FDA slams Juul, threatens seizure

[iVapeDIY]

Huh? juul was introduced to the market in 2015, more than a full year before the Deeming Regs' "no new products without a PMTA" rule went into effect. I know this for a fact because I bought one back then to see what all the hub-hub was about. Thus juul is allowed to sell until the PMTA deadline, currently May 11, 2020, and the Deeming explicitly grants them an additional year after that, assuming they submit an application prior to the deadline, which I'm quite confident they will.

Types of FDA Enforcement Actions

Warning Letters - are sent to the individuals or firms, advising them of specific noted violations.; These letters request a written response as to the steps which will be taken to correct the violation. These letters constitute one form of warning that can be issued under current Agency policy.

Seizure - An action brought against an FDA-regulated product because it is adulterated and/or misbranded within the meaning of the Act. The purpose of such an action is to remove specific violative goods from commerce.

Injunction - An order by a court that requires an individual or corporation to do or refrain from doing a specific act. FDA may seek injunctions against individuals and/or corporations to prevent them from violating or causing violations of the Act.

Criminal prosecution - may be recommended in appropriate cases for violation of Section 301 of the Act.; Misdemeanor convictions, which do not require proof of intent to violate the Act, can result in fines and/or imprisonment up to one year. Felony convictions, which apply in the case of a second violation or intent to defraud or mislead, can result in fines and/or imprisonment up to three years.​

All of the above are at play.

 

[Rossum]

All of the above are at play.

Maybe so, but not on the basis that Juul is selling without market authorization. Again, there's nothing in the TCA or Deeming Regs that requires them to have authorization at this point.

Now if it can be proven that they've made claims that they're not allowed to make, such as the claim that their product is "safer" than smoking (which any reasonable person would have to admit is a truthful claim), then that might indeed be problematic for them. But I bet they have enough money to pay lawyers to take that all the way to the Supreme Court, and I'd be very happy to see someone contest the notion that laws and regulations can bar a person or other entity from making a truthful claim.

 

[zoiDman]

Types of FDA Enforcement Actions

Warning Letters - are sent to the individuals or firms, advising them of specific noted violations.; These letters request a written response as to the steps which will be taken to correct the violation. These letters constitute one form of warning that can be issued under current Agency policy.

Seizure - An action brought against an FDA-regulated product because it is adulterated and/or misbranded within the meaning of the Act. The purpose of such an action is to remove specific violative goods from commerce.

Injunction - An order by a court that requires an individual or corporation to do or refrain from doing a specific act. FDA may seek injunctions against individuals and/or corporations to prevent them from violating or causing violations of the Act.

Criminal prosecution - may be recommended in appropriate cases for violation of Section 301 of the Act.; Misdemeanor convictions, which do not require proof of intent to violate the Act, can result in fines and/or imprisonment up to one year. Felony convictions, which apply in the case of a second violation or intent to defraud or mislead, can result in fines and/or imprisonment up to three years.​

All of the above are at play.

True.

But this is what Is Going to Happen...

Criminal Fines for Food Drug and Cosmetic Act Violations

Misdemeanor fines under the Act may reach $500,000 under some circumstances. The Criminal Fine Enforcement Act of 1994 (Public Law 98-596) provides for fines for violations of Federal law. Although it is not part of the Act, the Criminal Fine Enforcement Act of 1994 applies to all fines levied under the Act, as well as other statutes that contain provisions enforced by FDA.

The following fines are applicable for each offense:

• Up to $100,000 for a misdemeanor by an individual that does not result in death.
• Up to $200,000 for a misdemeanor by a corporation that does not result in death.
• Up to $250,000 for a misdemeanor by an individual that results in death, or a felony.
• Up to $500,000 for a misdemeanor by a corporation that results in death, or a felony.

Types of FDA Enforcement Actions

JUUL is going to get Slapped with a 100K Fine or so. And then some Form of Public Admonishment via a harsly worded stement from an Acting FDA Commissionaire.

And JUUL will Not contest it. Even though they make a Statement accepting No Guilt.

Then some Politicians will say that this is Not Enough.

But things will get Drowned Out by some Bigger Story of the Week. Like the Government Shutting Down. Or some Senator calling for Stricter Enforcement of the thing we used to Not be able to talk about here.

 

[iVapeDIY]

True.

But this is what Is Going to Happen...

Possible. Scott Gottlieb is still a wildcard. Also, the army of lawyers with active class action lawsuits could also push for injunctions and/or seizure as leverage to get several billion in settlements.

The fun begins in 15 days

 

[zoiDman]

Possible. Scott Gottlieb is still a wildcard. ...

Who?

 

[nomore stinkies]

Now "Be Best" has weighed in on the issue, so the roll toward a vaping ban continues.

I am appalled with the news coverage. I have heard one mention that it was TXX that is the culprit. The CDC and FDA has failed at their one job, to protect the public. Illinois' DD is gearing up for a ban. Jumping the gun once again. You cannot convince me that they don't have a clue about the source of contamination. Black market, Juul, blank pods...something.

 

[iVapeDIY]

Who?

Gottleibs's invisible influence is evident on Sharpless' actions.

Ned Sharpless Holds the Gottlieb Line in Two Addresses to Health Organizations | BioSpace

Vaping deaths: Here's what you need to know - CNN

Friday, after the news of additional deaths tied to vaping spread, Durbin called on Sharpless to move to regulate e-cigarettes and flavors in the next 10 days. Durbin said he would call for Sharpless' resignation if he did not take action.

Then on Monday, Durbin said again in a news conference that it's time Sharpless "either does something or resigns." He added that public education on the issue is not enough and enforcement is needed.​

Sharpless is under pressure to look strong and decisive; injunction and seizure options may do just that ... would also work in Chantix favor if they push for only non-vaping nicotine replacement therapies again.
14 days to go

 

[zoiDman]

Gottleibs's invisible influence is evident on Sharpless' actions.

Ned Sharpless Holds the Gottlieb Line in Two Addresses to Health Organizations | BioSpace

Vaping deaths: Here's what you need to know - CNN

Friday, after the news of additional deaths tied to vaping spread, Durbin called on Sharpless to move to regulate e-cigarettes and flavors in the next 10 days. Durbin said he would call for Sharpless' resignation if he did not take action.

Then on Monday, Durbin said again in a news conference that it's time Sharpless "either does something or resigns." He added that public education on the issue is not enough and enforcement is needed.​

Sharpless is under pressure to look strong and decisive; injunction and seizure options may do just that ... would also work in Chantix favor if they push for only non-vaping nicotine replacement therapies again.
14 days to go

Ahh... The Invisible Influence. Something that is Very Often overlooked.

Because... wait for it.... wait for it... wait for it... it's Invisible.

That, or because it Doesn't Exist.

 

[zoiDman]

BTW - Did Current Events Today make all this Suppositions about JUUL Meaningless?

 

[iVapeDIY]

BTW - Did Current Events Today make all this Suppositions about JUUL Meaningless?

Trump Ban adds more teeth.

 

[bobwho77]

Maybe so, but not on the basis that Juul is selling without market authorization. Again, there's nothing in the TCA or Deeming Regs that requires them to have authorization at this point.

Now if it can be proven that they've made claims that they're not allowed to make, such as the claim that their product is "safer" than smoking (which any reasonable person would have to admit is a truthful claim), then that might indeed be problematic for them. But I bet they have enough money to pay lawyers to take that all the way to the Supreme Court, and I'd be very happy to see someone contest the notion that laws and regulations can bar a person or other entity from making a truthful claim.

I agree with this completely.
The FDA rules are what they are, but is it Constitutional for them to stop people from making statements that (even the FDA at this point admits) are true?
I think that the lawyers at Juul & co. are itching to find out.

 

[jjcordone]

I am appalled with the news coverage. I have heard one mention that it was TXX that is the culprit. The CDC and FDA has failed at their one job, to protect the public. Illinois' DD is gearing up for a ban. Jumping the gun once again. You cannot convince me that they don't have a clue about the source of contamination. Black market, Juul, blank pods...something.

Trump has no idea what any of this is, nor will he investigate to learn more.
Be Best's only accomplishment has been to buy up every blood red Christmas tree in the country for the white house last year. He needed a win for her going into his campaign and vaping is an easy target.
Remember this when you vote in 2020, Trump will be the man that killed the vaping industry.

 

[nomore stinkies]

Just heard Trumps team Azar (?) is going to ban flavors for now except for tobacco. Flavors can be submitted by PMTA by deadline

Trump has no idea what any of this is, nor will he investigate to learn more.
Be Best's only accomplishment has been to buy up every blood red Christmas tree in the country for the white house last year. He needed a win for her going into his campaign and vaping is an easy target.
Remember this when you vote in 2020, Trump will be the man that killed the vaping industry.

The guy also said in a different interview that they understand that ex-smokers rely on these products and they don't plan on any action for a ban. Flavirs one month after the policy it whatever. But Dickie D. is ready to pull all products off the market. Please don't get political. You may not like me.

 

[jlazarus]

Thing is, kids/young adults are (at the moment) more likely to buy illegal carts off the street because....well duh, prohibition. I'm not suggesting kids should be able to buy them legally - just observing the reason that population is more vulnerable.

......and.....any Trump Administration "ban" on flavors is NOT going to help this. Yes, many vape veterans make their own juice, and are experienced/understand precautions required, etc...but inexperienced youths wishing to have flavored juices for legitimate vapes will now be buying *those* off the streets, too - juice that isn't made in a clean room, with god knows what.

When will society learn that prohibition never yields intended results?

Btw - how many smokers died today? And, how many youths died today from alcohol?

(PS Big Tobacco and Big Pharma are loving this.)

 

[Rossum]

Remember this when you vote in 2020, Trump will be the man that killed the vaping industry.

Do remind us, under which administration was the Tobacco Control Act passed? Under which administration was the vape industry condemned to death by the the Deeming Regulations? Hint: None of this happened under Trump.

What the Trump administration did is to give the industry a reprieve from the execution that the previous administration had scheduled for August 8th, 2018. Without that reprieve, it would already all be gone.

 

[iVapeDIY]

What the Trump administration did is to give the industry a reprieve from the execution

Only to execute the vaping industry at his pleasure and leisure?

 

[jjcordone]

Do remind us, under which administration was the Tobacco Control Act passed? Under which administration was the vape industry condemned to death by the the Deeming Regulations? Hint: None of this happened under Trump.

What the Trump administration did is to give the industry a reprieve from the execution that the previous administration had scheduled for August 8th, 2018. Without that reprieve, it would already all be gone.

You did see him on the news last night saying he was signing a ban on all flavors and only tobacco flavor would be allowed, right? He said within ten days.

 

[jjcordone]

Just heard Trumps team Azar (?) is going to ban flavors for now except for tobacco. Flavors can be submitted by PMTA by deadline

The guy also said in a different interview that they understand that ex-smokers rely on these products and they don't plan on any action for a ban. Flavirs one month after the policy it whatever. But Dickie D. is ready to pull all products off the market. Please don't get political. You may not like me.

Defend his politics all you like. All I know is he was on the news last night saying vaping is not wonderful and he was banning all flavors and would allow tobacco only. It's all over the news this morning.

 

[nomore stinkies]

Defend his politics all you like. All I know is he was on the news last night saying vaping is not wonderful and he was banning all flavors and would allow tobacco only. It's all over the news this morning.

I wasnt defending him. I just repeated what he said. Its killing kids- he had to say something. Our problem is that all of the anti vapers are not addressing the M problem. DD from Illinois would wipe all of them off the shelves. I think we agree.

Defend his politics all you like. All I know is he was on the news last night saying vaping is not wonderful and he was banning all flavors and would allow tobacco only. It's all over the news this morning.

I think we are saying the same thing. For years they have been waiting to get bubble gum and the rest of the "candy" off the market to "save the children" for a long time.

 

[Dacholiday Dach]

But would this ban not also mean we could not buy the diy flavorings from the vape industry. I'm a mint vapor, I detest anything that tastes like tobacco, I just want mint. (since I can't for the life of me find a cotton candy that tastes like cotton candy anymore) I don't want tobacco flavored vape of any kind, period.