Jarrow B12 now on Prohibited List?

[Lethal Lee]

Hi Catherine,

Wonder if you have seen this?

Jarrow Methyl into Australia
http://www.pernicious-anaemia-society.o ... hp?t=11835

Basically saying that as the product contains Xylitol & since Xylitol was added to list of prohibited items in Feb this year that importing would result in confiscation.
http://www.health.gov.au/internet/main/ ... cursor.htm

I have just becaome aware of this. interestingly I have ordered Jarrow twice this year (after Feb) each was inspected & nothing was confiscated.
I placed another order last Wednesday too...hope no issues there.

I can't find anything to say WHY it was added. It can be imported but only if a permit is granted first.

Just searching if Jarrow is available from Australian source. Just found this one
http://www.evidencia-australia.com/bc/3 ... lamin.html

AU$29.95 for 1000mcg & AU$49.95 for the 5000mcg. Thats at least 100% more expensive than sourcing from iHerb!!!

[Nigel]

How strange. Hopefully no one will catch on.

At least there are other products out there that work well, but not quite as well as the Jarrow one. Looks like a higher dose of another product would be necessary.

[Lethal Lee]

I just checked out iHerbs site. Iif you add Jarrow Methylcobalamin to shopping cart, select Australia as destination, then press calculate, you get additional info as follows....

Information specific to our customers from Australia:

May 2010 - Please Note: According to the latest feedback from our customers in Australia, orders shipped there by International Airmail take an average of 9 business days to be delivered.


Important note: Due to on-going issues with the Australian customs in regards to free product samples, and the extra delays and expenses they were creating for our Australian customers, they can no longer be added to the shopping cart.

International Airmail, Favorite shipping method for our Australian customers. This option applies to orders valued up to $80.00, and weighing no more than 3 lbs., and the average delivery time is 10 days, including weekends. Although very reliable, this method provides no tracking number.

DHL and UPS, with a 5 business day average delivery time. These options offer tracking information and are reliable. However, there may be extra delays and expenses due to customs. Please note, DHL requires someone to be home at the time of delivery.

If using UPS, please do not use a Postal Office Box as your shipping address.

Each country has different laws and regulations about buying products from other countries. As an Australian customer, you are responsible for making sure that buying nutritional supplements from the United States is allowed in Australia. As a general rule however, we suggest that you don't order any hormones, such as Pregnenolone, HGH, 7-Keto etc. Customs appears to not be allowing some Enzyme products to be imported. Please check with customs before attempting to import a product that contains enzymes.

For further information about DHL’s Quarantine Processing Fee and any other queries in relation to shipping with DHL to Australia, please contact DHL Express Customer Service in Australia on +61 7 3845 7850* or by email at http://www.dhl.com.au/en/contact_center ... press.html as certain surcharges may apply to your shipment. (*Please note that this is not a toll free number).

Please Note As of October, 2009: Supplements containing DHEA, Melatonin, XYLITOL, Egg Yolk, Bee Pollen, Banana, Hoodia, Camu Camu Powder, or Cordycepts Powder are NOT ALLOWED to be imported into Australia.
Please do not order.


Please note: if customs confiscates any restricted item from your order we will be unable to refund you for the item.

For further information about customs, import duties, etc., visit:

Therapeutic Goods Administration and Complementary Medicines Regulation


Feedback from Current iHerb Australian Customers

Customers have reported having trouble importing products that are in powder form in Australia. Customs is looking over these products and this can incur extra fees from customs. Please be careful when you purchase items in powder forms, especially teas. This charge can be as much as $50 for one product!

New restrictions include milk products, products that include worm wood as an ingredient and hemp oil (based on 3/53 individual comments)

For additional information regarding Australian Customs Information, check out the following websites:

Australian Customs Website
http://www.customs.gov.au/

Australian Customs Website – Contact Info
http://www.customs.gov.au/site/page5834.asp

Australian Customs Website – Prohibited/ Restricted Imports
http://www.customs.gov.au/site/page4369.asp

Australian Department of Health & Aging - List of drug substances requiring import / export authorizations
http://www.health.gov.au/internet/main/ ... cursor.htm

Australian Quarantine and Inspection Service - Imports Conditions Search
http://www.aqis.gov.au/icon32/asp/ex_querycontent.asp

[CatherineOz]

Hey Lee!

Thanks for this, no, I didn't know, I'll make it a sticky so everyone here knows.

I have never been happy with the xylitol in Jarrow B12 but no-one else seemed to mind (any wood alcohol sweetener is still a wood alcohol as far as I'm concerned) and am very surprised that customs have flagged this - HOWEVER - my brain just reminded me that anything that is an animal or plant product that can be wildly imagined to compromise a primary industry plant or animal product in our pristine land comes up for banning now and again. I know one of our members was not allowed to import bilberry (an OTC product here) because it is of plant origin, and therefore a threat to primary production. I saw a lot of things on that list being organic, plant, animal or in origin.. and the hormones thrown in for good measure... maybe, just maybe that's what it's all about?

ok gang, the hunt is on for alternate sources!! or petitioning customs!!

[Lethal Lee]

Hi Catherine,

I still find this quite puzzling. There is nothing on Customs or TGA about why or when Xylitol was added.
Certainly there are many Australian shops & Australian online sources where you can buy 100% pure Xylitol in bulk amounts???

The only thing I found was this....

http://www.health.gov.au/internet/main/publishing.nsf/Content/health-mediarel-yr1999-gt-gtsp981203.htm
Early action, based on Australian adverse reaction reports, saw the banning of intravenous Xylitol when ADEC associated it with life-threatening metabolic acidosis and liver damage

[CatherineOz]

Frustrating innit? that's why I mentioned other things you can buy OTC which can't be imported for reasons of infecting our crops, livestock or native flora and fauna. That was the reason for not being able to import bilberry, despite it being processed before encapsulating not to mention sealed etc.

no idea!!

[Nigel]

But you could pee out the bilberry and kill some fish, right? ahaha

[CatherineOz]

hehehe good thought Nige! They said it was because Australia was a producer of Bilberry so it wasn't to be imported as "foreign" Bilberry might contaminate the local stuffs... xenophobic maybe???

[Nigel]

I don't think it's even native to Australia.

What I really want to know is how I can turn that supplement into a plant!!!??? Grow baby grow.

[CatherineOz]

not just about natives Nige, it's about anything in agriculture also, if it lives here, indigenous or not, commercial or not, has cultural or financial value, then it's likely to come up as an issue, probably moreso things with a commercial value.. like Bilberry, or so I was told...
the emails are on my dead HDD and not sure if my file recovery endeavours rescued them or not.. soz.
could also be due to some study that we haven't found yet on xylitol... I did some research on it when it was first used as an artificial sweetener, because I am opposed generally to the use of artificial sweetener - what's wrong with bitter anyway? and there were some iffy responses out there but most were positive, so I let it go.. plus, the jarrow methylcobalamin is a tiny amount of xylitol.. not like drinking litres of artificially sweetened soft drink or soda or whatever it's called xxx

[Nigel]

It's okay, I didn't like the taste of Jarrow either and use others.

It's all called Coke in the south-southeast USA, Cat. "Pop" if you're north of Texas. Not soda pop, just pop. You'd spell it more like "parp". Make sure you clamp your nose shut and you'll get the right flair if you choose to say pop.

-Xyliphobic Nigel

[CatherineOz]

parp gimme a big parp.... STAT!!!

[Lethal Lee]

Ok I rang TGA 1800020653 to clarify.

Xylitol is a prohibited substance
-it is not BANNED
-however you need to get an import permit
-there is NO distinction between 100% pure or an a minor excipient in a proprietory product
-so this applies to ANY product (not just Jarrow methyl B12) whether a toothpaste, chewing gum, vitamin, etc that is considered a 'therapeutic good'.

List of Prohibited Imports/Exports
http://www.health.gov.au/internet/main/ ... cursor.htm

The correct way to legally import is via the SAS (Special Access Scheme)
http://www.tga.gov.au/hp/sas.htm

Download Guide here
http://www.tga.gov.au/docs/pdf/unapproved/sas.pdf

Step 1 Apply for SAS Approval to Import (will have to be signed by a Doc) for EACH Patient

Download form here
CATEGORY B FORM SPECIAL ACCESS SCHEME
http://www.tga.gov.au/docs/pdf/unapproved/sascatb.pdf
Doc must fill out sign & fax to number on form

Step 2 TGA will consider & send Letter Giving Approval
Approval is valid for 12 months
Must hold letter & produce if asked by Customs
Will likely send this to Doc so will have to ask Doc to forward COPY to you (Doc needs to keep ORIGINALS).
You will need to attach copy to each import permit application (need to get one BEFORE each order you place)
told takes 4-5 working days

Step 3 As Xylitol is on Prohibited list will also have to apply for an IMPORT PERMIT every time you want to place an order
Application for a permit to import goods with Special Access Scheme approval
processing will take 4-5 working days each time

How do I get the product once the TGA has given approval?
http://www.tga.gov.au/hp/sasfaq.htm
If the product is available from a supplier in Australia, you should contact the supplier (sponsor) to organise supply.
Within an institution supply of a medicine can usually be arranged by the pharmacy department.
The supplier will require authorisation to release the product. In the case of supply for a category A patient, the completed 'Authority to Supply' form acts as the authorisation.
For category B patients, an approval number is issued by the TGA and will appear in an approval letter sent to the requesting doctor by the TGA.
This number must be quoted in all correspondence with the sponsor.

If the product is not available from an Australian sponsor, the requesting doctor will need to find an overseas source.
The product will then need to be imported from that supplier. This can be done by the doctor, a pharmacist, hospital, by the patient or by a licensed importer.
When seeking to arrange importation of an unapproved medicine, it is important to check whether it is controlled under Customs (Prohibited Import) Regulations,
in which case it cannot be imported without an import permit.
A list of controlled substances can be found on the Australian Government Department of Health and Ageing website.
When approval is given under the SAS for supply of a controlled medicine, an import permit will be issued by either the TGA or the Office of Chemical Safety and Environmental Health.
The TGA may be contacted on 1800 020 653 or 02 6232 8101 and the Office of Chemical Safety and Environmental Health may be contacted on 02 6289 2686.

In the case of Xylitol Import permits are issued by the TGA.
There is no formal template/application form for an individual to apply for the permit.

You merely write a letter & either post or fax as follows......

Experimental Products Unit
TGA
PO Box 100 Woden ACT 2606
Fax 02 62328112

Experimental Products Unit TGA
PO Box 100 Woden ACT 2606
Fax (02) 62328112
Email eds@tga.gov.au

Further to SAS approval (see attached copy) I wish to apply for an import permit for personal importation of
-xxxx bottles of product specifics (manufacturer Brand, active & inactive ingredients)
note amount of Xylitol in product MUST be specified too
Also important to specify WHERE permit is to be sent (otherwise will go to the Doc who applied for SAS Approval)
Note only attach COPY of SAS approval letter (Doc must keep ORIGINAL)

SAS approval is valid for 12 months only & must be renewed by repeating approval process
Amounts imported are subject to personal importation guidelines (3 months supply per order only 15 months supply in any 12 month period)

I am writing to Jarrow to find out specifics of how much Xylitol is in their 1000mcg & 5000mcg Methylcobalamin

[Lethal Lee]

Ok I rang TGA 1800020653 to clarify.

Xylitol is a prohibited substance
-it is not BANNED
-however you need to get an import permit
-there is NO distinction between 100% pure or an a minor excipient in a proprietory product
-so this applies to ANY product (not just Jarrow methyl B12) whether a toothpaste, chewing gum, vitamin, etc that is considered a 'therapeutic good'.

List of Prohibited Imports/Exports
http://www.health.gov.au/internet/main/ ... cursor.htm

The correct way to legally import is via the SAS (Special Access Scheme)
http://www.tga.gov.au/hp/sas.htm

Download Guide here
http://www.tga.gov.au/docs/pdf/unapproved/sas.pdf

Step 1 Apply for SAS Approval to Import (will have to be signed by a Doc) for EACH Patient

Download form here
CATEGORY B FORM SPECIAL ACCESS SCHEME
http://www.tga.gov.au/docs/pdf/unapproved/sascatb.pdf
Doc must fill out sign & fax to number on form

Step 2 TGA will consider & send Letter Giving Approval
Approval is valid for 12 months
Must hold letter & produce if asked by Customs
Will likely send this to Doc so will have to ask Doc to forward COPY to you (Doc needs to keep ORIGINALS).
You will need to attach copy to each import permit application (need to get one BEFORE each order you place)
told takes 4-5 working days

Step 3 As Xylitol is on Prohibited list will also have to apply for an IMPORT PERMIT every time you want to place an order
Application for a permit to import goods with Special Access Scheme approval
processing will take 4-5 working days each time

How do I get the product once the TGA has given approval?
http://www.tga.gov.au/hp/sasfaq.htm
If the product is available from a supplier in Australia, you should contact the supplier (sponsor) to organise supply.
Within an institution supply of a medicine can usually be arranged by the pharmacy department.
The supplier will require authorisation to release the product. In the case of supply for a category A patient, the completed 'Authority to Supply' form acts as the authorisation.
For category B patients, an approval number is issued by the TGA and will appear in an approval letter sent to the requesting doctor by the TGA.
This number must be quoted in all correspondence with the sponsor.

If the product is not available from an Australian sponsor, the requesting doctor will need to find an overseas source.
The product will then need to be imported from that supplier. This can be done by the doctor, a pharmacist, hospital, by the patient or by a licensed importer.
When seeking to arrange importation of an unapproved medicine, it is important to check whether it is controlled under Customs (Prohibited Import) Regulations,
in which case it cannot be imported without an import permit.
A list of controlled substances can be found on the Australian Government Department of Health and Ageing website.
When approval is given under the SAS for supply of a controlled medicine, an import permit will be issued by either the TGA or the Office of Chemical Safety and Environmental Health.
The TGA may be contacted on 1800 020 653 or 02 6232 8101 and the Office of Chemical Safety and Environmental Health may be contacted on 02 6289 2686.

In the case of Xylitol Import permits are issued by the TGA.
There is no formal template/application form for an individual to apply for the permit.

You merely write a letter & either post or fax as follows......

Experimental Products Unit
TGA
PO Box 100 Woden ACT 2606
Fax 02 62328112

Experimental Products Unit TGA
PO Box 100 Woden ACT 2606
Fax (02) 62328112
Email eds@tga.gov.au

Further to SAS approval (see attached copy) I wish to apply for an import permit for personal importation of
-xxxx bottles of product specifics (manufacturer Brand, active & inactive ingredients)
note amount of Xylitol in product MUST be specified too
Also important to specify WHERE permit is to be sent (otherwise will go to the Doc who applied for SAS Approval)
Note only attach COPY of SAS approval letter (Doc must keep ORIGINAL)

SAS approval is valid for 12 months only & must be renewed by repeating approval process
Amounts imported are subject to personal importation guidelines (3 months supply per order only 15 months supply in any 12 month period)

I am writing to Jarrow to find out specifics of how much Xylitol is in their 1000mcg & 5000mcg Methylcobalamin

Step Four place your order!!!!

[Lethal Lee]

Just wanted to add Xylitol is NOT a recent addition. It has been on the Prohibited list for many years.

TGA would LOVE for folks to complain about Xylitol being Prohibited when it is a minor excipient in Proprietory products.
It wastes their time, your Doc's time (assuming you can get one to sign the SAS approval application) & ours.

Of course the legislation predates Xylitol's approval in USA & other countries as safe & it's use as an excipient in proprietory products.

Original concerns with it was as an intravenous product. Apparently the Wine Industry also 'abused' it's use (according to the person I spoke to at the TGA).

The only side effects I have been abler to find with Xylitol is bowel related (purgative) at high doses.

With the Diabetes explosion it should be Australian approved anyway IMHO.