Listen to Croft Woodruff's interview with Dr. Dean here 

(7.2mb mp3 file) 35 minute interview.

Medical errors kill 100,000 people per year in the USA (1.8mb .pdf  file)

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Questions & Answers about Codex, Australia and New Zealand

First and foremost allow us to direct your attention to an article written by Eve Hillary. This article will give you a deeper insight as to the Therapeutic Goods Administration (TGA) Government and regulatory bodies in Australia. The second article is from Dr Rath of Germany, it is an open letter to health food stores around the world relative to Codex. Without reading these articles you will miss important information which will render invalid your full understanding of issues and the motives of groups such as the TGA, ACCC, DOC's, etc.

WHO Privatised the TGA: http://www.evehillary.org/who.privatised.tga.htm

Dr Raths Open Letter http://www.ahf-au.org/dr.rath.health.industry.letter.htm

List of acronyms:

Secondly, when consumer health advocates in Australia talk about Codex affecting Australia they do not use Codex in its simplistic obvious regulatory framework as Codex clearly pertains to foods. In Australia our supplements are regulated as "Therapeutic Goods" by the TGA and are treated in a similar regulatory framework as drugs. 

Many self styled experts in Australia present this difference in regulatory frameworks as absolute evidence that Codex can not affect our access to health supplements and dosages. They are in error. These self styled experts know little, if anything, about international free trade agreements or WTO trade dispute settlement bodies. Ironically this lack of expert knowledge has been displayed during our signatory to the FTA with the United States. These Australian self styled experts knew little about the FTA either yet they all assume to have a solid understanding of the future, because of the FTA Australia has now been sold out to American interests. Now Australia has a another major problem, with the price of health supplements set to escalate dramatically in the coming years and the dosage levels serverly reduced.

http://www.theage.com.au/news/Breaking-News/Warning-on-cost-of-vitamins-under-US-FTA/2005/04/01/1112302207776.html

At this stage if you are sceptical it may be of interest to read the latest third party analysis below commissioned by the Australian supplement company, BioCeuticals.

Who says Codex isn’t a risk to nutritional therapy in Australia?
This article arose from recent conversations between the Alliance for Natural Health and Michael and Alex Hall of BioCeuticals. Michael and Alex remain unconvinced the existing regulations for nutritional substances in Australia will not be changed by future governments to bring them in line with what is alarmingly occurring in Europe. They believe it is imperative the Europeans resist the implementation of what can only be called draconian restrictions. In this article, Dr Robert Verkerk, ANH’s Executive & Scientific Director, explains why he feels Michael and Alex are right to be concerned.

Click here for full article >> http://www.ahf-au.org/ANHwebsiteDoc_249.pdf .

Now moving further, technically the USA do not have to be concerned about the Codex standards either because firstly, like Australia and any other sovereign country outside Europe they are not obliged to conform to any international standards. Secondly they have the DHEA, ratified in 1994, which protects access to health supplements and dosages. But as you can see below, even an astute Congressman or two in the USA can see the writing on the wall....Not so in Australia, the land of the not so astute! We ironically believe, because of our isolation on this tiny island here in the Pacific, that we are immune from world politics, free trade disputes, FTA's and other influence...

If the USA indeed have nothing to fear at this point in time relative to Codex and the WTO then I doubt we would be seeing the likes of Congressman Ron Paul becoming alarmed. Granted that Australia has a different regulatory system, but as already mentioned, this will not stop a trade dispute being brought against us. And if the USA falls to the WTO - Codex regulations then our free trade agreement with the USA makes us even more vulnerable via the SPS measures.

If you would like to understand our FTA with the USA more adequately  >>> Click here ...... Please ask the self styled Australian experts to read this book also instead of just downloading the latest information from the TGA website....which is not an act of research...it is just repeating......and not researching.

Now before we go on lets tackle the introduction that precedes most replies from politicians and health industry experts.

(1) Codex Alimentarius, formed in 1962 is just an inert and well intentioned international body set up by the World Trade Organisation (WTO) and the Food and Agricultural Organisation (FAO) to regulate international food laws such as packaging, safety, labelling and so forth? Yes and no. I wish everything was this simple. On the surface, yes, Codex seems harmless enough, various people involved from many different countries are genuinely working for the common good of the food industry but even the history of how Codex was formed warrants caution and suspicion...It seems the pharmaceutical interests have always been in the driving seat with regards to Codex. Please read the information on this link.... Click here for more......At the very least it makes you question the underlying integrity of the pharmaceutical industries...

(2) The TGA says supplements are regulated as Therapeutic Goods and not foods, and that everything in Australia will be ok. If health supplements are regulated as Therapeutic Goods in Australia and not foods then HOW can Codex affect us here in Australia? True, supplements are regulated as "therapeutic goods" here in Australia. The Therapeutic Goods category regulates supplements similar to drugs. However Codex legislation, in time could "indirectly" influence Australian manufacturing and compliance costs, making supplements prices prohibitive as well as removing certain dosages or combinations...So, how can Codex affect us here in Australia exactly?

In Australia it will be more of a back door mechanism, a Trojan horse, rather than a full, front door, frontal attack as is happening in the UK and soon possibly the USA. At this moment Codex can more directly affect Europe and the USA as the Codex legislation pertains to food and can directly affect their "food regulations" as supplements are regulated as "Foods" in these countries. However, the mechanisms with which these new regulations could be enforced globally is relevant to Australia, the USA is a good example. The USA had passed a bill called the Dietary Health Education Act (DHEA) in 1994 which protects supplements as being regulated as drugs and extends greater consumer choice. Via the North American Free Trade Agreement (NAFTA), Free Trade Area of the Americas (FTAA) and the Central America Free Trade Agreement (CAFTA) this European Codex regulation could eventually be foisted upon the USA regardless of the domestic DHSEA Bill. If the USA and Europe adopt these new regulator standards, especially the new Maximum Permitted Limits (MPL's) & Safe Upper Limits (SUL's) http://www.ahf-au.org/suls.alan.r.gaby.htm  then Australia, still operating under Recommended Daily Allowance (RDA's) can be challenged in the WTO international courts for creating trade barriers against international manufacturers wishing to import into Australia or when our manufacturers export into other countries, then these Australian exporters may be accused of creating trade barriers...as the world is operating under one standard and Australia is operating under another standard. 

Even without the threat of trade barrier legal proceedings, our manufacturers, instead of running two separate production lines, one for export and one for domestic product, would eventually switch to a one size fits all approach and harmonise voluntarily....these are the back door mechanisms that CAN affect Australia.

And even before any of the above scenarios transpire, Australia could still feel the effects of Codex. If Europe and the USA adopt Codex like standards (still being vigorously fought in legal challenges by the UK based ANH), then supplements will be subject to multi-million dollar drug like  trials....this will decimate the smaller manufacturers and add more costs to production. Research will slow as only the large corporations will be able to spend that sort of money. Australia does very little research in the way of dietary supplements, instead Australia relies on research from overseas...

See Dr Caroline Dean's summery (short version) http://www.ahf-au.org/dr.dean.mp3 Even though Dr Dean talks with relevance to the USA, she explains how years earlier Codex was not a threat, then all of a sudden they find it is a threat via free trade agreements....

For a simple outline of the implications of MPL's & SUL's: http://www.alliance-natural-health.org/_docs/ANHWebsiteDoc_145.doc

For a complete and thorough understanding on the gross lack of science in the WHO's so called "Nutrient Risk Assessment" process, read ANH's submission to them at: http://www.alliance-natural-health.org/_docs/ANHWebsiteDoc_121.pdf 

(3) Why do the replies I receive from the politicians say all this seems to be generated from websites overseas in the USA? Because the politicians have done no research at all, they have been given a standard template to reply to their electors with. If they had of done any research they would have found there are at least three sites (below) in Australia and New Zealand who are generating this information. If the politicians can not get this right then what hope do we have of their assurances of "everything will be ok"? Bugger all hope really....they are just regurgitating party policy and TGA dis-information.

http://www.ahf-au.org

http://www.evehillary.org

http://www.nzhealthtrust.co.nz/newsletter_mh16.html

(4) Isn't this just happening in the USA and Europe? Australia does not have to conform to Codex or the WTO?

In part this is true. Technically it is not happening in the USA, at this point in time, however the health advocates and consumers, unlike Australians, can see into the future. Technically Australia or any other nation does not have to conform (at the moment) to Codex. The difference between now and the future is the cost of penalties arising from trade disputes. At this point in time there are no real international standards with regards to health supplements therefore no concern about trade disputes...In the future, even if our supplements are regulated as "Therapeutic Goods" in Australia, it will not stop a trade dispute levelled at us from another participating member country. The WTO's plans for the future are "approved once, accepted everywhere". 'Suzanne Harris writes with regards to the USA experience (link below). The USA supplement industry is regulated as "Foods" and this makes the USA more immediately vulnerable however talk about trade disputes and trade barriers is universally applicable. http://www.thelawloft.com/Freedom/050125_us_law.htm

I was struck recently by an article appearing in the NNFA Today magazine, Volume 18, No.11 entitled "International Products Regulation Q&A: What Affect do They Really Have on the U.S.?" While some parts of the article were good, a number of the questions and answers struck a discordant note including the following:

It was the therefore that really bothered me. If NNFA asked that unnamed bureaucrat about acceptance of guidelines, then it really asked the wrong question. The U.S. generally doesn't accept Codex guidelines nor do other countries. The Codex Secretariat hasn't received a notice of acceptance in the last 10 years. The better question is whether Codex standards and guidelines act as a template or containment within which countries must then write their laws and regulations or face enormous political and legal pressure. To this latter question the answer is clearly yes — write laws within the acceptable field set forth by the applicable Codex standard or guideline or be prepared to accept the consequences, including the risk of cross-sector trade sanctions if you don't.

At this point in time there is a US congress bill H J Res 27 being tabled which withdraws the US from participation of the WTO. This is something Australians should look to implement. http://capwiz.com/jbs/issues/alert/?alertid=7655411

The below synopsis is by author Gary North. North sums up the international trading climate very succinctly.

(5) Why are we sending Australian delegates to the Codex forums?

Very good question. If Australia doesn't have anything to worry about because our supplements are regulated as drugs (Therapeutic Goods), therefore being immune from accepting any international legislation, pertaining to the new Codex Maximum Permitted Limits (MPL's) and Safe Upper Limits (SUL's) http://www.ahf-au.org/suls.alan.r.gaby.htm , then why is Australia sending delegates to the international Codex meetings such as the meeting in Bonn, Germany on 3-7 November 2003 where an Australian delegation headed by Ms. Janine Lewis of FSANZ proposed an application of risk analysis to vitamins and minerals including determining their upper “allowable” limits. Why is Australia proposing guidelines for other countries if we are not going to harmonise to these same proposed "allowable limits"?

                                                              Australian Codex Representatives

(6) What do the pharmaceutical companies have to gain from this restrictive legislation? Don't they also sell supplements? Yes they do sell supplements. In Australia most natural health brands are all owned by pharmaceutical companies. Centrum is owned by Wyeth… Mayne owns Cenovis, Natures Own, BioOrganics, Golden Glow and Hilton products….Natures Way is Australian owned having been bought from Roche. Pharmaceutical companies have been slowly buying health supplement companies over the last decade or more. This then buys the pharmaceutical companies a place at the bargaining table with regards to the industry organisations such as ASMI and also TGA committees. This way the pharmaceutical industry have been able to slowly manipulate the health supplement industry in Australia. So why would they create legislation that would make it harder for consumers to purchase their products?....Their business is disease! They make billions from patented drugs and only millions from health supplements.....If they play their cards right they will be able to hedge their bets. By increasing the entry compliance costs into the health industry they lock out any small newcomers into the natural health arena. Any smaller companies now operating will fold because the expense of compliance has become exorbitant or they will be bought out by the drug companies....People will still be able to get their supplements however at vastly reduced dosages and at higher prices.....as by then we will have conformed to the new international guide lines (MPL's & SUL's) therefore the drug companies will still make money from the ineffectual supplements, the people will be hypnotised thinking they still have access to the supplements, and the people will still get sick and eventually use drugs as the real dosages of vitamins and minerals needed for good health are impossible to sustain or obtain....Even if the supplement brand names the pharma companies own do not make a profit, it doesn't matter as the drug business will be making many more billions rather than just millions! They take a loss to make a gain! That's clever business practice!

(7) They would never try to ban supplements or remove our access to supplements in Australia, Isn't this just conspiracy theories? Ironically the Liberal Government in 1981 have already tried to remove supplements from the shelves and make them prescription only http://www.ahf-au.org/vitamin.scare.htm So, yes they would if they could, just to please their corporate drug company mates.

(8) But surely the TGA and the Australia Government will resist pressure to conform to these international standards? Ahhh...the TGA? There is a special place in my heart reserved for the TGA...The TGA's director recently confirmed in an interview that the TGA receives 100% of its funding from the pharmaceutical industries. When asked if this could cause conflicts of interest he said he could not comment on government policy!

Once again, the TGA's track record of protecting the pharmaceutical interests is an open book. VIOXX, 139,000 deaths and still counting......but no inquiry.....VIOXX is still available for sale!!! http://www.abc.net.au/4corners/content/2005/s1340327.htm Need I say more?...How about ZYban....76 deaths, 8737 adverse reactions.....and how about the class 1 recall of all health supplements that PAN produced when dimenhydrinate (Travelcalm), a pharmaceutical drug manufactured by PAN, only caused dizziness and nausea...How about the enquiry into the natural health industry that followed, recommending sweeping changes and vastly increased compliance costs with criminal penalties and goal terms for offenders! All because of a pharmaceutical drug manufactured by PAN that caused dizziness and nausea but no deaths like VIOXX or Zyban which is still for sale.....Are you starting to join the dots yet? http://www.ahf-au.bigpondhosting.com/eve.hillary.who.privatised.tga.htm#zyban

If heavy fines are levied against Australia because of "trade barriers" the government will say they have no choice but to conform as the fines and penalties from the WTO are too great! 

The governments track record tells a different story. If we look at how the government has sold us out to the US corporations with regards to the Australian PBS, making it easier for the drug companies to make greater profits buy vetoing the cheaper alternative drugs that the PBS committee recommends....

The future in this regards is quite transparent! Of course they will sell us out!

(9) Surely Australian experts from industry bodies like CHC or practitioner bodies like ATMS have done their research? Below is an excerpt from an interview of Robert Verkerk of the Alliance for Natural Health in the UK...

http://www.alliance-natural-health.org The ANH have just been to court in the EU to try to over turn a directive that will make over 300 natural elements illegal and remove from sale over 5000 products....read what the expert body said about proposed EU legislation (this is about how Robert first started getting involved):

"Then a large vitamin company, asked for my views on the EU Food Supplements Directive because they had been informed by the UK Health Food Manufacturers Association that it would not be a major problem. This was around January 2002, just as the Directive was coming into its second reading at the European Parliament. This company had looked at the Directive and seen the so-called Positive List of allowed vitamins and minerals on it. The list contained vitamins and minerals that would be allowed to be sold in Europe after 1st August 2005. A huge range of natural food supplements and organic forms of vitamins and minerals had been omitted from the list which contained mainly inorganic forms."

http://www.zeusinfoservice.com/current_issues.htm

Notice that the "UK Health Food Manufacturers Association" said "that it would not be a major problem". The TGA and ASMI are just another carbon copy of the UK Health Food Manufacturers Association....In the UK, over the next 2 years there were MAJOR problems! The CHC and ATMS are just mindlessly echoing what the TGA and ASMI churn out....and then this 

"supplements are Therapeutic Goods and not foods" mantra goes around in a self perpetuating cycle! Yes supplements are regulated as Therapeutic Goods here in Australia but this does not protect us from WTO trade disputes...

In summery, it seems that the ATMS and the CHC have little idea as to the issues of the future but choose to naively rely on information pushed by the TGA and ASMI....sloppy research really...actually, no research at all!. It seems that the ATMS and the CHC never saw the implications of our latest free trade debacle which will add 5-10% onto the cost of vitamins and minerals, as supplement manufacturers now have to subject their products to drug style patent searches.....In fact no one in the industry saw it until it was too late! And this will be just the tip of the ice berg...
http://www.theage.com.au/news/Breaking-News/Warning-on-cost-of-vitamins-under-US-FTA/2005/04/01/1112302207776.html

Unfortunately very few industry players in Australia have any understanding of free trade agreements and the mechanisms which can be used to implement Codex style regulation in Australia in the coming years....And the ATMS knows almost nothing about free trade agreements!

(10) How can the Trans Tasman Agency/Treaty change how Australia regulates health supplements?

On the surface it doesn't look like it will make much impact to Australia, what is sure is that it will decimate the New Zealand health industry in the short term. With regards to Australia and New Zealand in the longer terms, keep in mind the following paragraphs and sections of the Tran Tasman Treaty as the spirit of the document certainly seems to be setting us up to harmonise with world standards and the WTO: http://www.jtaproject.com/Downloads/Key%20Documents/TreatyText.pdf

Pg1, paragraph (7)
ACKNOWLEDGING their commitment to securing trade liberalisation and an outward-looking approach to trade;

Pg1, paragraph (8)
CONSCIOUS of their obligations under the Agreement establishing the World Trade Organization done at Marrakesh on 15 April 1994;

Pg 5, paragraph (c) 

To avoid barriers to trade except where such barriers are necessary to safeguard public health or safety, or to fulfil other legitimate objectives consistent with the Parties’ international obligations.

(11) How will the Trans Tasman Treaty affect NZ's health industry?

At the moment it seems that it will benefit some of the larger health companies in New Zealand and Australia. The new compliance costs that the TGA will enforce upon NZ health companies will essentially send the smaller players broke as they will not be able to afford to stay in business....The larger companies, especially the ones already owned by pharmaceutical interests will prosper as will other larger non-pharma health companies. New Zealand already regulates their health products as food. This regulation has worked well for many years, it doesn't really need fixing, maybe some small regulatory changes. If New Zealand falls to the TGA Trans Tasman Treaty we may then find we no longer have access to health products, we in Australia once purchased from New Zealand because they were illegal in Australia...now they will also be illegal in New Zealand if the TGA takes control.

(12) Is NZ's health industry in its present form (food) more vulnerable to Codex harmonisation than Australia?

Yes, as the Codex legislation pertains to foods. This would make a good TGA argument for New Zealand to harm-onise to the Australian "Therapeutic Goods" regulations to give NZ more protection ....however, in the longer term there will be no difference as products produced and sold under the "Therapeutic Goods" banner could still be subject to international trade disputes hence having to conform to international regulatory practices such as MPL's & SUL's instead of RDA's...in the long run there is no difference.

(13) Why doesn't my multi level network marketing company get involved, they say there is nothing to worry about? Like the retailers, manufacturer's and wholesalers, the MLM's are concerned about inviting the wrath of the TGA to their door steps. If you put the TGA off side then you could pay dearly, PAN for instance. Multi level marketing companies, like the rest of the industry know little or nothing about free trade agreements. Secondly, many MLM companies especially do not like to stick their heads out if they can avoid it as the press traditionally have been unkind to MLM's, probably because the retail sector see them as a threat, therefore the two groups are not always on the same team! Add to this the MLM's greater need to maintain credibility, membership and sales, the last thing they want to do is rock the boat, lead the charge and initiate action and or public debate....they would sooner just get on quietly with business as usual until the threat becomes so obvious that the whole industry is up in arms....this way they are not an isolated voice which would endanger their reputation and credibility...They will wait for a common consensus....They are not unlike the rest of the industry, retail or manufacturing....no one will go out on a limb...especially while the Government and TGA are saying the opposite.... As in business, the demise of your competition is also to your benefit, so if one MLM becomes vocal and is ostracised, even shut down as in the case of PAN by Government and TGA, then it will be to the benefit of the other MLM's...greater market share for them...It is interesting to note that many Neways (MLM) distributors purchase Neways products from New Zealand because the TGA will not allow these products to be sold in Australia....If the Trans Tasman Treaty goes through I would expect the products that are illegal in Australia now will then be illegal in New Zealand in the future so the Neways people can probably say good by to such incredible products as D-Toxerate, Maximol & Life Enhancer in their present forms.

(14) Why does my practitioner association who represents health practitioners in Australia say the same thing as the TGA, that "health supplements are regulated as Therapeutic Goods and not foods therefore health supplements in Australia can't be affected". The right response from these associations would be to say that: at this point in time there is no threat as health supplements are regulated as Therapeutic Goods here in Australia however in the medium to longer term we may be subject to complexities of international law via free trade agreements hence there could be a threat down the track!

But unfortunately they like to pretend that they are the all seeing all knowing oracles of the industry. They believe it is their job to keep everyone calm, to allay fears that may be detrimental to the industry. This is akin to the band playing on the Titanic....everyone being as calm and happy as Hindu cows while the ship slides beneath the ice cold waters....These associations do everyone a disservice. Like the rest of the industry the associations know little or nothing about free trade Agreements. As well, the practitioner associations are subject to similar business survival needs as that of the health retailers, manufacturers, wholesalers and MLM's. The associations are essentially businesses, they have market share and benefit from the another associations demise. Once again they don't want to be the first ones to stick their heads out either....they are waiting for a collective consensus...Some employees who work for our associations are also members of TGA committees....this could be a conflict of interest or it could simply be that they believe they are representing the associations and members the best way they can....it is hard to tell at this moment. Either way they are doing a disservice to their members in the longer run.

(15) Why aren't some of the health industry companies more vocal and why aren't they raising these issues with the government? Same as the above reasons for MLM's and associations. The larger retailers or manufacturers benefit from the demise of their competitor....they are positioning themselves in the market place. Many health supplement companies, small and large, made many millions of dollars more after the PAN collapse...Secondly, many companies are also fearful of the TGA, they do not want to go up against the Government or TGA when the issues are not easy to articulate here in Australia at present. They are waiting until the issues become more tangible, however when issues become "more tangible" it will be very much too late as the rest of the world would have fallen into line via free trade agreements and Australia & New Zealand will just be a formality! Everyone is hedging their bets, waiting on the fence, watching....until it is all too late! The fence will collapse under the total weight of ignorance and naivety. Many companies believe that if they tread softly, then the TGA will leave them alone. This is akin to helping shovel the bodies into the furnace hoping you will not be next!

(16) Why do the industry bodies like (Australian Self Medication Industry) ASMI and Complimentary Health Council (CHC) repeat the same dis-information as the TGA, that health supplements are regulated as Therapeutic Goods and not foods therefore health supplements in Australia can't be affected! 

Once again...The right response from these industry bodies would be to say that: at this point in time there is no threat as health supplements are regulated as Therapeutic Goods here in Australia however in the medium to longer term we may be subject to complexities of international law via free trade agreements hence there could be threats down the track!

As I have said, they like to pretend that they are the all seeing all knowing oracles of the industry. They believe it is their job to keep everyone calm, to allay fears that may be detrimental to the industry. This is akin to the band playing on the Titanic....everyone being as calm and happy as Hindu cows while the ship slides beneath the ice cold waters....These industry bodies do everyone a disservice. Technically the "Therapeutic Goods" mantra is correct, for this present point in time, but not so for the future. This is what the TGA wants everyone to believe. It is like an anaesthetic putting everyone back to sleep again... ASMI is different to the CHC for one reason. ASMI is mostly the conglomerate of the pharmaceutical industry, the CHC is more aligned with the natural health industry. ASMI seems to be working behind the scenes to undermine the health industry while the CHC seems to be just naive and has not done their research or just do not want to stick their neck out. The unfortunate result is the echoing of the TGA's "Therapeutic Goods" Mantra. Some employees who work for the CHC are also members of TGA committees....this could be a conflict of interest, once again, it is hard to tell at this time. Either way they are doing a disservice to the industry in the longer run.

(17) Why do the lecturers at my college or university say the same thing as the TGA, that health supplements are regulated as Therapeutic Goods and not foods therefore health supplements in Australia can't be affected!
Once again these people teach natural therapies, they know nothing of free trade agreements. Universities and colleges share the same vulnerabilities and business needs as retailers manufacturers and MLM's. Universities and colleges rely on enrolment numbers, they are remise to talk about the future in bleak terms as this will affect there enrolments and budgets. While many academics have worked very hard over the last many years to get university funding for natural therapies this could be put in jeopardy by talk of impending peril and doom ....What academics express to their students and publicly may be very different to what they think and say behind closed doors. It is a balancing act but either way they are also doing a disservice to their students in the longer run. Short term gain at the expense of long term demise!

Other related info: