NDPSC Kava News

[Thelema]

PIPER METHYSTICUM (kava) – Amend entry to read:

PIPER METHYSTICUM (kava) in preparations for human use except when included on the Australian Register of Therapeutic Goods in preparations:

(a) for oral use when present in tablet, capsule or teabag form that is labelled with a recommended maximum daily dose of 250 mg or less of kavalactones, and:

(i) the tablet or capsule form contains 125 mg or less of kavalactones per tablet or capsule; or

(ii) the amount of dried whole or peeled rhizome in the teabag does not exceed 3 g,

and, where containing more than 25 mg of kavalactones per dose, compliant with the requirements of the Required Advisory Statements for Medicine Labels;

( in topical preparations for use on the rectum, vagina or throat containing dried whole or peeled rhizome or containing aqueous dispersions or aqueous extracts of whole or peeled rhizome; or

© in dermal preparations.

from october minutes of meetings

here

[Torsten]

has been posted at least once already with extensive commentary on the definitions etc.

[piper678]

This is the latest NDPSC on kava (as of today 08.05.09) which says they have done nothing further. http://www.tga.gov.au/ndpsc/record/rr200902.pdf

[Torsten]

This is the latest NDPSC on kava (as of today 08.05.09) which says they have done nothing further. http://www.tga.gov.au/ndpsc/record/rr200902.pdf

It's an interesting read though. It seems like the TGA is leaving itself a backdoor open and is shifting policy blame onto the PREVIOUS federal government. I just got the feeling they mentioned the political policy and health imperatives of the previous government a few too many times. Normally the TGA likes to take credit for it's 'pro-active' scheduling role, but in this case they don't seem to feel they are on firm ground and are clearing the way for a few backdoor retreats.

I am also glad they spelled out the exact interpretation of the SUSDP entry in this document as there seemed a lot of confusion about it [incl within the TGA and customs itself]. It is exactly the same interpretation I gave in another thread here several months ago.

[piper678]

That latest submission was written from my camp. We are forced into taking a new view in this ridiculous kava war. LAW. When politics, reason and science fail, law will not. The law approach can also be broadened to include “research” bodies who do not bother to check what their researchers are up. Allowing dodgy personal politics and dangerous “scientific” practises to masquerade as genuine research and then go ahead and blindly publish deliberate untruths until it becomes fact in the minds of the lazy and ignorant is simply not on. If factual scientific presentation does not work with Regulatory bodies, than the Courts with their power of awarding damages is the only option left.

Some sensible supporting public comments to NDPSC would be useful. If they want to back door out that is fine by me, as long as they simply get out as this beat up of kava is simply BS at its finest.

[kenny]

Excuse my ignorance on the matter.... couple questions though, in the interest of not stupidly breaking the law.

From the above information I understand it to be saying that It is legal to consume Kava preparations in those specified forms. Are these tablet's requiring a prescription to purchase? A post I read earlier gave me the feeling that the answer is yes, however I have spotted tablets for sale openly. So I'm still a bit confused.

I pulled this from http://www.customs.gov.au/site/page.cfm?u=4369#e1065 regarding importation of Kava.

"blah blah..

Exemption:

A passenger, on a ship or aircraft, aged 18 years or more, may import up to two (2) kilograms of kava in either root or dried powder form in their accompanied baggage without a permit.

blah blah.. "

Which was helpful considering I have an International Pilot friend who I am going to ask to bring me back some on his next flight.

Even though it clearly states ' root or dried powder ' does that leave any room for interpretation. Such as some interesting 'chocolate kava' dips I have seen online (which unfortunately didn't list the amount of kava used.

Or is it all just a matter of.

1) if your in AU you need to get it via a doctor

2) entering australia, root/root powder is the only legal option.

Thanks.

[Torsten]

That whole personal import thing is actually a contradiction in the law. The TGA scheduling does not make any allowances for ANY kava unless it is on the therapeutics goods register. So, essentially the way the law stands it is legal to carry 2kg on your person through customs, but once you enter australia that 2kg of kava then becomes S4 and you are guilty of being in possession of an S4 without prescription. Hilarious how crappy laws become when they are politically motivated and rushed.

Anyway, I think the kava laws are really about stopping the import and sale of kava and that authorities don't care about the personal consumption. That's not to say the law won't be enforced strictly at a later point. The slide of kava from panacea to poison has been a gradual one and I doubt we have reached the end. When the government introduced compulsory registration for all kava importers and wholesalers last decade I already knew the next step would be to then prohibit it. That's how they make sure they catch everyone involved.

[kenny]

Thanks for pointing that out to me. I never considered that loop hole, its quite funny actually. I may make a few phone calls and see what they tell me

[Torsten]

as you can see from some of the other discussions here, no one really knows what is going on with kava at the moment, so don't get your hopes up.

[piper678]

According to our Australia High Commission in Vanuatu, and direct information from Trade Departments in Tonga and Samoa, "in recognition of the cultural value of kava to the Pacific Islanders" the 2 kg import has been signed off as allowable by the appropriate Minister in Australia, so it is legal to CARRY on you 2 kg in person. I would not recommend phone calls as an answer from Office of Chemical Safety, get this in writing. As this is a plant product it MUST be declared to Quarantine on arrival and that’s it.

International flight airline staff can and do bring in kava. If they drink it themselves who knows, it has not yet reached the stage where the enforcement agencies follow them around. What I would like to see is the police raid a Ministerial Pacific island meeting in Canberra, where kava is being shared with Australia politicians and they all get busted for supplying for sharing a prescription item not prescribed by a doctor or supplied by a pharmacist. Or a big raid on a Tongan or Samoan wedding, funeral or celebration.

However you could bring in 10 ton of piper wichmanni. It is NOT illegal.

[Thelema]

The personal importation laws clearly allow the importation of [most, if not all] S4 medicines into Australia via personal baggages in transit. However, these laws clearly do not cover international post.

The assertion that then once in Oz you could get 'busted' for possession of an S4 w/o prescription I find doubtful. What might you be basing this on? Your reading of personal importation as a carrier is clearly at odds with mine.

[Torsten]

The personal importation laws clearly allow the importation of [most, if not all] S4 medicines into Australia via personal baggages in transit.

Yes, but you need to have a valid prescription or evidence of prescription [eg pharmacy label in your name]. You can't just import prescription medicines into australia on your person without some authorisation. Also, the amount you can import is limited to 3 months supply as per pharmacy label as far as I remember.

[Thelema]

Hi, you're right about the 3 month thing, sure.

But I'm really quite sure there is no clause specifying that the s4 was issued to you offshore by a foreign apothecary or doctor. Offshore doctor's prescriptions carry no weight when trying to order in s4 through the post, so why would they count as a form of legal instrument in justifying legality of carry-through s4's? I'm sure the pharmaceutical guild of australia would object to such a requirement.

Maybe you're mixing this up with the requirement that s4's ordered by post must have an Australian Doctor's approval [prescription] accompanying it for the substance to be passed.

Foreign prescriptions are not recognized at all in Australia in the way you are suggesting, or in any way.

[Torsten]

so anyone caught in possession of an S4 in australia could just say that a mate carried it in on their person a few weeks ago?

If you are right that no name label is required then there is no proof of who the medication was given to and as you say once it is in the country the S4 restrctions don't apply to it as it was a carry in import.

something doesn't match up.....

[piper678]

Pardon the pun, but that part has me rooted too! According once again to our esteemed High Commission if is common knowledge that kava is shared. Hope the Court feels the same if everyone is charged at Pacific Island celebration sharing their prescription item. Apparently not been gazetted, and I cannot find same, so I can only imagine it is not law... yet. Maybe I missed something. Any updates?

[Torsten]

wow, I can't believe the TGA is actually going to re evaluate the scheduling of plain kava root [announced today]. Kava may once again be legal come June.... mind you the fuckers take nearly 2 months to publish their bloody decisions, so it's more like august.

[piper678]

wow, I can't believe the TGA is actually going to re evaluate the scheduling of plain kava root [announced today]. Kava may once again be legal come June.... mind you the fuckers take nearly 2 months to publish their bloody decisions, so it's more like august.

Yes, they were kind enough to write to me and say so, however.... Now note the key word. "reconsidering" http://www.tga.gov.au/ndpsc/gazette/g0906pre.pdf page two 1.4 Piper methysticum (Kava) – consideration of scheduling, including a proposal to exempt the dried

root or rhizome from scheduling (see item 12.1.5 of the February 2009 Record of Reasons).

I was also informed that there will be advertisements (where??) so that the general public can have a chance to comment on this rescheduling. Is this standard or normal? The last thing I need to see is that aging economist and the dodgy researcher being once again the only two who favoured for very suspect reasons the original prescription scheduling that appeared out of the blue popping. Do mot need them popping up by stealth again. I have already had my camp do the latest submission that triggered the rethink so I guess I will no doubt be not considered proper to make further comments. I can get some very high level support from overseas scientists and industry groups but I will need to tell them where to send their comments and/or submissions to.

All suggestions greatly appreciated. Thanks.

Edited April 23, 2009 by piper678

[Torsten]

The forms for submission are on the TGA website. what sort of submissions would help? ethnic australians and anxiety patients are probably the best voices outisde the science world, but who else?

[C_T]

What about those guy's that got prosecuted for importing kava...

[piper678]

What about those guy's that got prosecuted for importing kava...

You mean the ones that tried to hide it? That is the same as trying to sneak in an amount of yams, coconuts etc.. Failure to declare agricultural or animal products will mean Quarantine will rightfully kick your backside all over the place for things like that.

[piper678]

The forms for submission are on the TGA website. what sort of submissions would help? ethnic australians and anxiety patients are probably the best voices outisde the science world, but who else?

Will post more on that as soon as I can, Working with a broken shoulder, out of hospital, but ouch factor too high and this is not yet urgent as have plenty of time to reply and suggest.

[Thelema]

so anyone caught in possession of an S4 in australia could just say that a mate carried it in on their person a few weeks ago?

If you are right that no name label is required then there is no proof of who the medication was given to and as you say once it is in the country the S4 restrctions don't apply to it as it was a carry in import.

something doesn't match up.....

here it is from the health website: here

Importation of Kava

From 26 June 2007, the existing regulations on importation of kava were strictly enforced with the effect that commercial importations of kava were no longer allowed except for medical or scientific purposes.

Import and Export of Controlled Substances

Links to information and guidance for importers and exporters

General Guidance for Commercial Importers and Exporters

Application forms and guidelines

General Guidance for travellers bringing medicines to and from Australia

List of drug substances requiring import and/or export authorisations

Importation of Kava

Incoming passengers who are over the age of 18 years are allowed to bring 2 kg of kava into Australia in their accompanied baggage.

Frequently asked questions about restrictions on the importation of kava

What changes have been made to the import arrangements for kava?

Consistent with existing regulations set out in the Customs (Prohibited Imports) Regulations 1956, the importation of kava will only be permitted for medical and/or scientific purposes.

The potential for diversion of such kava to non-medicinal or non-scientific uses will be assessed and monitored.

Recognising that kava has traditional ceremonial and cultural uses for people of South Pacific Islander descent, the existing approval that allows for the import of up to 2 kg of kava in the accompanied baggage of an incoming passenger (aged 18 years or over) to Australia will continue.

Why have these changes been implemented?

The action was taken in response to concerns that the abuse of kava was contributing to negative health and social outcomes in some Indigenous communities.

I have been granted an import permit that is still current but I have not yet imported any kava using the permit. Can I import the amount specified on the permit?

All imports of kava under existing permits that are not for medical and/or scientific purposes will be detained by the Australian Customs Service from 26 June 2007.

What about existing shipments of kava that are not for medical and/or scientific purposes?

A "buy back" scheme was established for kava that is not for medical and/or scientific purposes, and which is detained as part of the decision to tighten import restrictions of kava.

The "buy back" scheme applies to permit holders who have paid for the kava or became legally bound to pay for the kava on or before 25 June 2007 and can provide appropriate evidence to validate their claim. The value of the kava will be calculated in accordance with Customs valuations arrangements.

Please contact the Office of Chemical Safety for further advice.

I have stocks of kava that were imported using previously issued permits. Can I continue to use/sell/supply kava?

All kava delivered into home consumption before 26 June 2007 can be utilised for the purposes for which it was imported. No new import permits will be granted for other than medical and/or scientific purposes. Note that you will also need to comply with all State and/or Territory legislation in relation to kava.

Top of page

Can I apply for more permits to import kava?

From 25 June 2007, import permits will only be issued for medical and/or scientific purposes.

Can I import kava without a permit?

If you are aged 18 years or more you can bring into Australia up to 2 kg of the root or dried form of kava in your accompanied baggage when entering the country. Under any other circumstances importation of kava without a permit issued by the Office of Chemical Safety is an offence under the Customs Act 1901 and subject to prosecution.

I use kava for cultural purposes. How can I get supplies of kava?

Kava for cultural use can only be brought into the country in the accompanied baggage of a person entering Australia. Any person aged 18 years or more entering Australia from overseas can bring up to 2 kg of kava (in root or dried form) into the country as part of their accompanied baggage.

Note that products listed or registered under the Therapeutic Goods Act 1989 cannot be imported via this mechanism.

Why has the allowance for 2 kg of kava in accompanied baggage been retained?

This practice has been maintained to reflect the cultural significance of kava use by people of South Pacific Islander descent.

I want to import therapeutic products approved by the Therapeutic Goods Administration that contain kava or kava raw material for manufacture of approved therapeutic products or for scientific purposes. How do I legally import kava for this purpose?

Kava in any form is a prohibited import and in accordance with the Customs (Prohibited Imports) Regulations 1956 you must hold a licence and a permit issued by the Office of Chemical Safety before importing it for medical and/or scientific purposes. You will be required to substantiate the approval status and/or use of the imported material and any permit may be subject to conditions on the custody or use of the substances. You are advised to contact the Office of Chemical Safety before you import kava.

You may contact the Office of Chemical Safety at [email protected] for further information or to obtain application forms to import kava for medical and scientific purposes.Top of page

[apothecary]

Can anyone get a copy of this paper which just came out? I saw a dumbed down piece on it in the newspaper today on my lunch-break.

Kava Anxiety Depression Spectrum Study (KADSS): A mixed methods RCT using an aqueous extract of Piper methysticum

Complementary Therapies in Medicine, Volume 17, Issue 3, Pages 176-178

J. Sarris, D. Kavanagh, J. Adams, K. Bone, G. Byrne

Time for a reassessment of the use of Kava in anxiety?

Complementary Therapies in Medicine, Volume 17, Issue 3, Pages 121-122

J. Sarris, J. Adams, J. Wardle

St. John's wort and Kava in treating major depressive disorder with comorbid anxiety: a randomised double-blind placebo-controlled pilot trial

Jerome Sarris 1 *, David J. Kavanagh 2, Gary Deed 1, Kerry M. Bone 3

These would be perfect submissions to the TGA I think.

[Alchemica]

Only have access to the first one at the moment:

The_Kava_Anxiety_Depression_Spectrum_Study.pdf

(Assume it's similar to the Complementary Therapies in Medicine paper just with more details...)

The_Kava_Anxiety_Depression_Spectrum_Study.pdf

The_Kava_Anxiety_Depression_Spectrum_Study.pdf

Edited May 13, 2009 by The Alchemist

[apothecary]

Only have access to the first one at the moment:

The_Kava_Anxiety_Depression_Spectrum_Study.pdf