Which Popular E-cigarette Manufacturers Submit Application To Fda?

"In a letter sent to the FDA on June 7, the Small Business Administration (SBA) Office of Advocacy asked the regulators to seek a court order extending for an additional year the current moratorium on enforcement actions against small vape manufacturers who submitted Premarket Tobacco Applications (PMTAs) before last year’s Sept. 9 deadline."

"The SBA letter doesn’t mean the FDA will ask Judge Grimm to extend the enforcement grace period, but it is an encouraging development."

See whole article he
SBA Urges Another Year of Sales for PMTA-Submitted Products - Vaping360  

Copied from another group.
With permission

I am the owner of Sapphyre Nicotine. I have been in the e-cig and vape business since 2009. This post is a little long but hopefully it is informative for some.

In 2009 the FDA started seizing shipments of electronic cigarettes under the claim that they were drug delivery devices and therefore need to pass FDA approval prior to being marketed and sold in the USA. The industry was just starting out and this was a big blow. Shipments of product were not allowed to enter the USA. Credit card companies were not allowing ecig companies to work with them. It was not looking good for ecigs. A company called Smoking Everywhere sued the FDA and made the argument that ecigs should be regulated as a tobacco product since they contained nicotine which is derived from Tobacco. Njoy joined the litigation and eventually took over when Smoking Everywhere went out of business. In 2010 Njoy won the litigation and ecigs ended up being regulated as tobacco products. This was the best outcome of two evils. The FDA appealed the decision and lost that as well. That’s when the ecig industry really started taking off. Bigger players got into the market and eventually RJR, Altria/Philip Morris, BAT and other big tobacco companies came out with ecig products. They quickly became the dominant sellers in c-stores. The tobacco companies were happy selling tobacco and menthol flavors only. That’s what they knew and that’s what they were good at.

A few years later eliquids and open systems started getting popular. These products were not very popular in c-stores. That is when vape stores started opening up. They were mainly concentrating on open system (eliquids, mods and great tasting flavors). For a short time c-stores tried to sell eliquids, but they didn’t have the know how or the time to educate customers. C-stores were good at selling closed systems and vape stores were good at open systems.

To the uninformed public we are all lumped in as one industry --- electronic cigarettes.

In reality there are 2 different industries that are somewhat related.

A) The ecig/closed system industry: In the USA as of Sep 2019 is a $6.4 billion industry. It is controlled mostly by big tobacco companies. Juul (Altria/PM), Blu (Imperial Tobacco), Vuse (British Tobacco, formerly RJR), Njoy (only independent supplier), Logic (Japan International). 75% of ecigs are sold in C-Stores, drug stores and food stores. As a comparison, regular cigarette sales in the USA are around $80 billion dollars and about 75% comes from c-stores.

While ecigs sales increased at a 40% year over year rate, regular cigarette sales dropped by 7% year over year. That is a large number that is troubling to big tobacco.

The closed system industry sells primarily tobacco and menthol/mint flavors. If flavors were banned it would not impact the industry very much. The companies selling closed systems are not going to join our fight to save flavors. They have no monetary incentive to do so. In addition all of these companies are going to apply for PMTA. They are not going to sue the FDA and risk getting PMTA approval unless it greatly impacts their business.

The vapor/open system industry: In the USA as of sep 2019 is a $2.6 billion industry. It is NOT controlled by a few large companies. There are a lot of hardware and ejuice suppliers. It is mostly sold at adult only vape stores. $1.7 Billion sold at vape stores, $350 million in c-stores and $550 million online. Lots of suppliers, distributors, small businesses are part of this industry. They mostly sell flavored eliquid as opposed to tobacco and menthol flavors.

Having been involved with both the ecig business and the vape business, I can say that they are completely different. The vape industry is getting punished for crimes committed by the ecig industry. Unfortunately we are being lumped in as one. We are the easier one to target. We need to do a much better job getting this message out.

I would also like to make a point regarding zero nicotine flavors being regulated by the FDA. The reason our industry is regulated by the FDA as a tobacco product is because the eliquid contains nicotine. This is the only reason the FDA has authority over these products. Because zero nicotine ejuice does not contain nicotine, it is no longer a tobacco product. While the FDA is going to try and enforce regulation of zero nicotine ejuice as a tobacco product by using the “intent to use” rationale, that argument is simply not valid. The FDA will also not be able to regulate zero nicotine ejuice as a drug/drug device combination either. Ejuice with no nicotine does not cause a change in the body and therefore will not be classified as a drug. This is only my educated opinion. I am not an attorney and am not making any legal claims.

I hope this was somewhat informative to people that have not been involved with ecigs and vapes as long as I have. Feel free to add, correct if you have information that I missed.

Feel free to share  

Hi, all.

I already know about Trueman and BestEcig, but I was hoping some of you can let me know of other ecig manufacturers that sell retro gear like cigalikes (808, 801, 901, etc) and even eGo style batts, 11mm and 14mm, clearos, etc. These types of manufacturers usually sell the products they make unbranded - and therefore their prices are usually extremely low even though their are selling retail. I guess you can kinda call them "factory outlets".

I'm not interested in Alibaba, DHGate, etc sellers even if they are manufacturers. Has to be real manufacturers who have their own retail websites you can order from like the above mentioned companies.

Companies like Aspire, Kanger, iSmoka, etc don't count because they don't sell older stuff besides some small clearomizers.

Thanks.  

I've just received a notice that Paypal is changing its terms and conditions, and buried deep inside the changes I found this.
PayPal said:
The Acceptable Use Policy currently prohibits use of PayPal for activities that violate applicable law or industry regulations regarding the sale of tobacco products or prescription drugs and devices. We're replacing that prohibition with new policy language covering these types of items, as well as e-cigarettes. Under the new language, use of PayPal for cigarette transactions will be prohibited. In addition, merchants will be permitted to use PayPal for sales of non-cigarette tobacco products, e-cigarettes, and prescription drugs and devices only with PayPal’s pre-approval.

...


The relevant parts of the chart under Activities Requiring Approval will be revised to read as follows: “PayPal requires pre-approval to accept payments for certain services as detailed in the chart below. [TABLE="width: 552"]
[TR]
[TD] Service Requiring Pre-Approval​
[/TD]
[TD] Contact Information​
[/TD]
[/TR]
[TR]
[TD] … selling … non-cigarette tobacco products, e-cigarettes or prescription drugs/devices.[/TD]
[TD] Please send contact information, business website URL and brief business summary to aup@paypal.com[/TD]
[/TR]
[/TABLE]
Click to expand...

Let's hope that this doesn't involve you telling them and them freezing your account while they sit on your application for months. But it seems like they might at least be warming to the idea that e-cigs are not the root of all evil.  

Sounds like other States had better Get In line Quick if they want their piece of the Pie.

Juul Will Pay North Carolina $40 Million To Settle A Landmark Suit Over Teen Vaping

Oh wait... Some Already have.

Attorney General Becerra and Los Angeles Leaders Announce Lawsuit Against JUUL for Deceptive Marketing Practices Targeting Underage Californians and Endangering Users of Its Vaping Products

And the AG who brought this Suit against JUUL is Now the Secretary of US Health and Human Services. Which oversees the FDA. That same FDA that is Evaluating JUUL's PMTA Application.

When it Rains it Pours.  

I'm new and don't know if anyone posted this yet - But it is important that everyone wanting to keep on vaping sign it - Here is a link to the pro vaping association where they make it easy to sign and submit online.

Support a Citizen’s Petition to FDA for delaying the PMTA deadline for certain small vapor manufacturers!
National – FDA Citizen’s Petition – PMTA Delay - CASAA  

I thought I'd start a thread on this so we can keep track of who is planning on submitting what in their PMTAs. (Unless there is another climb down from the FDA, always possible)

Some companies are being very vocal about it, others are keeping quiet, but from what I've been able to gather a lot of products are going to be submitted. The first ones are just off the top of my head I've seen in recent press releases etc.. so please add ones you know about (and link if possible).

Confirmed
Vuse
Blu
Juul (yawn)
Turning Point Brands (Brands including Solace)

I presume this is what Trump promised would be coming soon:
September 20, 2019
FDA issues proposed rule for premarket tobacco product applications as part of commitment to continuing strong oversight of e-cigarettes and other tobacco products  

Hello,

Let me introduce my new Windows Universal Application around the ecigarette, EasyCigarette. I hope you'll enjoy it since it took me so much time to develop it.
It's a free application, no adds !
Feel free to give me tips, feedbacks, report bugs, give me new ideas, or simply tell me you like it , ...

EasyCigarette features :
Expenses Management Eliquids DIY Coils Calculator Shops Location HomePage Customization (avatar + cigarettes statistics) Good Deals Multiple Devices Sync ... and more to come
Screenshots below (phone version) :



! Important !
As you can see, this application seems to be France geared (oriented). It's only because i'm french and it's more easier to find informations / partnerships in my language. Moreover i dont know what are the (US - EN) references in the ecig field.
But don't worry this application is developped to be international. It's really easy for me to add a new data provider (new address list in geolocation, new good deals provider, for example). Feel free to contact me for this or help me to find contacts !


Windows Store Application : http://apps.microsoft.com/windows/app/easycigarette/9c5bd992-eebc-4696-85dc-55ab82225a1a

Windows Phone Store Application : EasyCigarette | Windows Phone Apps+Games Store (United States)  

I'm a 45yo New Zealander, and I have absolutely no axe to grind, except one:

I smoked for 25 years. Therefore the tobacco companies have had more than their fair share of my money, and more importantly my health.

Thanks to vaping, using RBAs and mods, and diying my own ejuices - I've been smoke-free for 20 months.

One company that looks like winning, with all the fake news and hysteria being dredged up in USA over vaping is Phillip Morris International. And I'm not talking about their cigarette products - but rather their IQOS product.

A Device That Heats Tobacco, But Doesn't Burn It, Can Now Be Sold in the U.S. Here's What to Know About IQOS

The FDA have already approved this product for sale in USA. And how does the IQOS work?

the FDA says the pen-like IQOS device heats, but does not burn, “tobacco-filled sticks” wrapped in paper, creating an aerosol that contains nicotine. Marlboro, an Altria brand, will make the tobacco sticks used inside the cartridge, which will come in menthol and unflavored versions.
Click to expand...

It's pretty much a cigarette, that goes into a device which 'heats' the tobacco, so you can inhale it.

Here's Why IQOS Could Completely Own the U.S. E-Cig Market | The Motley Fool

And how safe is it?

Comparison of Chemicals in Mainstream Smoke in Heat-not-burn Tobacco and Combustion Cigarettes. - PubMed - NCBI

There is little scientific data, however, of the hazards and toxicity of iQOS. In this study, we evaluated several harmful compounds (nicotine, tar, carbon monoxide (CO) and tobacco-specific nitrosamines (TSNAs)) in the mainstream smoke and fillers of iQOS, and compared their concentrations with those from conventional combustion cigarettes.

The concentrations of nicotine in tobacco fillers and the mainstream smoke of iQOS were almost the same as those of conventional combustion cigarettes, while the concentration of TSNAs was one fifth and CO was one hundredth of those of conventional combustion cigarettes. These toxic compounds are not completely removed from the mainstream smoke of iQOS, making it necessary to consider the health effects and regulation of iQOS.
Click to expand...

iQOS may not be as harm-free as claimed, study finds

The University of California study found that, since the device could only be used for six-minutes before it needed to be recharged, it may cause some people to shorten the interval between puffs in order to make sure they did not waste any of the tobacco stick which could increase the possible toxic exposure.

But of greater concern was that the polymer filter melted slightly during use and released formaldehyde cyanohydrin, a toxic substance which could be fatal to humans. The compound is metabolised in the liver and broken down into formaldehyde and cyanide.

"This study has shown that the iQOS system may not be as harm-free as claimed and also emphasises the urgent need for further safety testing as the popularity and user base of this product is growing rapidly," the study concluded.

University of Otago public health and marketing Professor Janet Hoek said the findings led her to question whether it really was a "reduced harm" product as claimed by the manufacturers.

If users inhaled more frequently as it was suggested, it was likely they would "increase their nicotine intake and exposure to harmful compounds present in the inhaled aerosol", she said.

She said those who had tried unsuccessfully to quit smoking were better off considering e-cigarettes.
Click to expand...

Just my