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FDA tells four firms to stop selling flavored e-cigarette, hookah products

5150sick

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https://wsau.com/news/articles/2019...-flavored-e-cigarette-hookah-products/925878/

They seem to be busting these companies on the deeming rule claiming that they weren't on the market before 08/08/2016 (they weren't):

https://www.fda.gov/inspections-com...vo-manufacturing-distribution-582569-08082019

https://www.fda.gov/inspections-com...s-usa-llc-dba-likido-labs-usa-582106-08082019

https://www.fda.gov/inspections-com...s/v8p-juice-international-llc-577723-08082019

https://www.fda.gov/inspections-com...ng-letters/hookah-imports-inc-584666-08082019

Why only these four when there are MANY others?
I have no idea.
 
JuicyLucy

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Well, I read the bottom one (see my glazed over eyes?) to Hookah-Imports

It appears the company made some kind of submissions to the FDA, and the FDA investigated Hookah-Imports

The most disturbing part (not that any of it is good) is the FDA invoking the 2007 marketing date

The FDA says after reviewing Hookah-Import's "FDA has determined that the ROR Tobacco hookah tobacco products listed in the table above were not commercially marketed in the United States as of February 15, 2007."

Also, selling to minors online "FDA’s investigation of the website https://www.rortobacco.comExternal Link Disclaimer revealed that you sold hookah tobacco products to a minor. Specifically, during FDA’s investigation of https://www.rortobacco.comExternal Link Disclaimer, a person younger than 18 years of age purchased the following hookah tobacco products from your website: "

And also for not having the giant tobacco warning label: FDA’s review of the website https://www.rortobacco.comExternal Link Disclaimer revealed that the labeling and/or advertising for the following hookah tobacco products that you manufacture, package, import, distribute, or retail in the United States does not include the required nicotine warning statement:
 
The Cromwell

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(Reuters) - The U.S. Food and Drug Administration has told four companies to remove 44 of their flavored e-liquid and hookah tobacco products that do not have the required approval for sale in the U.S., the agency said on Thursday.

The move comes against the backdrop of the FDA’s efforts to curb the usage of the addictive substances among young adults.


The agency said it has issued warning letters to Mighty Vapors LLC, Liquid Labs USA LLC, V8P Juice International LLC and Hookah Imports Inc and has sought their response within 15 days.(reut.rs/2YUeBn7)

The FDA said the products had been introduced into the market after the effective date of a rule that extended FDA’s authority to all tobacco products, thereby making them adulterated or misbranded.

https://www.reuters.com/article/us-...red-e-cigarette-hookah-products-idUSKCN1UY1U2
 
The Cromwell

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DogMan said:
Why do you do this?

http://vapingunderground.com/thread...-flavored-e-cigarette-hookah-products.494555/

Existing thread from days ago. I'm sure you do it just to antagonize your fan club. And I'm sure this will end up moved to u mad bro? Because no one cares when 5150 says it. But you say the same thing and the nutters will have kittens
Click to expand...
LOL
YOU do have a point.
I musta missed the other post.
But yes you surely do have a point.

Admins please close this thread before my admirers show up :)
 
The Cromwell

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Come next May the 2007 date will be all there is...
or have I missed something?

My understanding is that next May no vape products not on the market prior to Feb 2007 may be sold in the USA unless they either have a pending or approved PMTA?
And no Vape products not on the USA Market prior to 8-8-2016 without an approved PMTA.
 
Last edited:
The Cromwell

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5150sick said:
Why only these four when there are MANY others?
I have no idea.
Click to expand...
Takes a while to work em all in.
I expect this to be a regular thing until next May.

and my understanding is that it is legal to make and export ejuice and vape stuff just not sell here or import for sale here?
 
The Cromwell

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JuicyLucy said:
Well, I read the bottom one (see my glazed over eyes?) to Hookah-Imports

It appears the company made some kind of submissions to the FDA, and the FDA investigated Hookah-Imports

The most disturbing part (not that any of it is good) is the FDA invoking the 2007 marketing date

The FDA says after reviewing Hookah-Import's "FDA has determined that the ROR Tobacco hookah tobacco products listed in the table above were not commercially marketed in the United States as of February 15, 2007."

Also, selling to minors online "FDA’s investigation of the website https://www.rortobacco.comExternal Link Disclaimer revealed that you sold hookah tobacco products to a minor. Specifically, during FDA’s investigation of https://www.rortobacco.comExternal Link Disclaimer, a person younger than 18 years of age purchased the following hookah tobacco products from your website: "

And also for not having the giant tobacco warning label: FDA’s review of the website https://www.rortobacco.comExternal Link Disclaimer revealed that the labeling and/or advertising for the following hookah tobacco products that you manufacture, package, import, distribute, or retail in the United States does not include the required nicotine warning statement:
Click to expand...
Yep the warning statements and labeling and age things did NOT get delayed in implementation.
Maybe explains why they got jumped on before next May...
 
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