Just got this from the FDA

[Docliv]

DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
Silver Spring, MD 20993

March 31, 2011

Docliv
North Las Vegas, NV

Dear Mr. Docliv:

Thank you for your correspondence to Senator Harry Reid. regarding the status of electronic cigarettes (e-cigarettes). Senator Reid requested that we respond directly to you.

The regulatory status of e-cigarettes has been the subject of recent litigation. In 2009, two e-cigarette distributors filed suit against the Food and Drug Administration (FDA or the Agency) seeking declaratory relief that FDA lacked jurisdiction to regulate their products as drug-device combination's under the Federal Food. Drug, and Cosmetic Act (FD&C Act or the Act), and an injunction preventing FDA from detaining and refusing importation of their products. On January 14. 2010. the district court granted the e-cigarette distributors' motions. FDA appealed and successfully moved to stay the injunction pending appeal.

On December 7. 2010. the U.S. Court of Appeals for the D.C. Circuit ruled that e-cigarettes and other products made or derived from tobacco are "tobacco products" under the Act and are not drugs/devices unless they arc marketed for therapeutic purposes (Sotterra, Inc. v. FDA, 627 F.3d 891 (D.C. Cir. 2010)). On December 15. 2010. the U.S. Court of Appeals for the D.C. Circuit dissolved its earlier stay of the district court's decision. Thus, the district court's injunction, with respect to e-cigarettes imported by these these firms, is currently in effect.

On December 20. 2010. FDA requested a rehearing with the U.S. Court of Appeals and requested that the court reinstate its stay of the district courts Injunction while the request for rehearing was as pending. On January 24. 2011, the Court denied these requests.

The Agency is currently considering its legal and regulatory options. However, in the interim, FDA is in full compliance with the D.C. Circuits December 7, 2010, decision regarding e-cigarettes. FDA field offices have been advised to release any detained e-cigarette shipments whose label or labeling does not include therapeutic claims.

I thank you for contacting us concerning this matter If we can be of further assistance, please let us know.

Sincerely,

Elane Vinnez for Karen Meister



PS from Docliv:
This was an actual snail mail. Does this mean that everyone got their shipments back and they are no longer seizing shipments? Anyone?

 

[tybin]

sounds like it's a step in the right direction...for now at least

 

[Cassie]

Wow, yes it does. =) baby steps are still steps.

 

[rothenbj]

"On December 15. 2010. the U.S. Court of Appeals for the D.C. Circuit dissolved its earlier stay of the district court's decision. Thus, the district court's injunction, vvith respect to e-cigarettes imported by these these firms, is currently in effect."

That only says they are not holding up importation for the named two c-cigarette distributors.

 

[Vocalek]

I guess Margaret H. and Kathleen S. decided that going to jail on Contempt charges wasn't really how they wanted to spend the next several months.

 

[dput]

I placed an order recently of both starter kits and liquids. Received it without any problems at all.

 

[Docliv]

"FDA field offices have been advised to release any detained e-cigarette shipments whose label or labeling does not include therapeutic claims."

This sounds like it includes all importers as it uses the word "any". I can't imagine any supplier having "smoking cure" or some such language actually on their products or customs declaration. It looks to me as though the battle is over... for now. Please, all China e-cig importers, let us know if this is real as you are the only ones who will know. Thanks!

 

[mwa102464]

Would this letter not suffice to have any shipments the FDA currently has customs holding to be released ?

 

[tybin]

IF this is true, I'd say it is mainly happening because vaperites started bugging their representatives Power to the People

 

[Steef]

Remember when Burgers tasted better before the FDA got involved???? If they would just look the other way(IMO)

Good Vapes~~~~~~

Steef

 

[daisyd]

I HOPE this is true because I have avoided ordering from China like the plague because I can't afford to buy small amounts with such high shipping, and I really can't afford to have THAT much stuff seized by customs. *fingers crossed*

 

[Izatech]

"therapeutic claims"......... these 2 words are the real crux of the argument. Ask an attorney how many possible definitions could be covered by those 2 words. A claim of, healthier alternative to smoking", is a "therapeutic claim". Pretty much any verbiage making a comparison to tobacco could be argued as one.
How to market the product without mentioning ANY benefit of helping get people off tobacco cigarettes is what we should be looking at. I think the moniker, 'E-Cigarette', is an unfortunate part of the problem. 'Personal Vaporizer', is a much less alarming term.

 

[Vocalek]

"therapeutic claims"......... these 2 words are the real crux of the argument. Ask an attorney how many possible definitions could be covered by those 2 words. A claim of, healthier alternative to smoking", is a "therapeutic claim". Pretty much any verbiage making a comparison to tobacco could be argued as one.
How to market the product without mentioning ANY benefit of helping get people off tobacco cigarettes is what we should be looking at. I think the moniker, 'E-Cigarette', is an unfortunate part of the problem. 'Personal Vaporizer', is a much less alarming term.

Actually, Judge Leon's opinion document gives some examples of what the FDA considered a therapeutic claim that the judge says are not. The main thing that needs to be avoided is any wording suggesting that the product can prevent, treat, or mitigate any disease. The FDA considers "smoking" a disease. So instead of saying, the product can help people to stop smoking, the vendor would need to say that the product is an enjoyable alternative to smoking or a substitute for smoking.

The judge pointed out that a testimonial letter from a customer stating that his/her health has improved since using the product does not count as a health claim on the part of the vendor.

Vendors would need to check with their company attorney, but I believe that if you have lab tests that verify your statements you can truthfully state that your product does not contain X, Y, or Z. Just don't add a comment about how much healthier you will be without X, Y, or Z. But you could get away with saying, "Testing shows that this product does not expose the user to the harmful effects of X, Y, or Z." Notice that you have not claimed your product is healthier, but it's an obvious conclusion that the reader can draw based on the absence of the harmful stuff.

 

[JustJulie]

Popping in to share some documents filed today by FDA (in the NJOY v. FDA case) talking about this very issue.

 

[fuzznut]

The FDA considers "smoking" a disease.

This is the pivot phrase which allows the FDA to lay claim to "therapeutic statement control". I still don't get it. A DISEASE?!! I tried looking up the "disease of smoking", but all I could find were smoking *related* diseases. Smoking is an action. Like drinking coffee. Or stuffing your face with doughnuts. Are those actions diseases too? If by definition smoking is a disease, then what that people do in everyday life is NOT a disease?

 

[CJsKee]

I know...it just defies all rational thought, doesn't it?

This is the pivot phrase which allows the FDA to lay claim to "therapeutic statement control". I still don't get it. A DISEASE?!! I tried looking up the "disease of smoking", but all I could find were smoking *related* diseases. Smoking is an action. Like drinking coffee. Or stuffing your face with doughnuts. Are those actions diseases too? If by definition smoking is a disease, then what that people do in everyday life is NOT a disease?

 

[Vocalek]

About a year ago, I asked the same question. I believe it was Yvilla who pointed me to an obscure FDA regulation wherein the Agency defines smoking as a disease. I do know that in 1995 FDA head David Kessler gave a speech in which he stated that Smoking is a Pediatric Disease.

 

[BCB]

A Pediatric Disease???????? WTF?

 

[Rosco]

About a year ago, I asked the same question. I believe it was Yvilla who pointed me to an obscure FDA regulation wherein the Agency defines smoking as a disease. I do know that in 1995 FDA head David Kessler gave a speech in which he stated that Smoking is a Pediatric Disease.

that's how "pediatric" brains work.....

 

[house mouse]

About a year ago, I asked the same question. I believe it was Yvilla who pointed me to an obscure FDA regulation wherein the Agency defines smoking as a disease. I do know that in 1995 FDA head David Kessler gave a speech in which he stated that Smoking is a Pediatric Disease.

Hmm.....So if the FDA is saying that smoking is a disease then aren't they implying that smokers have a disability? And by extension, aren't all these anti groups going after disabled folks? Just saying.