OTC vs prescription

[Symmetric]

everyone is making it sound as though the FDA designating the PV as a drug/device combo is a nail in the coffin. My question is, what designates a "drug" as perscription? Is it dosage? Acetomedaphin and Ibuprofen are both drugs and regulated by the FDA, but we have Advil and Tylenol available OTC at every gas station without a prescription, why is that?

I'm just trying to be proactive (one word that I'm sure I didn't misspell in this post) and focus attenton on things we may be able to control over others.

 

[Vocalek]

My guess would be that the FDA decides, based on how safe they believe it would be for folks to use it without being under a doctor's care. You will notice that there are zero OTC drugs for high-blood pressure and managing blood sugar. There may be some herbal remedies, but nothing that was developed as a synthetic by a Pharmaceutical company.

If the e-cigarette was submitted for approval as a drug-delivery combo device, would FDA OK it for use without a prescription? It's anyone's guess.

There is such paranoia about "addiction" that my fear is that they would only approve it with dosages that were too teensy to do us much good, in sealed, non-refillable cartridges. And I would also guess that they would start out making it prescription only.

 

[Vaporer]

Ok..lets say the FDA gets it........

They decide its ok at OTC @ 4mg nic...........
Pretty worthless for us considering the adsorption rate via a PV.
A high percentage will fail due to constant vaping with no satisfaction.
So, it will fail like the rest of their approved stuff has.

Now, add you own DIY nic? Not an easy task and can be very dangerous as it takes high dollar equipment to determine content.

It instills an underground market instead of manufactureres quality control known levels.

 

[Sun Vaporer]

everyone is making it sound as though the FDA designating the PV as a drug/device combo is a nail in the coffin. My question is, what designates a "drug" as perscription? Is it dosage? Acetomedaphin and Ibuprofen are both drugs and regulated by the FDA, but we have Advil and Tylenol available OTC at every gas station without a prescription, why is that?

I'm just trying to be proactive (one word that I'm sure I didn't misspell in this post) and focus attenton on things we may be able to control over others.

Symmetric:


In 1951, the Durham-Humphrey amendments to the Food, Drug, and Cosmetic Act established the distinction between prescription and OTC drugs. For drugs that could not be labeled with sufficient instructions to allow safe, unsupervised use by consumers, these amendments allowed labeling directed to physicians and pharmacists instead of to consumers. Drugs with physician- and pharmacist-directed labeling were then available by prescription only.
In 1962, the Kefauver-Harris amendments to the Food, Drug, and Cosmetic Act were passed, requiring that drug products be proved not only safe but also effective for their intended uses. Enactment of these amendments compelled the FDA to determine the effectiveness of more than 4,000 newer drug products, including more than 500 OTC products, that had been marketed before the enactment of the amendments. The OTC Drug Review was begun in 1972 as an FDA-initiated scientific review of OTC product ingredients in use at that time to ensure that appropriate safety, effectiveness and labeling standards are met. This review process consists of three phases: an advisory panel review, creation of a tentative monograph and publication of a final monograph.


Sun

 

[Vaporer]

Sun, isn't it true that FDA approval can take up to 7 years?
Then as I suggested, what if the level approved is only 4mg?
That may work, be expensive and require a script for usage,
but it will not satisfy a majotiry of the vaping people...so back to analogs they will go.

Also..what do people do during the long approval time.....if it ever happens?
With so many satisfied with vaping, at higher levels than 4mg, it's a failure, long timed and promotes a black market for e liquid of higher strength.
Not something most want. I don't want bathtub nic liquid.

 

[dragonpuff]

Sun, isn't it true that FDA approval can take up to 7 years?
Then as I suggested, what if the level approved is only 4mg?
That may work, be expensive and require a script for usage,
but it will not satisfy a majotiry of the vaping people...so back to analogs they will go.

Consider this: Step 1 dosage for a nicotine patch is standard 22mg. They always say this is a very high dose, and that if you use this you must abstain from all other forms of nicotine lest you overdose and have heart failure or something equally dreadful.

However, while a 22mg vape may be delightful, absorbtion of nicotine through your skin is far slower, and the 22mg patch is often ineffective as a result. An interesting study:

High dose transdermal nicotine therapy for heavy smokers: safety, tolerability and measurement of nicotine and cotinine levels.

They found that they had far more success using a 44mg patch, and that this caused no more adverse effects than the lower dose. If you google "blood nicotine levels," you'll find many studies on all NRT's showing similar results. Scientists have known about NRT underdosing for years.

So why do pharmaceutical companies, in the face of such glaring evidence, still drastically underdose their consumers and keep them from actually quitting?

Hmm...

 

[Sun Vaporer]

Sun, isn't it true that FDA approval can take up to 7 years?
Then as I suggested, what if the level approved is only 4mg?
That may work, be expensive and require a script for usage,
but it will not satisfy a majotiry of the vaping people...so back to analogs they will go.

Also..what do people do during the long approval time.....if it ever happens?
With so many satisfied with vaping, at higher levels than 4mg, it's a failure, long timed and promotes a black market for e liquid of higher strength.
Not something most want. I don't want bathtub nic liquid.

Vaporer--It really depends on how novel the drug is. In the case of the e-cig, the effects of inhaling PG and Nicotine have a long history of being studied while the flavoring may be an unkown. So I would say more along the lines of 2 years for the e-cig, and even faster if "fast tracked".

As for the 4mg cap---that is derived from the FDA's conclusion that any consumption under 5 mg daily is non-addictive. But it is not all about nicotine. Many of the ultra light cigarettes such as Carlton, are delivering far less than that currently.

But there is nothing to say that the FDA will hold to the 4mg like they did with Nicotine Water. Nicotine Water's approval was based on the homopathic route and hence the 4mg threashold. Regulation is a double edge sword for sure, and we can only hope that it cuts more for us.

Sun

 

[Vaporer]

I hope for all vapers sake its higher.
I realize many vape 0 nic or abt 10-12mg, I think you do, and that works for them.
I'd tend to say the majority vape 18-36mg, seat of the pants guess here, and thats going to be just another failed FDA approved product sending people back to analogs IMHO.

 

[Sun Vaporer]

I hope for all vapers sake its higher.
I realize many vape 0 nic or abt 10-12mg, I think you do, and that works for them.
I'd tend to say the majority vape 18-36mg, seat of the pants guess here, and thats going to be just another failed FDA approved product sending people back to analogs IMHO.

Vaporer--I concur that absent nicotine at a meaningful level, the e-cig will fail in the marketplace.


Sun

 

[Chasm]

I hope for all vapers sake its higher.
I realize many vape 0 nic or abt 10-12mg, I think you do, and that works for them.
I'd tend to say the majority vape 18-36mg, seat of the pants guess here, and thats going to be just another failed FDA approved product sending people back to analogs IMHO.

I was a 2 pk/day smoker, started vaping 30 & 36 mg/ml juice about 7 weeks ago, cut smoking immediately (instantaneously?) to 1 pk/week. I decided to try stronger juice, tracked down some 48 & 60 mg/ml stuff, and about 1 week later I was down to 1 analog every 2-3 days. I think I can eventually get to ZERO analogs, but it probably won't happen (hasn't happened in the past, at least) if I have to settle for anything "FDA Approved".

 

[Vaporer]

Chasm,

Great that you've cut back that far. It is amazing all the more minor things that vaping has satisfied than just " gimme the nic" approach. The oral fixation, seeing "smoke" come out....many things play a part in analog addiction. The FDA's approach is "it's all about the nic" and they keep approved levels so low thier failed NRT products may look good in the short run but fail miserably in the long run.
No other method has proven so successful.
In other threads testing has been actually done that shows the PV is about 46% efficient in nic delivery. So vaping 36mg, you get about 16.56mg of nicotine. Thorugh questioning most people seem to need 2-2.5 intake via a PV. Assuming that its due to the method of delivery in a PG/VG carrier being more slowly adsorbed and nicotine covering for many of the others chemicals in analogs. A person that smoked ultra ligts (.6mg nic) 1 1/2pks a day (30) is consuming 18 mg a day of nicotine but will quit analogs when vaping 36mg. A little time is required for all the other constituients to be eliminated form the body and it to recover to a "normal" state.
2 great reading threads on all this are:
http://www.e-cigarette-forum.com/fo...erest-determining-nicotine-dvap-new-post.html

http://www.e-cigarette-forum.com/forum/nicotine/44958-so-we-getting-we-not-nicotine-new-post.html

Long reads, but very informative.

 

[sepper33]

What I don't get... the FDA is urging for e-cigarettes to be subjected to restrictions and to be purchased by prescription... But last time I checked, no one required a prescription for me to start smoking, but to quit, well, that's a different story I guess...

 

[Vaporer]

They need to develop the best long term profit from it 1st and safety of course.
I think if the FDA had their way it would all be banned and the gov gets so much money from it, they say "no way".
Politics at its finest ! MHO

 

[Vocalek]

Regarding the strength needed, according to a poll on this forum, just about half need a stregth of 24 mg or higher. The kits come with 16 mg if you're lucky. How many folks bought a kit and couldn't make a go of it on what they received and just gave up?

http://www.e-cigarette-forum.com/fo...hat-level-nicotine-keeps-you-off-tobacco.html

 

[Vaporer]

24 - 36mg seems to be the acceptable range of many people that quit.
Heavy smokes 48 solid is just hanging on.
Some do with less but were very light smokers.