FDA reply from Public affairs specialist

[ichaya]

OK I finally received an answer from the FDA. Here it is in full. (sorry I do not know how to post this in multi-forums, or make it sticky. Feel free to post this in full to any forums where it applies).

Mr. Dyer:


I apologize for my late response but I was out working in the field all of this week and I am just returning to my office. I had to wait until I heard from someone in the Center of Drugs in order to respond to your question and this is what I received. I hope this helpful!

We are not aware of any ruling. The only thing on FDA’s site is OASIS refusals and import alerts.


Whether a particular product is a drug (or a device) under the Federal Food, Drug, and Cosmetic Act depends on its “intended use.” In making that determination, the agency considers the product's label and labeling, its advertising or promotional materials, and other relevant sources. In order to make a definitive determination of the regulatory status of any product we have to evaluate the relevant information on a case by case basis.

FDA has reviewed several "electronic cigarettes" and determined that those products were making "drug" claims. We have detained and refused several such products on the grounds that they were unapproved new drugs as defined by section 201(p) of the Act (21 U.S.C. § 321(p)) requiring approval of an application filed with FDA in accordance with section 505 of the Act (21 U.S.C. § 355) to be legally marketed in the United States. Additionally, because they were drug-device combinations under 21 U.S.C. 353(g)(1), they were also adulterated devices.

We will continue to review these products on a case by case basis.

Anitra
Public Affairs Specialist;
CER\Philadelphia District
215-717-3004
anitra.brownreed@fda.hhs.gov​

Quote:
Originally Posted by ichaya
OK, I am tired of all of the running in circles, with people screaming that the sky is falling!

I looked around on the FDA website, and could not find any information about a decision.

So I have written an e-mail to a Field Public Affairs Specialists for the FDA.

Specificaly here is what I sent:

I am writing in order to find out, from a definitive source, a question that many people are asking.

It is my understanding that the FDA is reviewing a product referred to as an "Electronic Cigarette".
I had heard that a decision was to made on this on 5/5/9,
I have been searching the FDA website, and I am having great difficulty in finding any information on this.

Would it be possible for you to provide a definite answer?
I am primarily concerned about the legality of the following:
The ownership of this product
The use of this product
The importation of electronic cigarettes
The importation of the "E-Liquid" that is used in this product
The sales of this product, both within Pennsylvania, and across state lines.

If there is a ruling on this a link to the ruling would be very helpful, and I will post it to several forums that relate to this topic.


Thank you very much for your time in this matter.


I will post any and all information (provided they actually reply).

Hopefully that will clear it up.

 

[IntoxiNation]

FDA has reviewed several "electronic cigarettes" and determined that those products were making "drug" claims. We have detained and refused several such products on the grounds that they were unapproved new drugs as defined by section 201(p) of the Act (21 U.S.C. § 321(p)) requiring approval of an application filed with FDA in accordance with section 505 of the Act (21 U.S.C. § 355) to be legally marketed in the United States. Additionally, because they were drug-device combinations under 21 U.S.C. 353(g)(1), they were also adulterated devices.

Hmmm but Cheerios makes the same claim and they can still be sold? That seems rather curious.

 

[Boston George]

Cheerios arent imported.

 

[robw]

Ive been saying the same thing for months. It is all in the packaging and the claims made.

If the electronic cigarette companies would just say nothing about being healthy or better etc. and just say this is a personal fog machine that contains natural nicotine, PG and artificial flavor. Then the FDA would not be able to stop it.

 

[LaceyUnderall]

I am with Rob on this one (always have).

This response though is more clear than the other letters though in that she clearly states: "FDA has reviewed several "electronic cigarettes" and determined that those products were making "drug" claims."

 

[fsu1dolfan]

I am with Rob on this one (always have).

This response though is more clear than the other letters though in that she clearly states: "FDA has reviewed several "electronic cigarettes" and determined that those products were making "drug" claims."

Yup but that sad thing is that you have to balance claiming nothing which we want in order to have them available....and what the ecigs companies want which is to sell products....so if one says it helps you quit then the next says it helps you quit and is better for your health and so on and so forth in order to entice buyers through advertising....getting them all the stop seems impossible but would be the desired approach...otherwise it will be banned eventually.

 

[LuckySevens4U]

When I get stuff from best ecig it just says personal vaporizer on it value $10 and I have no problems.

 

[OutWest]

another part of it - if there's a problem with labeling on an imported item, youre supposed to be allowed to rectify the situation. At least, that's my understanding and is what i've read on govt sites and what i've been told by import brokers. For the ecig stuff theyre stopping, though, theyre not giving people that opportunity. Heck, I've heard reports of shipments of batteries being blocked, shipments of empty cartridges being blocked, etc. Not to mention times theyve failed to issue a detention notice for held shipments.

 

[LaceyUnderall]

Yup but that sad thing is that you have to balance claiming nothing which we want in order to have them available....and what the ecigs companies want which is to sell products....so if one says it helps you quit then the next says it helps you quit and is better for your health and so on and so forth in order to entice buyers through advertising....getting them all the stop seems impossible but would be the desired approach...otherwise it will be banned eventually.

And that is why there needs to be some regulation... not necessarily government regulation. What we can do through the ECA is tell the FDA hey... we will regulate ourselves. Supplier members of the ECA will uphold certain safety standards as well as marketing claims.

Yes... it is sad that there are some really bad apple ecig suppliers who have made these claims. Unfortunately, that happens with everything (kind of like that kid in class who constantly acts up so the whole class has to sit inside for recess.) What boggles me is that those suppliers making those claims simply do not have to make claims as the ecig... sells itself! Smokers, although made out to be very stupid, are actually quite smart and are obviously looking for something else, or they wouldn't have been search for smoking alternatives or smokeless cigarettes or electric lighters! (all terms that others have noted they were searching for when they found the ecig)

Now, is it a shame that even the NRT's on the market now are restricted in their claims and can't say that their products are safer than tobacco? I think so. I would like to see the pharmaceuticals restrictions lifted a bit... but that is an entirely different battle.

 

[LaceyUnderall]

another part of it - if there's a problem with labeling on an imported item, youre supposed to be allowed to rectify the situation. At least, that's my understanding and is what i've read on govt sites and what i've been told by import brokers. For the ecig stuff theyre stopping, though, theyre not giving people that opportunity. Heck, I've heard reports of shipments of batteries being blocked, shipments of empty cartridges being blocked, etc. Not to mention times theyve failed to issue a detention notice for held shipments.

Well... and we can't forget that right now the FDA is leaderless AND Sharfstein (sp) who is slated to take over, used to work in Waxman's office and helped to write the Waxman bill. There are several levels working against us here. (Still not the end of the world.)

Oh... and Outie did you see... the Kennedy bill is up now: Search Results - THOMAS (Library of Congress)

 

[OutWest]

Well... and we can't forget that right now the FDA is leaderless AND Sharfstein (sp) who is slated to take over, used to work in Waxman's office and helped to write the Waxman bill. There are several levels working against us here. (Still not the end of the world.)

Oh... and Outie did you see... the Kennedy bill is up now: Search Results - THOMAS (Library of Congress)

no i hadnt, thank you. Will give it a good reading. At first glance, this tidbit looks a little bit promising Search Results - THOMAS (Library of Congress)

 

[LaceyUnderall]

no i hadnt, thank you. Will give it a good reading. At first glance, this tidbit looks a little bit promising Search Results - THOMAS (Library of Congress)

My understanding is that it is 90%+ the Waxman bill... but I am just starting to read it now... so we shall see. There are apparently some good provisions in there that might apply to us.

 

[IntoxiNation]

The best place to follow the status of this bill is here:

S. 982: Family Smoking Prevention and Tobacco Control Act (GovTrack.us)

That's where all the non-governmental sites that track this stuff pulls their data from.

 

[TropicalBob]

Lacey, you don't have to get far beyond definitions of "adulterated" and "misbranded" to get an idea of the impossible task e-cigs face. Is there any e-product anywhere that can meet the legal requirements to avoid those two definitions and subsequent removal from the market order?

The bill also makes smaller companies like Star Scientific, maker of my dissolvables, throw up its arms and sell out.

If you have a yellow marker, see how many paragraphs are a death knell. After awhile, I stopped counting.

 

[LaceyUnderall]

Lacey, you don't have to get far beyond definitions of "adulterated" and "misbranded" to get an idea of the impossible task e-cigs face. Is there any e-product anywhere that can meet the legal requirements to avoid those two definitions and subsequent removal from the market order?

The bill also makes smaller companies like Star Scientific, maker of my dissolvables, throw up its arms and sell out.

If you have a yellow marker, see how many paragraphs are a death knell. After awhile, I stopped counting.

This whole thing makes me want to puke. On so many different levels... wipe away the issue of ecig and blah... I still want to puke.

But... you know me... nothing is impossible. (I added the rolleyes so you didn't have too!)

 

[TropicalBob]

Me, too. I'm really, really hard hit if this becomes unamended law.

But .. and this is a big one .. it all pertains to tobacco products. The FDA claims it has sufficient authority over drugs and drug delivery devices, which is what it says e-cigs are. By definitions in this bill, we are NOT a tobacco product.

So how do we want that SE lawsuit to end up? If we're tobacco, we are doomed, doomed, doomed. If we're not, we're a drug product and still await the FDA decision. Me? We're a drug product. Get to work on your studies, liquid makers.

This is the only section that directly applies to e-smoking. We're an "innovative product".

‘(b) Report on Innovative Products-

‘(1) IN GENERAL- Not later than 3 years after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, the Secretary, after consultation with recognized scientific, medical, and public health experts (including both Federal agencies and nongovernmental entities, the Institute of Medicine of the National Academy of Sciences, and the Society for Research on Nicotine and Tobacco), shall submit to the Congress a report that examines how best to regulate, promote, and encourage the development of innovative products and treatments (including nicotine-based and non-nicotine-based products and treatments) to better achieve, in a manner that best protects and promotes the public health--

‘(A) total abstinence from tobacco use;

‘(B) reductions in consumption of tobacco; and

‘(C) reductions in the harm associated with continued tobacco use.

And .. just for the record .. in the looooong list of reasons why this law is necessary, this is the number one, top reason:

SEC. 2. FINDINGS.

The Congress finds the following:

(1) The use of tobacco products by the Nation’s children is a pediatric disease of considerable proportions that results in new generations of tobacco-dependent children and adults.

Number ONE. It's all about the children, folks. It's all about "not one more generation hooked on nicotine". No small matter, eh, as it was belittled here in some threads.

 

[Vicks Vap-oh-Yeah]

Number ONE. It's all about the children, folks. It's all about "not one more generation hooked on nicotine". No small matter, eh, as it was belittled here in some threads.

That's a tall order, as long as tobacco products remain on the market.... and they will, for the revenue streams alone.

In fact, I'd say their goal is unobtainable and a pipe dream.....

Not belittling, not an aggressive, and I'm not mocking.....as long as tobacco remains a substance that you can purchase, there will be new generations of people hooked on them....period. That's human nature.

 

[Glock]

Hmmm but Cheerios makes the same claim and they can still be sold? That seems rather curious.

Perhaps you missed this thread:
http://www.e-cigarette-forum.com/forum/e-cigarette-news/16902-fda-finally-acts.html

 

[TropicalBob]

You're right, Vicks. Prohibition won't work. For an article I wrote, I did a short history of tobacco. There have been countries where smokers had their hands cut off, their tongues cut out, etc., yet still smoking by others continued.

Tobacco's use, form and popularity has risen and fallen over many years. We're hitting another low point, where villagers carrying torches are stampeding streets to root out Demon Nicotine.

Unfortunately, I'm living in this down time! It's painful.

The Kennedy bill is horrendous in its requirements and ramifications. I got a headache just reading it ....

 

[IntoxiNation]

Perhaps you missed this thread:
http://www.e-cigarette-forum.com/forum/e-cigarette-news/16902-fda-finally-acts.html

I saw that thread (and the few others about the same thing) and was my point exactly. The FDA has said Cheerios is "making 'drug' claims" exactly like they are saying about E-Cigs. Yet Cheerios is still on the market and selling. They were given a moratorium and time to correct their labeling. I don't remember seeing at any point in time where the FDA contacted a supplier and said "hey you really need to change your labeling, and if its not done by this date then your in trouble". Instead they just blocked the shipments. Now that's a pretty big double standard.

And actually it really this seems to go into the claim SE has made in their lawsuit against the FDA and not being given time to adhere (or whatever it was called). In other words, it seems the FDA gave SE an awesome piece of evidence on the very week they go to court.