YFI FDA offical reply

[ichaya]

OK I finally received an answer from the FDA. Here it is in full.

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.

[bri1270]

Very interesting. On a case by case basis...More about marketing than I thought it would be. I'm curious as to why they're holding things up from V4L and other then...

[EDO]

The problem was a lot of the ecig retailers were promoting these to be a safe way to quite smoking or that these things are healthier than smoking etc. Some of the marketing would have you believe that ecigs are completely safe. When a major manufacturer is called Health....and on the box you see Health ecigs...the FDA considers this false marketing unless it can be backed up by research. If ecigs were sold with no marketing or claims....FDA wouldn't be involved. Because of the few of the larger suppliers were marketing these things real hard and making unsubstantiated claims ...I think they messed it up for everyone.

[KoS]

Just like the Cheerieos thing. If you claim it will cure anything the FDA will slap your hands. All sellers need to promote these as a herbal novelty and pull all claims to anything about health from there site. This has been said SOOO many times

[pwholmes]

FDA's comments:

Whether a particular product is a drug (or a device) under the Federal Food, Drug, and Cosmetic Act depends on its “intended use.”

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.

This is all bureaucratise to me. It's a very generalized statement that gives us no specifics about what some of these claims were. What are "drug" claims. And what are drug-device combinations? Anything sold with nicotine?

It makes me feel like we're getting a smokescreen, an excuse to slowly ferret out any shipments of e-cigs and deny them, which gets back to the politics, St. Lautenberg, Big Tobacco, Pharma, etc. putting pressure down and this is the "reasonable" explanation they give without really explaining anything.

Paul

[ichaya]

I would tend to agree with this.

I mean what does the FDA consider a "drug"?

They have definitions for over the counter, prescription, veterinary, etc.

I find it interesting that the FDA DOES NOT regulate tobacco, that falls to ATF.

BUT, they DO regulate nicotine, and cotinine (Yeah there is a whole chemical question there that I will not go into. The info is available on the web if you are curious) as laboratory test chemicals.

Anyone else begining to see how convoluted this really is?

Or does merely mentioning that a product has "possible health benefits" mean that it can be considered a drug? {Hello cheerios}

Originally Posted by pwholmes

FDA's comments:



This is all bureaucratise to me. It's a very generalized statement that gives us no specifics about what some of these claims were. What are "drug" claims. And what are drug-device combinations? Anything sold with nicotine?

It makes me feel like we're getting a smokescreen, an excuse to slowly ferret out any shipments of e-cigs and deny them, which gets back to the politics, St. Lautenberg, Big Tobacco, Pharma, etc. putting pressure down and this is the "reasonable" explanation they give without really explaining anything.

Paul

[OutWest]

NJoy hasnt made any health claims nor any stop smoking claims. Even their ecig manuals are devoid of such things, yet they've had stuff stopped as well.

I agree with PWHolmes, I think it's more about the political pressure than anything.

[nicowolf]

Here is my take on the whole thing.

Drug-device combination means nicotine combined with a device. We need to keep the device separate from the liquid. A starter kit should come with blank carts, no nic carts, or no carts at all. Right now our retail packaging contains nicotine cartridges along with a device to use those cartridges. I am unsure of how far the FDA would take that (i.e., devices and drug and different cases, or different shipments all together).

I think the website owner himself should not make any claims at all. He/she should say we stock all parts and accessories for these amazing little devices. If you want to learn more about them read our customer reviews. The customers reviews can contain all sorts of anecdotal information about how it helped them to quit or cut back, about how much better they feel, about all the benefits. The words written by the site owner or administrator or webmaster (basically, the official company words) should not contain any claims about health, only how well the device performs, reliability, value, etc. This takes the liability for such claims away from the supplier.

We as a community need to find some other things that can legally be vaporized in our devices. We also need to look into BigPharma's nicotine. Can it be bought and turned into e-liquid by a manufacturer? Can the process be replicated cost-effectively by a manufacturer? We also need to come out of the vaping closet so to speak. We need to unabashedly use our vaporizers in public and answer questions from strangers and educate the public so that more and more people know about them, use them, and advocate them. We have no advocates right now because we are keeping it all under wraps but under their noses.

[Flitzanu]

as for them calling it a "drug" there was another post about this.

i'm summarizing, so don't "quote" this, but their definition of it being a drug was that it is designed to alter the body's basic chemical functions.

i'll have to see if i can find that post, with all teh FDA ones there's no telling

[bri1270]

i'm summarizing, so don't "quote" this, but their definition of it being a drug was that it is designed to alter the body's basic chemical functions.

I saw that too...so Nicotine in cigarettes must be different...