Page 1 of 3 123 LastLast
Results 1 to 10 of 25
  1. #1
    Senior Member
    Join Date
    Apr 2011
    Location
    Melbourne VIC
    Posts
    1,992

    A question of Scheduling

    I've finally gotten around the summarising the responses I have received from the TGA and Health Department into the promised article. The original post is available here: http://smokescreen.info/wp/archives/503 and has been copied below:

    For the past week I’ve been emailing the Therapeutic Goods Administration, Office of Chemical Safety and Environmental Health and the Department of Health (Victoria) to try and clarify the situation regarding the personal importation of ejuice containing nicotine. In some cases it took multiple emails, in others we received no response at all, but we have received some promising information.


    Office of Chemical Safety and Environmental Health:

    “Nicotine for inhalation for human therapeutic use is included in Schedule 4 (prescription-only medicines) unless it is for use as an aid in withdrawal from tobacco smoking, in which case it is classified in Schedule 2 (pharmacy-only medicines). Any product meeting the definition of a therapeutic good under the Act may not be imported(unless specifically permitted), exported, supplied or manufactured in Australia unless it is included on the Australian Register of Therapeutic Goods (ARTG).”

    Fortunately this information is really in regards to retailing such products. In the case of personal importation it is incorrect.


    Therapeutic Goods Administration:

    “Where nicotine is used for therapy, for example in patches to help with the cessation of smoking, these goods are regulated by the Therapeutic Goods Administration. Such therapeutic goods are subject to the personal importation exemption which allows medicines to be imported for use in the treatment of the importer or a member of their immediate family. Under the personal import scheme exemption, you may import up to three months supply per import and, no more than fifteen months supply per twelve month period.”

    “However in the case of electronic cigarette and nicotine cartridges where they are not being used for therapy, existing restrictions are implemented at the state and territory level. Personal importation of these goods may be possible in some jurisdictions.”


    So we ARE covered by the Personal Importation Scheme as long as we don’t break any state laws in the process. Now as stated above Nicotine falls into the parent category of Schedule 7 making it illegal to obtain or possession in most states (this is controlled by state law). Luckily it would appear that ejuice might not be S7 after all…

    Department of Health and Ageing:

    QUESTION 3: SCHEDULE6: Nicotine in preparations containing 3 per cent or less nicotine when labelled and packed for the treatment of animals.
    Does this mean nicotine liquid could be imported by an individual if labelled and packed as above, as long as nicotine content is below 3% (30mg/ml)?
    Answer: YES.


    This is not ideal, but it is used as a “loop hole” but other industries. One example I can give is a product called “Rapigel” sold by many chiropractors as a “muscle and joint relieving gel”. It is not approved by the TGA so the packaging states “For Animal Treatment Only”.

    QUESTION 4: By the above definitions directly from the Poisons Standard 2010, the usage of electronic cigarette liquid would be considered Schedule 2 as it "aid in withdrawal from tobacco smoking in preparations for inhalation"?

    Answer: YES if it is an aid in withdrawal from tobacco smoking in preparations for inhalation. If it is not for this use (eg. for recreational use) the Schedule 7 parent entry would apply.

    Please note that the Secretariat only provides advice on the meaning of schedule entries. The determination of whether a product is for recreational use or use as an aid in withdrawal from tobacco smoking is up to the enforcing authority (i.e. States and Territories - contact details are provided under Question 1 - http://www.tga.gov.au/industry/sched...t-contacts.htm)

    In addition, a Schedule 2 classification does not indicate that a product is approved. For information on accessing unapproved therapeutics for personal use, please refer to our response under Question 2. (See the above response from the TGA)


    The (Victorian) Department of Health has been contacted to clarify their stance on the classification of ejuice containing nicotine, but has not yet responded. A further follow up email has been sent today and we will keep you informed of whatever response we receive.

  2. #2
    Junior Member
    Join Date
    Apr 2011
    Location
    Canberra
    Posts
    21

    Onya mate

    Kudos, soundasleep, for your sterling efforts on our behalf ...

    It is most definitely an aid in withdrawal from/cessation of smoking - the only one I've found that works.

    Keep up the good work, mate.

    ADS
    Free since April 2011
    T3S clearomiser and Ego-T batteries

  3. #3
    AVF Regular
    Join Date
    Mar 2011
    Location
    Brisbane
    Posts
    1,409
    Quote Originally Posted by AllDaySucker View Post
    Kudos, soundasleep, for your sterling efforts on our behalf ...

    It is most definitely an aid in withdrawal from/cessation of smoking - the only one I've found that works.

    Keep up the good work, mate.

    ADS
    Everything AllDaysucker said.
    Fantastic Soundasleep

  4. #4
    Sik
    Sik is offline
    Senior Member
    Join Date
    Jan 2011
    Location
    melbtarctica
    Posts
    1,671
    Well done mate interesting read. What a fuckin spaghetti trail.

    If u wanna draft a revision for the state legislation and u thing I'm happy to either edit the OP of that or rip it down and get a new one stickied.

    It's intersting that the states point to the TGA and the TGA points at the states and no one does **** all enforcement. Also intersting that qld have backed off with the seizures.

    It's funny tho, if the state and federal authorities would actually do their jobs instead of finding ways to not take responsibilty for anything. (it's not us it's that other governemnt) and law makers could actually make sense instead of speaking gobble de gook. The legal profession would be half the size, so would the public service and those people could do something constructive with their time rather than deciphering the poltician drivel we otherwise know as legislation
    Last edited by Sik; 28-05-11 at 12:46 AM.
    Current Vape: Variable Wattage mod, EPM Boge tanks, Something Fruity

  5. #5
    Senior Member
    Join Date
    Apr 2011
    Location
    Melbourne VIC
    Posts
    1,992
    Bad news guys. Despite the fact that the Federal Department of Health told us that nic juice COULD be considered Schedule 2 I spoke to the Victoria Health Department today (since states get to make the final call) and they consider it S7. The reasoning behind this is as S2 is meant as "Pharmacy Medicine" the Victorian viewpoint is it would need at a minimum TGA listing to be considered.

    Here in lies the problem. To get TGA listing not only costs $630 to apply, $830 per year plus $8390 to go through (maximum 50 pages) of research data to show it's "safe". I'd bet my right lung that the TGA would then still say no since the product isn't "absolutely safe". And all this is for ONE product.

    Money makes the world go round, right?

    So where to go from here?
    1. TGA listing looks to be impractical in the short term - even long term this would mean only big business could sell nic and I think it's safe to say NONE of us want to go down that path.
    2. Don't worry about it while shipments are still getting through.
    3. If seizures start to happen everywhere, we can use the "animal usage" loophole for maximum 30mg/ml juice if we could get an OS vendor to mark the packaging and products "Animal Usage Only". Not ideal, as this still means you might be able to get it, but usage would still be technically illegal.
    4. Ideally, we need the same exception that tobacco currently enjoys, but I honestly can't see that happening either.

    I wouldn't be surprised if a legal challenge of the Schedule would succeed (and even Vic Health seemed to be hinting at this) but I'm sure THAT would cost more than TGA listing would.

    So where do we go next?

  6. #6
    AVF Regular
    Join Date
    Mar 2011
    Location
    Brisbane
    Posts
    1,409
    Hi Soundasleep..I'm hoping for no 2 but I doubt the zealots will let the authorities alone about it for long. I reckon they will try to get the Health people cornered and force them into showing their hand.
    After that the vetinary approach would be all we could try for.
    ridiculous situation isnt it. Thanks for all your hard work.

  7. #7
    Senior Member
    Join Date
    Apr 2011
    Location
    Melbourne VIC
    Posts
    1,992
    Heya Gert. It's far from over yet. I'm just not sure which direction to head in next.

    I'm going to get into the TGA to clarify listing details. If there is any way of getting a generic product listed then it might leave the door open for importing. The real question woul be getting together the $10,000 required

    It's just disgusting that Ms Roxon is so opposed to them in the first place. She so gung-go about getting people to stop, but must be getting enough funding from big pharma to not consider alternatives.

  8. #8
    Member
    Join Date
    May 2011
    Posts
    58
    I spoke to a TGA officer yesterday arvo regarding the personal importation of nicotine, from what I was told it seems that we are not actually covered by the personal importation scheme for unapproved therapeutic goods because TGA does not even recognise nic juice as a therapeutic good, as far as they are concerned its simply a poison. I don't know what it would take to get something recognised as a therapeutic good, still not listed and approved, or whether this would even help the cause. I guess, as it stands, the three month supply rule for personal importation doesn't apply, therefore as long as its not classified as a restricted chemical (QLD & VIC) an individual can import as much as they want...

  9. #9
    Senior Member
    Join Date
    May 2011
    Location
    Perth, Western Australia
    Posts
    143
    Quote Originally Posted by soundasleep View Post
    I'm going to get into the TGA to clarify listing details. If there is any way of getting a generic product listed then it might leave the door open for importing. The real question woul be getting together the $10,000 required
    I reckon it would cost more than that. As I read it there are two kinds of approval. One where you can use overseas studies done to an Australian standard, does not appear to be any. Or the second where you must do clinical trials at local research hospitals.

    I reckon initially you would need a 100k company, say 100 shares at $1000.00 each. Upon approval take on company debt or a second capital raisinng for half a million to get in stock and advertise.

    Potential market is huge compared to this investment given that you can sell at supermarkets and chemists.

    Put me down for a few shares if one of the local proprieters or a few of them collectively set up a company for this purpose.

    The market if similar to USA takeup of 1million here would be approx 100k users. Say 50% go on impoting and 50% buy from shops you could be up for turnover of a few million a month. Definitely worth the gamble in my opinion.
    Last edited by tom32; 08-06-11 at 01:17 PM.

  10. #10
    Senior Member
    Join Date
    Oct 2010
    Posts
    657
    I'll take a few shares in that

    Though my preference would be to keep e-cigs in the free market and out of the hands of the TGA, Big Pharma, Govt, etc.

    Cheers
    Last edited by MACCA350; 08-06-11 at 02:48 PM.
    Daily Setup: Modded 3400mah FDV iStick, Orchid v4 RTA
    Daily Juice: Vaporeyes - Lazer Lombardi
    In the mail: Vapor Flask DNA40

 

 
Page 1 of 3 123 LastLast

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •  
Powered by vBulletin® Version 4.2.4
Copyright © 2020 vBulletin Solutions, Inc. All rights reserved.
Search Engine Friendly URLs by vBSEO 3.6.0
All times are GMT +11. The time now is 10:39 AM.