Deeming Regulations have been released!!!!

[Alexander Mundy]

I would speculate that it's less than 5%, quite possibly much less.

And I think most of us know each other, at least in passing.

 

[Lessifer]

I sent Judge Jackson's Ruling to an associate of mine who is a Lawyer who has knowledge of Regulatory Lawsuits.

She said that it was one of the Most "Air Tight" Rulings she had read in a Long Time. And something Clearly written with an Big Dollar/High Profile Appeal in mind.

My Issue with it was that the TCA Clearly States that the FDA should be Promoting and Encouraging Less Harmful tobacco Products. When the FDA chucked e-Cigarettes in with Combustible tobacco, this Violated the Intent of Congress under the TCA.

And since the FDA says that it's Mission is to Protect and to Promote Public Health, it is Hard for me to make the Judicial Deference Argument that the previous FDA's Deeming (with regards to e-Cigarettes and other THR Products) is following the Intent of the TCA for THR Products or is aligned with the FDA's Public Health mission.

Yeah, I wonder what the burden of proof will be to get one of those through.

I'm no lawyer but it seems to me that this might be one area where a legal case could be made. The TCA and Deeming give lip service to the fact that the intention is not to ban, but to regulate and promote less harmful products. The issue, if you want to stay within the framework, is the measuring stick by which a product is judged to be modified risk, or rather the lack of a measuring stick. The FSPTCA, passed in 2009, states that the FDA will provide guidance on the MRTP application process, and they have yet to do so.

I keep wondering why they havent regulated nic itself yet? Nic could easily be made into the bottleneck of the whole distribution system.

Why do you believe that nicotine is not, or could not be viewed by the FDA as, a tobacco product component?

 

[mikepetro]

Why do you believe that nicotine is not, or could not be viewed by the FDA as, a tobacco product component?

You're putting words in my mouth, I didnt say they didnt view it as a component, as they probably do.

What puzzles me is the total lack of any attempt to regulate nic, beyond manufacturing, labeling, and packaging. In all of their deadlines, guidelines, webinars, various requirements, predicate dates, they never mention restricting access to nic. Nowhere have I seen any mention of limiting concentrations, or limiting sales (other than to minors). In one of their webinars they even mention leaving DIY alone.

I keep waiting for the other shoe to drop.

 

[Rossum]

What puzzles me is the total lack of any attempt to regulate nic, beyond manufacturing, labeling, and packaging. In all of their deadlines, guidelines, webinars, various requirements, predicate dates, they never mention restricting access to nic. Nowhere have I seen any mention of limiting concentrations, or limiting sales (other than to minors). In one of their webinars they even mention leaving DIY alone.

Most of the folks who do DIY are pretty hard-core. We're gonna do what we do whether the FDA likes it or not. If they're too quick to make it difficult to get our supplies legally, they know darn well that an "informal" market will develop in short order, and I don't think they're eager for that to happen.

 

[Robino1]

I didn't even think about that I filled out a bunch too.

Sweetie don't feel bad. Even our leaders fell for that ploy hook line and sinker. There were even lawyers on the board of CASAA. No one thought that the FDA would use our words against us. Well some thought that maybe they would but the majority actually thought the FDA would be fair if they could only see our side.

Well at least I quit smoking!

And THAT is what it's all about.

 

[leftyandsparky]

Thank you @Robino1

 

[Dubminer]

I keep waiting for the other shoe to drop.

When the shoe drops it will be more of a Ballet shoe. Silently without warning. I believe this will happen very shortly. Game over real quick then. I am fine but stock up Nicotine now is my advice.

 

[Lessifer]

You're putting words in my mouth, I didnt say they didnt view it as a component, as they probably do.

What puzzles me is the total lack of any attempt to regulate nic, beyond manufacturing, labeling, and packaging. In all of their deadlines, guidelines, webinars, various requirements, predicate dates, they never mention restricting access to nic. Nowhere have I seen any mention of limiting concentrations, or limiting sales (other than to minors). In one of their webinars they even mention leaving DIY alone.

I keep waiting for the other shoe to drop.

What I meant is, there's no need for them to single it out. Like any other e-liquid that contains nicotine, the regulations already apply, meaning that come November, 2018, No PMTA for concentrated nic means no nic available for sale.

 

[mikepetro]

What I meant is, there's no need for them to single it out. Like any other e-liquid that contains nicotine, the regulations already apply, meaning that come November, 2018, No PMTA for concentrated nic means no nic available for sale.

That could easily be challenged as a ban though, since they say nic is a tobacco product they cant ban it.

I suspect thats one thing that you could probably get an SE on, since extracted nic existed before the predicate date.

 

[Rossum]

That could easily be challenged as a ban though, since they say nic is a tobacco product they cant ban it.

I suspect thats one thing that you could probably get an SE on, since extracted nic existed before the predicate date.

Existed, yes. But I don't thing whether it existed or not is not the criteria that needs to be met. My understanding is that it had to be marketed to consumers, and I'm somewhat skeptical that anyone was marketing nic base in February of 2007.

 

[Lessifer]

That could easily be challenged as a ban though, since they say nic is a tobacco product they cant ban it.

I suspect thats one thing that you could probably get an SE on, since extracted nic existed before the predicate date.

Was it marketed by any of the companies currently marketing it? If so, perhaps they could get an SE, if the product hasn't changed substantially, including packaging, etc.

It wouldn't be a ban for the same reason as all other vaping products, not having any products that have gone through the approval process successfully is not the same as a ban, even if the effect is the same.

 

[zoiDman]

That could easily be challenged as a ban though, since they say nic is a tobacco product they cant ban it.

I suspect thats one thing that you could probably get an SE on, since extracted nic existed before the predicate date.

Product that have not been Submitted or have been Denied a Market Order would not be considered a Ban.

Not sure if there was e-Liquid that contained Nicotine sold in a US Market previous to the Predicate Date? I think we would have seen something about them if there was.

Same with Hardware.

 

[mikepetro]

e-liq.com (actually its parent) had it back then on their Chinese (English language) website, but they might have to use retro packaging. That Chinese site was my first undiluted nic purchase, before they opened their US facility.

"E-Liq is the US branch of E-Cig.com, which is the world first and largest official site for Electronic Cigarettes and E-Liquid products with the lowest prices and the most complete line."

About Us

Do the regs specify marketing in the "USA"?

 

[zoiDman]

...

Do the regs specify marketing in the "USA"?

Not just Marketed or Advertised. Must have had to be "Sold" in a US Market.

 

[mikepetro]

Not just Marketed or Advertised. Must have had to be "Sold" in a US Market.

It was.....

 

[zoiDman]

It was.....

I would Love to see a Predicated Product. From your Link, I saw this...

"In 2012, we have set up manufacturing and warehouse center in California, US to manufacture E-Liquid with US FDA approved materials to ensure the maximum safety and serve our customers better."

Do you have some information about Earlier Products?

BTW - When I buy stuff from FT, even though I am an American, living in the USA, using US Funds, I am doing business in a Chinese Market.

 

[mikepetro]

I would Love to see a Predicated Product. Do you have some information on it?

BTW - When I buy stuff from FT, even though I am an American, living in the USA, using US Funds, I am doing business in a Chinese Market.

That "About Us" link I posted has some info. They existed and sold to to US customers.

They changed their Chinese website in 2013 after the US branch opened.

Their WHOIS info is privatized. But they go way back, they used to be called Cixi E-Cig, they got sued by Ruyan back in the day.

"In February 2009, Ruyan released a press release saying that they had asserted patent rights to the e-cigarette in a key Chinese court ruling and that a rival manufacturer, Cixi E-cig, had been ordered to destroy its entire inventory and cease trading.[15] Cixi E-cig responded that they had not been ordered to destroy their entire inventory or cease trading.[16] A Chinese court had ruled that two of their products did infringe on Ruyan's intellectual property (both products contained piezoelectric technology) and they were required to stop producing only those."

Even on old thread here on ECF about them:
Cixi E-Cig Tech. Inc

E-liq.com is a direct subsidiary/descendant of them.

ETA: several old references to Cixi here on ECF:
https://www.e-cigarette-forum.com/forum/search/7305909/?q=cixi&o=relevance&c[node]=7

 

[zoiDman]

That "About Us" link I posted has some info. They existed and sold to to US customers.

...

If this Foreign company has No US Presence, I don't believe that selling to US Individuals would be considered Engaged in a US Market. I believe that is considered Exporting from a Foreign Market. And what the Individuals are doing is Buying an Imported Product.

Don't get me Wrong. I would Love to See an actual Predicate Product surface. Just haven't seen it yet.

 

[mikepetro]

If this Foreign company has No US Presence, I don't believe that selling to US Individuals would be considered Engaged in a US Market. I believe that is considered Exporting from a Foreign Market. And what the Individuals are doing is Buying an Imported Product.

Don't get me Wrong. I would Love to See an actual Predicate Product surface. Just haven't seen it yet.

It appears they had a Las Vegas address back in the day, and the FDA definitely knows it.

As quoted in the FDA warning letter:

“5 July 2009 - New Product E-...... has been released . . . we have developed this new Vaporizable ...... which have [sic] the same characteristic and the same effectiveness as the original ....... Now you can treat your ED or pulmonary arterial hypertension and improve your sexual capacity by smoking.

8 July 2009 - New Product E-Rimonabant has been released . . . this new Vaporizable Rimonabant which have [sic] the same characteristic and the same effectiveness as the original Rimonabant. Now you can Loss [sic] Your Weight and Reduce Your Smoking Addiction! by smoking.

5 May 2008 - Healthcare Liquid released . . . Healthcare Liquid is available now. These new developped [sic] Electronic Smoking Healthcare Liquid products not only give you the same feeling as a tobacco cigar or cigarette without suffering any tar and carbon monoxide smoking damages, but also give you the personal health care for your body.”

E-Cig Technology also distributes various accessories for electronic cigarettes, cigars, and USB cigarettes, such as syringes with needles, plastic dropper bottles, and plastic bottles, which are intended and labeled to aid users of these electronic smoking products when transferring the E-Cig Technology E-liquid into depleted or empty cartridges of various brands/models of these products and/or into empty E-Cig Technology cartridges.

All of these dates quoted by the FDA and addressed to a Las Vegas address prove the existance prior to the predicate date, and a US presence.

Mr. Sihui (Sam) Han
Cixi E-Cig Technology Inc, Ltd.E-Cig Technology Inc.
7488 Celosia St.Las Vegas, NV 89113

The companies that received FDA warning letters are:

• Cixi E-Cig Technology Inc. Ltd., Las Vegas, Nev.
• E-CigaretteDirect LLC, Parker, Colo.
• Gamucci America/Smokey Bayou Inc., Jacksonville, Fla.
• Johnson Creek Enterprises LLC, Johnson Creek, Wis.
• Ruyan America Inc., Minneapolis, Minn.

FDA Warns Five Companies Over E-Cigarette Claims

E-Cig Technology Inc.

 

[zoiDman]

It appears they had a Las Vegas address back in the day, and the FDA definitely knows it.

As quoted in the FDA warning letter:


All of these dates quoted by the FDA and addressed to a Las Vegas address prove the existance prior to the predicate date, and a US presence.

Mr. Sihui (Sam) Han
Cixi E-Cig Technology Inc, Ltd.E-Cig Technology Inc.
7488 Celosia St.Las Vegas, NV 89113



FDA Warns Five Companies Over E-Cigarette Claims

E-Cig Technology Inc.

But Mike, 2009 aint gonna to get you anywhere with the FDA.

The Predicate Date is February 15, 2007.