health, legislation, politics, studies, vaping

EPA & FDA: Vapor Harmless to Children

In the continued war on e-cigarettes, we hear about the “potential dangers” of e-cigarette vapor and the “unknown public health risks.”

First, I find it absolutely absurd that we’re attempting to pass laws based on unknowns, but what makes it even more absurd is the fact that there’s very little that isn’t known about e-cigarette vapor at this point.  The primary ingredient of concern to those who wish to see e-cigarettes banned is the propylene glycol vapor, which has been studied for over 70 years.

I recently came across a document titled, “Reregistration Eligibility Decision For Propylene Glycol and Dipropylene Glycol“, which was created by the United State Environmental Protection Agency (EPA).

Catchy title.  I was intrigued.

This quote caught my eye:

Propylene glycol and dipropylene glycol were first registered in 1950 and 1959, respectively, by the FDA for use in hospitals as air disinfectants. (page 4, paragraph 1).

In a previous post, I had shared the summary of research that had been done in 1942 by Dr. Robertson regarding the antibacterial properties of vaporized propylene glycol, but I had never heard that the FDA wound up approving it for the purpose of an air disinfectant in hospitals.

Indoor Non-Food:  Propylene glycol is used on the following use sites:  air treatment (eating establishments, hospital, commercial, institutional, household, bathroom, transportational facilities); medical premises and equipment, commercial, institutional and industrial premises and equipment; (page 6, paragraph 2)

Continued…

Method and Rates of Application

….

Air Sanitizer

Read the directions included with the automatic dispenser for proper installation of unit and refill.  Remove cap from aerosol can and place in a sequential aerosol dispenser which automatically releases a metered amount every 15 minutes.  One unit should treat 6000 ft of closed air space… For regular, non-metered applications, spray room until a light fog forms.  To sanitize the air, spray 6 to 8 seconds in an average size room (10’x10′). (page 6, paragraph 6)

A common argument used to support the public usage ban is that, “Minnesotans have become accustomed to the standard of clean indoor air.”  However, according to the EPA and FDA, so long as there’s a “light fog” of propylene glycol vapor in the air, the air is actually more clean than the standard that Minnesotans have become accustomed to.

General Toxicity Observations

Upon reviewing the available toxicity information, the Agency has concluded that there are no endpoints of concern for oral, dermal, or inhalation exposure to propylene glycol and dipropylene glycol.  This conclusion is based on the results of toxicity testing of propylene glycol and dipropylene glycol in which dose levels near or above testing limits (as established in the OPPTS 870 series harmonized test guidelines) were employed in experimental animal studies and no significant toxicity observed.

Carcinogenicity Classification

A review of the available data has shown propylene glycol and dipropylene glycol to be negative for carcinogenicity in studies conducted up to the testing limit doses established by the Agency; therefore, no further carcinogenic analysis is required. (page 10, paragraphs 1 & 2)

Ready for the bombshell?  I probably should have put this at the top, as it could have made this post a lot shorter, but I figured the information above was important, too…

2. FQPA Safety Factor

The FQPA Safety Factor (as required by the Food Quality Protection Act of 1996) is intended to provide an additional 10-fold safety factor (10X), to protect for special sensitivity in infants and children to specific pesticide residues in food, drinking water, or residential exposures, or to compensate for an incomplete database.  The FQPA Safety Factor has been removed (i.e., reduced to 1X) for propylene glycol and dipropylene glycol because there is no pre- or post-natal evidence for increased susceptibility following exposure.  Further, the Agency has concluded that there are no endpoints of concern for oral, dermal, or inhalation exposure to propylene glycol and dipropylene glycol based on the low toxicity observed in studies conducted near or above testing limit doses as established in the OPPTS 870 series harmonized test guidelines.  Therefore, quantitative risk assessment was not conducted for propylene glycol and dipropylene glycol.

In a paper published in the American Journal of Public Health by Dr. Robertson in April of 1946, Robertson cites a study published in the Edinburgh Medical Journal, which was conducted in 1944:

The report of the 3 years’ study of the clinical application of the disinfection of air by glycol vapors in a children’s convalescent home showed a marked reduction in the number of acute respiratory infections occurring in the wards treated with both propylene and triethylene glycols.  Whereas in the control wards, 132 infections occured during the course of three winters, there were only 13 such instances in the glycol wards during the same period.  The fact that children were, for the most part, chronically confined to bed presented an unusually favorable condition for the prophylactic action of the glycol vapor.

An investigation of the effect of triethylene glycol vapor on the respiratory disease incidence in military barracks brought out the fact that, while for the first 3 weeks after new personnel entered the glycolized area the disease rate remained the same as in the control barracks, the second 3 week period showed a 65 percent reduction in acute respiratory infections in the glycol treated barracks.  Similar effects were observed in respect to airborne hemolytic streptococci and throat carriers of this microorganism.

I don’t expect the prohibitionist lawmakers to delve this deeply into this subject on their own, but I certainly hope that when presented with this data that they reevaluate their stance on the subject and consider what science has to say.  If they don’t, they’re simply basing their judgement off of rhetoric, misinformation, and personal bias and we all know where that gets us.

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58 thoughts on “EPA & FDA: Vapor Harmless to Children
  • Jaocb says:

    wow im actually gonna save thi article to refer people to if they have concerns about e-cigarettes. this is a very unbiased and informative article and i aplaud you for being unbiased.

    • matt black says:

      Thank you!

    • rich says:

      All this is based on experiments from the forties? Maybe that’s why… Reulations and technology …awareness have come along way since then… This information inhold as obsolete

    • Liza says:

      This is great news indeed, but I wonder why vaporers continue to call our vaporizers “cigarettes”. We all know that cigarettes are bad for one’s health.

      • matt black says:

        Seriously – that was the dumbest name we could have come up with for vapor products. I think the name is slowly being changed, but associating vapor products with cigarettes has not done us any favors.

  • […] EPA & FDA: Vapor Harmless to Children. […]

  • Rory Gile says:

    Wow…what an idiot! He doesn’t even mention the nicotine…

    • matt black says:

      You mean.. the nicotine that has only been found in absolute trace levels in exhaled vapor? Such low trace levels, in fact, that it pales in comparison to your exposure to nicotine from eggplants, soybeans, and various other vegetables? That nicotine?

      Yeah, I didn’t mention it because it would be idiotic to do so since it’s virtually not present in the exhaled vapor. But, if you insist that I mention it, here you go: http://www.biomedcentral.com/1471-2458/14/18

      Side note – it might be wise not to call people idiots when you don’t know what you’re talking about. It kind of makes you look like, well, an idiot.

      • Joseph Filemu says:

        Matt, great work man. Research like this is what the vape community needs with our battle to get out a life saving product. I would say you take care of the research and let the little guys handle these small fry, but that reply leads me to believe you can hold your own lol.

      • Greg says:

        Hi Matt,

        Great article as well as your response to the person calling you an idiot. Hopefully he will think twice next time.

        If you have it handy, it would be ideal to include all of the ingredients in one list, simply because I think it would be forwarded all over the place. Got the pg down and a link for the nicotine. Do you have vg? I know vg (vegetable glycerin) is very good for the human body.

        We actually manufacture organic flavored liquids so if someone was vaping our Green Apple, they would be vaping Organic Green Apple (so fruit), food grade vegetable glycerin, distilled water with nicotine and pg optional. Now who in their right mind would still state that “we can not determine if electronic cigarettes are better or worse than traditional cigarettes”. Man everytime I hear that argument I want to slap the commentator!!

        Thanks again!

        • matt black says:

          Let me see what I can come up with.

          And yes, through this whole advocacy process, I’ve wanted to slap many, many people. I’ve also discovered just how damaging the media is to common sense.

    • Joseph Filemu says:

      Wow… what an idiot! You clearly have no research to site from and make and assumption regarding an irrelevant topic to the article. Great job! You my friend, win the Idiot award… Is what I want to say. But since I can’t say it, go ahead and knock yourself out reading it. Thank you for playing the internet.

  • zooted says:

    “Robertson cites a study …” This links to some kind of index/excerpt of a foreword, not to what I’m assuming you wanted to link to.

  • Ray Yeates says:

    Thank you Matt. Superb research. I’m posting it everywhere I go . Keep up the great work.

  • Kimberly Biggs says:

    Excellent work, very well done and streamlined! This relatively short, to the point, and informative piece of work is just what vapers like me need when the whole anti-freeze and “What’s in e-juice?” topics come up. Great job!!!

    • matt black says:

      Thank you! I came across the info last night while doing some research and was like, “why wasn’t I already aware of this?” So, I’m happy others will find it useful..

  • Matt Novak says:

    So, this all focuses on PG, and vaporized in a way different from how e-cigs convert the stuff (atomization vs. vaporization via heating).

    Do we know if the fact that the vapor is produced via heat, and not by being forced through a very small opening at high pressure, changes anything? I would imagine, through my fairly rudimentary understanding of chemistry, that yes, it does.

    And what about the flavoring chemicals? We all know about diacetyl, and other diketones, but what about the other ingredients, of which there are many? Yes, any reputable vendor/manufacturer will only put out eliquid flavored with ingredients at least GRAS/FDA approved, but those approvals tend to focus on the ingestion of the ingredients, NOT the heating and inhalation of them (as is the case with diacetly).

    So, we know that PG vapor, when atomized via physical forces, is safe, and indeed beneficial, but what about when heated and inhaled? What about VG? And the flavors?

    Don’t mean to try to rain on your parade/shit in your picnic, but these are things we need to know/that need to be addressed.

    • matt black says:

      If we look at Dr. Burstyn’s findings in his peer reviewed study, “Peering through the mist”, he makes 9,000 unique observations of every component of electronic cigarette vapor. His findings confirm the little to no toxicity of PG that these earlier studies discovered, even when atomized. (his study is here: http://www.biomedcentral.com/1471-2458/14/18). Here’s a quote from his conclusions:

      “Exposure of bystanders to the listed ingredients, let alone the contaminants, does not warrant a concern as the exposure is likely to be orders of magnitude lower than exposure experienced by vapers.”

      Which is similar to the conclusion in McAuley’s study, published by the National Institute of Health:

      “The study indicates no apparent risk to human health from e-cigarette emissions based on the compounds analyzed.” – http://www.ncbi.nlm.nih.gov/pubmed/23033998

      So the flavorings, nicotine, diacetyl, etc. are not really relevant to this article, because my focus was addressing the “unknown public health risk” argument that vaping advocates are running into when confronting public usage bans, and because these chemicals are only present at absolute trace levels, if at all, I chose to address the primary ingredient of concern with regards to public health via second hand exposure.

      Dr. Burstyn’s research addresses your concerns, and I highly recommend you check it out.. it’s good information and sheds a lot of light on this subject.

    • Greg says:

      Well let me help you out with that. We have a master Professor of Toxicology and Pharmacology that has almost 70 years experience. He was a chief advisor for the FDA, WHO (World Health Organization) as well as a senior global authority in approving many medications on a global scale and defining precautions with outbreaks and pandemics meaning if he makes 1 phone call and says “close the airport”, he is not questioned and the airport is closed. Huge, impressive and extensive curriculum. That being said, he has extensively researched ingredients in e-liquid and he approves most ingredients. He had an issue with “Linalool ” which is typically found in Chinese made e-liquids and also in the artificial flavoring in some eliquids made in the USA. He stated that he would thoroughly approve an e-liquid 100% which does not contain Linalool. We took his advice and went as Organic as possible.

      Now the professor went over the typical ingredients in e-liquid which are: Food grade vegetable glycerin, food grade propylene glycol, natural or artificial flavoring, nicotine (which is optional). Every single ingredient was thoroughly approved and safe for inhalation. The nicotine also did not have issue as far as an inhalation vs consumed application. Again he only had an issue with “Linalool” but it was not anything dangerous but something to steer away from if given the choice.
      So where do you get so many ingredients? In the e-liquids we manufacture, we use 3 ingredients: VG, Organic flavoring, distilled water. That’s 3 ingredients!! Again nicotine is optional so that could make it 4 ingredients.

      • matt black says:

        It would be AWESOME to get his message out to the masses. We need people like him to help dispel all of the misinformation and media hype over this crap. It gets tiring and seems absolutely ridiculous that we’re fighting with government over getting people to quit smoking.

  • Rob says:

    I thought everyone knew about that. PG is used by hospitals, pumped into the air system, to enhance sterility. The anti-bacterial and humectant properties of PG are well established. Further, PG is an acceptable carrier used in breathing treatments and can be found in some inhaler preparations. All this can be found on nih.gov for more info.

    • matt black says:

      I knew about Dr. Robertson’s research, I just had never heard of the FDA approval of it, nor the EPA’s findings of its use in closed environments.

  • Dragonmum says:

    Great article. I am so sick of defending the e-cig that I am going on the attack. In four years of vaping I have not had an asthma attack nor have I needed the antibiotics and steroids that were a steady diet; much of this I attribute to the germicidal properties of PG, and other vapers have had the same experience. May I use some of your findings in my campaign?

    • matt black says:

      Absolutely. If you could link/credit this article in someway, it would be appreciated. But I definitely want people using this info to help the fight.

  • Marji says:

    Information well done! I am very new to e-cigarettes (Jan. 8, 2014), but since then I have not had a REAL cigarette since then. I have smoked since I was 17 and am now 68. I can tell you that one of my daughters was very concerned about a cough I had. Since the change the cough is now completely gone! I also don’t ‘stink’ from the tar and can actually ‘smoke’ in my home (apartment) without concern of staining walls, furniture, etc.

    Thank you Matt for the wonderful confirmation of benefits! This WILL be shared!

  • Mike R. says:

    Good read. Though I think it looses some credibility by citing a study that was done in the 1940’s. Science and medicine have changed significantly since then. Lots of chemicals that were considered harmless then are not. While I don’t believe propylene glycol is harmless, a better argument would include reference to a paper published within the last 10-15 years.

    • matt black says:

      So… if we cite new studies, we’re blasted with the “no long term research” rhetoric. And if we cite older studies, we’re hit with “its age loses credibility”. We can’t win! lol

      Anyway, the EPA document, which is where the majority of the findings that I quoted came from, is from 2006. Additionally, there’s Dr. Burstyn’s peer reviewed study, “Peering through the mist” which was published in the BMC Public Health Journal in January of 2014. He made 9,000 unique observations and his findings just emphasize what these earlier studies show. It’s also ecig centric, so it examines all components, not just PG.

      Here’s the link. http://www.biomedcentral.com/1471-2458/14/18

  • kanor says:

    GREAT ARTICLE!!! now i have a concrete reference for educating people about vaping. i am from the Philippines and i will share this with all the vapers i know!

  • Robbie says:

    It’s not about safety. it is about money, but wisdom kills so many things.

  • Doug s says:

    Matt black. You crack me up. Spot on post, good banter. And a thank you for the time spent in letting us know. Ta

  • Doug s says:

    Why also is there so many negative idiots, who leave comments without obliviously reading the article…

  • Dave says:

    I have to disagree with you on one major point of this article:

    “they’re simply basing their judgement off of rhetoric, misinformation, and personal bias”

    Sadly, it’s pretty apparent that what they are basing their judgement off of is none of those things. It’s based off of money paid to lawmakers to make their judgement based on the special interests of tobacco and pharmaceutical companies.

    Other than that, fantastic article, and thanks for posting it!

  • Tatiana Castro says:

    I understand that propylene glycol and dipropylene glycol are not toxic. My question is, related to the nicotine. Is there a study showing the effects of the combination of nicotine with propylene glycol and dipropylene glycol? Also, is nicotine also expelled in the air when vaping an e-cigarrette?

    Thank you and God bless.

  • […] EPA & FDA: Vapor Harmless to Children […]

  • […] Actually, all that was complete bullshit as well. In fact, a recent study by both the EPA and the FDA proved that the vapor is 100% harmless, even to kids. […]

  • […] For those who point to propylene glycol as a "dangerous" ingredient: EPA & FDA: Vapor Harmless to Children | Minnesota Vapers AdvocacyMinnesota Vapers Advocacy […]

  • […] EPA & FDA: Vapor Harmless to Children […]

  • James says:

    I am more curious about the effects of the different extracts and flavoring used in e liquid. Any insight?

    • matt black says:

      This is one area that I will admit needs more research. This is, honestly, where the FDA should be spending their resources.

      There are a few flavor additives that we know not to use. One main one is Diacetyl, which is found in some buttery type flavorings. The well known flavor vendors are, however, aware of this and are no longer including Diacetyl in their flavor additives. And any flavors that do contain it are usually labeled.

      Any risk from flavorings and extracts, however, would be limited to the user.

  • […] A fascinating article about FDA & EPA research that provides proof  that vapor is harmless. Thi… […]

  • […] EPA & FDA: Vapor Harmless to Children | Minnesota Vapers AdvocacyMinnesota Vapers Advocacy […]

  • Dian Burnett says:

    I would like for people to know that I smoked since I was 13..and I quit smoking 2 years ago and have been vaping since then..I was smoking 2-3 packs a day of full flavor cigarettes. As we all know cigarettes can cost 5-7 dollars a pack. And that is not the best thing yet. I have cut the amount of how much it cost to smoke from 10 dollars a day per month..adds up to 300 bucks a month to 30 dollars with e liquid. I LOVED my cigarettes! I have not had a sinle cigarette for 2 years. I no longer get short of breath, no do I smell like a cigarette, and all you non smoking people have no secong\d hand smoke..So What is the problem?

  • Phil Busardo says:

    Although I think this in an excellent article Matt and should be shared, I feel it leaves several items out. Nicotine, VG, and even the flavorings. Not to mention the high temps that “Cloud Chasers” like to fry their liquids at. I think we can all agree that testing needs to continue, and as our vaping habits and devices change, the testing should follow suite. And when I talk about testing, I’m talking about testing everything… liquids, vapor, build materials, builds, temperatures, etc. If there are problems, let’s identify them and fix them without freaking out. If there aren’t… knowledge is power! :-) Nice work Matt!

    • matt black says:

      Hey Phil,

      Thank you! And… I agree. Since we’re all vapers, I think we all have a desire to know and understand the facts of what it is that we’re inhaling. I think Igor Burstyn’s study does a good job at summarizing it for us, but continued research is important. I just wish this whole issue weren’t so polarized, because it makes it impossible to identify & publicize potential problems & concerns without worrying about the anti’s using it as ammunition in their crusade to ban vaping. It’s incredibly frustrating. Ugh.

  • Ed W says:

    First the title hereis beyond misleading since there is no mention of nicotine. We don’t absorb all the nicotine into our bodies so trace amounts will be exhaled. Compared to other toxins in the air we breathe already the effects are likely non-existent but don’t use a the poor title of this article to justify blowing clouds at your toddler. My other beef is the age of the studies quoted. If I go back far enough I can find studies that say heroin is a good way to relieve migraines or women can only get pregnant during a full moon. A lot has changed since the 40s and we need new, legit, unbiased studies done to backup our argument that vaping is safe. Please, dont use articles like this to counter the fear mongering the NY Times uses, it makes us all look like idiots.

    • matt black says:

      You’ll notice that the bulk of the article is citing the 2006 EPA reregistration, which was re-registering vaporized PG. It was first registered and FDA approved for air sanitization in 1950 & 1959. So, this was the EPA saying that the original findings are still valid.

      Please read before offering to opine.

  • Alan Fletcher says:

    I must admit I already knew that PG was approved by the FDA as a hospital air disinfectant. I read it somewhere not long ago. As it is still approved and used, it is of no concern that earlier studies may be deemed worthless. There was no need to cover nicotine as well as it is also used in pharma NRT and deemed harmless there as well. Thanks Matt anyway for re-reminding or reminding the vaping community about PG.