Maybe you can help me please...I'm confused

[natura]

These question based on a recent post requesting our comments and/or signing a petition.

I thought, The Food and Drug Administration (FDA) is appealing a federal judge's ruling that the agency doesn't have the authority to regulate e-cigs

e-cig currently are not subject to FDA oversight as a drug delivery device
AND- The decision leaves open the possibility for FDA regulation as a tobacco product


Can some one tell me how these- what I consider facts could be wrong? I am new and willing to be enlightened.

 

[Janetda]

The FDA thinks it has authority. They have long put forward that nicotine is a medication and therefore anything with nicotine is under their jurisdiction. Under that authority, they have been directing US Customs to stop shipments coming into the country. SE & njoy is sue them over this point. Judge Leon granted a stay on the FDA's defacto ban, the FDA filed an appeal. The Court then issued an administrative stay to Judge Leon's stay on the ban and we're waiting for the Court to decide what they want to do. All this is before the whole thing actually comes before the court and a final decision on whether or not the FDA needs to consider them a tobacco product or if they can indeed go forward with the notion that all nicotine is a medication.

 

[natura]

So My facts are currently correct then, right?

In this other post it stated change from drug to tobacco...that would be technically incorrect currently? Oh shoot- I do not type or write so well sorry.

But here was my question "I wasn't aware they had classified it as a drug device?" It hasn't been right?

Which then when reading the place submitting the petition..let me quote from their web page on Tobacco:
"With all this in mind, and after being invited to do so by top level FDA leadership, I, on behalf of the AAPHP task force have submitted two Citizen Petitions to FDA relative to reclassification of E-cigarettes from “drug-device combinations” to “tobacco product.”

I just do not understand what is TRULY going on! A petition not based on facts complaining about wrong facts being released?? Am I crazy? Truly I do respect the original poster-BUT this give me reason to re-evaluate the situation and my opinions on facts.

I mean why do anything for a place who we do not want involved??
Is everyone assuming the FDA will get control somehow? I mean it's not like they got a great rep with what they have to oversee now! I am not sure anyone in their right mind would give them more.

 

[Janetda]

Again, the FDA THINKS it has jurisdiction and has taken control of it. They did classify e-cigs as a drug delivery device. The court case is about telling them, no you're wrong...or yes, you're right.

Congress gave them the authority to oversee legal drugs. For all intensive purposes, the could theoretically decide that animal crackers were a drug. Then animal crackers would be a drug until someone took them to court to make them stop.

The FDA has never said that they want to ban e-cigs. They have said that they want e-cigs to go through the same process that other drugs go through to get approved. That process is very expensive and can take years. That's why it's important that e-cigs are not classified as a drug and drug devices.

BTW, even if e-cigs are considered a tobacco product, the FDA will still have jurisdiction. They just won't be able to regulate them the same way.

 

[Vocalek]

The FDA has declared that electronic cigarettes are "unapproved drug-delivery devices."

FDA and Public Health Experts Warn About Electronic Cigarettes

The FDA has been examining and detaining shipments of e-cigarettes at the border and the products it has examined thus far meet the definition of a combination drug-device product under the Federal Food, Drug, and Cosmetic Act. The FDA has been challenged regarding its jurisdiction over certain e-cigarettes in a case currently pending in federal district court. The agency is also planning additional activities to address its concerns about these products.

There is a huge thread here on ECF that has been following the federal court case referred to in the FDA Press Release quoted above.
Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT STAYS JUDGE LEON'S RULING FOR NOW

To summarize, the FDA's position is that electronic cigarettes are unapproved drug-delivery devices and has begun enforcement by seizing incoming shipments. Smoking Everywhere asked for an injunction to stop FDA from seizing product. The case was later joined by Soterra (NJOY) whose products were also being seized by FDA. Judge Leon (finally!) granted the injunction and based his opinion on the idea that the products are tobacco products. FDA has appealed the injunction and obtained a temporary stay (allowing them to continue seizing products) pending decision by the appeals court. FDA continues to insist these are drug-delivery devices. It also continues to seize incoming products. Smoking Everywhere is struggling financially and many smaller retailers have had to close their doors.

The petition asks the FDA to stop insisting on their position. That would mean that they would stop seizing products at the border, because the products would no longer be considered an "unapproved" product that CDER can regulate. Instead, they would be considered a tobacco product that does not require approval. The products could, however, be regulated to ensure safety--allowing for such things as complete accurate labeling, child-proof packaging, and testing of liquids to ensure purity.

Early in that string SE vs. FDA, I argued for the position that electronic cigarettes are a consumer product -- not a medicine, and not a tobacco product. But the fact is that there is a court case that allows for only those latter two positions. The lesser of two evils is definitely to have these declared a tobacco product.


Other informative threads:

CASAA.org

The first two links on this page take you to the Judge's 32-page opinion and his ruling.

 

[natura]

Thank You Vocalek...
Do You think the Judges ruling will be overturned?

Also, I have a problem as a citizen to sign a petition to the FDA about a product that they have no jurisdiction over. Then to further muddy the water -sign a petition stating I understand them currently as a medical device.

I can not do that simply put

 

[Vocalek]

I just do not understand what is TRULY going on! A petition not based on facts complaining about wrong facts being released?? Am I crazy? Truly I do respect the original poster-BUT this give me reason to re-evaluate the situation and my opinions on facts.

I mean why do anything for a place who we do not want involved??
Is everyone assuming the FDA will get control somehow? I mean it's not like they got a great rep with what they have to oversee now! I am not sure anyone in their right mind would give them more.

Not to beat a dead horse, but the FDA will get control one way or another because of the court case. If they win the court case, they get to continue treating the products as drug-delivery combinations. Judge Leon has pointed out that they HAVE jurisdiction already to regulate them as tobacco products, but FDA is insisting, no, no, they are not tobacco products. Well, if they lose the court case and lose the appeals all the way up to the Supreme Court, I think we will suddently see FDA doing a 180 and jumping in to regulate them as tobacco products. They can always say "The court made me do it."

But I did want to comment regarding "wrong facts being released." The issue being addressed in the second petition is that the FDA did a major spin job last July in their press release. The media picked up on the idea that the FDA found carcinogens and anti-freeze in cartridges and this erroneous press release is STILL being quoted in news stories and blogs to this very day!

What the FDA "forgot" to mention was that the quantities they found were so miniscule that they present no danger to human health. They also "forgot" to compare these chemicals and quantities to tobacco cigarettes. Here are facts: The "carcinogens" referenced were Tobacco-Specific Nitrosamines (TSNAs). We know from testing performed by Health New Zealand that the 16 mg. cartridge of Ruyan e-cigs contain 8 ng/g of TSNAs. The same test report mentions that a nicotine patch contains 8 ng/g TSNAs. Now don't you think this is information that FDA should have included in their report? FDA also should have put the whole thing into perspective by revealing that a day's supply of tobacco smoke delivers 5,500 to 11,000 ng/g of TSNAs!

The FDA is supposed to be staffed by ethical scientists. They should not be misleading the public. A couple of countries actually banned electronic cigarettes outright, stating that the United States FDA declared they are dangerous.

 

[DirtyHarry]

For all intensive purposes,

I'm sorry to unduly hassle you, because you are clearly an informed and intelligent person, but this is a pet peeve of mine - the term is "all intents and purposes". Sorry; writer here... can't... let... go...

BTW, even if e-cigs are considered a tobacco product, the FDA will still have jurisdiction. They just won't be able to regulate them the same way.

This was the point of my post in the other thread that was linked to the announcement - The FDA is a creation of Congress, and Congress is free to legislate how and what the FDA can regulate. Congress can even eliminate the FDA entirely, if it wanted to. To a somewhat lesser extent the President can "regulate" the FDA as well (since the bureaucracies are generally Executive agencies and thus subject to Executive Orders), but to me the best place to fight this battle is in Congress, in terms of more solid and permanent effect.

Take the issue out of the FDA's hands entirely, and legislatively DICTATE to them how PVs are to be handled.

-Inspector 2211

 

[natura]

"Not to beat a dead horse, but the FDA will get control one way or another because of the court case."

"Judge Leon has pointed out that they HAVE jurisdiction already to regulate them as tobacco products, but FDA is insisting, no, no, they are not tobacco products. "

pieces of the puzzle -that may aid in my knowledge. Too tired to research/read this further tonight.

I do want to thank you for your time, information, and kindness.

 

[Janetda]

I'm sorry to unduly hassle you, because you are clearly an informed and intelligent person, but this is a pet peeve of mine - the term is "all intents and purposes". Sorry; writer here... can't... let... go...

You know, I knew that was wrong when I wrote it. I just couldn't think of the right way to say it. Sorry. I not be a riter.

 

[Janetda]

This was the point of my post in the other thread that was linked to the announcement - The FDA is a creation of Congress, and Congress is free to legislate how and what the FDA can regulate. Congress can even eliminate the FDA entirely, if it wanted to. To a somewhat lesser extent the President can "regulate" the FDA as well (since the bureaucracies are generally Executive agencies and thus subject to Executive Orders), but to me the best place to fight this battle is in Congress, in terms of more solid and permanent effect.

Take the issue out of the FDA's hands entirely, and legislatively DICTATE to them how PVs are to be handled.

-Inspector 2211

Congress did that already. The new law was only signed into effect in 2009. I think they had their say.

 

[Mister]

So My facts are currently correct then, right?

In this other post it stated change from drug to tobacco...that would be technically incorrect currently? Oh shoot- I do not type or write so well sorry.

But here was my question "I wasn't aware they had classified it as a drug device?" It hasn't been right?

Which then when reading the place submitting the petition..let me quote from their web page on Tobacco:
"With all this in mind, and after being invited to do so by top level FDA leadership, I, on behalf of the AAPHP task force have submitted two Citizen Petitions to FDA relative to reclassification of E-cigarettes from “drug-device combinations” to “tobacco product.”

Your understanding is not currently correct. I think you did not understand the sentence I have highlighted in red above.

As that sentence implies, the FDA has already classified e-cigs as drug delivery devices. And the FDA are the people who get to make the rules about this. The rules they choose are the final word on the subject unless someone successfully challenges them in court, or Congress makes explicit rules which override them. There is a court case in progress which challenges them but it is far from being a win. Congress definitely won't step in - there aren't enough vapers to matter to a politician, and there aren't any large commercial interests in favor. In fact there is the opposite - Big Tobacco and Big Pharm do not want e-cigs to be easily available, they want them to be treated the way the FDA is currently treating them.

 

[natura]

Your understanding is not currently correct. I think you did not understand the sentence I have highlighted in red above.

As that sentence implies, the FDA has already classified e-cigs as drug delivery devices. And the FDA are the people who get to make the rules about this. The rules they choose are the final word on the subject unless someone successfully challenges them in court, or Congress makes explicit rules which override them. There is a court case in progress which challenges them but it is far from being a win. Congress definitely won't step in - there aren't enough vapers to matter to a politician, and there aren't any large commercial interests in favor. In fact there is the opposite - Big Tobacco and Big Pharm do not want e-cigs to be easily available, they want them to be treated the way the FDA is currently treating them.

Yes I do understand the FDA has classified something as a drug device, I also understand courts said NO currently.

This petition takes the current stance that they are indeed drug delivery devices based on FDA desires AND not by current reality. If I were to sign- I TOO would be saying it is a drug delivery device.

I am also NOT interested in helping the FDA gain control over e-cigs. Petitions to the FDA about e-cigs? NO.. not now..WE ALREADY know HOW they are willing to LIE to get what they want which your second petition addresses GREAT -BUT you tied it to the first! just me maybe..and I can be picky...but it's my name and my voice.

Also "The FDA attorney suggested that the Supreme Court ruling doesn’t prevent the Administration from regulating tobacco items if they are drugs or devices." from here: FDA to Contest Federal Court?s Ruling on Electronic Cigarettes | Tobacco Facts.

SO FDA attorney states- THEY only regulate then IF they are drugs or devices? And what if..those high level FDA people who came to you and spoke with you..are only using you as pawns in their quest to get what they want? Clearly what they want and what you say YOU want -are diametrically opposed!

 

[natura]

Also from the other thread (These two appear to see things from my perspective- while your hearts and motives may be for us..truth is FDA can have a field day with this petition)

If we praise the great ecig genie, and it's wonderous ability to stop us from smoking... then we are in fact proving

their point. No?

AND

Unless they're planning on reading every single comment to see if you're against

something in the petition and removing you... You will be assumed as a supporter for what they say AND Your Name

Will Be Attached To The Petition wether you agree to it or not. To counter it, you need another petition on top of

those 2... It's a BS trick. Don't fall for it!

 

[Mister]

I also understand courts said NO currently.

You are wrong in this understanding.

Also "The FDA attorney suggested that the Supreme Court ruling doesn’t prevent the Administration from regulating tobacco items if they are drugs or devices."

If you are believe things that you read at www.tobacco-facts.net, a site which publishes articles with titles like "E-Cigarettes Cause Acute Health Risks", then I doubt I can say anything to convince you of the real situation.

 

[natura]

You are wrong in this understanding.

If you are believe things that you read at www.tobacco-facts.net, a site which publishes articles with titles like "E-Cigarettes Cause Acute Health Risks", then I doubt I can say anything to convince you of the real situation.

Pluses and minuses in everything--look at all sides is my motto. Article is very current too.

Wrong in my understanding about the verdict handed down by the judge last fall --->who said it is nic and not a medical delivery device?8-o
Are you saying they misquoted the FDA Attorney?

You keep saying I am wrong-BUT i have yet to hear HOW I am wrong : (

 

[DC2]

This petition takes the current stance that they are indeed drug delivery devices based on FDA desires AND not by current reality. If I were to sign- I TOO would be saying it is a drug delivery device.

The petition takes the stance that they are NOT drug-delivery devices.

 

[Mister]

Wrong in my understanding about the verdict handed down by the judge last fall --->who said it is nic and not a medical delivery device?8-o
Are you saying they misquoted the FDA Attorney?

You keep saying I am wrong-BUT i have yet to hear HOW I am wrong : (

Go and read the court pleadings and the decision to see how you are wrong.

They did not quote the FDA attorney at all. They stated their interpretation of what they think he said. The site is so clearly biased that I don't care about their interpretation of anything.

 

[natura]

The petition takes the stance that they are NOT drug-delivery devices.

They are stating it is currently and please change it. I get it.

 

[(So) Jersey Girl]

They are stating it is currently and please change it. I get it.

The FDA is stating it is a drug delivery device. The petition is asking the FDA to change it. Whether we like it or not, they are the only two choices available right now.