SE, NJoy vs FDA -- Discussion

[markmcs]

In California you can buy patches and nic gum without prescription. Same everywhere? There's nothing stopping anybody from chewing nic gum as much and for as long as they like. I know of a couple of people that have been chewing it quite awhile. I used to buy it at Costco. I still have some....

Same thing in NY. No prescription for patches, gum or lozenges any more. Only the inhaler needs a prescription. If e cigs are regulated by FDCA, as a drug, would they then require a prescription too? At least at first?

 

[Vocalek]

Same thing in NY. No prescription for patches, gum or lozenges any more. Only the inhaler needs a prescription. If e cigs are regulated by FDCA, as a drug, would they then require a prescription too? At least at first?

They would probably require a prescription at first if they were regulated under the FDCA as a treatment for a disease. There are no prescriptions required under the tobacco Act for tobacco products (what doctor who did not want to be driven out of business would write such a prescription ---other than the fictional Dr. House who recommended smoking as a treatment for irritable bowel syndrome.) See Nicotine and IBD - Effects of Nicotine on IBD

 

[Vocalek]

let me just make sure i have this straight...from Elaine's personal perception from the hearing, it SEEMS like the judges were swayed in NJOYS favor?

i realize the reality of it is that it could go either way...i'm just curious to get "the woman on the scene's" perspective...

That is correct. It seems as if the FDA lawyer was on the defensive during the majority of the time she had the floor. A judge would ask a question and her response would start with, "No, no no..." She seemed like a very bright woman, but the FDA's position in my opinion is illogical and not based in fact, so she has a tough row to hoe.

 

[5cardstud]

Thanks Vocalek for keeping us informed and taking time to sit through these hearings.

 

[5cardstud]

In California you can buy patches and nic gum without prescription. Same everywhere I suppose. There's nothing stopping anybody from chewing nic gum as much and for as long as they like. I know of a couple of people that have been chewing it quite awhile. I used to buy it at Costco. I still have some....
All the Pharmas can do is raise the nicotine level. More gum flavors - (...or not. Think of the children!)

Thats what gets me Nicotine gum is a product kids would turn to faster than a substance that requires buying a device to take it. Then because some of the flavors are fruity when gum only comes as gum.

 

[JustJulie]

No movement on the docket.

 

[freakindahouse]

Thanks, Yolanda. I'll keep watching. Heading off to meet with MHRA tomorrow, so will post an update as soon as I can.

Cheers,

Katherine

 

[maclean]

Yes, please keep us posted on the UK proceedings. This is a world-wide fight and we all need to join in.

mac

 

[freakindahouse]

Rather than post the update on the UK situation in two threads, I've posted it where it belongs and you can link to it here:

http://www.e-cigarette-forum.com/fo...97316-uk-regulation-discussion-thread-15.html

Cheers,

Katherine

 

[JustJulie]

Still no movement on the docket.

 

[Chris From Cali]

The suspense is killing me. They where supposed to me today correct?

 

[maclean]

Thanks, katherine!

mac

 

[JerryRM]

Thanks Julie....now we wait, for how long is anyone's guess.

 

[JustJulie]

Thanks Julie....now we wait, for how long is anyone's guess.

Yup . . . could be days, weeks, or months.

 

[Shadyshane]

Yup . . . could be days, weeks, or months.

I hope not weeks or months...where did the 9/28 date come from? I saw this posted somewhere else and was wandering why people thought we would have some sort of update yesterday...I was hoping for one...

 

[CJsKee]

Just guessing, shane, but 9/28 may have come from someone mis-remembering the date of the oral arguments...

 

[Bill Godshall]

For clarification, the FDA approved Over-The-Counter marketing for nicotine gums and patches around 1993/94. At that time, it was a bit contraversial within the anti smoking movement, and I was one of the most vocal advocates of allowing nicotine products to be sold OTC so they could more fairly compete against cigarettes.

Regarding the DC Court of Appeals opinion on Sottera v FDA, previous decisions by that court usually occurred 2-10 months after oral arguments.

 

[westcoast2]

I hope not weeks or months...where did the 9/28 date come from? I saw this posted somewhere else and was wandering why people thought we would have some sort of update yesterday...I was hoping for one...

Perhaps this is a reference to the UK MHRA meeting with ECITAS which was on the 28th Sep.

 

[lonercom]

Not sure about 9/28 but 9/30 is when the responses to the FDA warning letters is due.

 

[Chris From Cali]

I'm interested to see how that turns out. Especially with Johnson Creek.