There goes Australia……. Fine or Jail for importing unavailable Supplements
In a just a few months time, when the Australian government’s amendments to the Therapeutic Goods Act become law, any Australian doctor or member of the public bringing in non-TGA “approved” supplements from overseas, either for sale or for personal consumption, could face jail terms up to 5 years and fines of A$5.0m. Not only that, their ability to purchase, prescribe or otherwise obtain a large number of vitamins, minerals and herbal formulations in Australia at anything like a therapeutic dosage will be severely restricted, if not impossible.
This is just the first step in a concerted push by the Australian government’s Therapeutic Goods Administration (TGA) to curtail the market for complementary medicine in Australia, now worth some A$2.3 billion p.a., in favour of the pharmaceutical industry under the pretext of protecting the Australian public from natural supplements that can harm them or manufacturers trying to cheat them. When the Trans Tasman harmonization program comes into effect and Australia falls into line with the international Codex regulation and standardization of natural medicines the coup against natural medicines will be complete. No Australian doctor or health practitioner will be able to prescribe “unapproved” natural medicines to his patients, and no consumer will be able to obtain them for personal consumption from abroad or in Australian shops, without risk of breaking the law and facing fines and a jail sentence. Under the Tasman harmonization program New Zealand will be forced to follow, however reluctantly.
Only TGA-authorized goods will be available at non-therapeutic doses and only after a hugely expensive approval process, exactly the same criteria as the TGA applies to pharmaceuticals. In other words, from now on vitamins, minerals and herbs will all be classified as drugs, except at very low untherapeutic doses, and you will have to pay a lot more for them, plus having to pay for a consultation with a doctor to get them.
The TGA says it has to do this to protect the Australian consumer against natural medicines, which can be harmful. That is true, but it is a gross distortion of the facts to use that as a reason to schedule all natural medicines as drugs. In a very, very few cases you can harm yourself, but only if you are very, very stupid or very, very unlucky. It would be much more appropriate to require warnings about overuse and adverse interactions with medication. In the last several decades very few Australians have been harmed by natural medicines and even fewer have died. Contrast that with the tens of thousands who have been killed by pharmaceutical drugs, often available over the counter.
The TGA goes on to cite the case of Pan Pharmaceuticals, the largest Australian contract manufacturer of drugs and supplements, who were closed down in April 2003 by the TGA after people became seriously ill from a badly formulated drug for travel sickness (see www.baliadvertiser.biz for article). Pan Pharma was found to have been up to every nasty trick in the book. It did not manufacture its drugs hygienically, which was the cause of the problem, It substituted cheaper ingredients in its supplements and routinely lied on its labeling. The TGA was right to throw the book at them. They are not right to use Pan Pharma as an excuse to regulate away the Australian public’s access to natural medicines.Existing legislation gives the TGA more than enough power to act against Pan Pharma . Unhygienic production methods and falsely describing your goods are already illegal acts. The point is, the TGA had known about Pan Pharma’s cheating over the manufacture of supplements for years and didn’t give a rap. It was only when people nearly died from a Pan Pharma manufactured drug that the TGA felt forced to take action.
Thus, for the TGA so say that in order to protect the public from harming themselves and to protect them from unscrupulous manufacturers all supplements must be regulated in the same way as drugs is clearly not justified by the facts. The truth is that the TGA is acting at the behest of the pharmaceutical companies and a medical establishment that is in their thrall, aided and abetted by overzealous and ignorant regulatory officials. It is all about money and from now on Australians will have to pay a lot more for their supplements and they will be unable to obtain many lifesaving formulations. Even doctors will not be allowed to bring in what they need for their patients from overseas at any price, without risking fines and imprisonment.
In a written submission to parliament objecting to the passage of the new law Dr John Piesse, a prominent physician practicing complementary nutritional medicine said the new law made a bad situation worse. Natural medicine offers better outcomes, has fewer complications and side-effects, is more effective in preventing disease and is increasingly being sought by more and more Australians as an alternative to the use of pharmaceutical drugs.
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The TGA Bill with its amendments not only restricts the availability of safe medicines but cuts across the democratic principle of freedom of choice”, he said. “Making criminals of people who import safe and needed supplements not unavailable under TGA regulation is not only draconian but it is clearly not in the interest of better public health”, he went on.
Here are some examples of just a few products to show the absurdity of the new legislation and what is in store for Australians from now on.
Indole-3-carbinol (I3C): a phytochemical compound used effectively to treat breast, uterine and ovarian cancers in women, and prostate cancer in men. I3C is currently legal and available in Queensland only. It can be imported from New Zealand by practitioners only but with the Tasman Harmonisation in effect, this will no longer be possible. Anyone supplying patients with I3C without special permission of the TGA will face large fines or imprisonment.
5-hydroxy tryptophan: used in the treatment of depression and insomnia is also only available in Queensland.
Vanadium: an essential trace element necessary for bone development and insulin sensitivity. Vanadium is neither registered nor available in Australia. It can currently be imported from the US but under the new legislation any doctor or practitioner selling it to their patients would face fines and imprisonment.
Iodine: studies confirm deficiencies of this mineral of 75% to 80% in Melbourne and Brisbane. Iodine deficiency is responsible for hypothyroidism, which is common in Australia. Currently no iodine supplement is available in tablet or capsule form and it has to be imported from abroad. In future anyone doing so will face fines or imprisonment.
S-adenosyl methionine (SAMe): the most outstanding anti-depressant, effective, quick-acting and without side effects, in contrast with pharmaceutical anti-depressants. SAMe is also a potent anti-inflammatory for osteoarthritis and promotes health of the liver. SAMe is available in Australia but only at low dose tabs of 200mg. SAMe works best with an initial loading dose of 1,600mg followed by a maintenance dose of 800mg.
Other highly valuable non-toxic products unavailable in Australia through TGA diktat include: N-acetyl cysteine: important for liver detoxification and cancer; gamma tocopherol: the most effective form of vitamin E; L-Theanine: an outstanding calmative; lithiumorotate: used to remove aluminium from the body.
Other effective non-toxic products unavailable in Australia at therapeutic doses include: selenium: deficiencies leading to heart disease and cancer; chromium: important for hypoglycemia and type 2 diabetes; melatonin: the natural hormone for sleep and an anti-cancer agent; and vitamin D3; important in the treatment of diabetes, cancer and osteoporosis.
There is no reason why any of these safe substances and many others should not be available legally in Australia and why any doctor or practitioner wishing to use them for their patients should be treated liked a criminal.
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It’s an extraordinarily silly situation”, says Dr Piesse “and is the product of a pro-pharmaceutical, anti-supplement regulatory authority, which is Australia’s TGA”.
So there goes Australia…..
One of the first to criminalise the use of supplements on behalf of minority vested interests and eager to do so. With the passage of Codex by the European Union other countries will inevitably follow Australia’s example. In the months to come you can expect to have to pay a lot more for your supplements and many of them just won’t be available or so low dose you might as well not bother. If you try to get them from another country where they are still available, like America, you risk fines and imprisonment. Many people don’t care about all this and others find the subject all to complicated, but what an extraordinary development in a supposedly democratic society.
