NJoy response to discontinuation of flavors

[Cherice]

A buddy of mine emailed njoy recently relative to them discontinuing flavors. Below is the email sent and response received:



Sent: Friday, December 11, 2009 3:30 AM
To: Amy Linert
Subject: njoy to Discontinue Flavors, Takes Additional Steps to Prevent
Underage Electronic Cigarette Use

Dear Amy,

Haven't smokers been harassed enough? I have finally found something that allows me to stop inhaling combustibles into my lungs and now you take away my flavors? How dare you!

If you do this I will do my best not to purchase or sell your product. I am
an adult (50 years) and like ONLY non tobacco flavors.

This is just wrong. I wish companies had some balls and stood against the
nanny-state and fought for what they believed in. Stop taking choices away from legitimate customers.



From: Amy Linert [mailto:Amy.Linert@mcmurry.com]
Sent: Monday, December 14, 2009 4:51 PM
To: XXXXX
Subject: RE: NJOY to Discontinue Flavors, Takes Additional Steps to Prevent
Underage Electronic Cigarette Use

XXXXX, thank you for your note. We actually agree with your opinion about
flavors, about adults being given the ability to choose what's best for
them, and that someone needs to stand up for the industry and the consumers it serves.

In fact, no company has done more on these fronts than NJOY. We were the first to bring electronic smoking devices to the US public, we were the
impetus behind setting up the industry's association, we are leading the way on the science on electronic smoking products, and we are on the frontlines of the related legal and political proceedings in an effort to ensure that electronic smoking products stay on the market in the US.

We didn't make our decision about flavors without great consideration, the
most important one being the importance of finding a place that will allow
electronic cigarettes to stay on the market. Sometimes compromises are
necessary to achieve longer-term gains. Please don't lose faith, because we
sure haven't, and we will continue being the leader in the industry, a
responsibility which includes taking feedback to heart from people like
yourself.

Amy Linert

 

[Imboden]

wow very interesting response

 

[Silence]

Exactly what I would expect to hear.

 

[TropicalBob]

That's quite a candid response. What it is saying is what some others have concluded: To be classified a drug product is the complete kiss of death. To attempt to market as a new reduced-risk product is likewise a visit to the unknown at this time and a likely sentence of product death. (An FDA committee will investigate all new reduced-risk tobacco products and likely dismiss them all.)

The only hope to stay on the market is to be, exclusively, a tobacco product. No claims about reduced-risk. A new version of an older product. Just abide by all existing laws for tobacco products.

That seems the direction Njoy is going -- and it's smart. Not at all a sure thing, but a best gamble, and, as she said, lots of thought went into this first step toward abiding by new tobacco regulations.

 

[nubee]

I'm with you there TB!!! Seems the industry should just quit pushing to find new consumers - we're doing that job right here - and stick with this as just another "brand" or "style" of tobacco.

Heck...I got no problem with that (well, as long as they don't tax it to death)

 

[searcher]

I wish we didn't have to, but I can live with their decision. If we order 36mg and cut it with pg and add our own flavor (diy and I've never tried it), should be no big deal. It might even make a better juice and save money in the long run. At the rate I'm going through atties I could use it. My only concern is that you give the govt an inch and they take a mile of our rights.

 

[kristin]

Right now, the government doesn't recognize "reduced harm" as it's own catagory. To them, you are either a tobacco product or a drug. So, we have to choose to be a lesser of two evils, until we can prove the reduced harm concept.

As a drug, e-cigs will face even harsher restrictions and more likely be banned altogether as an unapproved device by the FDA.

As a tobacco, they avoid full FDA control and testing and have limited regulation.

If we can get tobacco status now, that would at least keep the product on the market for us, while we work on getting the reduced harm concept recognized and accepted. It'll give us time to get the testing and studies done that will be needed to prove our case.

 

[PhiHalcyon]

In the context of the best case scenario (where the hurdles of the combination prohibition, regulatory precedence, and intended use, are all successfully leapt - making it possible for the ecig to be regulated as a tobacco product), an important assertion that Amy makes is: "We were the first to bring electronic smoking devices to the US public," And when did Sottera introduce Njoy? "In or around April or May of 2007, Sottera began marketing and distributing smoking alternative products in the United States, under the NJOY brand name." ( http://www.courthousenews.com/2008/12/16/Smokem.pdf )

If both statements are true, (and there is no valid substantial equivalence argument to be made), then, under the FSPTCA, all ecig/e-liquid products would be New Tobacco Products.

Thus, whether it be a tobacco product or a drug/device product, the ecig and e-liquid are currently illegal to sell; and cannot become otherwise without an FDA approval.

As for gaining an approval as a New Tobacco Product, the criterion most subject to FDA discretion is:

910(c)(4) "For purposes of this section, the finding as to whether the marketing of a tobacco product for which an application has been submitted is appropriate for the protection of the public health shall be determined with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and taking into account— (A) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and (B) the increased or decreased likelihood that those who do not use tobacco products will start using such products."

By the time the FDA is 'convinced' through comprehensive vapor analysis, long-term safety studies, and the requisite public health arguments, a new drug and device application could have been approved.


.

 

[TropicalBob]

That's what I was referring to when I wrote "a new reduced-risk product." There will be no new products that aren't reduced risk. That's the only rallying cry anyone will rally around today.

But good luck to any who try (besides Philip Morris). An FDA committee (with two tobacco industry reps in non-voting roles) will consider each application for new product status and how the product would impact public health. Bets are they will conclude all new tobacco products are bad, bad, bad.

I've been told by good authority that Reynolds is going to try to ride the coattails of Star Scientific, by claiming the new Camel Orbs, Sticks and Strips are essentially to the same as Ariva and Stonewall, both marketed well before the February 2007 cutoff date for existing products.

E-cigs, however, were never approved. Note the Favor rejection. If e-cigs are tobacco products, they're new ones to reduce harm.

So, bottom line, tobacco or drug product, the FDA is judge and jury!

 

[PhiHalcyon]

You're right, TB. The FSPTCA has expanded the FDA's power to having full regulatory control over all nicotine delivery products; and a natural consequence of this is that the objective of harm or risk reduction must and will play a prominent, if not primary, role in its approval and regulatory decisions.

As tobacco product manufacturers get on the same reduced-risk page as Star Scientific, BigPharm will push for its current and future NRT products to be available in smaller packages, permitted for longer term use, switched from Rx-to-OTC, and otherwise be made more competitive with tobacco products - all in the name of improving public health.

For a very informative 70-page read on this (from GlaxoSmithKline's perspective), go here: Regulations.gov
(You may need to right-click the PDF icon next to "Views:", and save, before being able to open it.)