FDA Sends Warning Letters

[Vapulicious]

E-Cig Technology Inc it seems has been selling their e-pharmaceuticals like erectile dysfunction drugs etc and using the e-cig as their device- just the sort of ammunition the FDA needs, Ive never heard of them, nor could i find a website, based in Las Vegas apparently. The e-cig community shoud decry these sorts, they will ruin it for everyone if the FDA can make a case.
Truthfully, its NOT the device thats at fault here, no more than a pipe at a headshop should be banned as a "delivery device"
e-cig and the FDA will be at this for a while, and lets not forget, tobacco was not regulated by the FDA less than 2 years ago. So they may have a chip on their shoulder to prove they have the clout to do as they wish - "Now the Federal Gov is in charge" can you say "NANNY STATE" ?

 

[bombastinator]

They are a criminal organization =)

They are not. They can be manipulated by people with sufficient power though, and those people often have criminal intent.

 

[bombastinator]

the impression I got from what I read was they were primarily going after companies that were putting things OTHER than nicotine in ecig liquid. I believe erectile dysfunction medicine was specifically mentioned. That kind of crap could theoretically get dangerous real fast.

Philip Morris seems to be moving in on ecigarettes though and they are one of the biggest lobbyists in Washington. I would very much like to know what they are up to myself. it is likely they are the prime movers here. They are the ones with the motive and the money.

 

[jtcaseyjr]

Can't argue with that. We--and I speak collectively of the vaping community, which includes suppliers--need to clean our own house of these cockroaches: Electronic Cigarette | E Cigarette | E Liquid - Healthcare E-Liq

The issue at hand, though, is the written warnings to the five stateside suppliers. To that, I'd be helpless to articulate a better response than this: The Rest of the Story: Tobacco News Analysis and Commentary

I just read 2 of the "Rest of the Story" Articles, I thought they were GREAT. Very good points. This is the type of information that needs to hit mainstream media instead of all the media protecting both cigarettes and the FDA.

 

[Etch]

Realistically, if companies are putting weight loss drugs, ED drugs, etc in their products, im more then happy to have the FDA correct the issue. One of the reasons i jumped to pv's (trying to anyways) is knowing what im putting in my body - apparently some juice suppliers want to make that a mystery. I don't know how anyone can be opposed to making sure you know what you are putting in your body - FDA or any other agency. This part of the letter doesn't affect your choice to use - it only effects knowledge distribution.

The marketing bit on this...the laws on that are pretty cut and dry in the states..and im not overly opposed to forcing people to market truthfully. Again - doesn't affect choice...only knowledge. So, im ok with that too. Dont market something with only anecdotal evidence...seems fair enough to me. No?

If they decide to limit your freedom of choice - thats where i have issue. The issues mentioned are all standard business procedures.

We have to question the tactics of course. Afterall, I haven't heard from any of the companies in response (yet). But when they make a claim like..

FDA tests found that the firm's Vitamin C E-Liquid product contains dangerous amounts of DEG, a contaminant that the FDA says can cause "serious and irreversible" poisoning.

It makes me listen.

The FDA (and other agencies worldwide) have done some stupid stuff regarding ecigs...but making companies have safe production practices, and truthful marketing certainly isn't something i have a problem with.

We like to speculate on what these agencies are doing, why, and how...but this letter sounds very positive to me. This of course pending a response from the implicated companies, because it may be nonsense from the FDA.

 

[Steakpak]

The other day I sent an email over to ecig.com asking them to stop selling their healthcare e-liquid. They are a company in China, so they prob feel it's no big deal. I of course did not get a response and they are still selling it. Not that I really thought they would stop because I asked. Anyways, I went on the site tonight and see that the Live Support is online. So I figure, why not ask them what's going on? I click on the live support and this is the short conversation:

Jojo Joins.
Jojo Says:

Hello! Thank you for contacting E-Cig.com. How can I help you?

You Say:

Hi. Since the recent problem with the FDA in the U.S., will your company stop selling health eliquid?

Jojo Says:

deeply sorry that it is for product information.

You Say:

what does that mean?

anything? (I waited about 5 minutes before asking this)



Wonderful. What an answer that is. I'm upset that I was one of the fools that purchased from this site before. I refuse to support a company like this and will fire off another email to them. Or people here could just bomb their live support every day. maybe. just sayin'. but i'm not.

 

[NieNie]

Hello for real??? Its all about the money. Big tobacco is afraid. I live in Wisconsin and of course they won't be getting my cigarette tax anymore. Not to mention folks if they have their way we will be all smoking some crappy e-smoke that has pre-filled cartridges that doesn't give much vapor and will be needing a perscription. Not to mention will cost a small fortune to send us all on our way back to analog smokes.

Can you believe that the American lung Society is on this as well. If they find that e-cigs are bad for our health "are they going to ban the food that pg is in?"

It's all about the money.... The money we won't be giving to big tobacco or cigarette tax. They will need to tax the junk food because who else is going to fix the roads? They will pick on the obese instead?

 

[lisabsn]

I think the answer here is to ban juices from outside of USA. I buy from American companies who are owned by vapors. They don't want to lose their business or habit so they do toe the line. The overseas stuff is like the high lead level toys they market here. American juice, American products, honest businesses that's the key. I would rather spend a bit more for our people to make our products than to risk our health or an outright ban on something I safely enjoy. Around here some stores sell fake ........., it's treated with god knows what to give you a buzz, crack down on them and leave us alone.

 

[Etch]

I think the answer here is to ban juices from outside of USA.

i tend to disagree. Im all for supporting your local economy, and small businesses, but i dont think its fair to assume because a company is in china they are not reputable and should therefore be banned. There are numerous companies in all parts of the world operating with shady business practices and its unfair to label them all.

Afterall, didn't e-cigs start in china? What if they were banned before we ever got to try one?

Again - for me its all about choice. Let the imports come in, tax them if needed, but make sure all local products adhere to safe practices, etc. If an international supplier wants their product in the country - it needs to follow the same local rules. The problem is - there are no [clearly defined] rules currently (hence the FDA) - which is what this whole debacle deals with.

Ultimately though: Let the user of the product determine who/what they trust.

This is a sweeping oversimplification. Trade agreements, ISO standards, the fda (or similar) etc will all play a major role im sure. At the core though - i dont want my government telling me what i can and cant have.

 

[lisabsn]

I agree completely, what we are doing is perfevtly legal. If FDA feels they must control this industry let them look at the ones who are violation, not the entire industry. US products, and Canadian products for that matter don't seem to be the biggest offenders. I don't know who puts ED meds in their juice, I admit that, but look at it this way. In North America if we need a medication, prescription, we go to MD who prescribes this. In other countries the pharm will sell you what you want or need. Is it the same as what we would get at home, no. I know that we should be able to make our own choices and I doubt of the majority of us would choose something iffy. But it is the unscrupulous companies who take advantage. Couple that with the big cig companies fighting for their share of the market and we are caught up in a catch 22 position. Most NA suppliers of juice are small operations, they don't have the money to fight back. I mean really have you ever heard of a vape lobbyist? We have to police ourselves and buy wisely. We have to stand up and say we do not support these additives and not buy from anyone who makes them. Basically we are responsible for keeping our hobby clean. If it keeps the wolf from our door we have done well.

 

[MasterLink]

i dint understand how in some places you can get weed has the fda done any testing on that

 

[cruisedoc]

Yes, elections are important. The FDA is big, in your face gov. at it's worst. As a physician I could tell you stories (unfortunately, very long stories). Let's vote for smaller gov. and cut the FDA budget by 50% (along with some other agencies). (No, I'm a dem, but I keep hearing there's a party trying to say NO to all this big gov. crap ...and that's who I will be voting with)

 

[jtcaseyjr]

I think the answer here is to ban juices from outside of USA. I buy from American companies who are owned by vapors.

Some American Companies that are owned by people who Vape get alot of thier juice and other supplies from China Vapor4Life is one and I know Cignot does too. I have seen the Video of V4L about the Chinese manufacturing (https://store.vapor4life.com/Articles.asp?ID=136), I haven't seen an American company willing to show off how they make their juice or what QC controls they have. Not bashing American products, I know there are ALOT of good ones and I know V4L is even looking into American juice too. I'm just making a point in that you can't paint this with a broad brush and say it's all China's fault. Truth is NONE of us would be vaping if it wasn't for China in the first place.

 

[Macboy80]

Just wanted everyone to sign the petition. Looks old, but still took my sig. (ecigssavelives.info)

 

[Vapulicious]

The current Administration are all "Big Government" types, they all believe they can make better decisions on your health and money than you can. The more we let these bureaucrats control this country, the fewer freedoms we will have as individuals. I vote for which ever party claims to want to DECREASE the size of government.
All we need to do is look at our European Brethren to see what Socialists/Progressives want for this country. Nothing is free folks, Not your rent, nor food, nor medicine, someone will always pay more taxes to support those that dont. If you let government use your money to grow their bureaucracy, you'll get the nanny state you want, with all the trimmings of over regulation, over taxation, and an "IN YOUR FACE" attitude that they know whats best for YOU. Think about weather you want big government come November!

 

[Vapulicious]

EVERY vendor in the USA who sells ecigs kits/parts gets their products from china. Only SOME e-juice vendors make their own Nicotene Tincture in the USA now. As i understand it, most still use Chinese Nicotene with their own flavorings. Can we make our own atomizers and batts here in the USA ? I'm sure the cost factor would'nt be competitive with china, but it may come down to that if the FDA were to try and stop the import of ecigs altogether. I personally dont think it will go that far, but they may well try and stop or atleast tax and oversee the ejuice vendors, and that isnt neccessarily a bad thing. History teaches me that when gov gets involved, it usually ends up a mess or an expensive mess!

 

[The Rebel]

I think the answer here is to ban juices from outside of USA. I buy from American companies who are owned by vapors.

So you're saying you'd rather buy juices from a supplier that has no quality control systems in place, mixes their juices in an unsterile enviroment, in unsterile containers, using ingredients only known to them? Juice that is mixed by someone with no chemistry background, no formal training outside of trial and error, probably using uncalibrated equipment? Good luck...

I think I feel a little safer using someone like Dekang who is ISO9001 certifed, certified and recognized by SGS (a worldwide certification company), and has their own research and development center dedicated to nothing but the production of juice. Just my opinion....

I'm all for the regulation of e-cigs and juice. I've stated before, I want to know what's in my juice, how much of each ingredient, and to know that it is made in a safe, clean enviroment with good quality control processes in place. It's only going to take one garage would be chemist to mess up one time and this little slice heaven we enjoy right now will blow up.

 

[DC2]

Are they just blowing smoke...forgive the pun, or do they have any real power to regulate e-cigs?

They not only have the power to regulate them as tobacco products under the Family Smoking Protection and Tobacco Act, they have the power to remove them from the market as unapproved drug delivery devices if they win the current court case.


There is a lot of concern lately about the letters sent by the FDA recently.
But they are just a small part of the entire picture of what is and has been going on from a legal standpoint.

Anybody that hasn't listened to this yet really needs to do so.
Special Edition 9/12/2010 - kevbow | Internet Radio | Blog Talk Radio

There is no better way to get the complete history of where we are now and how we got there.
It is 76 minutes long, and worth every minute of it, so plan ahead.

 

[tweazee]

I wonder if the FDA is not really trying to stop ecigs or ejuice, but maybe limit the MG of nic available to the Am public with out a doctor's prescrip.

Nic Patches are available with out for strengts 5mg-22mg.
Gum is available for approx strength 2mg-??

Nic Nasal spray is available but WITH a doctors scrip in .5mg per spray.
A 10mg/ml bottle holds 200 sprays.

 

[Scucci]

Something's weird...

"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."

Under their own guidelines, I don't see any violations. They claim to help you to stop smoking cigarettes. Smoking cigarettes is not a disease, the nicotine addiction is. So... wouldn't the companies have to say "Will cure nicotine addictions" to be violating that rule? Also... are those the same guidelines that let the gum, patch, and pills run through when they have a pathetic success rate?

Annnnndddd....

"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."

Johnson Creek has had their hands out to the FDA for quite a while now. I mean, hell... look at the labels on their bottles for Christ's sake! They've been try'ng to work with the FDA for a while now and the FDA's been, basically, telling them to F-off. NOW the FDA sends them a letter criticizing them for not working with the FDA guidelines?