FDA Vaping Regulations: An Absurd Perverse Government Failure



thank you for joining me on may 10th 2016 the United States Food and Drug Administration's center for tobacco products officially released regulations regarding vaporization technology as they are written the regulations enact a complete prohibition from sale any vapor products in the United States within two years they basically make all vaporizers or electronic cigarettes illegal to sell anywhere in the United States unless those products are specifically approved by the government now the federal government through the FDA has made no claims that the products are inherently unsafe and has not presented any scientific evidence they're harmful and need to be banned from sale in fact most scientific evidence shows exactly the opposite that smokers who switched to vaping improve their help significantly a few weeks before the prohibition was announced the Royal College of Physicians in London England released a study of vapor products called nicotine without smoke tobacco harm reduction now the Royal College of Physicians is one of the has been one of the most respected medical groups in the world for five hundred years it was actually established in 1518 by King Henry the eighth and their report had the following conclusions that harm reduction has a huge potential to prevent death and disability from tobacco use and hasten our progress to a tobacco-free society in normal conditions of use toxin levels in inhaled a cigarette vapor are probably well below prescribed threshold limit values for occupational exposure in which case significant long-term harm is unlikely although it is not possible to precisely quantify the long-term health risks associated with e-cigarettes the available data suggests that they are unlikely to exceed 5% of those associated with smoked tobacco products in other words vapor products are 95 percent safer than the traditional combustible tobacco product and probably even more safe than that nicotine from exhaled vapor can be deposited on surfaces but at such low levels that there is no plausible mechanism by which such deposits could enter the body at doses that would cause physical harm in other words vapor products pose no secondhand smoke or secondhand exposure to by standards and finally they said harm reduction provides an opportunity to improve the lives of millions of people is an opportunity that with care we should take so in the UK they are embracing the concept of tobacco harm reduction for smokers but here in the United States the government is rejecting it the FDA's prohibition is achieved through a massive regulatory framework that does not treat vapor products like regular consumer products or even traditional tobacco products or even as a something new like a cigarette replacement they treat it like pharmaceuticals and put them under the same approval framework the regulations consist of a 500 page document that puts a nearly insurmountable hurdle on companies in order to obtain government approval for sale for their products the FDA estimates that an application for a product will take a minimum of 1500 hours to complete and in addition most industry analysts expect the application will cost nearly a million dollars per product and none of this guarantees approval the FDA is under no obligation to approve any products and certainly can reject all of them compliance with the government is set so high and so onerous and so expensive that only the biggest companies in other words in this case the big tobacco's cigarette companies will have the money and resources to get through the FDA approval process and most likely 99.9% of all vapor products in the market today will not be approved and will be banned from sale and this ventilation is actually not just for vapor products the center for tobacco products also released the same type of regular Asians for premium cigars and hookah as well so what we could see is a complete government prohibition of the legitimate sale of vaporizers premium cigars and hookah now let me address one thing at the beginning here this is not about kids it's not about protecting kids you don't need a 500-page regulation document to protect children what you need is just a one-sentence law that says you cannot sell vapor products to any person under the age of 18 much like what we do for alcohol we have laws restricting you know with age restrictions for use and I agree with the premise that the product should not be in the hands of minors and support all of the restrictions to that effect there's already a federal law that says that mandates childproof caps for a liquid which is used with vaporizers and electronic cigarettes but that's not what this is about what the executive branch of the US government is attempting to do is prohibit the legitimate sale of vapor and premium cigars and hookah to adults now let me say that again what the government wants to do is ban the sale of these products to adults now as I will explain the regulations are illogical they ignore science they pervert the entire effort to reduce the use of harmful combustible tobacco products and show an absolute failure of government regulatory policy so first on their face the regulations seem illogical and absurd so this is a vaporizer it's made of metal and Pyrex glass and has a battery inside under the regulations this would be labeled as tobacco this is e juice this is the liquid that you would put inside the tank of the vaporizer now the e juice is a glycerin suspension made up of two ingredients vegetable glycerin and propylene glycol and flavoring now it can contain liquid nicotine as well what I'm holding in my hand though does not this is called a zero this has no nicotine at all just the glycerin and flavoring this is another brand of ejuice and this company actually doesn't even put any propylene glycol in their ejuice this is just vegetable glycerin and flavoring those are the only only ingredients however under the regulations this would be labeled as containing tobacco so let's take a look at what the FDA regulations say the alternative warning statement for products that do not contain nicotine ie no nicotine at detectable levels is revised to read this product is made from tobacco and let's take a look on the FDA's website it says if the tobacco product manufacturer submits a self-certification statement to FDA that the newly regulated tobacco product does not contain nicotine and the manufacturer has data to support this assertion then the alternate alternate statement must be used on the product packages and advertisements this product is made from tobacco so this bottle of ejuice that is contains only a combination of vegetable glycerin and flavorings would have to have a label saying that it contains and is derived from tobacco this is government mandated Mis labeling of products and provides misinformation to the public the FDA actually wants consumers to be told incorrect and inaccurate information about vaping products the other components of vaporizers actually would also now be considered tobacco for example the battery so this is a battery this is called an 18 650 battery these were originally designed to be used in flashlights but because they're very powerful we use them in vaporizers and the way they work is that this is a typical vaporization device and what you would do is take the battery and put it in and then you can use the product the battery would now be labeled as tobacco this is wire this is called Kanthal a1 wire it's the most common wire used as a heating element inside of the vaporizer the wire is made of a made up of the elements iron chromium and aluminum under the FDA regulations this would now be labeled as tobacco this is cotton organic Japanese washed cotton it's one of the most common wicking materials that are used inside of Modern advanced vaporizers under FDA regulations cotton would now be labeled as tobacco so let's take a look at the regulations and what they say the following is a non exhaustive list of examples of components and parts used with electronic nicotine delivery systems and that's what they're calling them in this document in the regulations eliquid x' atomizers batteries cartomizers digital displays or lights would now be labeled as tobacco flavors will be tobacco the vials that contain a liquids will be Kotak tobacco and software programmable computer software if it is related to these devices would now be labeled as tobacco and what I find curious is do these products that are now labeled as tobacco retained that designation in other applications so for example the batteries if the you know now if you use the battery and a flashlight does it still retain its tobacco designation so now we have the surprising innovation of tobacco powered flashlights so in Congress passed the Family Smoking Prevention and Tobacco Control Act in 2009 did they direct the FDA to mislabel products well no in fact there's a section called misbranded tobacco products and in it the law states that tobacco products should not have labeling that is false or misleading and should show accurate contents as the amount of tobacco present in the product so it's clearly not the intention of the law to have products mislabeled in the public deceived but if you're pursuing a policy of prohibition then you can't accurately describe how good the products are or how they're not tobacco because then why are you banning it so part of the problem here is that the 2009 Family Smoking Prevention Act that the FDA is using to justify their regulations never mentions vapor or vaporizers or electronic cigarettes or any electrical devices at all the regulations were written focusing on limiting the use and protecting the public from harmful combustible tobacco products and so the FDA regulations are basically made up the FDA is usurping their power over these products and was never given specific authority over them through direct statute now the rules do not include a lot of items that you think would be necessary for good product regulation there are no uniform safety standards there are no manufacturing standards there is no description of what good manufacturing processes would be there's no description of how the science says that some products are better than others and there is nothing from the FDA of regulations that show how they would how the regulations would be impacting the public's health in fact over and over again in the regulations the FDA indicates is does not have sufficient data about vapor products to know how it would impact the public health so admittedly the government is regulating based on insufficient data but what the regulations do in abundance are very very strict regulations on how manufacturers and retailers can advertise the products of course if the manufacturers and retailers were able to truthfully explain the products then again the prohibition wouldn't make any sense so for example the zero nicotine ejuice the government does not want you to actually advertise and explain how this product does not contain tobacco because it has a warning label on it saying it does contain tobacco even though it doesn't you have retailers described you know advertising a tobacco free tobacco product which of course wouldn't make any sense so let's take a look at the regulations the restrictions on advertising the first part of it here says that they are restricting the vapor manufacturers and vapor retailers from comparing a vapor product to a traditional combustible product in a way in which the public would think that the vapor product is safer or less harmful the restriction the advertising restrictions also say and this is the very last line you cannot advertise what a product contains or is free of in other words again they don't want the retailers or manufacturers to be describing these products as tobacco free even though they are tobacco free because they're carrying a label that says that it contains tobacco this is for these zero nicotine eaters so what's going on here what is the FDA's philosophy regarding vapor products how come none of this seems to make any sense well bird about halfway through the regulations in this 500 page document they actually come out and explain their philosophy and so here it is for the purposes of this deeming regulation FDA does not believe that is necessary to distinguish between vapor products and combusted products so it considers vapor products and traditional combustible cigarettes to be the same they are trying to intentionally confuse the public and I think the best way we can describe this is that that statement is scientifically inaccurate once again this is not what Congress intended by the original legislation the 2009 Family Smoking Prevention Act if you look at the Act it clearly says that the FDA must consider scientific evidence when it's regulating so vegetable glycerin is not tobacco and when you heat vegetable glycerin into a vapor it is not smoke but in trying to establish a regime of prohibition based on a scientific falsehood the FDA has produced a set of regulations that are illogical absurd and intentionally misinformed the consumer but it actually gets worse so let's go a little bit deeper into the rabbit hole smoking tobacco cigarettes is the leading form of preventable death and disease in the United States the number of the government uses is that more than four hundred and eighty thousand people die each year from smoking cigarettes under these new regulations deadly combustible cigarettes will completely escape any additional regulation or sales restrictions all aspects of what many consider to be the most harmful consumer product ever manufactured and sold will remain the same and completely untouched so what does FDA regulation of cigarettes look like so this is a pack of USA cigarettes as they are legally sold in the United States and FDA approved on the pack there is very little information there are no ingredients there is no nutritional information no caloric information all the normal things you would see on most food or drug products in fact there's not even any indication of how much nicotine is in this product the main product that is killing people is allowed to continue to be sold unabated while the less harmful alternative that does not produce tar and can completely eliminate secondhand smoke faces 500 pages of governmental regulations just a few weeks before the regulations were released a study funded by the FDA by their National Institute on Drug Abuse found that the evidence suggests a strong potential for vaporized nicotine product use to improve population health by reducing or displacing cigarette use in countries where cigarette prevalence is high and smokers are interested in quitting the authors found that studies indicate that most smokers use vaporized nicotine products with the intention of quitting smoking cigarettes they also warned that countries whose policies discourage vaporized nicotine product use run the risk of neutralizing a potentially useful methods of reducing tobacco use however the FDA has chosen to ignore its own science while deadly tobacco cigarettes face no regulation or sales restrictions no additional regulation or sales restrictions the must much less harmful alternative faces prohibitive over-regulation the second point is that these regulations pervert tobacco control and harm reduction efforts because they empower the big tobacco companies on the same day of the introduction of the regulations Mitchell Zeller the head of the FDA Center for tobacco products appeared on PBS to defend his department's new rules he was asked about empowering the big tobacco companies and you'll see in this clip he doesn't deny it and in fact tries to dodge the question then change the subject let's take a look the industry is also pushing back as expected and saying look the fees and the process and the structure you have for the applications is gonna essentially close down some of those small businesses and small manufacturers and it's essentially gonna protect the big tobacco companies that have shifted and you're really gonna be giving them an advantage over the long haul this is a public health issue beyond e-cigarettes we're also talking about the need to regulate cigars every single day more teenage boys light up a cigar for the first time then light up a regular cigarette so between cigars and e-cigarettes we have a lot of work to do to protect kids from the harms of tobacco products no no I'm sorry mr. Zeller I completely disagree I do not agree that empowering multinational big cigarette tobacco cigarette companies is good for public health he didn't deny it and he changed the subject because he knows his department is turning the vaporization market over to r.j. Reynolds and philip morris and british american tobacco and wall street agrees Wells Fargo securities notes that regulation of the e cig vapor industry is broadly positive for the big tobacco manufacturers since it will increase the barriers to entry and likely entrench them even further the stifle investment group says we believe their FDA regulations will thwart new product innovation from many small companies and favor the large tobacco companies now in the clip he talked about cigars at first of all it is currently federally illegal to sell cigars to anybody under the age of 18 but I think if there's one thing we can all agree on its that premium cigars are totally adult products now I don't really smoke cigars but I think an adult should be able to go purchase one if they want mr. mint mr. Zeller actually did talk about protecting teenagers and that's something I agree with but do you know what the number one abuse drug of teenagers actually is alcohol the FDA has a sister agency in the Department of Health and Human Services called the office of Adolescent Health and they note that more adolescents drink alcohol than smoke cigarettes or use marijuana nearly four in 10 high school seniors report drinking some alcohol within the past month and more than two and ten report binge drinking within the past two weeks drinking in dangers adolescents in multiple ways including motor vehicle crashes a leading cause of death for this age group and so since alcohol is the number one abuse substance of teens in the United States the federal government has decided to prevent adults from purchasing vaporizers and cigars in releasing these regulations the United States Food and Drug Administration has produced an illogical an absurd set of rules that perversely empowers and protects the country's big tobacco cigarette companies a cripples innovation of vaporization technology the regulations on illiquid intentionally mislabel the products and misinformed the public it ignored much of the available science the FDA even ignored its own science but perhaps the government's biggest failure is that these prohibition-era tactics will create a black market now I can't predict the future but how could it not these are really good products and they work really well demand for them will not just vaporize because the government bans it it's estimated that the vaporization market is between three and a half and four billion dollars that is just not going to a four billion dollar industry is just not going to disappear where do you think it's going to go I think the conscious and deliberate creation of a black market through over-regulation is a monumental failure of government the black market doesn't care about safety or good manufacturing practices or labeling or age restrictions creating a black market for any product should be avoided at all costs because illicit markets bring crime and violence and a host of unintended and unwanted consequences black markets are completely uncontrollable and will have no idea what's going on now the FDA does address the concern of the creation of black market and its rules document and their response was that they would step up enforcement efforts if need be but is this really what we want to do as a society to employ law enforcement resources against adults to prevent them from using a product that can help them stop smoking I mean that doesn't even make a little bit of sense you know back in 1914 one of America's most mine's Thomas Edison was one of the first people to recognize the dangers of smoking cigarettes and even though there was very little science done at the time he identified the toxin acrolein as being a byproduct of burning tobacco cigarettes but Edison was a scientist and obviously believed in technology as a way to improve humanity I think he would be appalled that the government is now restricting vapourization technology yet allowing combustible tobacco cigarettes proven killers to be sold unabated dr. Michael Siegel of physician at the Boston University School of Public Health and someone who has fought for tobacco control for 25 years says of the FDA regulations this is going to be a disaster for public health so on many many levels the FDA's regulations on vaping make terrible public policy by prohibiting the legal sale of potentially life-saving vaporization technology to adults the Food and Drug Administration's Center for tobacco products has failed the American people thank you you

23 Comments

  1. Hi Ron,

    Could you review silver wire. Thanks!

  2. the government seems to be on meth.. thanks for explaining the madness of the FDA foolish dishonest agency!

  3. Singapore is more "advanced" than the FDA, look at their reasons to ban vaping:
    http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Tobacco_Control/Overview/Tobacco_Legislation/Prohibition_on_Certain_Products.html
    i) that resembles, or is designed to resemble, a tobacco product;
    ii) that is capable of being smoked;
    iii) that may be used in such a way as to mimic the act of smoking; or
    iv) the packaging of which resembles, or is designed to resemble, the packaging commonly associated with tobacco products.

    I am not surprise ultimately the FDA will follow suit !

  4. this is 2017, where is he ? ANSWER ME.

  5. Here in Europe we have the TPD. It's all just bullshit.

  6. Sir. I wanna know SS 316l wire is safe for vaping. can you tell it

  7. Fantastic! Very, very professionally done. And I love your Thomas Paine quote….so true!

  8. I also do not want to believe that there is nothing we can do, ya see. My mother passed last year. Stage three lung cancer, she was given 6 months to live and fought for 7. I watched my mother wither away it was horrible to say the least. Her death single handily destroyed my family. So I quit smoking, I went to vaping. I don't smoke at all, and if they take my ability to vape out in public away or I have to hide behind closed doors like I'm secretly doing heavy drugs. I can almost guarantee I will die the same death she has. Smoking /vaping is much more than a fix for people who are addicted to nicotine, there is a social aspect of the deed, I'd say many people are just addicted to that as well.

  9. will share alot as well. seems like FDA is just are run by tobacco companies.

  10. This is the best video I have seen on FDA laws regarding vaping. And I hope you continue to upload videos.

  11. You smack your lips alot. Very informative video tho. Vape on!

  12. we need more support like this for us vapors

  13. Sir, I applaud you.

  14. Absolute proof that today's governments don't truly serve the people, only corporate interests. How can a country that has the freedom to bear arms not have the freedom to vape? Yes it's a relatively new technology but it's abundantly clear that it's way safer than smoking tobacco. Greedy gov just wants their cut which I guess you can understand, however hundreds of thousands for an application that might get rejected is absurd. All the American innovation and enterprise in vaping will be neutered.

  15. Absolute proof that today's governments don't truly serve the people, only corporate interests. How can a country that has the freedom to bear arms not have the freedom to vape? Yes it's a relatively new technology but it's abundantly clear that it's way safer than smoking tobacco. Greedy gov just wants their cut which I guess you can understand, however hundreds of thousands for an application that might get rejected is absurd. All the American innovation and enterprise in vaping will be neutered.

  16. Vape on! The FDA regs will fall.

  17. let me get this straight. the FDA is not following the spirit of the law and they are intentionally mislabeling products.they are also ignoring their own studies and the advice of their own scientists. why is this perversion allowed. why does a judge just the 500 page document in the trash and instruct the FDA to start over with their regs

  18. Great video now let's go fight for our freedoms

  19. Great video – thanks for presenting the case with calmness and candor. Reason will overcome.

  20. Ron you are a legend for posting this…. I'm from the UK and we have our own battle here but it is nothing compared to what the FDA is doing to the vape community and those looking for a safer alternative to smoking in the US. I will be posting a video to my local vape community imploring them to watch this video. vaping is a global community and we have to fight our governments ridiculous attempts at empowering the tobacco and pharmaceutical industries!!

  21. Austrian vapors are on your side ! FDA works like Mafia.

  22. government will keep saying this kind of BS im not surprised its like when Obama said we need 5 to 30 years to defeat ISIS in syria!!! lmao Thanks for the video Ron

  23. I started smoking over 50 years ago, here in the UK, and continued until e-cigarettes came to be sold here. I am a nicotine addict. Through vaping I have discovered a way to satisfy my craving, without having to inhale the numerous poisons and carcinogens that tobacco gives out when burned, i.e. smoking.
    I started out using a strong nicotine juice, 24, and now I'm down to 1.5, after 2 wonderful years of vaping and not inhaling smoke. Obviously, I'm just a tad away from zero nicotine use, and also amazingly healthy compared to my smoking days.

    Here in the UK there is almost zero tolerance of smoking in public. Cigarettes are not displayed in supermarkets and all packets are made to display graphic details of the dangers of smoking, along with a warning from the health secretary. None of this deterred me and many like me, but the introduction of e-cigs did the job.

    I want to suggest that aggressive capitalism causes corruption and that someone in the business of making these rules must have a healthy account in an offshore bank.

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