MORTAL THREAT | Public Health NGO’s Legal Bid to Shutter Vaping

MORTAL THREAT | Public Health NGO’s Legal Bid to Shutter Vaping

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joining us today to walk us through the legal travails facing the vaping industry is azim Chowdhury he is a regulatory and public policy lawyer with a focus on food and drug law and for the past eight years he's been one of the most prominent legal advocates for the vaping industry azim thanks for coming on the show thanks for having me so let me ask you that about something that's hot on the presses right now which is the public health lawsuit and they're seeking to quash the extension of the pre-market application deadline so for those of you out there that know the numbers this was the extension of 2022 so what is this lawsuit that they're pushing and do they have a chance well they're arguing that you know the pre-market review process is a required part of the statute and that FDA when it comes to that particular requirement is there's no basis in the law to to allow them to extend the deadline for pre mark review which would which would require all non-grandfathered products that grandfathered product being anything on the market as of February 15 2007 to go through you know immediate premarket review who are the groups that have filed this this lawsuit so the so the public health organizations you know campaign for tobacco-free kids the truth initiative the American pediatric society Association American Cancer Society's there's a whole list of them they were supported by another group in an amicus brief including like 12 different public health organizations that their position is that FDA doesn't have the authority apparently to to change that deadline to use this enforcement discretion to to move the date from 2018 to 2022 and they're hoping to vacate the official guidance document which which was issued about a month later after the announcement that officially extended that deadline so we're talking about going straight at the heart of the only thing that has kept the industry alive and we're having any hope that's exactly right and keep in mind the industry for the most part has not challenged the vast majority of the deeming rule we're not challenging age restrictions challenging the registration and product listing requirement we're not challenging ingredient disclosures or Health document disclosures you know we're challenging you the right to to make certain claims about products truthful claims and we're also challenging that FDA should have created a more appropriate pmta process that continues that considers where these products fall on the continuum of risk so this concept that the industry is trying to avoid regulation that they don't want to do that they're trying to get away from premarket review even though cigarettes and the most harmful products our grandfather to exempt from that same process it's just not true and so you know here we are you know that's the only thing that has kept the industry alive today and again which has allowed more people to continue to transition away from from smoking has been the deadline extension to 2022 so azim things like this matters like issuing guidance matters like setting deadlines are these not exactly the kinds of activities that Congress has in mind when they shop out these responsibilities to regulatory organizations I mean this is this is bread and butter what agencies are supposed to be doing and what Congress empowers them to do that's exactly right and in fact the Tobacco Control Act actually has precedence within within the statute that permits FDA to extend deadlines for example the the statute permitted tobacco products that were on the market after the rule after the statute went into effect in in 2009 to submit what they call provisional substantial equivalence reports by March 2011 so there was a 21-month grace period so to speak that allowed traditionally regulated product cigarettes cigarette tobacco roll-your-own tobacco and smokeless tobacco – as long as they submitted a substantial equivalence report – to FDA by 20 March 2011 they were allowed to keep those products on the market FDA is effectively mirroring that mirroring that me process with these compliance policies in the deeming rule and you know to argue that they don't have that authority makes little sense so are they are the proponents of this lawsuit are they kind of asking for a jury nullification kind of an attitude what they're saying is that because companies are not being forced to submit PMT A's right now for their existing products that this somehow hinders the variability the public health groups ability to do what they do which is educate the public on the harms of tobacco use and the effects of different types of tobacco products and they're saying that they need the information that would become publicly available by you know companies filing these applications in order to do that and without that access to that data because of the delay they're forced to spend money to to figure it out on their own FDA has already responded to their to their motion for summary judgment and and make clear in my eyes to the court that that is simply not a viable argument that that's not an injury that's cognizable as the court will say because that's their job and they've already been reviewing you know it's been better job to figure out how to educate the public on these products and frankly have been doing a lot of misinformation over the last several years how is it that these groups can be so vicious so relentless so willing to completely disregard common-sense yet on the one hand they actually are starting to begrudgingly accept and and publicly acknowledge that there is benefit health benefits de service but on the other hand they're still in court trying to kill the industry well I think that's that's a good question I think there's there's two parts to it on the one hand I think there is a deep-seated ideology about tobacco and all tobacco products must be bad and that innovation in this industry is never good right it can never result in in the public health benefits and I think that's just something that they had a hard time grasping that this is not the Big Tobacco and this is not tobacco and this is not this is a new industry that you shouldn't apply those old you know dogmas to those to these new actors but the other part of it is frankly not quite understanding what is involved here and the reality of these are small businesses that don't have the resources to do what is being asked in the time that it's being asked to be done and that these are real people that are helping that are doing their best to comply with the law and want to live in a regulated environment and one that helps people and so I just think there's a lack of common sense lack of understanding about what what the reality is of these requirements can you call out their hypocrisy in court that's one of the first things we do in our brief if you take a look at our mickus brief we the very first page we highlight FDA's own comments we highlight the plaintiffs own comments about the benefits of these products we've done it in the Nick appear about to be smoke-free litigation we we show where FDA and we know this you know not just in the DD rule itself but golly PEZ said on numerous occasions that these products could provide a public health benefit the bait that they do and and so as Mitch Zeller the director of CTP so yeah we're bringing that to the table and showing the court that these are things that are being said these are truthful statements number one we should be allowed to make them to as an industry and communicate that to adults and consumers so that they understand because there's so much misunderstanding there's so much miscommunication about how harmful these products are about nicotine etc and so absolutely we we use the courts as an opportunity to to show them that here's what's being said about these products and what the truth is do they have a hope in hell of winning from my point of view and and point of view that we tried to make clear in our amicus brief that we filed on behalf of the right to be smoke-free coalition is that these are not valid arguments that FDA does have the ability to choose how and when to enforce the statutory requirements including changing those deadlines for those applications the issue however is making sure that the court and the judge understands that and if you read the briefs in these case you will see that they paint a very one-sided picture of this industry in the picture that they paint is is an industry that is that is designed to attract youth to harmful tobacco products and a dict the next generation of tobacco users and what we want to make sure that we make sure the judge understood is that that's not the whole story that's a very small part of the story that these are life-saving products that the FDA itself and many of the plaintiff organizations have already stated numerous times including the american cancer society including the FDA we want to make sure that the court the judge here in this case and in the district court in maryland understands that there are these are not just the next note evil invention from big tobacco that these are there's another side of the story here but these are helping millions of people live healthier safer lives and we presented those facts to the courts as well as the fact that it simply would have been impossible to get through the PMT process in during the initial two-year compliance policy so at a minimum we need the industry needs until 2022 if not longer to to be able to prepare adequate data to support whether or not these products are appropriate for the protection of the public health you

8 comments

  1. It still kills me that vaping is considered a type of "tobacco"…so nicotine = tobacco? You can vape without nicotine. Why doesn't the US take a look at the studies in the UK (where the government pays for public health). This country…OMGosh…!!!!

  2. How can the date extension for Vape products hinder public health groups from educating the public about the dangers of tobacco products? What has tobacco to do with e-juice? Where is the tobacco here? Even IF it was the tobacco industry who produced the vaping devices – which is NOT the case – but even if…so what!? The product still would be no tobacco product and it would still be almost a 100% less dangerous than smoking. They decided to ignore all the trustworthy evidence of 10 years of research. Instead they chose to believe in junk science or even paid for the making of fake (manipulated) "studies" (like those of Mr. Glantz, such a ridiculous person that at least I can't take the man serious). As always a very informative interview. Thanks for the effort. Great job. Greetings from Austria, EU.

  3. Vaping should not be considered a tobacco products

    Non adults will just take up smoking………..give our future the choice to a less harmful alternative

  4. One can only hope that the judge hearing this case in the US District Court in Maryland has good sense.  At least we know vapers and the vape-related industries are being well-represented by Mr. Chowdhury and his indubitably well-crafted amicus curiae brief.

  5. The FDA should realize if they can flavors and/or vaping , the underage vapers will just take up smoking and then underage smoking rates will just skyrocket again just like in the times pre vaping.

  6. Hi Brent, my name is Patrick. I live in Grimsby, Ontario Canada, I am so thankful that Health Canada legalised vaping and how they recognize that vaping is an excellent way to quit smoking. Shame on the FDA in trying to kill the vaping industry in the United States.

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