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Australia, CODEX, the facts without fiction?

 

 
 

Dear Health Freedom Advocate,

The last few days, in fact the last few months have seen an increase in people taking notice of international affairs regarding CODEX and vitamin supplements. Many so styled experts have made commentary. Some with a good grounding in international affairs and some with poor knowledge of international affairs.

Firstly, I would like to reinforce in everyone's minds that whilst the European Union (EU) court outcome may be promising http://www.alliance-natural-health.org/index.cfm?action=news&ID=151
, it still does not stop CODEX from ratifying its restrictive guidelines on vitamins, minerals and supplements within the World Health Organisation (WHO) and World Trade Organisation (WTO ) framework. The United Kingdom (UK) may not have to adopt these restrictive guidelines; however these guidelines can still be passed into WHO and WTO legislation. Hence, sooner or later, even if a win against the EU transpires, in the much further future we may have the same problems trust upon us by the WTO or WHO.

The bottom line is that nothing is absolutely certain - most especially with regards to Australia, the picture is a little clearer overseas in the US and EU. So don't go believing the "experts". I do not think that one commentator or speaker in Australia truly could call themselves an expert in free trade agreements, treaties, WHO and WTO legislation. This is evident by the fact that our health industry is only now waking up to the implications of our so called "Free Trade Agreement" with the USA which has left our health supplement industry exposed to rising costs relative to new patient infringement checks. http://www.theage.com.au/news/Breaking-News/Warning-on-cost-of-vitamins-under-US-FTA/2005/04/01/1112302207776.html

 ...Not even our most prudent experts saw this coming until after we signed on the dotted line.....So please keep this in mind when listening to this "expert opinion" from TGA, ASMI, CHC, ATMS, CRN, FDA sources, telling us that we have nothing to worry about! 

(Aust) Therapeutic Goods Administration (TGA) 
(Aust) Australian Self Medication Industry (ASMI) 
(Aust) Complementary Health Council (CHC)
(Aust) Australian Traditional Medicine Society (ATMS)
(USA) Council for Responsible Nutrition (CRN)
(USA) Food and Drug Administration (FDA) 

We don't know the specifics of how CODEX could affect Australia; however the TGA and the pharmaceutical industry are already slowly undermining our natural health industry. "New rules curb herbal drug sales" http://www.smh.com.au/news/National/Strict-new-rules-curb-herbal-drug-sales/2005/03/09/1110316095506.html

 

The TGA is slowly regulating many health products or electro-medical devices illegal. In fact the latest government initiative generated by the "Expert Committee on Complementary Medicines in the Health System" may come close to seeing Homeopathy illegal http://www.paradigm-changes.com/grec.2005.pdf


With regards to CODEX, yes it is true that Australia is regulated differently from the USA. Australia does class health supplements as "Therapeutic Goods" that are regulated in a similar fashion to drugs. However this is no absolute safeguard when it comes to international trade disputes or WHO and WTO legislation. And if the TGA's and governments new agenda takes force we will see natural health supplement prices rise to possibly unaffordable levels. Health products don't have to be made illegal, just too expensive! This will bar access to many of the populace! (please read Sydney Morning Herald article at URL above)

How may international affairs impact Australia?
1/ It is possible that the costs of vitamins, minerals and other supplements will escalate because of new international recommended daily allowances, new research criteria and/or packaging and manufacturing standards. In this case a product doesn't have to be made illegal as it may already be out of reach because the price tag is too expensive.

2/ If the USA is forced to take on restrictive legislation then research may slow to a trickle. Australia does very little research and development in the health field. Australia relies on data from the USA and overseas. Only last year did the Australian government dole out one million dollars in an arbitrary fashion. Australia relies very much on research from the USA, and if research becomes so costly (million dollar drug trials) in the USA then Australia will also feel the pinch.

3/ In a more extreme scenario, it may be possible that our access to certain supplements (or dosages) could be taken from us in Australia. This is hard to imagine given that our supplements are regulated as therapeutic goods, but it is a conceivable outcome given the power of the WHO, WTO and free trade agreements.

What we do know!
While this is all still a speculative issue here in Australia, what we do know is that the TGA is almost entirely funded by fees from drug companies, the drug companies are the TGA's clients! It can also be observed that prospective governments are not legislating for the health industries benefit and the peoples health. If the TGA was there for our own good then why allow allopathic drugs that kill and maim to be sold in Australia....still?. Two examples (but not least) being Zyban the anti-smoking drug that has killed 76 people in the UK and Australia? Another being VIOXX, where the death toll is presumed to be close to 139,000 people killed in the USA alone and a possible 300 in Australia to date! http://www.abc.net.au/news/newsitems/200504/s1342206.htm

and also see: http://www.abc.net.au/4corners/content/2005/s1340327.htm

 
Even the UK parliament (Select Committee on Health Fourth Report) have acknowledged the inappropriate level of industry influence the pharmaceutical industry has on government regulatory bodies. http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/4210.htm


The PAN debacle was another example where an allopathic drug was causative, ending with the 4th largest (privately owned) supplement company in the world being driven into bankruptcy along with many retailers. This was then followed by a parliamentary enquiry into the natural health industry ("Expert Committee on Complementary Medicines in the Health System"). All of this because of a drug called dimenhydrinate (Travelcalm). The health industry formulated a response to the enquiry, but the government has ignored the points and initiatives outlined in this response! So again, are the governments, TGA and FDA legislating for our own good?...No, of course they aren't.... At least it doesn't seem that way! Does Australia have anything to fear in the future?....Based on the past track record of the TGA and government here in Australia, yes we do! Just exactly how and when is a mute point at this place in time.

Please also read the article below from the Citizens for Health (http://www.citizens.org). This article explains why the USA is and can be subject to international treaties and FTA's. Even though the below article is relative to the US we may certainly draw parallels with Australia's obligations to WHO and WTO laws. And yes, of course, Australia will certainly comply after a trade dispute is brought against us because the fines or costs of sanctions will be financially burdensome. 

I could sum matters up by taking this quote from a recent NHCA newsletter http://www.nhca.com.au


"the industry in Australia and internationally is in a completely new ballgame and in Australia at least, we are ill prepared for the onslaught, or the aggressive competition that this new focus on preventative medicine is bringing to bear. The highly complex situation presented by Codex, Free Trade Agreement, TGA and the proposed NZ Harmonisation, regulation of nutrients under pharmaceutical guidelines, and the recent Expert Committee Recommendations, etc. etc. make it would be nigh on impossible for any one person or group to understand all the potential ramifications or the interrelated issues they present."

To be fair and unbiased, even though I disagree with most points, I have attached a news letter from Raymond Khoury of the Australian Therapeutic Medicine Association (ATMS) http://www.evehillary.com/Codex.atms.pdf
. In addition, I have attached a newsletter from Allan Crosswaite from the Complementary Health Council (CHC) http://www.evehillary.com/CActivismCHCcodex.pdf


The ATMS is supposed to represent over 9000 natural health practitioners in Australia. It is interesting to note that the ATMS never even showed up to the the forum designed to formulate a health industry response to the findings of the "Expert Committee on Complementary Medicines in the Health System". How interested is the ATMS in its members and the health industry? It is also of interest that Raymond quotes the CHC information releases in his own research. Keep in mind that Raymond and Allan Crossthwaite are on TGA committees and may or may not just be repeating TGA party policy! It may also be possible that they have vested interests. It is interesting that Allan seems to have titled his release as "CActivismCHC codex" - could we presume that this is abbreviated "Counter Activism CHC codex"? And if so...why does this activism need to be countered? Maybe Raymond and Allan are just well intentioned but naive people who trust the government and the TGA? Either way, I urge everyone not to take matters on face value, and don't place all your trust in the hands of experts because quite often the experts have their own agenda!

The aim of the Alliance for Health Freedom Australia (AHFA) is to secure a large public audience and membership (free). This membership of people concerned about the future of their health industry can be mobilised in a short space of time to provide the community with a voice and to deliver to the government of Australia a real mandate from the people instead of the governments assuming or pretending they have a consensus!. Unless we unite right now it will be almost impossible to unite when an issue needs to be addressed!

 

 

By James J. Gormley, Policy Advisor, Citizens for Health, March 25, 2005

MYTH: Your right to sell or buy supplements will end in summer of 2005
FACT: No. In fact, there are two completely different events that some have mixed together. 

First, in July 2005, the United Nations Food and Agriculture Organization (FAO) and World Health Organization's (WHO) Codex Alimentarius Commission is set to ratify vitamin and mineral guidelines that were finalized in Bonn, Germany, in November 2004. 

Second, as of August 1, the European Food Supplements Directive (EFSD), "the Directive"-a European Community (EC) not Codex directive-will restrict the sale in (or into) Europe of dietary supplements that contain any of hundreds of ingredients or forms of ingredients not on the EFSD "approved lists" (Annex I or II), except for ingredients that have received "derogation" (approval for continued sale) until 2009 in one of 25 European countries (member states) and which are being considered for addition to one of the approved lists by the European Food Safety Authority (EFSA). 

Aside from a potential one-year sell/buy-through grace period, taken together with upcoming dosage limit guidelines to be set by the FAO/WHO Nutrient Risk Assessment Project [see below], European retailers and consumers will most assuredly have their choice of innovative, high-potency dietary supplements greatly curtailed, officially, as of August 1, 2005. 

MYTH: Dosage limits that will be set are going to be based on an acknowledgment that dietary supplements are inherently benign
FACT: False. The dosage levels that Codex will set are going to be largely based on the findings of the FAO/WHO Nutrient Risk Assessment Project, the key event related to which is an international risk assessment workshop scheduled for May 2005. The framework upon which this project is based is one that is typically used for toxic chemicals and environmental hazards, not, say many, the best model upon which to develop a liberal set of recommended upper levels. To view Citizens for Health's comments on this, please click here.

MYTH: The Directive on supplements will have no impact on U.S. products
FACT: False, by omission. The scenario that is often overlooked is that some U.S. companies which export into Europe now---but which do not wish to have two entirely separate "catalogs" of products with very different formulations---may voluntarily decide to either no longer sell in Europe or may, for economic reasons, decide to "dumb down" all of its formulations to meet both the EFSD and the to-be-established FAO/WHO dosage level guidelines. 

In addition, according to the U.S. Food and Drug Administration (FDA), "other countries with more restrictive laws and regulations for dietary supplement products than the U.S. may create trade barriers to the importation of products manufactured by the U.S. dietary supplement industry."

MYTH: Codex is part of some huge conspiracy to take away our health freedom and our supplements.
FACT: No---a complex web of forces, interests and connections does not necessarily a "conspiracy" make. Codex was originally formed with the best of intentions. In fact, according to Codex, "The highest priority of the Codex Alimentarius Commission, as stated in Article 1 of its statutes, is to protect the health of consumers and ensure fair practices in the [sic] food trade." 

Nevertheless, what consumer protection means to European regulators is, in many ways, quite different from what that means to American consumers. In Europe, regulators have traditionally over-regulated dietary supplements, in many cases classifying supplements as drugs, partly due to what some regard as a coddling, paternalistic "nanny state" approach to consumer protection and, therefore, to dietary supplements. In addition, there are many international treaties that recognize Codex as the authority on food safety and dietary supplements within the context of an intricate matrix of global treaties and agreements that will, at least theoretically, provide "teeth" to Codex' regulation-like "guidelines."

MYTH: The FDA would never modify its regulations (through rulemaking) to adjust U.S. law to international standards
FACT: Maybe, maybe not. On October 11, 1995, the FDA stated, referring to an earlier notice, that "it is the intent of this policy to enable the FDA to "increase its efforts to harmonize its regulatory requirements with those of foreign governments." In the October 1995 notice, the FDA asked the following question: "If the agency concludes that it is appropriate to propose to revise its regulations to accommodate consideration of Codex standards, FDA plans to [...] outline specific revisions." According to attorney Justin J. Prochnow, these 1995 statements, "are not akin to [currently] mandated FDA policy."

In 2005, the FDA wrote the following, however: "Failure to reach a consistent, harmonized set of laws, regulations and standards within the free trade agreements and the World Trade Organization Agreements can result in considerable economic repercussions." 

MYTH: Codex will never get involved in WTO's international trade disputes
FACT: False, according to the WTO. The WTO writes that Codex "can be called in as experts to give advice to WTO dispute settlement panels."

MYTH: Codex, like other international guidelines, is just voluntary
FACT: False by omission, according to the WTO. The WTO writes: "Before the entry into force of the WTO, international standards, guidelines, recommendations and other advisory texts could be adopted by governments on a voluntary basis. Although these norms remain voluntary, a new status has been conferred on them by the SPS [emphasis ours] [Agreement on the Application of Sanitary and Phytosanitary Measures]. A WTO Member country adopting such norms is presumed to be in full compliance with the SPS Agreement."

According to a March 22, 2005 white paper by attorney Justin J. Prochnow, "of particular relevance to this discussion is Article 3 of the SPS Agreement, which reads: To harmonize sanitary and phytosanitary measures on as wide a basis as possible, Members shall [emphasis ours] base their [food safety] measures on international standards, guidelines or recommendations." According to Prochnow, "These provisions, with the use of the term 'shall,' effectively make the 'voluntary' Codex guidelines mandatory for Member Nations of the WTO," including the U.S.

MYTH: If the WTO, several years from now, imposes sanctions on the U.S., the U.S. would have to automatically change its laws to comply
FACT: False, technically. If the WTO Dispute Settlement Body imposed sanctions against the U.S. for a specific case of non-adherence to Codex guidelines in international trade, the U.S., according to Justin J. Prochnow, "would have to determine whether it could absorb the sanctions or whether the sanctions were onerous enough to force a change in the law to conform to the Codex guidelines. In order to adopt new legislation, Congress would have to use the standard legislative process.

MYTH: The FDA can just adopt Codex guidelines as new regulations 
FACT: False. To attempt to issue new more "Codex friendly" regulations regarding dietary supplements that wouldn't undermine the Dietary Supplement Health & Education Act of 1994 (DSHEA), the FDA would have to go through the usual deliberative process starting with a Notice of Proposed Rulemaking, a public notice that would likely generate massive consumer response, depending on what is proposed.

MYTH: There is nothing that I can do before July to help the U.S. delegation represent my interests in Rome
FACT: Not true! You can create your own health action letter click that will go to chief delegates at the U.S. Codex Office, or you can create your own. You can also be heard at an important pre-Rome Public Meeting on June 9, 2005, in Washington D.C.<Read more>