Comments Please on AAPHP Petitions to FDA

[SheerLuckHolmes]

Uh, I don't know about anyone else, but ecigs DO NOT fit this classification. Our devices may contain nicotine, but they do not contain any tobacco whatsoever. From my understanding of the above classification, any tobacco product must contain some type of physical tobacco.

Sorry, but I agree with many others that this is NOT the appropriate solution.

Obviously, in a common sense world, you are absolutely correct. But we are not talking common sense in the legal world. In fact, I would go so far as to say there is no common sense in the legal world at all. That leaves us with continuing to get the goverment to stop trying banning e-cigs. The best bet so far is jumpin on the Judge Leon bandwagon and working to get e-cigs classified as a tobacco product. Without that the FDA WILL BAN!!!!!!!! And the e-cig as we know it becomes Illegal and makes you and me a criminal.

Now unless you have 10 to 20 million dollars that you wish to use to fight the FDA in court to get e-cigs their own category..... you just don't have any other alternative. Its ban or tobacco category.

If you have a realistic alternative, we are all ears. If not, it is not constructive to just say it ain't right. All that does is play into the FDA's hand and get the e-cig banned.

 

[bogiediver]

There are several here who obviously cannot see the forest because of all the trees...

The FDA has, in fact, already, & unilaterally, decided that e-cigs are a combination drug/delivery device and is, in fact, banning them - to the extent they can (seizing shipments at the border). This is happening, it is not a 'what if'.

A Federal court judge has, in fact, already issued an opinion that the FDA is acting improperly - that e-cigs are, and should be regulated as, tobacco products. While the FDA is appealing this opinion - the FDA, in fact, continues to seize the products.

A third classification would be the best route for e-cigs; but, in fact, there is no third classification currently.

Whether or not you choose to admit it, even to yourself, life is (and always will be) a series of compromises. You need to choose your stances carefully, for without compromise there would be only chaos and war.

JMHO

-bogie

 

[ChipCurtis]

How it is that the nicotine gums and patches are able to be sold legally? They are not classified as tobacco products, are they? I thought they were sold as over the counter drugs and regulated by the FDA as such.

Gums and patches were invented and are manufactured by Big Pharma. Big Pharma has a lot of money, so they pay the FDA big funds to "fast-track" their products to market.

The e-cig, on the other hand, is seen by the FDA as some kind of "rogue device" that is stepping on their territory. No Chinese manufacturer is going to be able to pay the FDA to fast-track it, and those chinese companies probably don't even have the kind of money that Big Pharma does.

So, as CES has pointed out, e-cigs will never make it to the "completely safe and effective" category that the FDA has to give it. The FDA will simply stonewall the approval process for 10, 20 maybe 30 years. All while e-cigs remain banned and illegal drug-delivery devices. And that will be that.

It matters not that e-cigs are as safe as gums and patches, as they all have roughly the same amount of nictotine and tobacco-specific nitrosamines. The problem is that it's not Big Pharma's device. So Big Pharma will just use their friends the FDA (who they pay) as a screening agency to keep e-cigs off the market.

So now it should be clear what a big mistake classification as drug-delivery device would be.

 

[DC2]

BONGS are a drug delivery device and they have not been able to stop the sale of them.

This is a very dangerous fallacy.

The only reason you rarely see anyone go after bongs is because no one cares enough.

Here where I live, for one reason or another, enough people cared enough.
And they swept through the city of Vista and confiscated all paraphernalia such as bongs.

It not only can happen, it already has happened, right here in my backyard.

 

[natura]

So all of you who support the petition.... do so because you have no faith in the Judge's original ruling to stand? I think, I asked this earlier and no one addressed it.

Please black and white it for me..no what ifs..it is possible...this is logically what we think will happen

 

[DC2]

All of you people questioning the motives of the AAPHP need to do some learnin.
They are the best friends we have in this fight, and always have been.

 

[Mister]

Those who have posted notes opposing the AAPHP petitions are either lurkers who want the FDA to ban e-cigarettes, or are totally naive of federal drug and tobacco laws, FDA regulatory policies and procedures, the SE v FDA litigation and thousands of notes that have been posted on the ECF carefully explaining all of these things in great detail.

You know what. You have done nothing but bad-mouth ECF members in this thread. You don't want comments or discussion. You want a cheering section. I obviously misunderstood what this thread was all about. My apologies for that error and I will move along.

It seems that you are the one who is bad-mouthing someone. Bill's post seems correct to me. Before attacking him I suggest you google "Bill Godshall" and do some reading. Bill is the best friend a vaper could ask for. You do yourself a disservice by not reading up on the matters being discussed in this thread before throwing accusations around.

 

[ChipCurtis]

So all of you who support the petition.... do so because you have no faith in the Judge's original ruling to stand? I think, I asked this earlier and no one addressed it.

It's just a matter of keeping up the pressure and not sitting back hoping for the best. Anything could happen in the courts. We need to try different approaches (as long as the message is consistent; hence why fighting over drug or tobacco classification is counter-productive at this stage).

 

[DC2]

So all of you who support the petition.... do so because you have no faith in the Judge's original ruling to stand?

If the judges decision stands then there is no need for the first petition.
At least that's the way it looks to me, but I could be wrong.

 

[CES]

Hi Natura,

I don't know what the appeals court will rule, and i can have no impact on that outcome. No, I don't trust the FDA, i wish i could, but I *believe* that using my voice is the only chance that i have to be heard. I don't know what they'll do with what i wrote. I can't do anything about that either. But i also believe that if we don't take any and all options to speak out that we'll lose what we have. I'll be contributing to CASAA as soon as they take contributions. If we weren't already on the FDA's radar I'd be all in favor of hunkering down, but i think it's too late for that. My personal experience is that waiting for things to just go away just doesn't work very well.

 

[natura]

All of you people questioning the motives of the AAPHP need to do some learnin.
They are the best friends we have in this fight, and always have been.

I'm not questioning them for their past efforts- BUT the move their making NOW..YES I AM.

I'd like my concerns alleviated. But Have not gotten all the answers yet.

 

[Firegrl]

All of you people questioning the motives of the AAPHP need to do some learnin.
They are the best friends we have in this fight, and always have been.

I think you have been mistaken. No one here that I've seen is questioning MOTIVES at all. But, that doesn't mean we have to completely agree with everything they do. They may be on our side, but that doesn't mean they are correct all the time. Classification as a tobacco product is seen by some as just as wrong as a medical device classification. The time they are devoting to the cause is honorable, and they could devote some time coming up/searching for a better classification. Do you want to do without all the wonderful flavors from TV, V4L, and others? Wouldn't that make you mad that it would simply put all these hard working small businesses OUT of business?

That brings up another point. If all these distributors, creators of juice, small business owners will be majorly affected by anything the FDA does, why don't we ever hear from them on these things? Would be interested to hear if they are worried, what are their alternatives, etc. and what they truly believe should happen with ecigs and the FDA.

And to someone else's comment above, some of us just don't agree with comprimising with the government anymore. Look where that's gotten us already....

 

[Vocalek]

So all of you who support the petition.... do so because you have no faith in the Judge's original ruling to stand? I think, I asked this earlier and no one addressed it.

Please black and white it for me..no what ifs..it is possible...this is logically what we think will happen

Black and white:
The court case will take years and years before a final decision is rendered. Right now, the actual case has not even started yet. SE & NJOY filed for a "preliminary injunction" at the start, based on the grounds that with the FDA seizing their inventories, they would be greviously harmed (go out of business) if the court did not provide this protection.

Usually, rulings on an injunction take very little time -- a couple of weeks at most. During the many months it took Judge Leon to make a decision on the preliminary injunction, we bandied about the three possible classifications of electronic cigarettes:

• Drug Delivery Combination Device (FDA's position)
• Tobacco product
• New type of product

When Judge Leon granted the preliminary injunction, he said that the FDA was wrong about it being a medical device and declared that it is a type of tobacco product. Thus, the third definition is totally out of the running. There is no basis to have it delcared as such under any law or any court ruling.

The next thing that happened is that FDA appealed the injunction and asked the Court of Appeals to grant a "stay" of the "injunction" -- which it did on a temporary basis. This left FDA free to continue seizing products, which it did. We are still waiting for the Appeals Court to either deny the Stay asked for by the FDA or to grant it on a permanent basis. If the Appeals Court grants the Stay, SE and NJOY will need to appeal this ruling in hopes that FDA will eventually be stopped from seizing their incoming shipments.

Let's say that ultimately the Preliminary Injunction is upheld. We still have the court case to go through and that could take years. Meanwhile, since the Injunction only applies to the Plaintiffs (SE & NJOY) the FDA will merrily continue to block as many shipments of other companies as it can.

Now, do you understand the problem?

The point of the petition is to short-cut all of the waiting around for preliminary requests for injunctions and stays to be ruled upon, and then for the case to be tried, appealed, appealed again by the loser, etc. If the FDA can be persuaded to treat electronic cigarettes as a tobacco product, we the consumers, have a much better chance of continued access to the products. And fewer small companies will be driven out of business.

 

[natura]

It's just a matter of keeping up the pressure and not sitting back hoping for the best. Anything could happen in the courts. We need to try different approaches (as long as the message is consistent; hence why fighting over drug or tobacco classification is counter-productive at this stage).

It is appreciated. Now to digest more of this..but have to say my fears in regards to the petitions still hold water. I'm terrified that this could back fire on us BIG Time.

I do not wish to insult or make anyone feel as their not appreciated for all their hard work. This move JUST SCARES me.

I wish that I was more eloquent in words with ability to type them my message clearly..without it coming across as an attack or slap in the face of anyone.

 

[DC2]

I think you have been mistaken. No one here that I've seen is questioning MOTIVES at all. But, that doesn't mean we have to completely agree with everything they do.

That's cool, just don't want anyone questioning their motives.

 

[natura]

Now, do you understand the problem?

The point of the petition is to short-cut all of the waiting around for the case to be tried, appealed, appealed again by the loser, etc. If the FDA can be persuaded to treat electronic cigarettes as a tobacco product, we the consumers, have a much better chance of continued access to the products. And fewer small companies will be driven out of business.

The short cut method is a grave concern. Based on the petitions legal writing and the legal ability for the results to be used AGAINST US not for US.

We know the FDA has not be honorable in their handling of information in regard to electronic cigarettes. I think my message is clear? With this petition we are b4 the ruling is out..supplying them with names via a petition that DO recognize it as a medical device. I can't do it..sorry. Not a move I can recommend now. If Judge changed his stance..YES I could. If throwing fodder, I would have elected to something else.

 

[Vocalek]

The short cut method is a grave concern. Based on the petitions legal writing and the legal ability for the results to be used AGAINST US not for US.

We know the FDA has not be honorable in their handling of information in regard to electronic cigarettes. I think my message is clear? With this petition we are b4 the ruling is out..supplying them with names via a petition that DO recognize it as a medical device. I can't do it..sorry. Not a move I can recommend now. If Judge changed his stance..YES I could. If throwing fodder, I would have elected to something else.

I'm not following what you are saying. The petition doesn't say that the AAPHP recognizes e-cigarettes as a medical device. The point is that the FDA claims they are a medical device (option 1) and the petition asks them to select option 2 (tobacco product) instead.

If there were a third category available, the petition would ask for it.

But Judge Leon gave us only two categories via the courts, and that is probably because he saw that there are only two sets of laws that could possibly apply to the products at this point.

 

[natura]

I'm not following what you are saying. The petition doesn't say that the AAPHP recognizes e-cigarettes as a medical device. The point is that the FDA claims they are a medical device (option 1) and the petition asks them to select option 2 (tobacco product) instead.

If there were a third category available, the petition would ask for it.

But Judge Leon gave us only two categories via the courts, and that is probably because he saw that there are only two sets of laws that could possibly apply to the products at this point.

The undersigned submits this petition under ___ (relevant statutory sections, if known) of the ___ (Federal Food, Drug, and Cosmetic Act or the Public Health Service Act or any other statutory provision for which authority has been delegated to the Commissioner of Food and Drugs under 21 CFR 5.10) to request the Commissioner of Food and Drugs to ___ (issue, amend, or revoke a regulation or order or take or refrain from taking any other form of administrative action

The VERY basis for the petition assumes it
Any attorney would seem- could easily argue that point?

 

[Vocalek]

The undersigned submits this petition under ___ (relevant statutory sections, if known) of the ___ (Federal Food, Drug, and Cosmetic Act or the Public Health Service Act or any other statutory provision for which authority has been delegated to the Commissioner of Food and Drugs under 21 CFR 5.10) to request the Commissioner of Food and Drugs to ___ (issue, amend, or revoke a regulation or order or take or refrain from taking any other form of administrative action

The VERY basis for the petition assumes it
Any attorney would seem- could easily argue that point?

The paragraph you quote is citing the legal basis for the right of the public to come forward and make a request of the agency via petition to change a regulation or how it is implementing a regulation.

Here is a link to 21 CFR 5.10: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=10.30

 

[leannebug]

I read through the first document, and even checked several of the links. I was quite impressed with the amount of work put into the document, and also wanted to let you know the links are broken (and to request where I might find the NJ GASP report, I couldn't find it after searching the site extensively)

Then I came here and read the posts since mine.

As a "noob" it's really quite disturbing. I was under the impression this was a discussion thread. Is it to be assumed that anyone that has under 1000 posts is wrong? Or uneducated? Or insensitive?

Just because I am new to this forum, or to ecigs, or only recently joined, does not mean I haven't spent hours researching, or vaping, or lurking. Neither does it negate my opinion.

That's the great thing about our nation... we are free to speak our minds, and usually, in doing so, we may actually enlighten someone else. OR we may learn something ourselves. A few posters have asked very valid questions, and have been countered with "you are wrong because: a, b, or c". Why not enlighten us, counter us, teach us, for you will certainly catch more flies with honey.

I originally stated that I hadn't made up my mind whether or not to sign, but after coming back and reading the new comments, I am inevitably put off by the tone of this thread.