It's All in the Timing, But WHEN?

[Hangar]

I'm curious to know if there are any of you who might be somewhat familiar with the official process the FDA typically takes before implementing a U.S. ban?

Where exactly (how far along) IS the process right now, do we know?...and how soon are we likely to see it officially announced and enforced?

...just trying to get an idea if we are within days/weeks...or is more than likely months??

anyone know for sure?

 

[Ramblin]

We are kind of in uncharted territory here. President Barack Obama just fired the CEO of GM. Who is to stop him? Who is to stop the FDA from making the possession of PVD's and nicotine juice a federal crime?

 

[WillPower]

I'm curious to know if there are any of you who might be somewhat familiar with the official process the FDA typically takes before implementing a U.S. ban?

Where exactly (how far along) IS the process right now, do we know?...and how soon are we likely to see it officially announced and enforced?

...just trying to get an idea if we are within days/weeks...or is more than likely months??

anyone know for sure?

The idea that FDA is going to "ban" e-cig is actually a misnomer or misconception. They don't need to ban e-cig nor give any hearing. Marketing e-cig is in violation of the Food, Drug, and Cosmetic Act Section 505 (21 USC 355), which prohibits any induction of new drug without the FDA approval.

Some people claim that nicotine is not a new drug. This might be true in logical reasoning (for some people), but not legally. The legal interpretation would be, although I am not a lawyer, that this "new" method of delivery makes e-cig a new drug. Nicotine added to chewing gum (Nicorette), water (NicLite), and lozenges (Habitrol) were all considered as a new drug.

Perhaps, more important than the nicotine content is the marketing claim. Understandably, most vendors claim that their personal vaporizers are nicotine replacement therapy (NRT) or smoking cessation product. If they didn't, their sales wouldn't grow as no way nearly as fast.

So, the right question might be not when are they going to ban (e-cigs are already banned in essence). but when they are going to enforce this already existing violation.

But, there is a good news. Personal vaporizer with 0-nic e-liquid and sold without any medical claim is not covered by Section 505! So, I might suggest that people write to their suppliers than writing to Congress. Ask them to set up 0-nic web store.

After the ban, if you want nic fix, you can use Nicorette or Habitrol along with 0-nic vaping. Or if you really want the nic in the vapor, I think if you submerge Nicorette in Propylene Gylcol and repeatly apply pressure, you would end up with nic e-liquid. I personally have not tried this. But it seems cost-effective and relative safer (than others) method of getting nic e-liquid under the "ban," about 10 cents /mg. Perfectly legal--if anyone knows this violates any specific laws, let me know.

 

[Hangar]

ahh, thank you for that explanation...I understand a little better now.

You said the law states its already illegal to "market/sell" the product...but what does the law say about posession and/or usage of a new drug as far as the end user is concerned?...can we get in trouble for using this device out on the streets?...or is the law strictly about selling/importing?

 

[WillPower]

ahh, thank you for that explanation...I understand a little better now.

You said the law states its already illegal to "market/sell" the product...but what does the law say about posession and/or usage of a new drug as far as the end user is concerned?...can we get in trouble for using this device out on the streets?...or is the law strictly about selling/importing?

Well.. It all depends on what you put in the device.. There are many substances that you can get in trouble for, no matter how you carry them.

Seriously, I assume you are talking about nicotine suspended in propylene glycol in low concentration (i.e. e-liquid). Most people are thinking about DEA agents busting down their door. DEA enforces the Controlled Sustances Act which defines controlled substances in Schedules 1-5. Last time I checked, nicotine is not on the list for any of schedules 1-5. There is Schedule 6, which defined state-by-state. I doubt any of them would include nicotine.

Let's say you carry 10ml of 18mg e-liquid, which I don't see why you want to carry that much liquid on the street. That's only 180 mg. 100 pack of 4mg Nicorette contains about 400mg, which you can buy at Sam's Club and carry home, chewing one.

If you carry 10 pounds of undiluted pure nicotine, that's entirely different matter. But, not as Controlled Substances Act or Food, Drug, and Cosmetic Act. It would be laws regarding transportation of hazardous material and terrorism. Pure nicotine is very very dangerous. It is absorbed through skin. Lethal dose is about 70mg.

There are other laws involved in controlled substances, like .... Precursor Act. I don't know any of them classifies nicotine as controlled substances.

Of course, if you are using and SELLING on the street, then you would be in the same boat with other online vendors.

Once again, not dispensing any legal advice. If anyone knows any specific legal provisions that dispute my interpretation, let me know.

 

[yvilla]

The idea that FDA is going to "ban" e-cig is actually a misnomer or misconception. They don't need to ban e-cig nor give any hearing. Marketing e-cig is in violation of the Food, Drug, and Cosmetic Act Section 505 (21 USC 355), which prohibits any induction of new drug without the FDA approval.

Some people claim that nicotine is not a new drug. This might be true in logical reasoning (for some people), but not legally. The legal interpretation would be, although I am not a lawyer, that this "new" method of delivery makes e-cig a new drug.

***

Perhaps, more important than the nicotine content is the marketing claim. Understandably, most vendors claim that their personal vaporizers are nicotine replacement therapy (NRT) or smoking cessation product. If they didn't, their sales wouldn't grow as no way nearly as fast.

So, the right question might be not when are they going to ban (e-cigs are already banned in essence). but when they are going to enforce this already existing violation.

I disagree that it is as entirely cut and dry as you suggest.

It is simply an argument at this point that any ecig containing nicotine is a "new drug" subject to FDA regulation, and that therefore marketing them is "already" a violation.

It is quite possible that only ecigs marketed as smoking cessation devices or as NRT or with health claims will end up being deemed in violation of the Food, Drug and Cosmetic Act.

For as some FDA spokespersons themselves have said, both in writing and to reporters, "the determination of whether an e-cig is a drug is made on a case-by-case basis after the agency considers its intended use, labeling and advertising."

Here, from a news article:

"In the US, the Food and Drug Administration has "detained and refused" several brands of electronic cigarettes because they were considered unapproved new drugs and could not be legally marketed in the country, said press officer Christopher Kelly. He did not give more details, but said the determination of whether an e-cig is a drug is made on a case-by-case basis after the agency considers its intended use, labeling and advertising."

http://www.news24.com/News24/Technol...477587,00.html

And here, in a letter to a member of this forum:

Thank you for your comments to the Division of Drug Information in Center for Drug Evaluation and Research at the Food and Drug Administration.

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.

If, after reviewing this information, you have any unanswered questions, please contact the Division of Drug Information by phone (1-888-463-6332) or e-mail (druginfo@cder.fda.gov). Thank you again for your message.

Division of Drug Information
Center of Drug Evaluation and Research
Food and Drug Administration

Thus, it is entirely possible that only those marketing ecigs with health claims or as NRT/smoking cessation devices will find themselves with problems when the FDA decides to do enforcement actions.

And it is also entirely possible that even if the FDA does decide to attempt enforcement of a claim that all ecigs are subject to it's jurisdiction, there will need to be a court determination as to whether ecigs not marketed with health claims or as NRT do, in fact, constitute a "new drug" or "drug delivery device". Because it can certainly be argued that they do not, and I have no doubt that players like NJOY and other big sellers here in the US have their attorneys right on top of this issue.

 

[TropicalBob]

Does anyone really think the FDA will issue a specific ban on specific products, while allowing others?

Or will it ban all e-cigs and e-liquid and then tell wannabe sellers to submit proper applications from which a case-by-case determination of legality will be made?

 

[OutWest]

well, they (the FDA) have been known to ban vitamins from specific manufacturers because they made health claims. Same with colon cleansers. So, it is possible, imho, that they'd ban ecigs from certain vendors while allowing others.

 

[Hangar]

well so far it seems they're only following the first, but everyone suspects and fears the latter. I agree it's not so cut and dry or else you wouldnt see some of these U.S. based companies investing as much as they have in it, nor the shopping mall management allowing kiosks which also leaves them open for huge law suits if anyone should get hurt or sick from these devices. I agree with Bob...there is a big grey area legally speaking right now.

I was reading where someone posted that said something to the effect that if these e-cigs were marketed as cigarettes they wouldnt fall under anybody's jurisdiction as cigarettes arent a new drug, yet they wouldnt actually contain tobacco so they wouldnt fall under AFT jurisdiction either. This sounds like another grey area as well...however it seems interesting and almost ridiculous to me why the exact wording of advertising should dictate US health policy of a product.

In any event, id still like to know what sort of time frame of when more FDA decisions in this matter might become a bit more crystalized.

 

[WillPower]

I disagree that it is as entirely cut and dry as you suggest.

It is simply an argument at this point that any ecig containing nicotine is a "new drug" subject to FDA regulation, and that therefore marketing them is "already" a violation.

It is quite possible that only ecigs marketed as smoking cessation devices or as NRT or with health claims will end up being deemed in violation of the Food, Drug and Cosmetic Act.

yvilla, I agree with you. I don't think it is that cut-and-dry at all. But it is the vendors that make this so cut-and-dry. I posted several times that we should petition, not to the lawmakers and FDA, but to vendors, asking them to take off their NRT claim (or setup a separate storefront for 0-nic vaping customers).

A good example is: when the NicLite (nicotine water) was taken off the market, you could still buy low concentration nicotine suspended in USP grade water from chemical supply company without any restriction. The same thing sold in a different way.

Some vendors are already doing this, like puresmoker--refering e-cigs as personal vaporizer, no claim of NRT, etc.

But, I understand that it is a real catch-22 for vendors. If they don't market e-cigs as NRT, it would work very well in mass-marketing. I, myself, wouldn't have bought them initially at least, if they weren't marketed as NRT.

On the flip side, it is a real problem for FDA as well. If they are claiming medical benefits, they cannot NOT regulate them (such as applying section 505).

Don't get me started on the problem with e-cig patent in all this. In short, it won't make any sense for people who do not have the patent to get FDA approval, even if they could. The patented product, and the marketing thereof, define the "drug" to be approved or taken off the market.

Personally, the best possible route for us is to keep the devices legal. After all, delivery systems such as chewing gum, lozenges, pathes, and bottled water were never taken off the market while Nicorette, Habitrol, etc were. They had a legitimate alternate use, in our case, 0-nic vaping, aromatherapy, etc.

There are many ways to safely and cost-effectively extract or obtain nicotine or add nicotine to PG. Also, a completely unrelated note, I am working on a new chemical formula for shoe polish. Oddly it is nicotine suspended in PG at 36mg/ml density. It makes a great shoe polish.

My 1 ml of PG (2 cents)