FDA Michael Siegel at TMA: E-cig companies should make "quit smoking" claims.

[Oliver]

Yes, that's right - Greg Conley reported, via Twitter yesterday that

[tweet]469511034571878400[/tweet]

Of course, Dr. Siegel isn't a lawyer - but that's ok, because Greg is. I asked him via skype what he thought about this...

"I've been telling that to vendors for years"

Hmmmn - do we need to encourage vendors to make the claim?

 

[Endor]

I'm not a lawyer, so thinking out loud here, but isn't this a big part of what the Soterra vs FDA case was all about? If it's marketed as a smoking cessation aid, doesn't it put it back into the same realm as pharmaceutical gums/patches/inhalers and hence subject to the same (onerous) FDA approval process as a pharmaceutical?

Edit: I'm also much less of an expert than you or others (e.g. Roger), so I welcome standing corrected.

 

[Roger_Lafayette]

Some random questions from the peanut gallery:

1) Would the FDA go after such vendors? (In Soterra as I understand it, the vendor was simply posting user testamonials, some of which mentioned quitting.)

2) And then ... what would happen if this ended up in court -

2a) Could the vendor get a preliminary injunction? (If not, then could the FDA just shut them down in the meantime, leading to catastrophic costs requiring deep pockets to sustain? Or might the FDA send them a C&D letter, without taking other action, so then the vendor could challenge the C&D letter while getting back in business - sans the controversial "quit smoking" claim.)

2b) What might the final result be? (Would this prompt action at the national level in the US if the FDA loses? If the FDA loses and congress does nothing - could states and local jurisdictions act, or are they pre-empted?)

EDIT: Endor, if you're talking about me - I am no expert on anything and have never claimed to be

 

[Kent C]

Vendors could likely skirt the legal issue by just posting links to the West study on their sites:

"Study: E-cigarettes Very Effective at Helping Smokers Quit"
https://www.yahoo.com/tech/study-e-cigarettes-very-effective-at-helping-smokers-86362892929.html

Real-world effectiveness of e-cigarettes when used to aid smoking cessation: a cross-sectional population study - Brown - Addiction - Wiley Online Library

 

[Maurice Pudlo]

Claiming anything is not in my opinion a good idea, it really opens a company up for legal action.

I do not think in the long run it is worth it to make claims of this nature, especially since the success rate is not in the 66% to 75% range in every attempt.

Maurice

 

[Fitzie]

I think this old thread is instructive on this issue. It's by Bill Godshall.

http://www.e-cigarette-forum.com/forum/legislation-news/371175-stan-glantz-attacks-e-cigarette-industry-because-thousands-vapers-sent-comments-fda.html

 

[SeniorBoy]

You guys are REALLY good. LAW is your calling! Thank you.

I've read them but often have a very hard time digesting these Regs so a question for the Policy Wonks. What specifically does the current deeming Regs say with respect to advertising? I'm NOT referring to the juice bottle as even a mere mortal like me clearly understands this. I am referring to signage, point of sale, Tshirts, web sites, hand out promo gifts, etc.

I'm asking because I do not recall any specitivity with respect to this issue in the regs. If the FDA is currently "silent" and or lacks specifics on this issue IMHO, you can or should I say, I guess, they will get very specific.

 

[Bobbilly]

I thought that the vendor can't market it is cessation or healthier. If customers or "ancedotes" say they stopped smoking that isn't a claim.

 

[aubergine]

If a B&M they could always put up a big board - "Sign Here If You Quit Smoking". Web Vendors could have a Quitter's Congrats Page.

But that's not the point. The point is that all of this crap is evil and insane.

(Sorry, maybe too much time reading these threads.)

 

[Kent C]

If a B&M they could always put up a big board - "Sign Here If You Quit Smoking". Web Vendors could have a Quitter's Congrats Page.

But that's not the point. The point is that all of this crap is evil and insane.

(Sorry, maybe too much time reading these threads.)

That's a great idea!

 

[tombaker]

Its a waste of time, effort and causes needless regulatory exposure.
Anyone advocating making claims that E-Cigs are cessation enabling are ignoring the world as it stands. The FDA exists.

Conley is dead wrong also, as he thinks that there is a difference in Tobacco cessation, vs Nicotine Cessation. Its the same. You can not legally tweeze a difference.

What is the benefit of making "quit smoking" CLAIMS, as suggested by Siegel. More sales? Doubtful, because it is already understood by everyone. What benefit then is a company making CLAIMS....nothing really.

What are the risks.
Well it can be used against the industry. It flies in the face of what the court ruled in Sottera.
Sure it legal, but the regulations are not done, so what is currently illegal....nothing.

It serves no actual purpose, and is just done for a questionable need to piss off authority. It does not move the ball forward at all.
AGAIN, they are not talking about giving information on how to quit smoking, which is done often currently.
These folks are suggesting that people make cessation CLAIMS, for marketing.

 

[Gato del Jugo]

Any vendor want to volunteer to be the guinea pig?

 

[Bobbilly]

Man is this still a debate? What is it then? Sottera was about making a recreational product into a medical device and essentially ban it

 

[aubergine]

Man is this still a debate? What is it then? Sottera was about making a recreational product into a medical device and essentially ban it

"Hard to find anything lovelier than a tree. They grow at right angles to a tangent of the nominal sphere of the Earth."

Bill Nye

 

[Katya]

I take it Dr, Siegel doesn't own a vape shop, does he?

My suggestion would be for the good doctor (and Greg) to make the claims, based on good science, and for the vendors to vend, join SFATA--and possibly encourage their clients to join CASAA.

 

[Janusxvii]

Hmmmm.... this is an interesting proposition. I think any vendor who wanted to try this had better consult a lawyer that they have absolute trust in (and have a decent sized war chest). Even so, it is rather intriguing. A statement along the lines of "don't smoke, vape", "smoking is out, vaping is in", or maybe even "once you try vaping, you'll never go back to smoking" could probably be argued to be an advertising slogan targeted at BT's customer base with the intent of cutting into their market with their "alternative" product and neither an overt nor implied cessation claim. That being said, one could counter by trying to argue that any any statement or advertisement with the intent of luring those who use traditional cigarettes or other tobacco product away from said product is technically a cessation claim. However, by making that argument I think they would open themselves up to a rebuttal that so long as e-cigs are legally considered a tobacco product (i.e. for recreational use) themselves, the scope of what can be construed as a cessation claim is narrowed to only the most overt and pointed claims that usage of electronic cigarettes can/will aid those seeking to end their nicotine dependence. Any non-combustible tobacco product containing nicotine marketed as an "alternative" to traditional combustible tobacco products can't really be legally considered a cessation aid even if they used the words "stop smoking" unless it is overtly advertised as a system for gradually lowering ones nicotine dependence down to zero. For example, a rubber band manufacturer would technically be making a cessation claim if they said that their product helps people stop smoking because the intended meaning of "stop smoking" in this context implies cessation of nicotine dependence. Likewise, products like Nicorette and Nicoderm are even though they contain nicotine and are non-combustible are cessation aids regardless of whether or not they use the words stop smoking in their advertisements as their advertised, intended usage is to gradually lower one's nicotine dependence down to zero. That is just me thinking out loud though and it's late. Anyone see any major holes in my line of thinking?

 

[DeeLeeKay]

The way I see it. Vaping is not smoking ergo those who switch to vaping have quit smoking. Isn't this basic logic 101?

 

[Vocalek]

Dr. Siegel's point was that "smoking" is not a disease. So a claim of "smoking cessation" is not a claim that one's product is being used to treat a disease.

All products that the FDA refers to as "smoking cessation" products were actually approved for the purpose of "nicotine cessation." The nicotine replacement therapy (NRT) products came with directions to first switch 100% to the product (whether patch, gum, lozenge, nasal spray, or inhaler) and then gradually reduce the amount of that product over time. In the case of the patch, the directions were to use the highest dose (21 mg in the U.S.) for 6 weeks, then switch to the next dose (14 mg in the U.S.) for 3 weeks, and then to the lowest dose (7 mg in the U.S.) for an additional 3 weeks. After this 12-week regimen, you were considered cured.

Patients were warned that smoking a cigarette while using the NRT product could cause a heart attack. This created the bizarre situation of people ripping off their nicotine patch between planes, smoking a cigarette, and then slapping the patch back on.

The only problem with the "cure" is that shortly after "treatment" stopped, relapse would begin. Even to this day, between 90% and 97% of those using the approved NRT products have relapsed to smoking at the end of one year.

Dr. Siegel urged vendors to read Judge Leon's opinion document on the Soterra decision (available here: http://www.casaa.org/uploads/SE-vs-FDA-Opinion.pdf)

Judge Leon opined that what makes a product a drug that can be regulated under the Food, Drug and Cosmetics Act (FDCA) is "intended use." He pointed out that the FDCA defines a drug or drug-device combination as an article "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease." 21 U.S.C. §

But Judge Leon did not allege that "smoking cessation" is not a therapeutic claim. In a footnote, he stated:

15 To the extent that smoking cessation is a therapeutic claim distinct from the treatment of nicotine addiction and withdrawal, the Court is aware that the two customer testimonials referenced above suggest that electronic cigarettes are intended for smoking cessation, if not for treating nicotine dependence (as suggested by FDA). Given Smoking Everywhere's express disclaimer that its electronic cigarettes are not intended as a smoking cessation device, (AR DET 1), and given the overwhelming evidence in the record that its electronic cigarettes are intended merely as a recreational alternative to traditional cigarettes (and not necessarily as a therapeutic replacement for traditional cigarettes), the Court concludes that the two testimonials cited by FDA are not alone sufficient to support a finding that the product appears to be intended to help customers quit smoking.

So the judge indicated that customer testimonials are not necessarily health claims. However, even after the Soterra case finally came to a close, the FDA was still sending warning letters to vendors regarding testimonials posted on their web site. So it does no good to be technically correct if there are agencies intent on having their own way.

You can fight city hall, but the fight could prove to be an expensive one.

I believe that Janusxvii's suggestion is a wise one. Advertising aimed at urging smokers to switch away from conventional cigarettes to e-cigarettes cannot be construed (even by as stubborn an entity as the FDA) as a health claim as long as no mention is made of improved health as a result of that switch.

 

[Oliver]

Any vendor thinking of doing this should be ready to spend large sums of money defending themselves in court. There's no doubt here whatsoever.

But in terms of the utility? Actually, I think it is important. We have increasing published evidence that vapers are in fact quitting smoking (Toolkit, ASH UK, ETINCEL-OFDT) using the devices, in large numbers. Of course, this hasn't yet been collected in the United States, but I'm not sure that matters.

We also have influential academics in the US denying that any substantial numbers of people are doing so; that they are only "dual-using". Accordingly, the message going out to the American Public is that e-cigs have no utility save for 'convenience' (or as some would have it, sneaky public smoking).

The PATH study won't report back until 2015, so we'll have no good population level US data until then.

And a recent report has shown that the American public views e-cigarettes as being less safe now than it did two year's ago. Taken together, you're going to struggle to convince people that something they think is dangerous, and only has utility for 'convenience' should be on the market at all.

A high profile case where first amendment rights are asserted, and the legal definitions (tobacco/nicotine cessation / quitting smoking) are fleshed out properly actually could be exactly what the industry needs right now.

 

[Vocalek]

Any vendor thinking of doing this should be ready to spend large sums of money defending themselves in court. There's no doubt here whatsoever.

But in terms of the utility? Actually, I think it is important. We have increasing published evidence that vapers are in fact quitting smoking (Toolkit, ASH UK, ETINCEL-OFDT) using the devices, in large numbers. Of course, this hasn't yet been collected in the United States, but I'm not sure that matters.

We also have influential academics in the US denying that any substantial numbers of people are doing so; that they are only "dual-using". Accordingly, the message going out to the American Public is that e-cigs have no utility save for 'convenience' (or as some would have it, sneaky public smoking).

The PATH study won't report back until 2015, so we'll have no good population level US data until then.

And a recent report has shown that the American public views e-cigarettes as being less safe now than it did two year's ago. Taken together, you're going to struggle to convince people that something they think is dangerous, and only has utility for 'convenience' should be on the market at all.

A high profile case where first amendment rights are asserted, and the legal definitions (tobacco/nicotine cessation / quitting smoking) are fleshed out properly actually could be exactly what the industry needs right now.

Right on all counts. As long as ANTZ are in charge of the US government entities that collect tobacco use and smoking cessation data, the right questions won't be asked. Until the right questions are asked, we won't see that data coming out.

We heard a presentation at TMA about the PATH study, but I'm not sure that even that study is asking what method people have used to stop smoking successfully.

But we do have data showing that smoking rates are going down across all age categories (including the chiiiiiildren) and that smoking initiation rates continue to decline. Given those data, how can the CDC claim that e-cigarette use causes children to become smokers (and say it with a straight face?)

You're right about public opinion regarding e-cigarette safety going down. We have our government and Northern California research centers to thank for that.