UPDATE: FDA Warns Five E-Cigarette Makers, Says Products Need FDA Approval

[Bustastew]

This is on the Wall Street Journal web site. When I saw this news article I saw ZERO comments. So I added mine.

WE HAVE GOT TO SPEAK UP!!! PLEASE LEAVE COMMENTS AFTER MINE ON THIS ARTICLE =)


UPDATE: FDA Warns Five E-Cigarette Makers, Says Products Need FDA Approval - WSJ.com

I had to subscribe (FREE) to post.

Best way we can fight the FDA I think is this, call your local news station/paper/radio station's and ask them to review what the American Association of Public Health Physicians have to say against the FDA.
These are Doctors that are saying LEAVE THE ecig ALONE IT WILL SAVE LIVES!

 

[Poppa D]

With out the subscription there is little there to read. Any one have a subscription want to summarize?

 

[BoomBoom65]

Here is a bit more of it but there is another thread somewhere on the site here with more articles and discussions about todays FDA warnings.

The Food and Drug Administration warned five electronic cigarette makers Thursday that they were violating federal law.

The agency said the products, which use a device to turn nicotine liquid into a vapor mist, are drugs that require pre-market approval similar to other nicotine replacement products. The FDA recently started regulating traditional cigarettes under a separate tobacco law.

The FDA said the e-cigarette companies are marketing their products as tools to help people quit using cigarettes. The agency suggested the companies would need to conduct clinical studies showing the products are an effective treatment for nicotine addiction.

The companies receiving warning letters are E-CigaretteDirect LLC of Parker, Colo.; Minneapolis's Ruyan America Inc.; Gamucci America, also known as Smokey Bayou Inc., of Jacksonville, Fla.; E-Cig Technology Inc. of Las Vegas and Johnson's Creek Enterprises LLC of Johnson, Wis.

The FDA also cited Johnson Creek Enterprises, which markets Smoke juice, a liquid solution used to refill depleted cartridges in e-cigarettes, for deficiencies in its manufacturing processes and cited E-Cig Technology for using tadalafil, an erectile dysfunction drug, and rimonabant, a weight loss drug that's not approved for use in the U.S., in some of its products.

 

[Poppa D]

Oh boy this will make great copy. Good enough to make the Journal.

 

[Xanax]

Oh Jesus......

 

[VapnChief]

The FDA isn't concerned about your health. This is the Obama regime, they want TAXING authority...pure and simple.

 

[mtb]

After reading the Times story today, it appears to me that the FDA is actually taking a reasonable position. If companies are going to be selling products that contain nicotine (and claimed varying amounts of nicotine)...and....or..... marketing their products as a way to stop smoking, then there are certain guidelines that should be followed to protect the consumer. Who wants to suck down an unsafe product here?? Sure, it's 100000 times safer than tobacco, but....this is the U.S., and as a consumer, you have the right to know that there is a least a little safety net built into the production and sale of these products.

As far as taxing the product, it seems inevitable, but I don't think that is the FDA's primary motivation by any means. There simply aren't enough dollars involved (at this point in time) for that to be the driving factor.

Like it or not...the FDA is here. The studies I have seen indicate that e-cigs are safe. Doctors I've spoken with agree that based on the information they have read, e-cigs are safe. There is a lot of support (unorganized at this time, but still, support) for e-cigs. If the companies fight the FDA, it could have very negative implications for the e-cig industry and fate of the e-cig for consumers. Work with them, and hope for the best possible outcome. Either way I don't expect the FDA to just fade away.

 

[Vocalek]

After reading the Times story today, it appears to me that the FDA is actually taking a reasonable position. If companies are going to be selling products that contain nicotine (and claimed varying amounts of nicotine)...and....or..... marketing their products as a way to stop smoking, then there are certain guidelines that should be followed to protect the consumer. Who wants to suck down an unsafe product here?? Sure, it's 100000 times safer than tobacco, but....this is the U.S., and as a consumer, you have the right to know that there is a least a little safety net built into the production and sale of these products.

As far as taxing the product, it seems inevitable, but I don't think that is the FDA's primary motivation by any means. There simply aren't enough dollars involved (at this point in time) for that to be the driving factor.

Like it or not...the FDA is here. The studies I have seen indicate that e-cigs are safe. Doctors I've spoken with agree that based on the information they have read, e-cigs are safe. There is a lot of support (unorganized at this time, but still, support) for e-cigs. If the companies fight the FDA, it could have very negative implications for the e-cig industry and fate of the e-cig for consumers. Work with them, and hope for the best possible outcome. Either way I don't expect the FDA to just fade away.

I will answer your post with the comment that I left on the story:

The issue of whether or not e-cigarettes are a drug delivery device combination is currently under litigation. The FDA is defying the U.S. Federal court system by proceeding as if it has won the case. The lower court ruled that the products are not intended to treat a disease and are therefore not to be regulated under the Food Drug and Cosmetics Act. Judge Leon went on to point out that FDA has all the power it needs to protect public health by regulating the products under the Tobacco Act. What's the difference? It is estimated that half a million Americans have substituted the electronic cigarette for all their smoked cigarettes. As a result, they are enjoying better lung health and have reduced their risks of smoking-related disease. If the FDA insists on regulating them as if they were a medical treatment, they will be removed from the market. Where does that leave all these former smokers? Back on Winstons and Marlboros.

 

[wardge76]

If the companies fight the FDA, it could have very negative implications for the e-cig industry and fate of the e-cig for consumers. Work with them, and hope for the best possible outcome. Either way I don't expect the FDA to just fade away.

I respectfully disagree with this statement... Sitting back and "hoping" for the best outcome is not the way to go IMO... I don't think anyone expects the FDA to "fade away", but they definitely need to be taken back a few notches. The only way that we can protect our rights is to fight for them by signing petitions, writing letters to legislators, spreading the word on social media (Twitter, Facebook, YouTube), gaining media exposure, and donating our time and money to organizations that can help our cause.

I, for one am not ready to be steamrolled back to an analog death-sentence by the FDA

 

[mtb]

Does anyone know how that litigation is progressing?

I did not say, or mean to imply that anyone should just sit back and hope. I have, and will continue, to participate in supporting the cause, and encourage everyone that enjoys the benefits of e-cigs to do the same.

 

[markarich159]

After reading the Times story today, it appears to me that the FDA is actually taking a reasonable position. If companies are going to be selling products that contain nicotine (and claimed varying amounts of nicotine)...and....or..... marketing their products as a way to stop smoking, then there are certain guidelines that should be followed to protect the consumer. Who wants to suck down an unsafe product here?? Sure, it's 100000 times safer than tobacco, but....this is the U.S., and as a consumer, you have the right to know that there is a least a little safety net built into the production and sale of these products.

As far as taxing the product, it seems inevitable, but I don't think that is the FDA's primary motivation by any means. There simply aren't enough dollars involved (at this point in time) for that to be the driving factor.

Like it or not...the FDA is here. The studies I have seen indicate that e-cigs are safe. Doctors I've spoken with agree that based on the information they have read, e-cigs are safe. There is a lot of support (unorganized at this time, but still, support) for e-cigs. If the companies fight the FDA, it could have very negative implications for the e-cig industry and fate of the e-cig for consumers. Work with them, and hope for the best possible outcome. Either way I don't expect the FDA to just fade away.

I can't agree more with your analysis. I just started a thread in this subforum called "This is what I've been talking about for a year now" which quotes from the JC letter. The FDA has allowed non-regulation and irresponsible, possibly dangerous, manufacturing processes to go along with impunity in the US eliquid/ecig industry for sometime. The FDA is giving the industry one final chance to legitimize and being very lenient, in my opinion, with the way in which they are proceeding. (they could have shut JC down immediately upon their inspection if they wanted to). I only hope the industry realizes the break they've been handed and start implementing the recommendations cited so vapers will not have to worry about this in the future.

 

[wardge76]

Does anyone know how that litigation is progressing?

I did not say, or mean to imply that anyone should just sit back and hope. I have, and will continue, to participate in supporting the cause, and encourage everyone that enjoys the benefits of e-cigs to do the same.

I apologize... I didn't mean to come across negatively toward your post - I totally agree with you that if we all want to continue to enjoy our PV's, we all bear the responsibility to ensure that we don't lose them

I was probably hasty in my disagreement with your post, and again I apologize if my post sounded nasty - It wasn't intended to be.

 

[Vocalek]

I can't agree more with your analysis. I just started a thread in this subforum called "This is what I've been talking about for a year now" which quotes from the JC letter. The FDA has allowed non-regulation and irresponsible, possibly dangerous, manufacturing processes to go along with impunity in the US eliquid/ecig industry for sometime. The FDA is giving the industry one final chance to legitimize and being very lenient, in my opinion, with the way in which they are proceeding. (they could have shut JC down immediately upon their inspection if they wanted to). I only hope the industry realizes the break they've been handed and start implementing the recommendations cited so vapers will not have to worry about this in the future.

JC just had nationwide news coverage, so it would have looked very suspicious for the FDA to shut them down a few days later. If you will read through the list of "shortcomings" FDA cited you will see that there have not been any problems noted with impurities or unsanitary conditions. FDA is saying, "We consider what you manufacture to be a drug; therefore you must behave as if you were Upjohn and Pfizer and jump through a lot of hoops that may or may not improve your product, but they are our rules for making drugs." JC has been registered with the FDA since the day it opened its doors as a lab that manufactures products for human consumption.

See: Johnson Creek Original Smoke Juice - The Best E-Liquid in the World - Made Right Here in America

There has been a lot of information and misinformation in the news lately in regards to the e-smoking industry in general as it relates to the FDA. We do not anticipate any real issues with the FDA as they begin to develop rules and regulations for the industry. In fact, we feel that we already adhere to any regulations they're likely to impose, such as; child safety caps, plastic shrink banded caps, etc. We are also the first company to voluntarily list our ingredients on our bottles and print warnings for children and pets. We're also quite proud of the ultra sanitary conditions and use of personal protective equipment in which we bottle our Smoke Juice. Johnson Creek Original Smoke Juice is is made in America, with the highest grade ingredients available. Ultimately, we do not know what the FDA will choose to do with the e-smoking industry, but whatever they do decide, we're ready and we welcome their involvement.

I disagree that FDA is giving the industry a chance to legitimize. FDA's Warning Letter to General Mills regarding Cheerios simply required them to correct the health claims in their advertising and labeling. General Mills, Inc. 5/5/09

FDA did not tell General Mills that they were required to file a New Drug Application and get Cheerios approved as a new drug. There is no mention of an NDA in the Cheerios warning letter, as there is in all the letters to e-cigarette companies.

I have said this before and I will say it again and again until everyone has heard it: The FDA has all the powers it needs to regulate e-cigarettes as tobacco products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Act). This is not just my opinion. It is the opinion of U.S. District Court Judge Richard J. Leon. http://www.casaa.org/files/SE-vs-FDA-Opinion.pdf

It is also the opinion on many public health experts.

A different branch of the FDA, the Center for Tobacco Products should be setting up the standards and regulations for e-cigarette manufacturing. Instead, the FDA is sticking to its guns insisting that e-cigarettes are a drug-device combination.

This question (drug-delivery device or tobacco product?) is being litigated through the court system now. Oral arguments on FDA's appeal of the injunction imposed by Judge Leon are scheduled to be heard on September 23 and it will be (probably) January before the Appeals Court rules on whether the lower court injunction will be upheld. It is unconscionable for the FDA to proceed as if it has won a court case in which the trial has not even started!

 

[Vocalek]

Does anyone know how that litigation is progressing?

Yes. See this post: http://www.e-cigarette-forum.com/fo...tters-read-them-dont-panic-2.html#post1868248

 

[markarich159]

A different branch of the FDA, the Center for Tobacco Products should be setting up the standards and regulations for e-cigarette manufacturing.

Unfortunately, the industry could have been working with FDA hand in hand for the past year plus to set up this Branch(in fact, I brought this scenario-about a totally different and new classification of a non-therapeutic, recreational class of tobacco substitute regulations- in my 2nd thread ever on ECF titled "A pharmacists point of view" over a year ago and got blasted for it). It's a bit late now after fighting tooth and nail with this organization and demonizing it for months and months.

The Cheerios analogy is moot as Cheerios is a long approved food entity(a completely different product) and is and always was produced under FDA guidelines. This is completely different situation as all GM had to do was remove health claims from an already approved and properly manufactured product.

As for JC, not producing an unapproved product of this nature(liquid intended for direct pulmonary inhalation) via anything near cGMP IS tantamount to unsanitary conditions and FDA is not going to change their opinion on that(nor should thay, nor should vapers want them to). Finally, FDA REGISTRATION(as per a 2002 bioterrorism act) is completely different from FDA APPROVAL. This fact has already been established ad nauseum in multiple threads

 

[markarich159]

Yes. See this post: http://www.e-cigarette-forum.com/fo...tters-read-them-dont-panic-2.html#post1868248

Continue to believe what you want to believe and vape what you want to vape. If the JC inspection letter doesn't seriously concern you as a vaper, nothing I can say as a healthcare professional will either.

 

[kristin]

The FDA told JC that they were in violation of requirements for drug delivery devices.

significant violations of Current Good Manufacturing Practice (cGMP) regulations for Finished Pharmaceuticals

Regulations may be different for tobacco products. A federal judge has ruled that these are tobacco products, so the FDA is accusing them of not meeting the standards for the type of product they AREN'T.

Elaine's point about Cheerios was that Cheerios are NOT drug products, so they aren't expected to meet the same standards of testing, so long as they make no health claims. The FDA gave them the opportunity to stop making the health claims and that was the end of it. Conversely, the FDA is still requiring e-cigarettes - determined by federal ruling to be tobacco products and NOT drug delivery devices - to meet production standards of pharmaceutical products.

The FDA insists that claims of quitting smoking posted on vendor sites prove that these are meant to treat nicotine addiction, but they ignore the fact that none of the consumer statements they quoted said anything about quitting nicotine - just quitting smoking. If they don't claim to treat nicotine addiction, then they are not the drug delivery devices intended to treat disease. If they made claims of quitting nicotine addiction, THEN they'd be a drug treatment.

And nowhere in the letter does it accuse JC of having unsanitary/unclean facilities!

 

[Kate51]

I fear we are dealing with an FDA that has become the Sheriff, the Judge, and the Executioner all in one massive and convoluted entity that is bound totally to notch it's gunbutts (pun intended) with as many scars as possible. They must prevail, for their own political well being. While at the same time, they've bitten off more than they can chew simply to oversee the Food Industry. (Pun intended)
They now seem to be the Darth Vader for Big Pharma, and Big Tobacco seems to be meshed into the framework as well: they know something FDA may be averse to show? Complicity, for example?
We are more likely to die from Bad Eggs and Drug side effects than from Nicotine and E-cigs. Seems a hollow victory to us, but to them it's a key to their continued existence. Job Security. Along with a whole host of Public Service non-profits that hang their hats on FDA Hooks.
I am summarily disgusted with our "Progressive" government in general today, and I would certainly not be passive about the powers over the Tree of Liberty by the FDA or any other branch of the Behemoth Brotherhood.

 

[Aeturnus]

You know, out of all the eJuice companies FDA are going after, I'm surprised they're on Johnson's Creek's back. They seem to be the most responsible. At least Johnson's Creek mentions what they use in their juice, and I honestly would rather order from a company do more than just put 'Chocolate' on the bottle. The only reason I can see why the FDA would go after Johnson's Creek is if they're problems going on in their plant, or whatever you want to call it.

 

[CaptJay]

I wonder how the judge in charge of the appeal will view this action, seeing as it APPEARS to violate the original ruling?
Not sure of the sub judice laws here either. Has anyone brought it to the court's attention?