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

[Vocalek]

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.

If the situation at Johnson Creek is so dangerous, why did the FDA wait an entire year to notify Johnson Creek that they were out of compliance? It would appear that the situaiton didn't seriously concern the FDA.

 

[extolrox]

I believe we should be having a protest right now..... It is just me I guess but we should be getting info of who the judge is that is over the case. We should be shouting at our governors and state officials about this and making the case that when we say quit smoking we don't mean quit nicotine we are in competition with tobacco companies not pharmaceutical companies. We must make it known quickly please vendors and consumers contact your state government and the media with the statement " The FDA violates U.S. District Court Judge Richard J. Leon's ruling and continues to see the electronic cigarette as a drug device." We must explain to them that it is not intended to cure nicotine addiction but to deliver it in a different way than combustible tobacco cigarettes. The FDA is claiming it is a medicine which it is not and we do provide that information.

 

[Infernal2]

I just sent this letter to my representatives. I have tried to carefully reword it to focus on his sensibilities (he's Conservative).

Mr. ****,

My name is **** and I and my family live in ****. I'd like to bring your attention to an act of gross negligence with regards to an individual's right to choose. The Federal Food and Drug Administration has in the near past attempted to circumvent their own powers by regulating the cottage industry of electronic cigarettes.

While I am fully aware of the harm that tobacco can cause to individuals there are viable choices in the marketplace for those choosing to pursue nicotine addiction. Items like chewing tobacco, snuff, and even cigars are available that provide similar effects to standard cigarettes. However, in the case of the e-cigarette industry the FDA is attempting to classify these electronic devices as drug delivery systems in what seems to be an attempt to rework their own regulation to suit their own paradigm. I would urge that this viable choice be approached as a tobacco product rather than as a 'drug delivery device.'

I see in this an attempt by an overzealous Federal agency an attempt legislate through their own clever manipulation a viable choice from the hands of the private citizen. I see it as attempt by the same organization to punish the entrepreneur who provided a novel approach to an older industry. It saddens me to think that that the individual and the entrepreneur stand to be swept aside by the force of an overzealous Federal agency who has overstepped the bounds of their own laws.

Sir, I appreciate your time and realize that you may not be a smoker. I realize that you may not even appreciate smoking but I urge you to view this not as an issue of personal choice but an issue of the choice of man to decide his own fate. I have provided below an informational web address to CASAA, the Consumer Advocates For Smoke-Free Alternatives Association and urge you to review their materials and decide for yourself.

Regards,

 

[Bustastew]

United States District Judge Richard J. Leon

I loved this quote.

"I am not convinced that the threat to the public interest in general or to third parties in
particular is as great as FDA suggests. Together, both Smoking Everywhere and NJOY
have already sold hundreds of thousands of electronic cigarettes, yet FDA cites no
evidence that those electronic cigarettes have endangered anyone.

 

[Optimal]

Re-reading the FDA letters, all they seem to be asking the companies to do at the moment is address the cessation claims made:

"As described in 21 C.F.R. § 310.544, any product that bears labeling claims that it 'helps stop or reduce the cigarette urge,´ 'helps stop or reduce smoking,´ or similar claims is a smoking deterrent drug product."

Their reasoning in the letters seems to be:

- If the supplier makes (or uses) a smoking cessation claim then this makes the product a drug.

- If the product is a drug then it is a new drug.

- If the product is a new drug then approval is required.

There is nothing in the letter suggesting that removal of the cessation claims would address the violations cited, but it seems a reasonable interpretation. Looks like they're simply following the ruling that e-cigs be regulated under tobbaco law unless medical claims are made.

I don't think this means they consider e-cigs to be non-medical if no claims are made, just that for the time being they are enforcing the regulations that they can.

 

[Bustastew]

I just sent this letter to my representatives. I have tried to carefully reword it to focus on his sensibilities (he's Conservative).

Outstanding letter Infernal2!

 

[Vocalek]

Re-reading the FDA letters, all they seem to be asking the companies to do at the moment is address the cessation claims made:

"As described in 21 C.F.R. § 310.544, any product that bears labeling claims that it 'helps stop or reduce the cigarette urge,´ 'helps stop or reduce smoking,´ or similar claims is a smoking deterrent drug product."

Their reasoning in the letters seems to be:

- If the supplier makes (or uses) a smoking cessation claim then this makes the product a drug.

- If the product is a drug then it is a new drug.

- If the product is a new drug then approval is required.

There is nothing in the letter suggesting that removal of the cessation claims would address the violations cited, but it seems a reasonable interpretation. Looks like they're simply following the ruling that e-cigs be regulated under tobbaco law unless medical claims are made.

I don't think this means they consider e-cigs to be non-medical if no claims are made, just that for the time being they are enforcing the regulations that they can.

If you read the letters carefully, you see that they are really stretching the idea of "therapeutic claims". Example:“The RAPP E-Mystick is designed for adult smokers who want the look, feel and experience of a cigarette.”

What's next for the FDA to (mis)interpret as a therapeutic claim? "Battery-operated"? "Technology-based"?

In fact, the Ruyanamerica.com site was so innocuous that FDA was forced to throw in an evaluation of two other Ruyan-related web sites that are totally outside the control of Ruyan America.

The Johnson Creek site was so free of health claims that the FDA had to resort to criticizing the inclusion on the site of news articles and letters from customers.

Judge Leon was very specific in pointing out that customer testimonials cannot be used to determine the intended use of the product by the manufacturer.

And in the Gamucci letter:

"Your website offers these products as an aid to help smokers quit smoking: " Yes?

As soon as "smoking" is listed in the diagnostic code books as a disease, then FDA can complain that "help smokers quit smoking" is a therapeutic claim. The FDA's so-called "smoking cessation" treatments are in actual fact "nicotine cessation" treatments, as the disease being treated by those products is not smoking, but rather nicotine addiction.