. [0]

[0] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4553893/


> There's a VERY common misconception that nicotine itself is carcinogenic, while there is actually insufficient evidence for that

It's because of the obnoxious metonymy "nicotine -> cigarette smoke" that appears even in research paper titles.


Also, I believe, with vapes that some carcinogenic compounds are created when the liquid is vaporized. That is to say some small part of it burns on contact with the heating element in the vaporizer and some of those combustion byproducts are cancer causing.


The problem is the food flavouring which has been extensively tested... as food flavouring and not when vaporized and inhaled (and there's the whole thing about to which temperature it's heated).

Personally I believe (and afaik current science supports that) vaping to be far safer, but it's probably not safe and there are a lot of unknowns left.


E-cigarettes are not really vaporizers. What they do is heat and aerosolize the e-liquid. Small particles of certain substances can be harmful.


Vapes! I see these smoke breathing dragons all the time!


Gotta keep the live stock healthy long enough to maximize future rent extraction potential.


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And how much lead is OK in drinking water?


That's is a very disingenuous response. I know most people have been conditioned to hate smokers over the last 20 years, but don't by obtuse about it.


The water utility is anything but a free market. It's not a very good analogy.


Given how addictive nicotine is does the free market even work? Isn't the pressure the addicts feel to get more nicotine a HUGE external force on the market that may distort it until it doesn't work?

After all cigarettes didn't become healthier once the dangers were know (long ago). The government had to step in.

To say nothing of tobacco companies acting like a cartel.


The most deadly addictive substance on Earth is sugar, it kills far more than nicotine could ever hope to. But for some reason the FDA doesn't care to restrict everyone's sugar intake. As far as I'm concerned all we needed was appropriate tort reform which would allow people who get cancer to sue tobacco companies for damages (before the warnings).


Nicotine is not super highly addictive, as far as drugs go.

Tobacco smoke is. It has MAOIs (addictive) and possibly other drugs.


It isn't a free market for a reason.


Nictotine isn't so bad, actually.[1] You seem like a science denier. Next thing we know you'll be telling us the earth won't burn to a crisp from the poisonous gas known as CO2.

[1] https://www.scientificamerican.com/article/is-nicotine-all-b...


Come on, Nicotine and CO2 aren't even remotely close to the same sort of thing. It's quite true that nicotine is only responsible for a small part of the (direct) harm of cigarettes, but nicotine has a lot of bad effects that the linked article doesn't mention. A big one for young women are the adverse effects on fetal development. Because of addictivness of the drug, many pregnant mothers are unable to stop nicotine consumption during their pregancy.

It's quite likely that there are useful applications of nicotine (even botox has uses!), but that doesn't mean the drug is safe for general use.


I think they did already. And people died...


That is basically what happened until now. And it had very catastrophic result.


Nicotine-related products kill far more people on a yearly basis than guns.


That's saying that steel is responsible for car crashes. Nicotine isn't harmless but switching to pipes, gum, or patches is a hell of an improvement. Nicotine on its own is in the same league as caffeine.


And much much more then some schedule 1 drugs. But hey, alcohol and ciggarets are cool, but LSD or some plants for which there is no known overdose can get you a lifetime in prison


But not nearly as many as sugar related products.


There is no such thing as a free market. It's a myth.

In the absence of government regulation, companies would withhold as much information as possible from consumers, preventing those consumers from making informed decisions about which products and services to consume. There would be overwhelming information asymmetry, which would lead to sub-optimal choices. Such a market would not be free, because companies would have immense power over consumers and would undoubtedly abuse it in order to maximize profits.

Capitalism leads to the most efficient allocation of resources, but government regulation needs to exist in order to ensure the profit motive does not outweigh the need to treat consumers fairly.


Ah, but the government has intervened for more than 30 years to make sure everyone knows the dangers of tobacco use.


>...preventing those consumers from making informed decisions about which products and services to consume.

Doesn't this provide an opportunity for another business such as Consumer Reports?


Consumer Reports would be useful in a limited capacity, but they could only report on products and services after the fact. They would have no access to important pieces of information such as the conditions under which the products are being produced.

The meat industry is a great example of this. Battles are being fought currently between companies and the people who record their operations on video. The former obviously doesn't want consumers to find out the horrendous ways in which they treat animals. The latter have to rely on the legal system (i.e. the government) to ensure that information is available to consumers so that they can make informed decisions.


Yes, but enlightened capitalism realizes that killing your customers is only good in the short run. In the long run it is much better if they remain living.


Maybe, but the problem with that is that by the time capitalism has realized that, many people have died.


[flagged]


> Oh, you know, maybe take a whack at regulating health care costs would be great.

I don't think FDA regulate healthcare cost... they regulate stuff for safety.

edit:

I'm current at FDA, my last day, I can find somebody to answer this debate I guess... but preeeeetty sure we don't do this.


That was more in response to the general federal government not specifically the FDA. This article smells like a "look, we're doing something useful that people will understand!"


Then they should be able to block single-payer. :)


If anything, the FDA would advocate for single-payer since it increase quality of care.


It does? For everyone? How so? Not being sarcastic, looking for folks thoughts.


I don't think the single payer system here will treat me unless I am dying. I've waited four months to be scheduled for a dermatologist, each time it's a new "clerical error" or "honest mistake". First they "forgot to fax the file", then the dermatologist "forgot to process the fax", then they "forgot to schedule your appointment", surely they'll "get you in for Tuesday next week, if that's alright with you" :- \


What country are you in? This isn't common for me in the US.


Canada


Is this something that is in scope for FDA?


We'll know after the tobacco companies' first lawsuit gets to the Supreme Court.


Parent comment was referring to off-topic comment about regulating prices, not the article.


Yeah, it's food and drug. If you put it in your mouth, it's FDA


They can't regulate drug prices much more than they can regulate food prices.


Not directly, but they decide the hurdles someone has to jump through in order to get a drug. They control whether it's out on the shelf or behind the counter. They control whether a prescription is required. They control whether generics are approved, etc.


By that logic why is the DEA not setting the price of drugs i get from my dealer?


Don't they in effect?


I think alot of underage buyers use eBay for vapes. Even though the products are on the "prohibited" list, it's got to be one of ebays biggest categories.




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