Electronic Cigarettes' Nicotine Vapor Stokes U.S. Agency, May Torch Sales

[Bill Godshall]

Electronic Cigarettes' Nicotine Vapor Stokes U.S. Agency, May Torch Sales
Electronic Cigarettes' Nicotine Vapor Stokes U.S. Agency, May Torch Sales - Bloomberg

Bloomberg reporter Molly Peterson attended last week's FDA workshop on longterm nicotine use, where my comments criticizing FDA Deputy Commissioner Josh Sharfstein for misrepresenating the evidence about e-cigarettes and for trying to ban e-cigarettes prompted her to write this article.

Neither ALA's Paul Billings (who I've collaborated with for 20 years on other federal tobacco legislative issues) nor FDA's Siobhan DeLancey attended that conference, nor have either responded to many dozens of e-mails I've sent them on e-cigarettes, including all of the scientific studies and virtually all laboratory tests on e-cigarettes.

Meanwhile, GSK's Howard Marsh spoke at last week's FDA conference urging the FDA to allow GSK to market its nicotine products for long term use. But of course, Marsh knows that NRT cannot effectively compete against far more effective cigarette alternatives like e-cigarettes or smokeless tobacco products, so he wants the FDA to ban e-cigarettes and lobbied for the FSPTCA to confuse people that smokeless tobacco is as hazardous as cigarettes.

 

[kristin]

I was just about to post this! Nice quotes from Bill and CASAA's VP Elaine Keller (Vocalek)!!

 

[Vocalek]

E-cigarettes need the same FDA drug review as nicotine gum, patches and other approved cessation aids, said Howard Marsh, chief medical officer of GlaxoSmithKline Plc’s consumer health- care division.

Glaxo’s Nicorette was the top-selling brand-name drug for nicotine replacement in the year through June, with $144.6 million in sales, or 12 percent of the smoking-cessation market, based on data from IMS Health Inc., a research firm in Norwalk, Connecticut.

“You’ve got to be fair to consumers,” Marsh said in an interview. “They need the reassurance that these products have undergone the same degree of rigor in terms of demonstrating safety and efficacy.”

Translation:

E-cigarettes need to be put through the wringer by the FDA until their effectiveness is reduced from 55-80% down to our 2-7% success rate. said Howard Marsh, chief medical officer of GlaxoSmithKline Plc’s consumer health-care division.

"You've got to be fair to our bottom line," Marsh said in an interview. "Our investors need the reassurance that these products will not threaten our $144.6 million in sales."

And from one of the Alphabet Soup Gang's speakers:

Unless e-cigarette companies can prove the gadgets are safe, “people should not use them because we don’t know what they are,” said Paul Billings, vice president of national policy and advocacy at the American Lung Association in Washington.

Translation:

"We don't know what e-cigarettes are," said Paul Billings, vice president of national policy and advocacy at the American Lung Association in Washington. "We're afraid that they might prove to be safer than inhaling tar, carbon monoxide, particulates, and thousands of chemicals created by the process of combustion. We can't have that! People might stop buying GSK's products, which means that our organization's financial contributions from GSK could dry up."

 

[Thulium]

That's pretty much the way I read it, Elaine. Nicely done.

This is the quote that really stood out to me:

The FDA said e-cigarettes may work with smokers the way methadone clinics wean ...... addicts by giving them a less harmful form of an addictive substance.

The admission from the FDA combined with statements from GlaxoSmithKline that e-cigs should be subject to heavier regulation than tobacco products makes their agenda quite obvious, don't you think?

 

[Bustastew]

I hope Paul Billings and the others involved with this BS have everything taken away, then thrown in prison for life. They are so transparently greedy and selfish. It angers me he is part of an organization that is supposed to CARE! C'mon Karma, where are your teeth!

 

[Bill Godshall]

This news article has generated widespread circulation, and was even reprinted in today's Pittsburgh Tribune Review.

I think its the first time a drug company representative (GSK's Howard Marsh) has publicly urged the FDA to ban e-cigarettes unless/until they are approved by the FDA as a drug device to treat nicotine dependence. And yet, last week Marsh urged the FDA to approve NRT products for long term nicotine maintenance.

 

[Skud]

I think its the first time a drug company representative (GSK's Howard Marsh) has publicly urged the FDA to ban e-cigarettes unless/until they are approved by the FDA as a drug device to treat nicotine dependence. And yet, last week Marsh urged the FDA to approve NRT products for long term nicotine maintenance.

translation: somebody else proved the profitability of this new and growing market, and now we, GSK, want to be the ones profiting from this market. and since we have our own branch of government, known as the FDA, we can make sure that happens.

in a time where we are so worried about growing small businesses and creating jobs, you'd think they'd want to let this market grow with minimal impediment (i think we're all for common sense manufacturing standards), but i think at this point they've made it obvious that Big Pharma will be the only ones benefitting, while the little guys who don't have any kind of money to lobby with will be left in the dust, picking up the pieces of their outlawed business and putting their lives back together.

 

[Surf Monkey]

There's a middle ground. This statement:

“You’ve got to be fair to consumers,” Marsh said in an interview. “They need the reassurance that these products have undergone the same degree of rigor in terms of demonstrating safety and efficacy.”

is correct IMO. I don't want winning this battle to mean empowering manufacturers to put whatever they choose in my e-liquid. Conversely, I don't want regulations that place the entire market in the hands of existing players in the tobacco industry.

 

[Thulium]

There's a middle ground. This statement:

is correct IMO. I don't want winning this battle to mean empowering manufacturers to put whatever they choose in my e-liquid. Conversely, I don't want regulations that place the entire market in the hands of existing players in the tobacco industry.

That statement is intentionally deceptive. Why should e-cigarettes be subject to any stricter regulation than traditional cigarettes?

 

[Surf Monkey]

That statement is intentionally deceptive. Why should e-cigarettes be subject to any stricter regulation than traditional cigarettes?

You misunderstand what I'm saying. I'm NOT supporting the notion that they should be subject to greater regulation than cigarettes. I'm saying that taken in and of itself, it's not unreasonable to want some kind of content regulation for the liquid. Clearly cigarettes are under regulated, so if a comparison has to be made, my position would be that they should both be subject to the same level scrutiny.

 

[D103]

I agree with Thad, Marsh's statement is disceptive....and disingenuous as well. On its' face the statement seems reasonable and responsible. However, Marsh and the TC crowd know full well that statement really means - pulling the e-cig technology off the market and requiring and applying FDCA standards of safety and approval which means years of clinical trials, millions of dollars and in essence establishing a de-facto ban and all but assuring that Big Pharma will be the only player able to afford the eventual "pharmaceutical e-cig", if that...and if so, it will be expensive, ineffective, nothing like what we currently use and inevitably a colossal failure. If the pathological zealots get their way the e-cig will be squashed altogether because it "looks too much like smoking" and then Big Pharma will get their current NRTs approved for long term use. If either of the above scenarios comes to pass then it will be interesting to see how the black market grows and persists and how the "control freaks" decide to continue the "war" they've waged - of course they claim to be "fighting for the Public's Health" and ".....THE CHILDREN!!!!"
Yeah, Right.

 

[Surf Monkey]

Absolutely. We agree on all of that. My comment is completely outside of the rhetorical trope. I'm not agreeing with Marsh's overall thesis. What I'm agreeing with is the notion that some content regulation is reasonable to expect. That's why I said there's a middle ground. We're simply not going to see PVs legalized across the board without any kind of regulatory framework around them. On the other side of that coin, we (probably) won't see them legislated out of existence either. There's a middle ground. Because regulation is going to happen, we need to fight to ensure that it meets with our goals. Fighting against all regulation is a losing battle IMO.

I agree with Thad, Marsh's statement is disceptive....and disingenuous as well. On its' face the statement seems reasonable and responsible. However, Marsh and the TC crowd know full well that statement really means - pulling the e-cig technology off the market and requiring and applying FDCA standards of safety and approval which means years of clinical trials, millions of dollars and in essence establishing a de-facto ban and all but assuring that Big Pharma will be the only player able to afford the eventual "pharmaceutical e-cig", if that...and if so, it will be expensive, ineffective, nothing like what we currently use and inevitably a colossal failure. If the pathological zealots get their way the e-cig will be squashed altogether because it "looks too much like smoking" and then Big Pharma will get their current NRTs approved for long term use. If either of the above scenarios comes to pass then it will be interesting to see how the black market grows and persists and how the "control freaks" decide to continue the "war" they've waged - of course they claim to be "fighting for the Public's Health" and ".....THE CHILDREN!!!!"
Yeah, Right.

 

[Skud]

I concur D103: I don't think there's a single e-cig user out there that doesn't want common sense standards and regulations for the manufacturing and labeling of the juices and other products we use. we all want to know that what we're using is as safe and pure as possible, that's a no brainer. But that is certainly NOT what Marsh is talking about at all. Like you said, he's talking about forcing e-cigs through the same FDA clinical trials that their NRT's go through, meaning that Big Pharma will be the only ones able to foot the bill, effectively hi-jacking the market.

The FDA is downright controlled by a large handful of pharmaceutical companies and health insurance agencies. Has been for roughly 40 years now. I hate to say this, but it's going to take an act of Congress for us to get our way in this battle, and that is an uphill battle in itself, as Big Pharma and Big Insurance have more lobbyists, and more money to lobby with, than anybody, hands down. Our one glimmer of light right now is the courts, but even so, no matter the outcome of SE, NJOY vs. FDA, the FDA is not interested in our health or well being, they are interested in contributions from Big Pharma and Big Insurance, and they will get what they want, one way or another.

We may have a better chance with Repubs than Dems, simply because Repubs are more willing to listen to Big Tobacco, which believe it or not, is our friend right now. They want to be able to sell these things as well, and they have the marketing dollars and distribution networks to make sure they get the lion's share. You're simply fooling yourselves if you don't think they've had their eye on this market for some time now. What's better for Phillip Morris than having somebody smoke Marlboros for 40 years? Having somebody vape Marlboros for 80.

Money makes the world go 'round.

 

[Vocalek]

As Judge Leon pointed out, the Family Smoking Prevention and Tobacco Control Act ("Tobacco Act") gives the FDA the authority to regulate tobacco products. The Judge suggested that electronic cigarettes be regulated under the Tobacco Act. That might include requirements for how the products are tested, manufactured, labeled, etc. It would NOT include clinical trials.

 

[D103]

Surf Monkey, thanks for your post and I agree with you. Marsh et. al. have another agenda but the primary point is correct and I agree with you that middle ground is vital. We absolutely need safety and quallity assurance regulations and I agree wholeheartedly with you that as passionate consumers that should be our next area of focus-if we prevail in the courts and e-cigs end up being classified as 'tobacco products'-we should all do what we can to insure that "reasonable, fair and reliable" standards and regulations are established.

 

[Thulium]

You misunderstand what I'm saying. I'm NOT supporting the notion that they should be subject to greater regulation than cigarettes. I'm saying that taken in and of itself, it's not unreasonable to want some kind of content regulation for the liquid. Clearly cigarettes are under regulated, so if a comparison has to be made, my position would be that they should both be subject to the same level scrutiny.

I was pretty sure YOU didn't mean it that way, but unfortunately it is statements like that that seem fair and accurate but when you look closer you begin to read between the lies.

Cigarettes *can't* be subjected to the same amount of scrutiny because it is a different standard altogether. Drugs and drug device combo products have to undergo pre-market clinical evaluation for their safety AND effectiveness...for their intended use. Tobacco products don't have to be shown to be effective because they are intended to be used recreationally. Even if there was a therapeutic or medical intended use that cigarettes could be shown to be effective for, they would obviously fail testing for safety. That's the reasoning the Supreme Court used in Williamson to determine that the FDA did not have regulatory authority over tobacco products as traditionally marketed.

Since that ruling, FSPTCA 2009 gave FDA the authority to regulate tobacco products that aren't drugs but specifically forbade them from banning the products altogether or requiring the nicotine content to be reduced to zero. Unfortunately, the FDA is attempting to protect the marketshare of pharmaceutical companies that want to sell their drugs for long term use from competition from smoke-free alternative tobacco products by attempting to "shoehorn" them into a drug classification so they can effectively ban them until Pharmaceutical companies can get their version approved as a drug and delivery device combination product...in spite of the fact that the Tobacco Act instructs the FDA to fast track the approval of Modified Risk Tobacco Products.

The antis are trying to set up a straw man defense that we are advocating for the deregulation of tobacco or e-cigs. This is not the case at all. We are simply asking for the FDA to follow the law and properly classify smoke-free alternatives as tobacco products or modified risk tobacco products. Look closely at the following quote from the article:

“Some people are convinced that anything that has any kind of nicotine or tobacco in it must be subject to the FDA’s review and approval. Others think it’s almost certainly less harmful than cigarettes.”

It implies that one side wants FDA approval and the other side wants a free for all. This is obviously a straw man because the USFDA already has regulatory authority over drugs AND tobacco products...so the debate is not IF they should be regulated by the FDA, but HOW should the FDA regulate them.

 

[Skud]

the good part is, i don't believe classifying them as tobacco products would necessarily do away with non-tobacco or menthol flavors altogether, but it might mean any flavors we do use will have to be DIY, which is no biggie. it would be hard to argue that "unflavored" nic juice would be used to market specifically to children, and the flavorings we use have many, many uses outside e-cig juice and nobody would consider for a second banning them. so you might have to kiss your favorite pre-mixed waffles and syrup juice goodbye if e-cig juice becomes regulated as a tobacco product, but i don't think that will prevent you from mixing your own in any way.

 

[Thulium]

the good part is, i don't believe classifying them as tobacco products would necessarily do away with non-tobacco or menthol flavors altogether, but it might mean any flavors we do use will have to be DIY, which is no biggie. it would be hard to argue that "unflavored" nic juice would be used to market specifically to children, and the flavorings we use have many, many uses outside e-cig juice and nobody would consider for a second banning them. so you might have to kiss your favorite pre-mixed waffles and syrup juice goodbye if e-cig juice becomes regulated as a tobacco product, but i don't think that will prevent you from mixing your own in any way.

It is ridiculous and pointless to attempt to ban flavors, but even IF something like that were to happen it is really not even much of a concern because you can simply purchase flavor separately. The whole issue is nothing more than a scare tactic in the first place.

Quite honestly, as current vapers, we really don't need to fear ANY ban for our own purposes: They can't ban batteries, heating elements, glycerine, propylene glycol, or food flavorings anyway...and since the Tobacco Act forbids the FDA from banning nicotine completely, we will be able to continue vaping in spite of any ban. The concern that is left is how businesses are allowed to market e-cigs to make them as affordable and widely available as a smoke-free alternative for people who might be unable or unwilling to stop smoking otherwise.

 

[Bill Godshall]

If/when the DC Court of Appeals upholds Judge Leon's ruling, the FDA will have no alternative (if it wants to regulate e-cigarettes) but to reclassify e-cigarette products as tobacco products in accordance with the FSPTCA.

It is important to note that reclassifying e-cigarettes as tobacco will NOT ban flavorings in e-cigarettes, won't restrict their marketing (or even ban their sales to minors), but will prohibit e-cigarette manufacturers, distributors and retailers from distributing free samples, and will prohibit e-cigarette manufacturers/importers from claiming that e-cigarettes are less hazardous than cigarettes. There are also other FSPTCA regulations that e-cigarette companies would have to comply with, but there would be an additional year moratorium on many requirements since all e-cigarette manufacturers/importers would be considered "small tobacco manufacturers" since none employ more than 350 people.

But these restrictions shouldn't pose problems for e-cigarette companies because virtually everyone who has heard of e-cigarettes already believes that they are less hazardous than cigarettes, and many/most believe that e-cigarettes are smoking cessation aids (thanks to the repeated claims by FDA and other e-cigarette prohibitionists).

If the FDA wants to promulgate additional regulations for e-cigarette products, the agency would have to follow the guildelines in the FSPTCA, and doing so would take an additional one to two years (during which e-cigarette advocates would have many opportunities to testify and submit comments.

 

[Bill Godshall]

Also, after the FDA classifies e-cigarettes as tobacco products, e-cigarette manufacturers/importers can apply to the FDA to make "modified risk tobacco product" claims.