IS FDA BANNING VAPING?

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Vapeon4Life

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$$$$$$$$$$$$$
"
What’s Behind Michael Bloomberg’s vaping-phobia?"
".......
After his tenure as mayor, Bloomberg’s paternalistic strategy has been channeled through a constellation of non-governmental organizations (NGOs), supranational organizations such as the World Health Organization (WHO), and various grants to national governments coordinated by Bloomberg Philanthropies.

For years, this Bloomberg-funded activism has fiercely attacked any innovative alternative to tobacco harm reduction. Its great bête noire, tragically, is vaping.

Thus, in his failed presidential campaign, the tycoon announced that if elected he would ban flavors for all so-called electronic cigarettes. This would have been a virtual ban on vaping since 80 percent of the market is concentrated in flavored products.

This campaign idea was accompanied by a $160 million donation to fight vaping. It came in the context of the fake health crisis caused by a mini outbreak of lung injury (known as EVALI) attributed to nicotine vaping....."

"
However, in late 2019, and coinciding with the peak of paranoia regarding EVALI, an unknown Philadelphia-based company called Hava Health launched the “Hale,” a vaporizer intended to help its users quit smoking. Currently, its makers are waiting for approval from the U.S. regulator FDA.

"
The problem lies in the fact that one of the investors in the company is none other than Michael Bloomberg himself. Through a venture capital consortium called Village Global, which also includes Mark Zuckerberg and Bill Gates, Bloomberg has provided seed capital to the company Hava, creator of the Hale.

In fact, the Hale device has all the features of other vaporizers (Juul would be the most obvious example). Thus, the Hale looks ultra-modern and sophisticated, with a design very similar to that of a USB stick. It administers nicotine to its users and even offers flavors. Ironically, the possibility Bloomberg wants to curtail all other alternatives.

In his recent documentary You don’t know nicotine, sociologist and filmmaker Aaron Biebert not only warns about Bloomberg’s suspicious investments in Hale, but also, at the end of the film, suggests an interesting hypothesis: Could it be that the attempts to ban vaping and the disinformation campaigns driven by the American billionaire are aimed at creating a favorable environment only for his own product?"

It is certainly worth considering that Bloomberg’s postmodern puritanism is actually a pincer movement between draconian bans and limitations, on the one hand, and harassment of both innovators and small retailers, on the other.

This mechanism is known as regulatory capture. Through it, regulation becomes a tool that the powerful use to eliminate competition and create conditions in which only they can survive.

Perhaps the Hale device and the monetization of his crusade is just the icing on the paternalistic cake. Maybe the American tycoon is convinced that his efforts to generate a nanny state that tells us everything we have to do is for our own good.

Whatever his motivations, Bloomberg’s play on vaping is extremely dangerous and inhumane.

We should never encourage bans or treat adults as if they were children, but create as open a climate as possible for innovators to solve problems. This applies to smoking as well as in many other areas.

More importantly, according to a recent article published by the journal Science, “the most conservative estimates suggest that were vaping nicotine to replace most smoking over the next 10 years, 1.6 million premature deaths would be avoided and 20.8 million quality adjusted years of life would be saved in the United States alone. The greatest gains would be among younger cohorts.”

The stakes go certainly far beyond a billionaire’s ego and profits."

What’s Behind Michael Bloomberg's Vaping-phobia? - Austrian Economics Center


The facts speak for themselves - And how many congressmen, women, and members of the FDA are in the hands of Michael Boomberg {Bloomberg Philanthropies} is still open to speculation.

It was hard to prove and took some time, that cigarettes cause cancer - It may be easier and take less time to prove Michael Bloomberg and Bloomberg Philanthropies are malignant and cancerous influence peddlers
whose agendas are hardly or in any way philanthropic !
 

JordanVapes13

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So do you think we will win in the end?

FDA Fails to Meet Deadline to Decide on PMTA Applications for Vapes

"The day of reckoning will have to come another day.

On September 9, its longstanding deadline, the Food and Drug Administration (FDA) effectively announced that it would need more time to process the remaining premarket tobacco applications (PMTAs) that vape companies were required to file last year to stay legally on the market. Approval would mean that products were deemed “appropriate for the protection of public health”—a potential game-changer for tobacco harm reduction in the United States.

The agency did not mention how much longer it planned to take—nor did it officially state that it was essentially giving itself an extension. In a perspective hyperlinked to a press release, though, it did state that decisions would be made on a “rolling basis.” Hundreds of thousands of PMTAs, at least—including all of those submitted by the largest vape manufacturers—are left.

“We continue to work expeditiously.”

Despite this admission, the FDA did assure everybody that “significant progress” had been made, referencing its “taking action” on 93 percent of the PMTAs as well as its issuing of 132 Marketing Denial Orders (MDOs), requiring the affected companies to immediately stop selling their products. No authorizations have so far been issued........."

FDA Fails to Meet Deadline to Decide on PMTA Applications for Vapes

So 'Man of little faith' - "It ain't over till its over"- Yogi Berra

Not only are there business associations of vapers - There are law firms and there are laws based upon justice.

And all of Bloomberg's money and his minions from hell will lose eventually
- The FDA knows it can not make a compelling case for outlawing vapinig based upon a fantasy 'boogeyman' that is supposedly compelling teenagers and children to try vapiing and causing them to become overnight addicts.

In fact a case can be made that the FDA and groups such as Bloomberg Philanthropies are actually causing teenagers to try vaping - They did this with marijuana during my generation - The more they tried to suppress it the more people wanted to use it.

Maybe they should quit while they are ahead? - Otherwise, yes indeed, we will have a whole new generation of nicotine addicts !!!
 

Vapeon4Life

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So do you think we will win in the end?
I'm not sure we lost yet - In that article they admit that they can't possibly enforce total prohibition
- which 'may' be what they {the tobacco nazis} want them to do.

Meantime:
I'M THINKIING THAT MAYBE A 'CLASS ACTION LAWSUIT' not by dealers or manufacturers but by INDIVIDUALS who use vape products to avoid cancer and other health benefits !!!!

Meantime you've probably seen this article which came out recently showing legal grounds to fight right now:

Lawmakers’ Pressure On FDA Review Of New Tobacco Products Blurs Line Between Oversight And Undue Influence
".........
Over the past year, the volume of noise aimed at FDA over one particular duty—its review of applications for electronic nicotine delivery systems (ENDS) and other “deemed” new tobacco products—has been dialed to 11.

Pressure has come from a variety of voices and in different forms. Anti-tobacco activist groups, for example, have lobbied FDA to subject ENDS products to the new-drug approval process instead of the legislatively prescribed Premarket Tobacco Product Application (PMTA) process. FDA has thus far ignored that demand, as we discussed in our last Forbes.com commentary.


Members of Congress—several of whom co-sponsored the 2009 Tobacco Control Act—have stage-managed a pageant of outrage over ENDS that has featured committee hearings, press conferences, and information requests and letters to FDA. While those are common tools of legislative oversight, the Members’ ENDS pressure campaign may have stepped over the line between oversight and impermissible interference with agency adjudication.........."


Lawmakers’ Pressure On FDA Review Of New Tobacco Products Blurs Line Between Oversight And Undue Influence
 
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JordanVapes13

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Wow, thank you for adding so much optimism! I'm a little less concerned now.


I'm not sure we lost yet - In that article they admit that they can't possibly enforce total prohibition
- which 'may' be what they {the tobacco nazis} want them to do.

Meantime:
i'm THINKIING THAT MAYBE A 'CLASS ACCTION LAWSUIT' not by dealers or manufacturers but by INDIVIDUALS who use vape products to avoid cancer and other health benefits !!!!

Meantime you've probably seen this article which came out recently showing legal grounds to fight right now:

Lawmakers’ Pressure On FDA Review Of New Tobacco Products Blurs Line Between Oversight And Undue Influence
".........
Over the past year, the volume of noise aimed at FDA over one particular duty—its review of applications for electronic nicotine delivery systems (ENDS) and other “deemed” new tobacco products—has been dialed to 11.

Pressure has come from a variety of voices and in different forms. Anti-tobacco activist groups, for example, have lobbied FDA to subject ENDS products to the new-drug approval process instead of the legislatively prescribed Premarket Tobacco Product Application (PMTA) process. FDA has thus far ignored that demand, as we discussed in our last Forbes.com commentary.


Members of Congress—several of whom co-sponsored the 2009 Tobacco Control Act—have stage-managed a pageant of outrage over ENDS that has featured committee hearings, press conferences, and information requests and letters to FDA. While those are common tools of legislative oversight, the Members’ ENDS pressure campaign may have stepped over the line between oversight and impermissible interference with agency adjudication.........."


Lawmakers’ Pressure On FDA Review Of New Tobacco Products Blurs Line Between Oversight And Undue Influence
 
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Myrany

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Prepare for the worst and Hope for the best. Even if like me you are pretty sure that those with money or power or both have determined that if anything exists at all it will be BT or BP offerings none of us want.

Even if we prevail in the long haul it will be years with pretty much nothing good available on the legal market.
 

Vapeon4Life

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Prepare for the worst and Hope for the best. Even if like me you are pretty sure that those with money or power or both have determined that if anything exists at all it will be BT or BP offerings none of us want.

Even if we prevail in the long haul it will be years with pretty much nothing good available on the legal market.
But then I see this - After the 9/9 Vapopaclypse - Some companies claimed to have survived:

[NOTE: I have no commercial interest in vaping and know nothing about this company]

Mon, September 13, 2021, 6:30 AM·6 min read

"Other companies have received 168 FDA "Marketing Denial Orders" for more than 992,000 flavored electronic nicotine delivery system products, and "Refuse-to-File" letters for approximately 4.5 million other products

COSTA MESA, CA / ACCESSWIRE / September 13, 2021 / Charlie's Holdings, Inc. (OTCQB:CHUC) ("Charlie's" or the "Company"), an industry leader in both the premium, nicotine-based, e-cigarette space and the hemp-derived CBD wellness space, today announced Charlie's Premarket Tobacco Product Applications ("PMTA's") for the Company's best-selling e-liquids remain among the select minority of applications submitted to the U.S. Food and Drug Administration ("FDA") that have not received Marketing Denial Orders or Refuse-to-File designations. Including product-specific scientific data, thorough perception studies, and detailed environmental assessments, Charlie's PMTA's cost more than $5 million and are among the most comprehensive PMTA's in the entire industry. The Company has publicly expressed its commitment to full regulatory compliance and youth access prevention and believes its submissions to the FDA will be recognized as both distinguished and suitable for approval.........."

Charlie's Best-Selling E-Liquids Are in the Select Remaining PMTA Submissions to the FDA That Are Still Viable
 

Territoo

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    But then I see this - After the 9/9 Vapopaclypse - Some companies claimed to have survived:

    [NOTE: I have no commercial interest in vaping and know nothing about this company]

    Mon, September 13, 2021, 6:30 AM·6 min read

    "Other companies have received 168 FDA "Marketing Denial Orders" for more than 992,000 flavored electronic nicotine delivery system products, and "Refuse-to-File" letters for approximately 4.5 million other products

    COSTA MESA, CA / ACCESSWIRE / September 13, 2021 / Charlie's Holdings, Inc. (OTCQB:CHUC) ("Charlie's" or the "Company"), an industry leader in both the premium, nicotine-based, e-cigarette space and the hemp-derived CBD wellness space, today announced Charlie's Premarket Tobacco Product Applications ("PMTA's") for the Company's best-selling e-liquids remain among the select minority of applications submitted to the U.S. Food and Drug Administration ("FDA") that have not received Marketing Denial Orders or Refuse-to-File designations. Including product-specific scientific data, thorough perception studies, and detailed environmental assessments, Charlie's PMTA's cost more than $5 million and are among the most comprehensive PMTA's in the entire industry. The Company has publicly expressed its commitment to full regulatory compliance and youth access prevention and believes its submissions to the FDA will be recognized as both distinguished and suitable for approval.........."

    Charlie's Best-Selling E-Liquids Are in the Select Remaining PMTA Submissions to the FDA That Are Still Viable

    However, they may have not received a denial, but they haven't received an approval either. Technically they are selling their products illegally.
     

    Vapeon4Life

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    However, they may have not received a denial, but they haven't received an approval either. Technically they are selling their products illegally.
    Supposedly, according to that article, they spent millions to pass the PMTA - Possibly it's harder for the FDA to deny a truly thorough application? But I agree, until his products are actually approved - they really have nothing to brag about. As far as it being illegal....??? Some might say what the FDA is doing and the way they are doing it, is neither ethical or legal. I would bet the companies that can afford to will continue to fight this in court. I know some major court cases have been lost
    - BUT do you know if there was ever filed a "Class action Lawsuit" on behalf of vape users themselves who are not commercially involved in vaping?
    - Another words I, and a bunch of vape users file suit against the FDA for endangering our health in using a harm reduction tobacco product - On the false premise that the vape productt is risking the health of minors who are not legally allowed to buy the products in the first place ?!?!
     

    Territoo

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    Supposedly, according to that article, they spent millions to pass the PMTA - Possibly it's harder for the FDA to deny a truly thorough application? But I agree, until his products are actually approved - they really have nothing to brag about. As far as it being illegal....??? Some might say what the FDA is doing and the way they are doing it, is neither ethical or legal. I would bet the companies that can afford to will continue to fight this in court. I know some major court cases have been lost
    - BUT do you know if there was ever filed a "Class action Lawsuit" on behalf of vape users themselves who are not commercially involved in vaping?
    - Another words I, and a bunch of vape users file suit against the FDA for endangering our health in using a harm reduction tobacco product - On the false premise that the vape productt is risking the health of minors who are not legally allowed to buy the products in the first place ?!?!

    Such lawsuits take time and lots of money, neither of which your average group of vapers or the vaping advocacy groups like VTA or CASAA have. So unless something changes you are just blowing vape into the wind. Don't get me wrong. It's not that I wouldn't like to see such a thing happened, but it's going to take people with big money in the game to make a difference, and they're not enough big players on our side. Most probably sunk all they had in the PTMA fees, just to be outwitted by the PACT act, not to mention all of the state and local laws and taxes. I don't expect any lawsuits will be filed and certainly not by individuals.
     

    YoursTruli

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    I'm not sure what industry you are referring to but if the remaining vaping products who have by government hand suddenly corner the vaping market and can be taxed much in the same way as traditional tobacco products then yes it's well worth their efforts to protect THAT revenue. After all isn't that the whole point?
    .....or tax them even more than cigarettes
    Stop a Massive Federal Tax on Safer Nicotine Products!

    so no they won't ban vaping just create a hand picked market they can tax the h*** out of ....yeah... NO one saw THAT coming... :rolleyes:
     

    Vapeon4Life

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    Such lawsuits take time and lots of money, neither of which your average group of vapers or the vaping advocacy groups like VTA or CASAA have.
    So I just did some more research - Guess what? There is a whole bunch of class action lawsuits AGAINST VAPING - Especially targetting brands like Juul.
    And from last year:
    Nicotine Giants Fight RICO Claims in Sprawling E-Cigarette Class Action
    Lawyers for nicotine giants Juul and Altria pulled out all the stops Monday to defeat a multidistrict class action claiming they conspired to get young people hooked on addictive e-cigarettes with deceptive ads and marketing campaigns.
    https://www.courthousenews.com/nico...claims-in-sprawling-e-cigarette-class-action/

    Now I see why the FDA did not approve any vape products - FEAR - Not from us vapers but from the anti crowd that have now taken the war on cigarettes to the war on vaping.

    And now, in my opinion, what ever is left of the vaping industry, and 'independent vapers and vaping associations' - Should fight back legally with litigation.

    Win, lose, or draw, if we don't fight back, they will......??? They will create an atmosphere where everyone will be scared out of business, even if the FDA doesn't close them down.

    Could it even get to a point where they will sue and/or outlaw forums like this claiming it is condoning vaping and therefore causing teenagers to become life time addicts???

    I can say 'DON'T TREAD ON ME' but we all know if they can get away with it they will !
     
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    kristin

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    The main issue with consumers filing a class action against FDA is that you need to show actual damages (financial or physical.) There's really no way to do that at this point. Those lawsuits against JUUL are claiming damages to youth and creating problems in schools. The lawsuits against FDA are claiming youth are being harmed and misrepresent youth vaping rates to back up their claim. All vapers can say at this point is the FDA "may" be risking the future health of adult consumers, but can't point to any actual damages. (This may change in a few years if people who went back to smoking get sick, but FDA can argue that was from the smoking.) FDA can also argue that it hasn't "banned" anything, but rather companies have failed to meet the requirements for marketing. And that it's protecting youth, while adults can use other FDA-approved products or tobacco/menthol flavored vape products (in the event FDA actually authorizes any.)

    Additionally, suing the FDA wouldn't have any kind of payout for the legal team, so they'd charge for their work. The groups suing the FDA and JUUL all have VERY deep pockets -- either state attorneys using taxpayer dollars or Bloomberg-funded ANTZ groups. Vaping consumers don't have that kind of funding to pay for suing the FDA.
     

    Vapeon4Life

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    The main issue with consumers filing a class action against FDA is that you need to show actual damages (financial or physical.) There's really no way to do that at this point. Those lawsuits against JUUL are claiming damages to youth and creating problems in schools. The lawsuits against FDA are claiming youth are being harmed and misrepresent youth vaping rates to back up their claim. All vapers can say at this point is the FDA "may" be risking the future health of adult consumers, but can't point to any actual damages. (This may change in a few years if people who went back to smoking get sick, but FDA can argue that was from the smoking.) FDA can also argue that it hasn't "banned" anything, but rather companies have failed to meet the requirements for marketing. And that it's protecting youth, while adults can use other FDA-approved products or tobacco/menthol flavored vape products (in the event FDA actually authorizes any.)

    Additionally, suing the FDA wouldn't have any kind of payout for the legal team, so they'd charge for their work. The groups suing the FDA and JUUL all have VERY deep pockets -- either state attorneys using taxpayer dollars or Bloomberg-funded ANTZ groups. Vaping consumers don't have that kind of funding to pay for suing the FDA.
    I see your point - BUT: Wasn't one of the main points for advocating vaping over smoking was/is the fact that addiction to cigarette smoking is both addictive and proven harmful while vaping though still potentially addictive is far less harmful? Also, from what I've read, vaping and especially flavored vaping, has proven to be far superior to any other 'quit smoking' devices or drugs. Another words, and specifically, as an ex tobacco smoker I found it relatively easy to completely quit lit tobacco smoking because of vaping and especially flavored vaping.
    The FDA's blatant attempt to deny me access to a possibly life saving product is a threat to my health as the easy access to all the lit smoking products continuously puts temptation to go back to a much easier to acess tobacco product. Further, this threat to easy access to vaping products will cause many, possibly millions, of ex smokers to return to smoking. Accordingly millions may die as a consequence; and this may constitute a health disaster - This disaster is far more serious than the FDA's claim that teenagers will still find ways to obtain vaping products even though it is illegal for them to do so. Another words the FDA is claiming that because law enforcement is ineffective at protecting teenagers from a possible addiction - Millions of adults should die !!!
    What courts do you really think will sustain this paradigm especially when it can be shown that special interest groups {ie. Bloomberg Philanthropies, et al} have used undue and illegal influence to further their agenda of total tobacco/nocotine prohibition ?!?!

    And as far as your statement: "Additionally, suing the FDA wouldn't have any kind of payout for the legal team....."

    Billions of dollars are at stake here - Indirectly, if not directly there would be a substantial payout for the legal team IF THEY WIN !
     
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    kristin

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    Where are you establishing a monetary loss for consumers that would result in a payout for the legal team? The lawsuit would be about (as you say) a "threat to health." There's no amount that can be set to that for compensation.

    At this point, FDA is requiring companies to prove that flavors are more of a benefit to public health than a risk to youth use, a well-known and widely acknowledged "vaping epidemic" that is "addicting a whole generation" and causing "brain damage" all because of flavors. (The ANTZ lies that have been repeated often enough now to be pretty much accepted as truth by the general public.) No company has yet proved this and the threat to youth will be seen as more important than adults who smoke having flavors by pretty much any judge. Consumers simply have nothing to stand on in court--YET. Industry, on the other hand, does have some things they could sue over (monetary loss, political influence pressuring the FDA, poor handling of the PMTA process, favoritism for large corporations, etc) and hopefully they will sue.

    You're preaching to choir on the reasoning and I agree with you, but the reasons you give don't make a valid argument for a lawsuit.
     

    Vapeon4Life

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    You're preaching to choir on the reasoning and I agree with you, but the reasons you give don't make a valid argument for a lawsuit.
    So are you saying that an idea I have to start an online campaign asking current vape users to sign on to a
    'class action lawsuit' to sue the FDA for right to access 'harm reduction' tobacco products will not stand any chance of success?

    Let's say I soon get a few thousand online co-signers to this - maybe more? No chance a lawyer{s} looking to establish a name for himself and/or his law firm would want to take such a case? Remember if push comes to shove, would it be just as easy to prove the harm reduction potential of vaping as compared to the 'supposed' harm caused by vaping to teenagers - which I question 'they' can really prove - Make them 'prove' the supposed teen vaping epidemic and rampant addiction. - And again even if they could, it is now illegal to sell vaping products to anyone under 21 - Regulating laws and penalties, including adult identification required, which it now is anyway, to virtually fool proof underage sale - The fact then is that what the
    'tobacco nazis' want is 'Prohibition' and they still don't have that right - And I think it can be proven that they are using illegal influence peddling to gain it.

    Also please see another recent posts of mine here:
    Tobacco Control Experts Unite for Unprecedented Endorsement of Vaping
    Tobacco Control Experts Unite for Unprecedented Endorsement of Vaping
     
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    Bliss Doubt

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    Whoever hasn't clicked the CASAA link to contact your reps and protest the egregious vape taxes being proposed by the thugs at the House Ways & Means Committee had better do it, or it will be vapers who cover all the magic money being cranked out by our nanny government. Here is the taxing schedule:

    VapeTax.JPG
     

    kristin

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    So are you saying that an idea I have to start an online campaign asking current vape users to sign on to a
    'class action lawsuit' to sue the FDA for right to access 'harm reduction' tobacco products will not stand any chance of success?

    Let's say I soon get a few thousand online co-signers to this - maybe more? No chance a lawyer{s} looking to establish a name for himself and/or his law firm would want to take such a case? Remember if push comes to shove, would it be just as easy to prove the harm reduction potential of vaping as compared to the 'supposed' harm caused by vaping to teenagers - which I question 'they' can really prove - Make them 'prove' the supposed teen vaping epidemic and rampant addiction. - And again even if they could, it is now illegal to sell vaping products to anyone under 21 - Regulating laws and penalties, including adult identification required, which it now is anyway, to virtually fool proof underage sale - The fact then is that what the
    'tobacco nazis' want is 'Prohibition' and they still don't have that right - And I think it can be proven that they are using illegal influence peddling to gain it.

    Also please see another recent posts of mine here:
    Tobacco Control Experts Unite for Unprecedented Endorsement of Vaping
    Tobacco Control Experts Unite for Unprecedented Endorsement of Vaping

    1) "sue the FDA for right to access 'harm reduction' tobacco products"

    There is no legal "right" to access harm reduction products. FDA also cannot make access to harm reduction products a right - that would take Congress changing the Constitution/Bill of Rights.

    2) The FDA can easily argue that its not taking away access to harm reduction products. It can point to IQOS, Swedish snus, nicotine gum, lozenges and patches. It can also argue that its doing its due diligence to protect public health, any company who completes a sufficient application has the opportunity to sell and that it was Congress who made it the responsibility of the manufacturer to meet PMTA standards and prove their product "benefits public health." (I 100% agree with you that FDA or the government should have to prove that vaping is causing the "harm to youth" that the industry is somehow supposed to disprove! But again, that's a lawsuit for industry to put forth, not consumers.) So, if anything, it's Congress that needs to change the requirements given to FDA in the Tobacco Act of 2009 and Congress who needs to be convinced one way or another.

    3) The kind of lawyer/law firm that would be willing to take on such a case just to "establish a name for himself and/or his law firm" wouldn't have the skills, experience or funds to win such a case. It would take hundreds of thousand (if not millions) of dollars just to bring the case before a judge. You're talking about hundreds of hours of work and they wouldn't get paid for years. And who would pay them? Certainly not the vapers. The suit isn't for damages, just "access," so the government won't pay the plaintiff's legal team.

    4) "The fact then is that what the 'tobacco nazis' want is 'Prohibition' and they still don't have that right - And I think it can be proven that they are using illegal influence peddling to gain it."

    Then you need to sue the prohibitionists who are meddling.

    So, I'm sorry but no, I don't think your petition and class action suit plan has any chance of success. The only lawsuit that has a chance of success is going to be one funded by big industry with deep pockets. If you're still determined, though, I recommend contacting a few attorneys with your plan and get their opinions on the viability of such a lawsuit before starting a petition and getting people's hopes up. (But I'm 99.9999% certain they will tell you what I've told you.)
     
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