VapeAtron

Looks like the E-Cigarette battle is getting heated.

First worldwide regional bans and outlawing, then vague FDA statements, then random customs seizures and rejections, then Ebay US pulls all e-cig sales, then a wave off bad press, then a Senator coming out against it (earlier today), and now a multi-signed official stance on e-cigarettes from several large health organizations. Their statement is below:

Statement of the American Cancer Society Cancer Action Network, American Heart Association, American Lung Association and the Campaign for Tobacco-Free Kids

WASHINGTON, March 24 /PRNewswire-USNewswire/ -- The American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association and the Campaign for Tobacco-Free Kids applaud Senator Frank Lautenberg of New Jersey's call for the Food and Drug Administration to exert its authority and immediately remove e-cigarettes from the market.

FDA officials have been quoted numerous times in many publications during the past few weeks saying that e-cigarettes are "new drugs," which require prior approval from the FDA before they are allowed to be sold. Without this approval, e-cigarettes are illegal to market or sell. Despite these statements, no action has been taken to remove e-cigarettes from the market.

Currently, e-cigarettes are being sold in 62 kiosks at malls across the United States, with plans to expand to another 55. E-cigarettes are also being marketed towards young people, who can purchase them in fruit flavors and online, without having to verify their ages.

Makers and retailers of these products have been making unproven health claims about their products, claiming that they are safer than normal cigarettes and asserting that they can help people to quit smoking. Absent scientific evidence, these claims are in blatant violation of FDA rules.

In fact, no studies have been done on e-cigarettes to date regarding their health effects or their effectiveness as cessation aids. Like the "light" and "low tar" cigarettes that tobacco companies claimed were healthier for consumers, there is no evidence to back up the claims made by e-cigarette makers. In September of 2008, the World Health Organization stated that they have "no evidence to confirm the product's safety or efficacy."

Our organizations thank Senator Lautenberg for his leadership in urging the FDA to remove these products from the market and echo his call that the FDA move quickly to remove these products from the marketplace.

While the FDA currently does not have jurisdiction over tobacco products, it does have jurisdiction over other products that contain nicotine including e-cigarettes, which have been marketed as delivering nicotine without tobacco.

Primus

I just don't understand these comments. Like this:

How is that a fact? The fact is, these people don't have the facts. In fact, they don't know of studies, not "no studies have been done".

I hate politics. The fact that the American Heart Association and the American Lung Association would come out and make these statements really worries me as to their true agendas.

VapeAtron

I would be ok with them putting a stop-all on it if I knew it was because real tests and guidelines for the product were being done, so an eventual relaunch would be legal and regulated properly.

However, I think multiple groups just dont want it to exist, be available, in any manner. Anti Smoking because its a gateway, Pro-Kids because its too easy for them to get, Big Tobacco because it dips into their industry, and Big Pharma because it dips into their quit products. Odds are stacked up for these things to get ousted. Just didn't think it would come this fast and furious.

Primus

Agreed on all counts.

VapeMonkey

OMFG!............................................. .................................................. ..................
I had to walk away from the comp after reading this, it made me so angry. I dont understand what the manufacturers are waiting for, maybe a ban to raise prices?

Recycled

What is this? Not a true comparison.

jamie

Anti-smoking and "Pro-kids" anti groups are funded by big pharma and tobacco (settlement)

H3VAPER

There just toosing shit in the wind to see were it lands.. they just want to tax it... There have been studies done over seas .. And nothing was found .. that would harm anyone.. They were done by leading health sci... But the FDA has nothing better to do.. They should be inspecting our food plants.. Like the peanut butter crap.. that food product plant was found many times to have dangerous conditions.. but remaind open.. Now people are dead.. But nobody on the hill is pushing that... Sorry i get wound up to.....

andreo

I find it funny that the e-cig doesn't effect any of the organizations that are involved.
Doesn't cause cancer (that we know of), yet there's the American Cancer Society.
American Heart Association, Huh, I guess they had nothing better to do.
American Lung Association, well maybe. We are inhaling the stuff.
Campaign for Tobacco-Free Kids, yeah, when this things start using tobacco we will let you know.
I wish the honest reason why they are going after e-cigs would get leaked. We all have our suspicions. But there is something rotten at the bottom of all this. I mean honestly, All the organizations has written off smokers a long time ago. So they are not looking out for the best interest of the smoker. And now comes a device that doesn't harm anyone else.
No second hand smoke. No cigarette butts on the sidewalks, grass, roadside, etc. Heck, we don't even have that "just finished a couple of cigs in the car with the windows mostly up" smell.
So what's the problem? If anyone is going to be harmed by any unforeseen side effect, it will just be the person smoking the e-cig.
They have to understand that there are going to be people that will not quit. It doesn't matter how much you raise the taxes, how many places you ban smoking in, how many employers you convince not to hire smokers, or how many devices you ban from the market. There are people that will not stop, period. And there are going to be new smokers that want to smoke despite the information that is out there.
If they were to come into my house and confiscate all my e-cigs. I would just simply start growing tobacco on my land for my own use.
Why can't they get that through their thick skulls. And what is the real reason they don't want anyone to even simulate smoking a cig? And please don't tell me it's for the kids...

Alpine77

Yeah, this is all really sad. If only this country did not revolve around money, and who is taking who's share of what money. It's all a big game. I just hope that the e-cig comes out on top as it poses to do so, so, so much good for smokers and everyone else for that matter. No more harmful secondhand smoke for the guy sitting next to you while you vape. Truly amazing product, let's just all hope the big guns come around to seeing this!

Brandon

I've been doing a lot of research on this lately, and I feel as though this letter addresses two entirely distinct issues, only one of which FDA has jurisdiction over. First, the FDA assesses the safety of a drug product only insofar as it is meant to treat a condition. The DEA is responsible for determining the legality of recreational consumption of a substance (such as nicotine). Because nicotine is not currently a controlled substance, products containing nicotine can be marketed and sold to anyone, so long as no health claims are being made.

As soon as a product is marketed with health claims (such as "use of this product is safer than smoking" and "this product will help you quit smoking") the FDA is charged with evaluating those claims. False or unapproved claims mean that a product is "misbranded" under FDCA Sec. 301(k), and subject to seizure or injunction as appropriate. *This* is why some distributors have had their products seized (and why others have not). The FDA claims in form emails sent out on this subject that current enforcement is taking place on a "case-by-case basis." I interpret this to mean that the health claims are not yet so pervasive that the FDA does not have a choice but to regulate the product for all marketing. (Note: In the case E.R. Squibb & Sons, Inc. v. Bowen, 870 F.2d 678 (1989), the FDA did not permit a manufacturer that was making an invalid health claim to continue marketing their product without the claim, since their health claims were so pervasive already. In this case, FDA evaluation for that claim essentially became mandatory.) Also note that the nicotine-water solution marketed by Nico Worldwide presently avoided the issue brought up under this case by rescinding all health claims made in the past *and* selling its product within the guidelines of the Homoeopathic Pharmicopoeia of the US. Since electronic cigarettes probably don't have this dodge (I gather that the "e-juice" or "e-liquid" is significantly more concentrated than the 6X dilution permitted under the HPUS) I think this will be very interesting to see play out.

Brandon

Edit Fail: Also, note that the people pushing for FDA regulation of electronic cigarettes try to raise questions about inhalation of propylene glycol (the vaporizing agent - Propylene glycol - Wikipedia, the free encyclopedia) which is considered safe in foods, but for which there exist health concerns for inhalation. Probably trying to find some way to say that its use in electronic cigarettes constitutes adulteration under FDCA 301(k).

I'm speculating that they may not think their case against nicotine is strong enough, given that it's considered safe enough for normal ingestion in cigarettes and is not regulated by the DEA.

jacobl

Very informative Brandon. Thank you for that.
I personally feel that sooner or later they are going to ban e-cigarettes. I was going to invest and open up shop online, but I wont until someone comes up with a conclusion. Don't want to invest and then it because illegal to sell tomorrow. Its very unfortunate.

As another note. There was a news story shown here locally and had a member of American Lung Association in which she says that it could cause a problem of confusion, when seeing someone use an e-cigarette in a public or breathe easy place/facility (whatever), they could light up thinking its okay. I would have to say that I would agree. I personally do not use my e-cigarette anywhere smoking analogs are not permitted, simply because I don't want to cause any confrontation. When/if there becomes a common knowledge about e-cigs and people know what they are, it will then either be acceptable or not, to vape in particular areas. But until then I will keep my vaping experience as personal as when I smoked.

I did not start e-cigarettes so i could smoke anywhere, I did it to a) save money, and b) to eliminate second hand smoke. Not even because analog's are bad for you (I dont really care about that, I like smoking), but they are bad for my 2 year old son.

Brandon

Thanks Jacobl - really, the more I look into this, the less I predict e-cigarettes are going to come under the authority of the FDA. The FDA has previously mentioned (in form emails) that they are currently regulating (seizing) e-cigarettes on a case-by-case basis when distributors make improper health claims. I don't really foresee an obvious reason for them to change their policy though. The other controversial recreational nicotine product case I know of was NicoWater (now NicoLite - but under the same patent).

Apparently, the product (ultimately ~4mg of nicotine in an 8 oz dose) wound up being classified a "dietary supplement" and was granted a Certificate of Free Sale by the FDA as a lawfully marketed supplement. This was granted before (and independently of) NicLite's successful classification as a homeopathic medicine (via the HPUC), (the reason for past drama in the case - the first incarnation of the product did not conform to HPUC guidelines on the minimum number of nicotine dilutions).
Source (PDF): http://www.coreyquinn.com/files/CME%...PM%20Final.pdf - page 22 of 93

So... the FDA was okay with approving a recreational/supplemental nicotine product with a nontrivial concentration of nicotine as a dietary supplement. If kids begin to use them (and if people object to this), I expect some age-limiting regulation to come about, it just doesn't seem like the FDA would do it.

jacobl

That NicoWater sounds familiar.
The only difference I see here is that e-cigarettes are going to take the business away from pharmaceutical and tobacco companies. If RJ Reynolds produced an e-cigarette like this one, no one would have a problem with it and everyone could get it from your local gas station or convenient stores. My opinion is, the "right people" aren't getting paid. So...I figure they will be, either under tight regulation or banned until they start manufacturing them here in the US under FDA regulations and owned by big tobacco.

Primus

This is kind of how I see it as well. It's only a matter of time before big tobacco begins producing something similar to what is already on the market as e-cigs.

jacobl

Maybe big tobacco should make an evolutionary turn and get caught up with the digital age! Selling only e-cigarettes! Can you imagine, no analogs? I bet it would be a bigger and more profitable market.

Brandon

Just got off the phone with a representative at Nico Worldwide and the President of the HPUS. I've got some new information, though I don't know how to best relate it to e-cigarettes: The homeopathic monograph for nicotinum (nicotine) requires a 6x dilution (1*10-6 g/L), which comes out to approximately (by my math) 0.237 mg/8 oz bottle. I've been assured by Nico Worldwide that their product conforms to the 6x dilution guideline at 0.66 mg/8 oz bottle. The product is still apparently registered with the FDA as a homeopathic remedy. This seems to be in violation of FDA's conditions for marketing homeopathic drugs (FDA/ORA CPG 7132.15). All the same, I haven't found anything yet to support the position that the FDA can regulate either product so long as they aren't making health claims (so are being marketed for purely recreational use).

I also got an interesting email back from the FDA's Division of Drug Information concerning electronic cigarettes, which I'd like to reproduce here (since it's sometimes hard to find so much accurate information in one place). Note that the letter only refers to electronic cigarettes *that they have reviewed,* and that health claims seem to be an integral part of the case they make for regulation.

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Please note that in order to make a definitive determination of the regulatory status of any product it is necessary that we review a complete description of the product's design, function, its formulation, labeling and promotion (including statements and representations on the Internet), and any other information (e.g., patents) that describe the product's intended uses. In addition, as a matter of policy, we limit communications about the regulatory status of specific marketed products to those responsible for them, and we do not discuss our enforcement actions except with the targets of those actions. Nonetheless, we can make the following general comments:

The "electronic cigarettes" that we have reviewed are drug-device combinations under section 503(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 353(g)(1)) with their "drug" uses, as defined by section 201(g) of the Act (21 U.S.C. § 321(g)), as the primary mode of action. In this regard, these products contain no tobacco leaf or stem material, but are designed to look like conventional cigarettes. They are intended to be manipulated and used (inhaled) in ways similar to how a smoker manipulates and uses conventional cigarettes. And, like conventional cigarettes, they are intended primarily for the delivery of volatilized chemical substances to affect the body's structures and functions and/or to mitigate or treat the symptoms of nicotine addiction through a chemical or metabolic action on the body. The "electronic cigarettes" that we have reviewed are designed with a re-chargeable battery-operated heating element that volatilizes the chemical constituents contained within replaceable cartridges. These cartridges may or may not include nicotine. Since we are not aware of any data establishing that such products are generally recognized among scientific experts as safe and effective for these "drug" uses, they are "new drugs," as defined by section 201(p) of the Act (21 U.S.C. § 321(p)) requiring approval of an application filed in accordance with section 505 of the Act (21 U.S.C. § 355) to be legally marketed in the United States. None of these so-called "electronic cigarettes" is covered by an approved New Drug Application (NDA). Thus, the marketing of them in the United States would be subject to enforcement action.

Furthermore, the "electronic cigarettes" that we have reviewed are not subject to the Federal Cigarette Labeling and Advertising Act (FCLAA), Pub. L. No. 89-92, (15 U.S.C. §§ 1331 et seq), nor are they subject to the Comprehensive Smokeless Tobacco Health Education Act (CSTHEA), Pub. L. No. 98-474 (1986), (15 U.S.C. §§ 4401 et seq). Thus, they do not fit within the regulatory scheme that Congress has established for tobacco products.

A detailed discussion of the NDA process is available on FDA's Internet Web site at: Drug Approval Application Process. The sections of the Act referenced above are also available on FDA's Internet web site at U S Food and Drug Administration Home Page.

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I've omitted the various disclaimers, but they basically sum up to "don't rely on this information" - like every organizational communication these days.

Thoughts? Again, they didn't seem to address nicotine products that make no health claims.

jacobl

I've read documents online concerning inhalation of nicotine, propylene glycol and glycerin (glycerol) at tobaccodocuments.org. All of the documents I read were noting the tests involved and that these methods and chemical mixtures are approved by the FDA. I'm not understanding where they come back and say what they say about e-cigarette's when these methods of use were approved and are being used now in analogs since the 70's.

Brandon

Jacobl: I don't think any of those elements would actually be an obstacle to e-cigarettes getting approved by the FDA as a nicotine replacement therapy. Honestly, I don't think there would be a problem with e-cigarettes getting approval as a prescription product.

The difficulty is that it would never make an over-the-counter switch. The FDA evaluates a product for OTC distribution based on risk of abuse, among other factors (Office of Nonprescription Products). Back in the 1990s, Nicorette had to prove in studies that its mint flavor wasn't so appealing that it would lead to a significantly increased risk of abuse (http://www.fda.gov/cder/foi/nda/98/1..._admindocs.pdf - p9). With a product as appealing as electronic cigarettes, there is a very real risk of people using the product for recreational purposes - which isn't a problem unless the FDA regulates all distribution of the product and concludes that it's a problem.

jacobl

Brandon: Interesting, I wish i could understand all these regulations better. I'm just too closed minded I guess. If they would get rid of the flavoring and just market it as a cleaner, less toxic and safer alternative, do you think it would have made a difference in the kind of uproar going on right now? Maybe if they got rid of all the different colors and models and flavors, it would be different. You can always add flavor and paint your cig.

Brandon

Jacobl: I don't think so. The product would still retain the potential for abuse the FDA would be so worried about. I really just can't see e-cigarettes getting OTC approval, so long as people see recreational use of nicotine as something to discourage. The message that would need to become gospel is that the societal benefit of having such an appealing alternative to smoking (measured in ex-smokers) outweighs the societal harm from the increased likelihood of people taking up a nicotine addiction (the habit being less harmful and easier to support, whether by supplementing or replacing traditional cigarettes with e-cigarettes). If that's supported by whatever studies the FDA would perform when weighing the overall impact of making e-cigarettes available OTC, there's an outside chance they could get approves. Nothing I'd bank too heavily on, though.

For the moment, I'd just keep my fingers crossed and avoid making health claims. (And to encourage everyone else to avoid making health claims too. I theorize that a product that gets predominantly associated with a health claim, can be considered generally misbranded if there is a general presumption that it is intended to treat a condition. I don't think it's been tested, though.)

jacobl

brandon: Well, I figure if they go and make me get a prescription for an e-cigarette, I would just stick to analogs. It would be too pricey, they would sell them as disposables and my insurance wouldn't cover it I'm sure. Not to mention that it wouldn't look and feel so much like a cigarette anymore.

I understand the need to regulate due to potential abuse. I could probably stand for buying my own e-cig and component online and then going to the drug store to get the carts. I just don't see that happening.

The problem with analogs is that, no matter the price, there are 1,000's of people that will budget for cigarette regardless. It would just be easier than a prescription I think, mainly due to coverage. I know my insurance would say something like

"We currently show 9 different alternatives to quitting smoking. For that reason, you must file an appeal by having your doctor fax us a letter of necessity and all documentation showing the necessity. However, the appeal is no guarantee and will have to be reviewed by our doctors. The appeal then takes 7 to 14 business to process. At that time we will contact you and your doctor by mail. If that is all Mr doe, I would like to thank you for calling CareMark. Do you have time to take part in a 2 minute survey to rate the success of this call?"

.LOL. The only necessity they could show is if the patient has tried and failed all other alternatives.

bowenkanobe

Since Congress is passing out trillions anyway, why not spend a few billion on testing?

Oh wait, this is Congress we're talking about, where "Common sense will not be tollerated"

Brandon

The FDA is currently regulating e-cigarettes as a new drug/device combination when distributors make unapproved health/treatment claims indicating intent for use as a drug to affect the structure and function of the body. This is fine for distributors who seek to market e-cigarettes as an alternative to smoking, or generally as a recreational product.

The FDA would be within its authority to determine that e-cigarettes are intrinsically intended to affect the structure/function of the body, and could be regulated without any explicit health or treatment claims. This the authority the FDA originally attempted to exercise with tobacco products, and the authority the FDA successfully exercised in Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645, 653 (1973). If the FDA exercises this authority, the marketing and distribution of e-cigarettes in general will be prohibited until they approve a new drug application (NDA) for e-cigarettes. NDAs are expensive and usually take years and many tests to approve. Even at this point, it seems unlikely that the approved product would be approved for over-the-counter (OTC) sale (given that the FDA still requires studies performed and analyzed for each new flavor of Nicorette to weigh its potential for abuse), much less that the FDA would publish an OTC drug monogram for it (specifying the characteristics of e-cigarettes that would not need to submit an NDA or ANDA to be available OTC).

Essentially: General FDA regulation will result in e-cigarettes being removed from the market for years pending approval, then being available again only by prescription, in few varieties, and (probably) at a higher price.