FDA slams Juul, threatens seizure

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iVapeDIY

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iVapeDIY

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Juul warned over claims e-cigarette safer than smoking

The FDA letter highlights an incident recounted by two New York high school students during a congressional hearing in July. The students said a representative of Juul was invited to address the school on addiction issues. During the presentation, the representative told students the company’s product was “totally safe.”

The “totally safe” statement is going to haunt (and hunt) Juul ... maybe "totally" was said like some surfer dude.
 

bombastinator

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Yep, it's against the law for them to make truthful statements. :facepalm:
JUUL when it isn’t adulterated IS VERY LIKELY safer than cigarettes. It’s even outside possible that it’s safer than unprotonated nic. Not likely, but not impossible. The problem is there’s no info one way or the other. There is a deep and conspicuous data hole that needs to be filled. Badly.

The “totally safe” thing is obvious bullpucky. At the very very least, Nicotine has serious addiction issues no matter what form it comes in.
 

GOMuniEsq

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Something far safer than tobacco comes along. Government unilaterally and inappropriately classifies it as tobacco product; retroactively fines seller for making safety claims about a tobacco product. In defiance of studies that actually support such claims.
 

bombastinator

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Something far safer than tobacco comes along. Government unilaterally and inappropriately classifies it as tobacco product; retroactively fines seller for making safety claims about a tobacco product. In defiance of studies that actually support such claims.
Not disagreeing with you, I just feel compelled to add that One thing to remember in general is a study at its smallest is by definition only just barely science. It’s a drastically over used word.

We need more science.publicly available rigorous science. The abuse of the “study” is I suspect one reason hat there are som many flat earthers out there.

The CDC has totally be not helping with this one lately, which worrries me a lot. The CDCis there to deal with really deadly problems. Expending credibility on something this stupid is going to kill people long term.
 

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The “totally safe” statement is going to haunt (and hunt) Juul
Do I understand correctly that this wasn't a written statement, and there doesn't even appear to be a recording of this statement being made, that all we have is some students who claim it was made to them verbally?

If so, I think this might just be considered "hearsay" in legal terms.
 

bombastinator

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Do I understand correctly that this wasn't a written statement, and there doesn't even appear to be a recording of this statement being made, that all we have is some students who claim it was made to them verbally?

If so, I think this might just be considered "hearsay" in legal terms.
Undoubtedly. Goes to verbal credibility though, which is something in ever decreasing supply it seems.
 
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iVapeDIY

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FDA criticizes Juul for telling students its e-cigs are ‘totally safe’

FDA wrote:

"Referring to your ENDS [electronic nicotine delivery system] products as "99% safer" than cigarettes, "much safer" than cigarettes, "totally safe," and "a safer alternative than smoking cigarettes" is particularly concerning because these statements were made directly to children in school. Our concern is amplified by the epidemic rate of increase in youth use of ENDS products, including JUUL's products, and evidence that ENDS products contribute to youth use of, and addiction to, nicotine, to which youth are especially vulnerable."

The letter says Juul "should immediately correct the violations." The company now has 15 days to respond to the FDA and detail the steps it's taken to right its wrongs. If Juul's actions fail to appease the FDA, the company could face penalties and potentially have its products seized.
 

zoiDman

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How do we know what the students are saying is true.? Did the students offer evidence? Has there been a response from the person accused?

Hello... This is the Court of Public Opinion.

All you need is Loud Voice and a Soap Box to Stand On.

LOL
 

iVapeDIY

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Burden of scientific proof rests with manufacturer ...

FDA says Juul ‘ignored the law’ and warns it may take action – TechCrunch

“Companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful,” said Acting FDA Commissioner Ned Sharpless in a news release.

Details from FDA here ...

FDA warns JUUL Labs for marketing unauthorized modified risk tobacco products, including in outreach to youth

In 15 days we'll know if Juul products will be seized.
 

zoiDman

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Burden of scientific proof rests with manufacturer ...

FDA says Juul ‘ignored the law’ and warns it may take action – TechCrunch

“Companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful,” said Acting FDA Commissioner Ned Sharpless in a news release.

Details from FDA here ...

FDA warns JUUL Labs for marketing unauthorized modified risk tobacco products, including in outreach to youth

In 15 days we'll know if Juul products will be seized.

I'll bet your next Paycheck that Nothing will be Seized.
 

zoiDman

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Unlike the FAA who seem to be Boeing's puppets (eg 737 Max), the FDA appear to be following their original mandate. As traders like to say, "never bet against the Fed".

Oh Yeah... The FDA is a Model of a Non-Biased, Scientifically Based Government Agency who Places Public Health above All Else.

:lol:
 
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iVapeDIY

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See post #2.
"The Law" and lawyers are having a field day.

FDA Warning Letter, Class Action Lawsuit Slam JUUL E-cigarette Maker and Parent Altria Group

“We are happy to see the FDA stepping in. We have said for months that JUUL went to market without proper approval and now federal health officials agree,” said Jonathan Gdanski, an attorney at Schlesinger Law Offices in Fort Lauderdale. “They say they’re not targeting kids. But the success of their advertising and industry say otherwise.”

In August, the firm filed a motion for preliminary injunction asking a federal court in Florida to ban the sale of JUUL electronic cigarettes nationwide.

Schlesinger filed a class-action lawsuit on behalf of the Nessmith family of Sarasota County, Fla. The suit claims JUUL and Altria, which owns Marlboro manufacturer Philip Morris USA, Inc., continue to promote harmful products
Is Juul the new big tobacco? Wave of lawsuits signal familiar problems

“The types of cases to come will really start to change, and you’re going to see more and more catastrophic injury cases in addition to these [addiction] cases,” Van Zandt said, referring to Juul lawsuits as “tobacco 2.0”.

Beasley Allen alone is handling more than 200 clients’ vaping suits filed in state and federal courts. Florida’s largest law firm, Morgan & Morgan, filed a class action suit against Juul for “improperly targeting children with e-cigarettes”, and another Chicago law firm filed a class action against the company this summer.
 

Rossum

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We have said for months that JUUL went to market without proper approval
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.
 
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