Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY

[Sun Vaporer]

I noticed there's no way we can post our opinions there!

Territoo--You are right--if you take a look at the FDA's website, the offer no place to leave comment and if you try to e-mail them, you never get a response unless you keep it up for a month.


I got a response and it basically said, what is being said in this case, the e-cig is a combination drug-delivery device system subject to approval and regulation.

Sun

 

[Territoo]

Territoo--You are right--if you take a look at the FDA's website, the offer no place to leave comment and if you try to e-mail them, you never get a response unless you keep it up for a month.


I got a response and it basically said, what is being said in this case, the e-cig is a combination drug-delivery device system subject to approval and regulation.

Sun

I've heard they have a phone number where you can call in any complications w/ vaporizer use, but not one to call in any positive effects.

I feel like calling that number and saying, "Help! Because of vaping I don't crave a cigarette anymore!"

 

[Mister]

Legal One: Thank you. This is helpful.
Reseracher John Hughes told me, "If problems persist after 6 wks, very unlikely to be due to withdrawal." (email message 8/4/2009) Translation: many smokers have underlying conditions that are permanent, which is what keeps them using nicotine.

I think that statement may be misleading regarding the nature of cigarette addiction. Addiction to cigarettes, as a delivery mechanism for nicotine, is extremely complex and far from fully understood.

Sections 2, 3, and 4 of the "Report by the Tobacco Advisory Group of the Royal College of Physicians, October 2007" make fascinating reading if you are interested in a very detailed report on the mechanisms of nictotine addiction, dependency, and withdrawal.

The summary at the end of section 4 contains three items which should be of great interest to anyone who has felt that they were still in withdrawal 6 weeks, or 30 weeks, or even more after quitting. A quote from section 4.7 (bolding is mine):

Treatment of dependence and withdrawal can restore brain function, mood, and cognitive abilities, and thereby support cessation, but individuals appear to vary widely in how long they may require treatment, and probably in what forms of treatment are acceptable and effective.

However, some of the changes in brain structure and function in smokers, particularly in those who began smoking when very young, may not be entirely reversible.

Some smokers may never fully overcome their addiction, or even ever be able to quit all nicotine use.
​

A link to the report (please copy, paste, and add the usual prefix, I'm not allowed to post links yet):

rcplondon.ac.uk/pubs/contents/bbc2aedc-87f7-4117-9ada-d7cdb21d9291.pdf
​

 

[DisMan]

If the FDA gets power over the electronic cigarette, it will either disapper entirely forever, or be turned into the FDA defintion of an NRT, making it useless for our purposes. Millions will continue smoking tobacco and millions will die.

I doubt that will happen. Nicotine will be treated like caffeine if the safety of the whole can be guaranteed. If the vapor from the e-cig can be shown as non-dangerous to all around, then the laws against smoking, and e-cigs in general, will be eliminated. Remember, the laws came about *not* for the safety of the user but for the safety of the bystanders. It is important for people to remember this fact when round two evolves (the "where you can use them" argument)

Second hand smoke is the reason why cigarettes are "justifiably" taxed. The tax is not to make up for the money to treat the individual user. The tax is to treat the people who "had no choice" to be around smokers (bar workers, office workers, etc.)

Just remember that.

Oh, and just remember that I believe that Judge Leon will not allow the FDA to ban these things. I believe he will find a useful purpose for e-cigs and will allow them to be sold and used in the USA and will advise the FDA to work with manufacturers on how to provide the safest method for manufacturing and delivery. I just wanted to be the one to call it if it should happen.

Remember, politicians are emotional...judges are rational.

 

[Applejackson]

There is no FDA-approved treatment for "difficulty concentrating" outside of methamphetamines. These drugs have many contraindications and side effects, and the FDA recommends that they not be used long-term. They are a temporary (if that) solution to a permanent problem.

Not entirely true. I have ADD and there is ONE approved non-amphetamine treatment drug that is approved. It's called Strattera (about $170 for a one month supply without a prescription plan), and while effective on the concentration part, carried many unpleasant side-effects. I won't bother to go into how I treat my ADD now, but let's just say it's definitely not FDA approved, though much better for me with minimal side-effects.

 

[Sun Vaporer]

Just remember that.

Oh, and just remember that I believe that Judge Leon will not allow the FDA to ban these things. I believe he will find a useful purpose for e-cigs and will allow them to be sold and used in the USA and will advise the FDA to work with manufacturers on how to provide the safest method for manufacturing and delivery. I just wanted to be the one to call it if it should happen.

Remember, politicians are emotional...judges are rational.

Your anyalsis, unfortunatly, is fatally flawed for the simple reason that Judge Leon does not have the power to order the FDA to do anything with regards to mandating regulation---only with regards to wheather the FDA has the authority to regulate. Judge Leon only has the authority to find either that the FDA has jurisdiction or not---period.

On the other hand, as I have prior referenced, the parties can settle this case should they try hard enough and get the e-cig on a fast track to approval.

Sun

 

[Applejackson]

The "Indented Use" as fully set forth states:

The words intended uses or words of similar import in §§201.5, 201.115, 201.117, 201.119, 201.120, and 201.122 refer to the objective intent of the persons legally responsible for the labeling of drugs. The intent is determined by such persons' expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. It may be shown by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised. The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he received the drug, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses. But if a manufacturer knows, or has knowledge of facts that would give him notice, that a drug introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a drug which accords with such other uses to which the article is to be put.
[41 FR 6911, Feb. 13, 1976]

Unfortunalty, as underlined above, the indended use can be inputed and does not hinge on what the manufacture states or does not state.

It is very hard to have Judge Leon not find that the "intended use" of the e-cig is to mitigate the harm of the use of cigarettes. And mitigating use means FDA regulated use.

Sun

I may be misinterpreting, but if that's the case, shouldn't Oxycotin (among other prescription drugs) have to have on their label, "This stuff is GREAT for getting you really high and feeling awesome. Later, this will likely lead to withdrawal and pain and general suckiness. Also, possibly death."

 

[Sun Vaporer]

I may be misinterpreting, but if that's the case, shouldn't Oxycotin (among other prescription drugs) have to have on their label, "This stuff is GREAT for getting you really high and feeling awesome. Later, this will likely lead to withdrawal and pain and general suckiness. Also, possibly death."

Apple--when it is a drug approved by the FDA and the side effects are noted, then the "indented use" does not change nor does abuse of the drug.


Sun

 

[LoneRanger]

Sun,Can a fast track for approval already be in the works or have to wait for outcome?

Lone

 

[Applejackson]

Apple--when it is a drug approved by the FDA and the side effects are noted, then the "indented use" does not change nor does abuse of the drug.


Sun

Well I certainly know a lot of people that intend to use it for just that purpose. In fact, I'd wager that more people use it for that than actual pain therapy. Seems like a bit of a double standard to me. Or do you mean the "intended use" clause only applies to non-drugs, essentially negating the FDA's case since that would be admitting that the e-cig is not a drug?

 

[Sun Vaporer]

Sun,Can a fast track for approval already be in the works or have to wait for outcome?

Lone

Lone--unless the parties are totally unreasonable, their should always be talk of a settlement at least being kicked around and I would not doubt at all that this has been presented. So no, this kind of settlement would be being talked about by the parties now. If it goes anywhere is a different story. I would sure hope that the are trying as Judge Leon has to adhere to the law, and right now he does not have much to work with.


Sun

 

[Vocalek]

Not entirely true. I have ADD and there is ONE approved non-amphetamine treatment drug that is approved. It's called Strattera (about $170 for a one month supply without a prescription plan), and while effective on the concentration part, carried many unpleasant side-effects. I won't bother to go into how I treat my ADD now, but let's just say it's definitely not FDA approved, though much better for me with minimal side-effects.

It may not be an amphetamine, but still has the same "temporary solution" problem: "Strattera is not meant for long-term use. Because ADHD may be a long-term condition, especially in children and young adults, your doctor may recommend another ADHD medication after you stop taking Strattera.'

Also: "Strattera can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert."

And why would this be an improvement -- or even an acceptable replacement for -- nicotine? I use nicotine so that I can stay alert and awake and not have impaired thinking.


So it still boils down to the same thing: I have this permanent problem and the FDA does not have an acceptable solution for it. Nicotine treats it quite nicely, as long as I don't have to inhale noxious poisons from tobacco smoke along with my nicotine.

 

[Applejackson]

It may not be an amphetamine, but still has the same "temporary solution" problem: "Strattera is not meant for long-term use. Because ADHD may be a long-term condition, especially in children and young adults, your doctor may recommend another ADHD medication after you stop taking Strattera.'

Also: "Strattera can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert."

And why would this be an improvement -- or even an acceptable replacement for -- nicotine? I use nicotine so that I can stay alert and awake and not have impaired thinking.


So it still boils down to the same thing: I have this permanent problem and the FDA does not have an acceptable solution for it. Nicotine treats it quite nicely, as long as I don't have to inhale noxious poisons from tobacco smoke along with my nicotine.

Oh, I agree. I was just pointing out that I had been treated with Strattera, and initially I thought it would be good, but the negative side effects grew to be too much to bear. They even started treating side-effects of the Strattera with other pills. It was ridiculous.

 

[Sun Vaporer]

Today there was no movement on the Docket sheet--we are only 6 days away from the Hearing date.


Sun

 

[Territoo]

Sun,

What do you think is the likely outcome? If a potential settlement is in the works, what do you think it might entail?

I would like to see the following compromise result:

1. E cigs and nic liquid are not banned, but can be imported, manufactured, sold, and used.

2. These items can only be sold to those of legal age to purchase tobacco. Sale or marketing to minors is forbidden and can be prosecuted the same way the sale or marketing of tobacco products is.

3. They should be marketed as a tobacco alternative, not a smoking cessation method. No health claims can be made. They should not be marketed to nonsmokers. Pregnant women and persons w/ certain health conditions should be warned about possible dangers. Consumers should also know that these devices have not been determined to be safe.

4. A reasonable tax on the nicotine products can be applied. This tax should be used to test: 1. the safety of the devices and nicotine. 2) use as a smoking cessation method, and 3) effects of long term usage, in that order. Sales taxes on equipment and nic juice can be collected by states and cities.

5. All importers, manufacturers, and vendors of e-cigarettes or nicotine juice must be registered w/ the FDA and comply w/ their policies.

6. Should studies indicate that use of these products leads to an increased health risk, they can be banned &/or regulated further; prescription only, etc.

What do y'all think?

 

[LoneRanger]

My 2 cents..... #3 is on the box of a well known e cig company along with minimum age requirements 0f 21

 

[Sun Vaporer]

Sun,

What do you think is the likely outcome? If a potential settlement is in the works, what do you think it might entail?

I would like to see the following compromise result:

1. E cigs and nic liquid are not banned, but can be imported, manufactured, sold, and used.

2. These items can only be sold to those of legal age to purchase tobacco. Sale or marketing to minors is forbidden and can be prosecuted the same way the sale or marketing of tobacco products is.

3. They should be marketed as a tobacco alternative, not a smoking cessation method. No health claims can be made. They should not be marketed to nonsmokers. Pregnant women and persons w/ certain health conditions should be warned about possible dangers. Consumers should also know that these devices have not been determined to be safe.

4. A reasonable tax on the nicotine products can be applied. This tax should be used to test: 1. the safety of the devices and nicotine. 2) use as a smoking cessation method, and 3) effects of long term usage, in that order. Sales taxes on equipment and nic juice can be collected by states and cities.

5. All importers, manufacturers, and vendors of e-cigarettes or nicotine juice must be registered w/ the FDA and comply w/ their policies.

6. Should studies indicate that use of these products leads to an increased health risk, they can be banned &/or regulated further; prescription only, etc.

What do y'all think?

Territoo---take your list and just add to it a fast track timeline for application and Manufacture funding of the requisite research and that would be a fair settlement to all.

The question is, will these two companies try to settle or is it all or nothing for them. It also begs the question as to why the ECA did not implede itself into the case. Having the President of NJOY on the Board really did not help with the cause as our voice could have been heard via the ECA---but that is just my opinion.

Sun

 

[Territoo]

Sun,

I think your fast track application is a very good point and should be included. Over 3.5 million people will die of smoking related illnesses in the 8 years that NJOY has stated that it would require to go through usual FDA procedure for a new drug approval. (numbers based on Dr. Whalen' article in the Washington Times.)

Having the manufacturers funding the research vs. taxes isn't really that much different, since the cost will passed on to the consumer either way. Just so the extra cost goes to this research and not it someone's pocket is the big concern. I think that most will accept this increase in price if it results in the needed research to assure us that vaping is safer than smoking.

I believe that if Judge Leon rules against NJOY and SE, without any type of compromise, then vaping will become a blackmarket business w/ increase costs and no potential of learning of risks and benefits of vaping. IMO

Territoo---take your list and just add to it a fast track timeline for application and Manufacture funding of the requisite research and that would be a fair settlement to all.

The question is, will these two companies try to settle or is it all or nothing for them. It also begs the question as to why the ECA did not implede itself into the case. Having the President of NJOY on the Board really did not help with the cause as our voice could have been heard via the ECA---but that is just my opinion.

Sun

 

[Sun Vaporer]

Sun,

I think your fast track application is a very good point and should be included. Over 3.5 million people will die of smoking related illnesses in the 8 years that NJOY has stated that it would require to go through usual FDA procedure for a new drug approval. (numbers based on Dr. Whalen' article in the Washington Times.)

Having the manufacturers funding the research vs. taxes isn't really that much different, since the cost will passed on to the consumer either way. Just so the extra cost goes to this research and not it someone's pocket is the big concern. I think that most will accept this increase in price if it results in the needed research to assure us that vaping is safer than smoking.

I believe that if Judge Leon rules against NJOY and SE, without any type of compromise, then vaping will become a blackmarket business w/ increase costs and no potential of learning of risks and benefits of vaping. IMO

Territoo--You are right on point and it is time to call SE and NJOY out to make sure that they do not shoot us in the foot. Again, I do not know for the life of me why the Electornic Cigarette Asssociation would not what to implede themselves into the case unless they consider their interests are severed by NJOY---which to me is a huge mistake in my opinion.

Sun

 

[LoneRanger]

Territoo---take your list and just add to it a fast track timeline for application and Manufacture funding of the requisite research and that would be a fair settlement to all.

The question is, will these two companies try to settle or is it all or nothing for them. It also begs the question as to why the ECA did not implede itself into the case. Having the President of NJOY on the Board really did not help with the cause as our voice could have been heard via the ECA---but that is just my opinion.

Sun

Sun,Am I missing something? The ECA was set up by the manufacturers & I believe started by Njoy


Lone