FDA acts against electronic cigarette distributors

[Tom09]

FDA Press Release Sept. 9, 2010

FDA acts against 5 electronic cigarette distributors
Agency cites unsubstantiated claims, poor manufacturing practices

The U.S. Food and Drug Administration today issued warning letters to five electronic cigarette distributors for various violations of the Federal Food, Drug, and Cosmetic Act (FDCA) including unsubstantiated claims and poor manufacturing practices.

Also today, in a letter to the Electronic Cigarette Association, FDA said the agency intends to regulate electronic cigarette and related products in a manner consistent with its mission of protecting the public health. The letter outlines the regulatory pathway for marketing drug products in compliance with the FDCA.

For a drug product to gain FDA approval, a company must demonstrate to the agency that the product is safe and effective for its intended use. The company must also demonstrate that manufacturing methods are adequate to preserve the strength, quality and purity of the product.

“FDA invites electronic cigarette firms to work in cooperation with the agency toward the goal of assuring that electronic cigarettes sold in the United States are lawfully marketed,” the letter to the association read.

FDA has determined that the electronic cigarette products addressed in the warning letters to the distributors, and similar products, are subject to FDA regulation as drugs. Under the FDCA, a company cannot claim that its drug can treat or mitigate a disease, such as nicotine addiction, unless the drug’s safety and effectiveness have been proven. Yet all five companies claim without FDA review of relevant evidence that the products help users quit smoking cigarettes.

The companies receiving warning letters today are: E-CigaretteDirect LLC, Ruyan America Inc., Gamucci America (Smokey Bayou Inc.), E-Cig Technology Inc. and Johnson’s Creek Enterprises LLC.

Certain companies received warning letters for additional reasons. For example, E-Cig Technology markets drugs in unapproved liquid forms, such as tadalafil, an erectile dysfunction drug, and rimonabant, a weight loss drug that has not been approved for use in the United States. These liquid pharmaceuticals are designed to refill cartridges used in e-cigarettes so that the drugs can be vaporized and inhaled.

The FDA cited Johnson Creek Enterprises, which markets Smoke juice, a liquid solution used to refill depleted cartridges in e-cigarettes, for several significant deficiencies in its manufacturing processes, including failure to establish quality control and testing procedures required under the FDCA.

Follow this link for press release and FDA warning letters

 

[rothenbj]

The escalation of their war to keep cigarettes and pharmaceutical products safe from competition has begun. They will continue to stomp unless someone stomps on them.

 

[trying]

I take it SE and njoy were not included because of their current legal case against the FDA.

 

[CJsKee]

Holy .......I'm speechless... So they can just ignore the fact that they are involved in litigation over this very thing???

 

[rothenbj]

They have to get the news moving in their direction somehow. I expect we'll be seeing plenty of this in News at Five. Johnson Creek appeared to be pretty sure they were working with the FDA. Guess they ASSumed wrong. I would expect that this is only the start, this looks like escalation at its finest. Blu wasn't included which is a bit of a surprise, but next week is coming.

 

[Steakpak]

Some of it seems right. These companies should not be making the claim that an ecig will help you quit smoking. That will be the death of it if they keep doing that. The way to go is just say it's a smoking alternative. These tobacco companies, such as Phillip Morris, being one of the biggest supporters of anti-smoking ads, should jump on this and start releasing their own products. Maybe we can actually get an ejuice that tastes like their products that got us addicted in the first place.

Technology has been changing our world like crazy in the past few years. It's time we moved on to a better, healthier way of smoking. And these companies need to wake up and realize it. This could become a huge business and has already become a main source of income for a few people on this forum. However, this will surely hurt the tobacco industry. So if they don't join in and support it, this stuff will become the new .......... People getting locked up and an unimaginable amount of tax payers money spent on a ridiculous "war on drugs". However, with ......... gaining some ground now, people have a much different mindset than 20-30 years ago. We won't just sit back and allow them to outlaw this. Hopefully.

Booo to censorship. Context, people, context.

 

[Vocalek]

What is absolutely outrageous is that in the letter to Gammucci, they quote information from the TobaccoHarmReduction.org web site as proof the products are being marketed as drugs!

TobaccoHarmReduction.org

[T]he leading source of information of safer alternatives for smokers who cannot or do not wish to quit using nicotine.

Electronic Cigarettes . . .

Are they really safer than regular cigarettes? -Yes.

Are they as safe as using smokeless tobacco? -Maybe.

Could these help me quit all nicotine use? -Maybe.

They might. Switching away from smoking is the most important thing to do so even if you end up not quitting. At least it won't harm you the way smoking will. Some people have found that electronic cigarettes reduce their need to smoke somewhat. E-cigarette Direct has posted a collection of e-cig user comments [http://www.e-cigarettedirect.co.uk/research/comments.html] about their experiences with many reporting that they have reduced or quit traditional smoking. The products are available with varying levels of nicotine, from a lot to none, so they can be used as a weaning product.

It does not strictly qualify as scientific evidence but indications are that e-cigarettes are being used successfully by many to quit smoking, with many of the quitters having a history of trying other methods and failing . . . Every anecdote so far appears to tell the same story; a cigarette smoker is switching over, sometimes just part time but more often full time, to this safer alternative.

Other quit smoking methods have little success with many smokers, so it is not surprizing [sic] that people who are trying to quit will try this too. And given the reports, it seems to be working for many. In time we should see some formal studies but in the meanwhile, on a person to person basis, some smokers are rapidly reducing their health risks . . .

The above statements demonstrate that the Gamucci products marketed by your firm are intended both to affect the structure or function of the body and to mitigate, treat, or prevent disease.

 

[ashworth]

I just wanna say that I've been (happily) vaping for almost two years now and my "pee pee" works just fine. That is all.

 

[ashworth]

These tobacco companies, such as Phillip Morris, being one of the biggest supporters of anti-smoking ads, should jump on this and start releasing their own products. Maybe we can actually get an ejuice that tastes like their products that got us addicted in the first place.

Amen.

 

[spivey]

What still irkes me is their totalitarian method. These products shouldn't be banned until proven safe; that's not how or government is 'supposed' to work. We should be left to our own devices unless they are found to cause harm.

 

[rothenbj]

FDA Sends Warning Letters to E-Cigarette Companies - ABC News

"But in a letter to the Electronic Cigarette Association, the FDA said the actions against the companies were not meant to be seen as a larger effort to ban e-cigs. The agency encouraged the industry group to work with the FDA to ensure the safety and effectiveness of the devices to help people quit smoking traditional cigarettes through usually expensive clinical trials."

No, we don't want to ban them, just spend millions and maybe ten years or so we'll agree to allow some ineffective variant to emerge approved by us. Then again, maybe not. What's there to lose, 4.4 million Americans?

 

[chrisl317]

My god, how stupid do they think we can be? They, right now, are stuck in limbo with e-cigs just like us. They can't regulate, they can't tax or do anything really at all about e-cigs and they are asking distributors and sellers to put their collective heads in the noose? Don't the distributors/sellers understand that right now FDA compliance is voluntary according to their release. They "want" them to work with the FDA to lawfully sell these drug delivery systems?! I didn't know anyone declared them drug delivery systems yet, or that e-juice is a drug. Work with them and you'll be admitting that they are! The FDA is trying to get a foot in the door to regulation by using the distributors/sellers foot!

 

[jayvap33]

Here's the page with all the info; a good link for future and past FDA issues too:
Electronic Cigarettes

 

[Vocalek]

Judge Leon made it clear in his opinion document that there could be two classifications of electronic cigarette:

Purpose: Recreational use of nicotine, as a partial or complete replacement for smoking = Tobacco Product that can be regulated under the Tobacco Act
Purpose: Treat nicotine addiction (weaning down and off) = Drug that can be regulated under the Food, Drug and Cosmetics Act.

http://www.casaa.org/files/SE-vs-FDA-Opinion.pdf

Companies that want to go the "it's a drug" route and make nice-nice with the FDA should be cautioned. What I have seen of the FDA's past behavior in (excruciatingly slowly) approving the currently available NRT products is that FDA wants the starting dosage of nicotine to be well below what people can take in from smoking. This may cause the success rates we have seen for smoking abstinence with the products as currently designed to plummet dramatically when they are redesigned to be "safe".

IMHO "We don't need no more steenking NRTs" designed to the FDA's vision and incapable of helping 95% of smokers.

 

[Vocalek]

Here's the page with all the info; a good link for future and past FDA issues too:
Electronic Cigarettes

Here is the FDA Press release. It has a link to the above page along with links to all the letters.
FDA acts against 5 electronic cigarette distributors

 

[SquirrilahFish]

I know your gonna hate me for saying it, and I know its the government so I know their trying to use this as a back door to get control of ecigs.
but IMHO

THEY HAVE A LEGITIMATE ARGUMENT. MOSTLY

Said it bf ill say it again, we got to work with them, not against them, because these are safer alternatives to smoking, and the truth will prevail in this situation.

People putting unapproved drugs in vapor, people making crappy juice, and even crappy ecigs (usually overpriced too, i might add, by at least 200%) needs to be stopped, IDK about you but I want a quality, safe product when I order my ecig.

Thank god we live in a country that allows us enough freedom to use these products, and makes an effort, (Yes, an effort with a biased agenda) but none the less a effort to safely allow these products. Look at how many countries out there simply told their citizens NO! NO ECIGS FOR YOU.

ONE MORE TIME,

We have to work with them

(....ty and ridiculous as it may be)

 

[Vocalek]

Having read through the letters I have this to say. The company trying to sell vaporized drugs and vitamins other than nicotine needs to have its head examined. Rimonabant isn't even approved for distribution as a PILL in the US. And E-......? What were they thinking? E Liquid | Electronic Cigarette | E Cigarette,

My recommendation to the other companies would be to scrub their web sites and any other promotional materials for any mention of the products being able to help relieve symptoms of nicoitne withdrawal or to function as an aid to quit smoking. Yes, we all know these are not untrue statements. They are, however, the statements that make the product into a drug as opposed to a smoking alternative in the eyes of how the U.S. laws are written.

The products should be promoted only as a pleasant alternative to smoking. (We consumers can get the word out that they make an excellent permanent replacement for smoking.)

After doing that, I would contact NJOY and ask to join their lawsuit as an Intervenor Plaintiff.

 

[thorn]

Holy .......I'm speechless... So they can just ignore the fact that they are involved in litigation over this very thing???

The FDA realizes at this point that they may very well lose their case or are seeking "willingness" of companies to be governed by the FDA before the outcome of the case so they may present it as evidence that similar companies agree it is a drug. Those 5 companies should be easily protected from the FDA involvement until the outcome of the case.

By no means should any company state that e-cigs help people quit smoking. There have been no formal university studies proving or disproving that fact. Companies should be given the chance to re-word their advertising. Which then goes the other direction, can they state that "E-cigs do not help people quit smoking"?

 

[LowThudd]

So in other words...since the FDA is not sending this letter to PM et al...The FDA *Must* then be pro-cigarette??!!?? I can only assume through logical deduction 2+2-1=3
If they are not treating ALL nicotine products with the same reguard(IE snus), then they are either playing favorites, or just plain dumb butts. Either way, I think the FDA should be baned...they are bad for your health.

 

[chrisl317]

I know your gonna hate me for saying it, and I know its the government so I know their trying to use this as a back door to get control of ecigs.
but IMHO

THEY HAVE A LEGITIMATE ARGUMENT. MOSTLY

Said it bf ill say it again, we got to work with them, not against them, because these are safer alternatives to smoking, and the truth will prevail in this situation.

People putting unapproved drugs in vapor, people making crappy juice, and even crappy ecigs (usually overpriced too, i might add, by at least 200%) needs to be stopped, IDK about you but I want a quality, safe product when I order my ecig.

Thank god we live in a country that allows us enough freedom to use these products, and makes an effort, (Yes, an effort with a biased agenda) but none the less a effort to safely allow these products. Look at how many countries out there simply told their citizens NO! NO ECIGS FOR YOU.

ONE MORE TIME,

We have to work with them

(....ty and ridiculous as it may be)

Show me an instance of truth prevailing in regards to gov't interdiction.