It's Political: Interview with Dr. Gilbert Ross on FDA Deeming Regulations

good evening ladies and gentlemen this is Dimitri with VAP team media I am joined by dr. Gilbert Ross he is the executive director medical director of the American Council on science and health dr. Raza a lot of panic the last 24 hours a lot of sleepless for a lot of the vendors and a lot of the vapors out there give us your initial reaction to the proposed FDA regulations well as you say I was about to head for the sack last night when I I know I've got an alert about the FDA regulations and then I was forced to go on Twitter and next thing I knew it was 4:00 in the morning so yeah I'm feeling your pain the FDA regulations that we've been waiting for since last October if not earlier finally hit the streets this morning and there's something in there for everybody and unfortunately it's not not all good by any means not that anybody really expected it to be all good but it could have been worse we've been fearful at the American Council on science and health that the hysteria that seems to have swept the federal agencies over the last couple of years about e-cigarettes the alleged dangers of e-cigarettes and the all of this hype with nicotine poisoning and other you know not not strongly science-based mythologies about e-cigarettes might have led the FDA's hierarchy to enact some severe restrictions or even forced them to jump through pharmaceutical type hoops which would basically have suppressed the market for years so from that point of view the fact that e-cigarettes and vapor products will remain available to America's smokers who are desperate to quit indefinitely is the bottom line good news out of the regulations passing past that there's a lot of a lot of bad things in these regulations the requirements that new products new vapor and a cigarette products will have to submit new product applications basically and be approved by the FDA which they have shown no tendency towards so it's rendering any expeditious decisions is is a bad bad part of the regulations when I say new products of course I mean anything since February 15th 2007 and we're hoping that that date would be pushed up a little bit but unfortunately it did not we were hoping it wouldn't have taken much you know creativity or flexibility for the Zeller Center for tobacco products who he has spoken on the issue of continuum of risk and he seems to be pretty well-versed on the subject that cigarettes are the most highly toxic nicotine delivery systems and he seems quite well aware that e-cigarettes are far less harmful it would have been a fairly simple thing I think for that day to have been flexed a little bit to 2013 and the best possible circumstances and yet they did not do that so these new product application requirements are going to be applied to 99% or more of the current e-cigarette market the it makes no sense of course because the products on the market before 2007 were primordial products you know it was more like a beta test of an e-cigarette than anything that would come to to know and love these days they were all coming from the hinterlands of inland China and nobody really knew what was going on there of course the FDA chose those particular products to to assess in 2009 thanks to dr. Scharff Steen blessed memory and that's been their basis for their approach to e-cigarettes since then you know as unscientific and groundless as it's been they've maintained these alerts about that we don't know what's in cigarettes morning smokers not to try them just like the CDC and many academic centers so while we're on the talk of these products aside from the business aside from the business industry that has to apply for these products even for the end-user we know that the the innovation the technology and the products that have come out in the last two three years are really what has propelled users to actually get away from tobacco cigarettes and use this product there's no question about that that many adult egg smokers have had switched to vaping with the the vapor products mods and the personal vaporizers while the siga like type ii ii cigarette products continue to improve in their their sales each year seems to be is skyrocketing still that is level off to some degree the the big increase in an e-cigarette use over the last year or so seems to have been more in the personal vaporizer market and that market is going to be severely impacted in a very negative way by these regulations so going into the business side of it so let's talk about this application the implication that having to apply for before for products that came into the market after 2007 well I'm gonna have to supply studies and evidence that their products are well they're gonna try for substantial equivalence which is one part of the regulations but again that has to do with prior to 2007 I frankly wouldn't be bragging about my product being substantially equivalent to a product from before 2007 you know that's like saying we've introduced a brand new automobile model and it's very much similar to our 2006 model it makes absolutely no sense so they're gonna have to supply I think substantial equivalence it's really strong me and it's not really a factor in the current discussion so they're gonna have to go for new product application thank goodness it's not a new truck application which they could have enacted as a you know making it into a medicinal or a pharmaceutical product that did not happen but new product application is still gonna require quite a lot of regulatory hoops and approvals and data collection X an expense correct well of course the legal fees alone will bankrupt many small companies and that's where I'm going here is that the the smaller each cigarette companies will thankfully they're going to remain on the market if they choose to be on the market while their application is being processed and as we've learned over the last couple of years that process will take a long time if it's months I'd be surprised it's more likely to be years and during that contemplation period when the FDA will be going through the data their products will be allowed to remain on the market as long as they've submitted an application so that's good but frankly if I was a CEO or CFO of a small e-cigarette company while I was submitting that application I would be looking around to see who's going to buy me out and I know who that's going to be the makes of tobacco companies that so the two big points I'd like to make are one the good news that smokers who want to quit will find vapor products and e-cigarettes available to at the end of the day the winners here are going to be the big tobacco companies which frankly I think we could all have predicted at one time that giving their their cash crowd their cash availability and their expertise in nicotine and tobacco and their marketing skills not to mention the lobbying skills they will wind up standing whether they'll be standing alone at the end of the day or they'll be standing among a few of the bigger eat cigarette companies that now exist who have the cash and the expertise and the time to go through those regulatory hurdles we know that the big tobacco companies will be Victor at market indefinitely I frankly have no problem with that really I feel sorry for the small economy cigarette company so I think we'll suffer the consequences of this to a large degree unscientific regulation these onerous regulations are not more to any kind of scientific or public health statistics or data or evidence so it's unfortunately politically motivated to some extent I feel sorry as I was saying for the small companies who will suffer the consequences I don't think they have the financial resources to go through these years of applications hopefully I'm wrong but from a public health point of view which is are so concerned here at the American Council on science and health the fact that that much less harmful and effective these cigarettes of one form or another will be available to the smoker desirous of quitting is the bottom line good news as you well know most smokers want to quit and half or more of them try to quit each year but the FDA approved products only helped 10% or 15% depending on how you formulate your study system and quitting so basically they're highly ineffective they're quite expensive they have child attractive flavors and they have a lot of side effects and yet the FDA and the CDC especially and various academic centers mostly UCSF Mayo Clinic etc campaign for tobacco-free kids have all been haranguing smokers not to try each cigarettes but to stick with the FDA approved products you know which is just counterproductive and it's antithetical to public health so if if Lorillard or al trio are jr. or whoever are selling non combustible tobacco and nicotine products and smokers are using them to get off deadly addictive cigarettes that's fine with me speaking for public health and I totally agree being from the science side of this industry now the one concern that I have is section 9 1 1 where it actually requires the manufacturers to you know they won't be able to give the intended purpose of the product and you know the the less harmful factor that we have been using for so many years promoting this product yes it forces the makers and marketers of e-cigarette and vapor products to lie let's say or obfuscate evade dissemble whatever word you use they're not allowed to tell the smokers and the public the truth about e-cigarettes being much less harmful than cigarettes it's unfortunate again I'm not sure how much regulatory wiggle room the FDA had here cost the Family Smoking Prevention Tobacco Control Act section 911 as you pointed out is quite clear they're not allowed to do that then you know the FDA could do anything they wanted and if they floated the law somebody would possibly sue them I guess but that would take years if anybody had the wherewithal to to pursue that so you know they could have done that but I could see that they might have hesitant because it is an actual you know it's it's it's not what the law says so the e-cigarette companies will have to continue to be light around the facts and tell smokers if you can't smoke you know use our cigarette or here's an alternative product of for smokers who want an alternative product and sell instead of saying if you want to reduce your exposure to the tobacco carcinogens in cigarette smoke or the highly addictive psychoactive conglomeration of chemicals that's present in tobacco smoke or improve your health your lung function your circulatory system by using switching to e-cigarettes they're not allowed to do that and that's bad on the other hand the fact that the e-cigarette market is booming and that many smokers I'm sure will encounter colleagues and friends who have previously been smokers who are now of a ping and they will find that firsthand how much better they that vapors feel compared to smokers so that word of mouth I think will will be a big plus finally and I know gotta let you go dr. Ross you know in the interest of protecting public health as the FDA claims it is clear it is clear and I know this is very close to you that science did not play any role and announcing these deeming regulations what are your thoughts on that so what else is new we have been not we have been experiencing the vacuum of science coming from the official public health agencies at every level frankly not just the federal agencies but the state a so-called public health agencies the big nonprofits who are guardians of our public health I'm referring of course to the American Cancer Society American Heart Association especially the American Lung Association campaign for tobacco-free kids and until recently anyway the Legacy Foundation as well as the big academic centers for whom we seek guidance UCSF in the Mayo Clinic these have been hotbeds of unscientific hysteria mythology and baseless dire warning about hypothetical risks of e-cigarettes warning smokers not to even try each cigarettes because we don't know what's in them we don't know what's going to happen to you five and ten years down the road your kids will get into these toxic nicotine and god knows what will happen to them all of this is feeling from these fonts of Public Health Authority and thus it shouldn't be come as a big surprise that the fda regulations are not tightly bound to sound scientific principles we should I suppose be thankful that they adhere to some science in terms of at least allowing each cigarettes on the market you know instead of forcing them off the market so for that to that extent we can be thankful to mid seller and the Center for tobacco products and dr. Hamburg but frankly there's the FDA has been warning smokers about the dangers of e-cigarettes since 2009 at the infamous Sharfstein conference and they pulled back somewhat you know with these new regulations but you know it shouldn't come as a surprise that that they're still based on agenda of politics and the fact that e cigarettes often resemble cigarettes you know is nostalgic for them back to the big tobacco Wars of the 20th century and it's unfortunate that they cannot pull our minds out of the the old days and seek to help addicted smokers now if they were a little more flexible and creative it would be a much better set of regulations but we have to look you know be thankful for what we got I suppose briefly dr. Ross are you surprised flavors and internet was not affected no I wasn't surprised frankly I don't believe the FDA has the authority to rule on internet sales that's not something the FDA's mandate includes as far as flavors are concerned I guess I was somewhat surprised they could possibly have have ruled on flavorings as the Family Smoking Prevention Tobacco Control Act banned certain flavors from cigarettes although those flavors were not actually being used by anybody so it's basically a political point the FDA to trumpet that we banned the cherry and banana flavored cigarettes you know I'm saved millions of lives you know they could I imagine have also banned those flavors but there is a good point that some sort of science did apparently prevail that somebody at the FDA must be aware of the fact that adult vapors prefer flavors and that children are not really that attracted to the flavored east cigarettes that's that's again another straw man another bogus so concerned the internet and advertising and marketing restrictions also we're not if the FDA had taken on trying to try to mandate how a cigarette companies could market their products I think they were asking for an awful lot of trouble that's a big red flag for litigation because of the First Amendment obviously a commercial speech so from that point of view we do have a little bit more to appreciate short term now what do we do next seventy-five days there is an open comment period what do you suggest for users of this product which a lot of these users are going to be watching this interview what can we do for the next two to three months absolutely submit comments most definitely well I'm not a user of e-cigarette so I quit smoking in 1990 and I I've only occasionally used these cigarettes as an illustration for educational purposes only but I'm going to submit comments the more comments they get especially sound science based comments the more at least the worst case scenario it'll take them more time to plow through than we anticipate hundreds of thousands of comments and they're legally bound to peruse all of those comments so any of these onerous restrictions will not be enacted we're only on stage I think it's five out of a nine staged approval process so uh there's a long way to go in the best case scenario these laws are not going to be implemented for three years of for absent litigation I believe there will be litigation so one silver lining here is that these restrictions will not be implemented for at least three or four years probably longer another silver lining I would like to mention if I may is that this is there golde movement from state to city around the nation to ban and restrict these cigarettes and rescind to vapours outdoors has to some extent and based upon the fact that the FDA has not given us guidance on e-cigarettes so we better take the matter into our own hands you know politicians with a barely a college-level education and very very little education on science have taken the matters into their own hands to tell the public that secondhand vapor is is dangerous and the vapor should be sent outdoors nicotine is highly addictive in these cigarettes so the fact now that the FDA has issued some guidance for good or ill will hopefully take that a back drop out of the out of the quiver of politicians seeking to exploit some public hysteria about e-cigarettes and may hopefully impede thus rush to ban and restrict e-cigarettes that we've seen in cities starting with our own New York City in December Philadelphia Chicago Los Angeles and the various states even in New York State now their proposals in the hopper now in the Senate of New York State – seriously restrict and ban e-cigarettes and nicotine liquids and we're trying to put a stop to that any politician now says the FDA hasn't given us a guidance so we're gonna take this matter in our own hands well no longer have that to say that's a good thing sure that's a good thing we can actually use this for on a state and local level with the proposed bands that are going and some of them that have been enacted as well well I think that the the road to revoking some of those bans is a really tough road but hopefully new proposals maybe maybe impeded by this FDA guidance as poor as it is right dr. Rusch so you got the last few minutes anything else that you want to add thanks for having me I hope that vapors will keep the faith you know and keep calm vape on and I anticipate that the e-cigarette market will continue to flourish because by the time these laws are going to be actually implemented I think the market smokers are voting with their feet basically and the market is going to continue to burgeon and I think innovation will continue until it's actually suppressed hopefully maybe by that time some new measures might be passed when legislators perhaps will see the handwriting on the wall and know that they can't interfere with this process forty four million smokers are going to have their their preferences heard I mean I was astounded last year when the people spoke up in Europe and the European Parliament decided not to institute those horrendous directives that were initially proposed although that popular uprising was somewhat thwarted later on we should have the same kind of civil action here in this country where vapors should speak up their minds and let their congressmen and their local legislators know their thoughts on this as well as submitting their comments to the FDA and I understand that over the past few years we have had this free market and there hasn't been as much serious attention paid to advocating for this product I think now is the time with the release of these regulations for everybody to stand up and as you said that a little time that we have kind of bought these two or three years more people will transition to this product if it's accessible and affordable more power and numbers maybe we can make our voices heard dr. Gilbert Ross thank you so much for joining us here on vape teen media looking forward to more of your very helpful and educational insight thank you for having me thank you doctor


  1. Saw this back when it was originally posted, but… wanted to watch again. Truly hard to believe anyone has the audacity to bash Dimi, Phil, et al… esp. when all they've done SO much of & for SO long now… is dedicate themselves to protecting & preserving the right to vape. YOUR right to vape & to that better, proven >95% healthier (I.. can say it!!) alternative to the KNOWN deadly cigarettes "$$$$$" keeps them maintaining! People should be ashamed of themselves. All the agreements made with different States after the 2009 Fam Tobacco Act.. to receive a %, in advance.. nahhh, wouldn't have any bearing on all of this. All the money/taxes being lost by the day.. due to those no longer buying cigarettes. In a panic, feeling that pinch… they want IN on the e-cig $$$. What scares me is all the pricey applications now.. are SOO detailed. Recipes, instruction, piece by piece, bit by bit.. I'd be afraid to buy OR use anything the FDA has any part of approving. They'll prob be putting whatever keeps people addicted so highly to cigarettes, in this too now!! Keep that money rollin' regardless. Wouldn't surprise me at this stage, that's for sure. Doesn't matter that vaping/e-cigs isn't tobacco? Shouldn't that nullify the classification from the get-go? How on Earth can eliquid with NO nicotine….. or a COIL made of stainless steel….. be considered a "tobacco" product?? Better throw wedding rings, buildings…. cars….. any/everything in there too then! SO ridiculous, wouldn't even think it's possible. Teens, flavors, blahhh… they aren't (like I was) TWELVE year old's "smoking" known toxic cigs (that also can & has killed those even remotely close to…. forced exposure via 2nd hand smoke) = WIN imho, sorry. From all research, nicotine is not only a nutritional necessity, it's something in many items that's present in everyone. Something not one person could even test 'negative' for at any given time. Only testing made public has been done IN cigarettes & IN combination w/ all the other things in them… Never has nicotine been shown to be addictive on its own (and if it was trust… they'd put it out there!) So… how does "might be"…. "we don't know IF"….. "we believe"…… "could be"…… allowed to enter something "AS". Guilty unless/until??? Even so.. wouldn't THEY be the ones who need to prove whatever it is they are claiming? Not us.. that it isn't??? Unless/until they can prove its harmful, this that OR the other…. nicotine is addictive… blah blah don't think so…… contains "tobacco" to be a tobacco product, etc… How on Earth can it be classified as OR regulated as tobacco along w/ cigs?? Ironically, they don't focus ONE smidge of all this effort towards getting rid of what they've known to kill millions now…………… for so long!? Interesting. "things that make ya go, hmmmmm". Common sense should tell anyone vaping/e-cigs are, at the very LEAST…. better than smoking would ever be! They say "we don't know what's in them"………………right, ya don't. We DO know what's in cigarettes tho……………. & so until they prove otherwise, people should stay away from THEM… the NRT's in place for false hope & to send 'em right back to smoking (while making $$$$) …… etc etc… Ugh. This World scares me to death!!! Fair, right/wrong, truth, science, proof… innocent until…. NONE of it seems to matter! =/ Be afraid, be very afraid. I know I am. THANKS DIMI'… for ALL you do, have done & continue doing, no matter what…………… Great interview w/ Dr. Ross too!!! Appreciate his time & input. =) ((wish many would've taken this as seriously back then….. as they do now………)) LIVE LONG(er) & VAPE ON! #ABillionLivesFilm

  2. Just more thieving of the rights of American citizens, nothing more.

  3. This video is relevant once again today. Thanks for the upload!

  4. do you fucking libtards still want more government

  5. a tor network market for e cig shit sounds highly wonderful, and imported shitty products from china sold there on there also sounds nice.
    #FucktheFDA #StartAnotherProhibitionDIPSHITS #CuntPuntTheFDA
    Seriously get ready to surfing DeepWeb Market places on your tor browsers and checking out the prices in bitcoin for made in china clones, either mixin your own juices, or buying something from the deepweb and taking a chance.

  6. Follow the money…government (cigarette sin tax on each pack) big tobacco, big pharma, and even the healthcare industry stand to lose a crapload of money…it's all about that.

  7. Smoker since 1977 and have tried to quit many times, many ways.  I started vaping in September, 2014, I haven't had one cigarette on New Years Eve, 2014.  I never planned to stop smoking but I prefer E-Cigs.  Take E-Cigs away and I will go back to smoking.  I will never try Chantix again and the other stuff doesn't work. All I know is that today, I can breathe deeply and I couldn't do that six months ago. What's wrong with E-Cigs? They didn't exist in 1977!

  8. Sir, I am a 39 year old male in the United States Air Force.  I have been a smoker since I was 25 and was at about 2-3 packs a day.  As of right now I have been smoke free for a year (along with my wife) and according to my doctor am in much better health.  My oxygen levels have returned to normal along with blood pressure.  I also work in a shop of about 100 military men and women and over half of us have switched to E-cigs, that's about 15 people out of 30 that are NO longer smokers!! We all run better, feel better and are in much better health.  If this regulation goes through most of them already said they would just go back to smoking. If you want to share my story please do my name is Damian Perkins and I live at McGuire AFB NJ 08641.

  9. The ignorant people against vaping have already begun their bans. The city of Delray Beach, Florida have gone so far as to ban e-cigs at outdoor restaurant patios.

  10. Is it time to rally up people and speak up and stand up protest against Fda and or Big tobacco…?

  11. The reason they never forced them off the market is because the popularity has bitten them on the arse, and now they want a piece of the pie, funny how they were so concerned back in 2007 NOT ! about the supposed effects of E cigarettes ! or is it loss of revenue ? hmmmm Scientifically they will not have a case and that's why they won't go down that route, fucking disgusting !!

  12. So how do Tobacco companies get there product approved and passed with 4000 killing chemicals ? !! 

  13. You have to wonder just how much influence the big tobacco companies have to do with this. I have no doubt they have noticed a significant drop in sales over the past years as people switch from Cigarettes to vaping as a healthier alternative to those stinky things they sell. The tobacco lobbyists are hard at work in Washington trying to prevent e-cigs from taking sales away from them.

  14. stop smoking cigarettes

  15. Not sure how all this will affect my procuring nicotine, but I have DIY'ed my own juices from the start, a cheap and liberating alternative.  I have gradually reduced the amount of nicotine in my juices, and I'm happy that the flavors and carriers cannot be affected, the only ingredient in question would be nicotine.  Hopefully I can eventually wean off of it to vape 0 nic, and continue to vape with rebuildables and good old mechanical mods, if it comes to that.  E-cigs were the only way I could quit cigarettes over 2 years ago, and I will never go back no matter how our insanely corrupt gov. tries to force their heavy hand!  What ever happened to our country that was born to liberate the people from tyranny and oppression?  It is such a blatant insult to all who have died to defend our freedoms, it makes me ill!  Democracy my @$$! What a horrible joke we've become, and are virtually powerless to do a thing about it!  $$$=power, we the people are just ants at the picnic.  So sad.


  17. It's funny how ciggeretes aren't banned but they can give you cancer but the ecig is being banned even more??? Really????

  18. it's howard hughes all over again…yea make e-cigs illegal so big tobacco can keep selling it's garbage

  19. i got my box mod already and RDA im good :p cant stop me from Vaping FDA!!!

  20. The FDA is looking out for Big Pharma because cancer is big business.

  21. Does anyone else get the point that "big tobacco" is funding all of this misdirection?

  22. great video. thanks for posting. Keep up the great work.

  23. It is bullshit, Its all about the Mighty Dollar that these assholes are not getting and Cigerette sales going down because we are trying to stay alive with a healthier alternative, The FDA says they dont know enough about the long term affects of vaping, Its easy, You know whats in the juice you purchase from your local vape shops and If youve done the research on the ingredients in them you would know there is nothing in them cancer causing which leads me to believe the Tobacco industry wants us dead and to market our juices and everything else to have something that can possibly kill us, We as Vapers have a voice and we need to stand up against the FDA and pretty much tell them to fuck off !!!!!

  24. "THE FDA CAN SUCK MY VAPE" !!!!!

  25. Getting rid of smaller companies will remove the competition, that and the over regulation will stifle innovation, So the customer looses.

    I agree it could have been worse. But I dont think we should just be grateful for what "we got" – We need to act. We need to be outraged, but in a controlled manner.
    I look to you Dimitris on what that controlled action should be! 🙂
    I will be writing my congressman and the FDA to submit my thoughts, comments, and experience. 

  26. Get rid of the Democrats in Congress in November. They almost all oppose ecigs, not the Republicans.Say what you want about them, I'm neither, but at least the Republicans don't try to micro manage peoples lives to the extent that the Dems do.

  27. Sue them, can we? What if it was made class action and included every vendor and adamant vaper. What if someone thinks to challenge this all the way to the supreme court, over and over again if neccessary because its just this damn important.

  28. Dimitri I can't thank you enough for all your efforts you put into the vaping community. I smoked for 42 years, tried all the FDA approved products and nothing worked. I took me just 4 days vaping to quit smoking. I haven't smoked now in over 3 years. Frankly all this legal and regulations stuff scares the hell out of me. It is a big relief that they are not banning Ecigs outright but it is still really concerning as to what products and devices will be allowed to remain on the market. Again, thank you so very much.

  29. just think, big tobacco can put all the goodies in their e-juice that they put in in ciggs… fun

    Make sure your Voice is Heard Make sure to sign….

  31. Nice job on that interview, it was very informative.

  32. Funny…I haven't done a shitload of research into the correlation, but I'm starting to notice that the same factions in the government that are trying to legalize weed are trying to kill vaping.  Don't think I have a problem with weed…I don't choose to use it, but it doesn't bother me that people do.  But look at the call to action map on ECF…the states that are red-lights for vaping are largely the same ones green-lighting marijuana, whether it be for medical or recreational use.  I'd bet my left twin that the only difference on the politicians' desk between the two is TAX DOLLARS.  

  33. Is this the same FDA that approves all these drugs for us to use?  The same FDA that collects all the money from drug companies so they can get the latest drug on the market that kills and hurts people?  This is such a money game for the FDA and Big Tobacco companies.  They "SAY" people need to quit smoking and now we have something that is 10 times better than smoking and they just want a piece of the action!  Regulate = Money 

  34. Get one product group regulated, a nicotine base with different strengths and with different PG/VG ratios. Other than that, nothing about the e-cig can be regulated as tobacco as they can be used to vape zero nicotine liquids which cannot be linked to tobacco.

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