If you weren’t already aware, the FDA are currently accepting commentary on “Nicotine exposure warnings and child-resistant packaging for liquid nicotine, nicotine-containing e-liquids, and other tobacco products” whereby they are looking to, from those that are interested to comment, for information on the regulation of “tobacco products”. They are specifically looking for comments, data, research results and any other information that may inform regulatory actions that the FDA might take. If you haven’t done so yet, the link is here, it’d be worthwhile adding your own comments.
But for now it is worth noting that the University of California San Francisco (UCSF) Tobacco Centres of Regulatory Science (TCORS) have submitted theirs already, and frankly it is everything you would expect from these folks. Starting out with “exposure warnings”.
- Should FDA consider requiring nicotine exposure warning(s) text on liquid nicotine? If so, why?
Now you and I know that ‘liquid nicotine’ would generally entail such liquid to be pure nicotine. Liquid nicotine is pretty harmful stuff in its pure form and it is often quoted that 40 to 60 mg of nicotine is classified as a “lethal dose” though there are some arguments against that where it is suggested that 0.5 to 1 g of ingested nicotine (corresponding to an oral LD50 of 6.5–13 mg/kg) is the dose required to “kill an adult”. What do our “friends” at UCSF and TCORS say?
“Because liquid nicotine (which area solution that generally contain 1-2% nicotine in propylene glycol [PG], glycerol [vegetable glycerin, VG] or a mixture of the two) can be readily absorbed through intact skin, accidental exposures are considerably more hazardous for e-cigarettes than for conventional tobacco products. It is likely that the liquids pose a much greater ingestion hazard than conventional tobacco products as well, since nicotine in the liquids is likely to be absorbed much more rapidly than nicotine in a solid tobacco product. Large quantities of liquid nicotine can be purchased over the Internet, increasing the likelihood of serious accidental poisonings.”
So, in a nutshell these fnools believe that e-liquid (not to be confused with liquid nicotine here) is “considerably more hazardous” for e-cigarettes than for conventional tobacco products. Woo-wee. That’s a humdinger right there. Going by all the research into nicotine I can get my grubby mitts on, the amount contained within a standard 10ml bottle of e-liquid doesn’t come particularly close to the LD50 level of 60mg as is the generally accepted belief. Sure, ingesting 10ml of 1.8% (18mg) nicotine containing e-liquid isn’t going to be particularly beneficial to you, and I would strongly advise against doing such a thing, but it is unlikely (barring any unusual circumstances) to actually kill you. It’ll make you feel pretty crappy, nausea, vomiting, the works. Remember, the body knows just how much it can handle before it starts throwing warning signs at you, ignore those and you’re in for it.
“Calls to Poison Center in the U.S. have been increasing steadily since 2010, with calls per month increasing from one in September 2010 to 512 in February 2014. Exposures were most commonly ingestions (68.9%), followed by inhalations (16.8%), eye exposures (8.5%) and skin exposures (5.9%). E-cigarette calls involves children age 5 or less (51.1%), with 42.0% calls from peole > 20years. E-cigarette calls were more likely to report and adverse effect (57.6%) coampared to cigarette ingestions (36.0%). The most common adverse effects were vomting, nausea and eye irritation, with one suicide death from intravenous injection.”
I truly feel sorry for my American friends here, most of these “calls” could easily be avoided if adults behaved like adults and took responsibility for keeping potentially harmful stuff out of reach of kids. I mean come on, it isn’t rocket science really is it, kids know not to touch stuff like bleach, detergent tablets and so forth yet they still do. The only reason this particular argument gets any traction is that in the US there is this “let the State take care of it” type mentality where it seems (and yes I’m generalising here) that if anything at all happens, call your local poison centre or some such nonsense. What these folks fail to mention in this particular paragraph is calls don’t equate interventions where said daft youngling has been taken to his (or her) local hospital for actual treatment. What makes it worse is the definition of a “Call” (taken from the Morbidity & Mortality Weekly Report April 2014):
An e-cigarette exposure call was defined as a call regarding an exposure to the e-cigarette device itself or to the nicotine liquid, which typically is contained in a cartridge that the user inserts into the e-cigarette.
By that definition, a “Call” classed as an “e-cigarette exposure” wouldn’t necessarily mean exposure to the e-liquid, but would include the actual device itself. That on its own handily skews the results. Clive Bates performs his usual brilliant analysis based on American Association of Poison Control Centers report data, which when taken in context suggests that whilst the increase in “calls” regarding e-cigarette exposures have indeed increased they are still less than alcohol. Is it a cause for concern? Possibly, which is why there does need to be child resistant caps for all e-liquid as well as some bloody parental responsibility.
The next few answers ramble on about children and how they are “frequently ingesting tobacco products” until we get to some of the proposed “warning” messages.
It wouldn’t surprise you to know that these folks drew on “evidence from cigarette warnings and the World Health Organization recommendations” which is why the proposed warnings are more than a little cuckoo. “This product can cause and maintain addiction” is a prime example of how out of touch they are, nicotine on its own is not addictive, I get fed up with saying it. Nicotine is a poison, in concentrated pure form and I wouldn’t want to drink e-liquid anyway it is pretty vile stuff. Just so you know, when filling any of my tanks, I regularly spill some or find it all over my fingers, I’m still here, so the “do not let the liquid touch your skin”, “even in very small amounts” and “less than a teaspoon can kill you” are pure insanity. I’d be willing to bet a fair number of vapers regularly spill e-liquid or wind up with their hands covered in the stuff and none of us wear “protective gloves”. I can just imagine donning a pair of protective gloves in a vape-friendly pub just to refill my Lemo2, can you imagine how daft that would look?
- “Whether information about what to do in case of an accidental exposure to liquid nicotine should be included (in the warnings)
Sadly, these kooks take a wrong turn here:
I’m sorry, whilst UCSF may actually be good at some research (just not tobacco or nicotine research), I’d hardly call anything they produce in this field as “qualitative”. Instead these folks deride the vapour product stores whilst citing their own entirely flawed studies then go on to say “hey, if you’ve been exposed to liquid nicotine, call your local poison centre”, which will only bump the stats mentioned earlier. Got to keep those tax dollars rolling in somehow right?
If you’re still with me, I’ve skipped ahead in their “response” a bit to have a look at a potential “ad” that they claim will discourage smokers from starting to use smokeless tobacco. I think the ads speak for themselves really.
Aren’t they the ones claiming that vapour products and smokeless tobacco is being “marketed to children”? But yet they cite “research” on how effective the ads are:
They have plenty of “data” suggesting that the ads are effective, and as a side-bar some of the respondents actually think that smokeless tobacco is as harmful or more harmful than combustible tobacco! Who’da thunk it? Still will all this information on “nicotine liquid poisonings” and so forth (remember the beating of the “think of the children” drum), you’d expect them to have plenty more to say about child resistant packaging wouldn’t you?
Huh, they have no answer to some of the questions, or “not enough data” (cue the “more research” chant) to answer. But they do have one final nugget:
I’m guessing they have ignored or badly misinterpreted the latest research; especially when the “85%” statistic is drawn from a ridiculously small sample.