Codex update.

[Guest guest]

For those of you who did not understand what was involved

with CODEX, here is the best article I have seen thus far. It will take a

little bit to wade through, but it is worth understanding just what the risks

of this legislation hold.

Now there has

been a challenge to the CODEX in Europe that

may end up working to save the majority of their vitamins, minerals and

supplements, FOR THE TIME BEING, but it is a fight that is far from finished. I

have sent this in HTML because I highlighted in color several paragraphs that

deal with the direct impact on the U.S. markets and why we are not out

of the woods on this issue yet. IN case it gets switched to plain text,

the paragraphs to note are: Europe

holds the decisive vote in Codex, Natural medicines under threat,

Corporate feudalism

fuelled by patents and fees.

The U.S.

market for supplements is worth $1.5 trillion dollars annually and that is the

reason that big pharma is fighting for control. MONEY IS THE KEY.

The

fight is over how vitamins and minerals are evaluated. Vitamin and mineral

guidelines should be evaluated by nutritional science rather than the

toxicological science used to evaluate toxins. Codex categorically states that

nutrients should be treated as toxins and that foods and nutrients are not

useful in treating disease and therefore supplements are of little value.

Congressman Ron has put forward the Health Freedom Bill

(HR 4004) to combat the potential threat we still face. Please understand

how critical this is. We have a reprieve, we do not have a pass.

The Institute of Science

in Society

Science Society

Sustainability http://www.i-sis.org.uk

ISIS Press Release

31/08/05

Compromise on EU

Vitamins and Minerals

A

legal challenge to overturn the EU’s controversial Food Supplements

Directive is over, but the corporate takeover of herbal medicine and natural

remedies continues. Sam

Burcher

A fully referenced version of

this article is posted on ISIS members’

website. Details here

EU

Directive upheld with key provisions

The European Court’s

final judgment on the European Food Standard Directive (FSD) was delivered in

July 2005. The Alliance of Natural Health (ANH) and many thousands of

their supporters had hoped the opinion of the Advocate General given a few

months previously, would be upheld by the rest of the European Court judges [1]. It was

his opinion that the FSD is invalid under EU law and as “transparent as

a black box”. The European court judges usually follow the Advocate

General’s advice, but not in this case.

The ANH

is a pan-European and international organisation of supplement manufacturers,

retailers, practitioners and consumers. They began their landmark challenge

of the EU Directive at the High Court in London in 2004. Two hearings at The

European Courts of Justice followed; the first ruled in their favour and the

second against them. The ANH are now satisfied, nevertheless, that

their main concerns have been addressed without invalidating the Directive;

and that this has been achieved through a process of legislation, which has

provided a win-win situation.

The ANH

chief executive, Dr Verkerk said, “The Court has made clear some

key provisions of the Directive (see Box 1), which massively reduce the

difficulty of getting onto the once-feared ‘Positive List’”

[2]. The Positive List excludes many natural and organic forms of selenium,

vitamin C, vitamin E, and boron and calcium that strengthen bones. (See

“European Directive Against Vitamins and Minerals” http://www.i- sis.org.uk/vitamins2.php

or SIS 20) [3]. Verkerk is

confident that the simplified requirements for getting onto the

‘Positive List’ will no longer constitute a barrier for those

ingredients allowed in food supplements.

Thousands

of health products saved from European ban

Had the

Court not accepted the legal challenge and the key arguments against the

Directive, seventy five percent of supplementary vitamin and mineral

ingredients found in five thousand natural health products would have been

banned on 1 August 2005.

The

Health Food Manufacturers Association (HFMA), the National Association of

Health Stores (NAHS) and Consumers for Health Choice (CHC) felt, however,

that the legal challenge did not go far enough. Together they began a process

of “national derogation” (a ‘subsidiarity’ in legal

parlance), which will allow ingredients used in food supplements prior to

2003 to continue until at least 31 December 2009. The Directive and the Food

Standards Agency have accepted the derogation dossiers. Now the HFMA hopes to

protect the interests of the UK

food supplements industry by enlisting the support of ministers and PM Tony

Blair while he holds the six-month rotating EU Presidency [4].

The

fight is by no means over; it has moved to the international arena of the

Codex Alimentarius Commission.

Europe

holds the decisive vote in Codex

The Codex Alimentarius Commission is the body set up in

1963 to set international food standards in conjunction with the Food and

Agriculture Organisation (FAO) and the World Health Organisation (WHO) [5].

Codex Alimentarius means “food code” and the Commission covers

other important aspects of food trade such as GMOs, and pesticides and

hormone residues in food. Although these standards are supposed to be

voluntary, they are nevertheless adopted by the World Trade Organisation

(WTO), which levies draconian fines and sanctions to countries failing to

comply with their rules, which are anything but fair.

Codex international standards for vitamins and mineral do

not override national legislation, but do provide national governments with a

blueprint for domestic vitamin and mineral regulation more restrictive the

American dietary supplement law. The guidelines are fraught with risks

for consumers and producers alike. As nations begin to adopt laws that

embrace the guidelines, in order to avoid losing international trade

disputes, there is risk that the world market in supplements will level off

at a relatively few, low potency products.

If markets shrink then pressure will bear on the US

supplements industry advocates to adjust its laws to international

standards. And critics fear that Industry will have little commercial

incentive to keep resisting Codex. [6].

Consumers for Health Choice (CHC) cite the EU as the

single most important influence on Codex decision-making [7]. Basil

Mathioudakis, who drafted the EU Directive on behalf of Codex, also heads the

EU Commission delegation at the Codex meetings on Nutrition and Foods for

Special Dietary Uses. In May 2004, ten new candidate countries joined the EU,

and Mathioudakis represents all twenty five-member states at the Codex

meetings. When he votes, the other twenty-five member states are unable

to do so. Essentially, the European block vote covered almost fifty

percent of attending countries. The 28th meeting of the Codex

Alimentarius Commission met in Rome

just one week before the European

Court judges gave their final decision on the EU

Directive, and voted to accept the Codex restrictive guidelines on vitamins

and minerals.

To counter Codex’s restrictive guidelines on the

supplements market in the US, Congressperson Ron has put forward the

Health Freedom Bill (HR 4004), which prevents the Federal Government from restricting

the distribution of a dietary supplement or other nutritional food on the

grounds that the manufacturer makes health claims unapproved by the Food and

Drug Administration (FDA).

Natural medicines under threat

“Harmonising” standards of vitamins and

minerals internationally effectively hands control of many traditional

remedies over to the pharmaceutical companies and, in turn, to supermarkets

and pharmacies [8]. This would prevent independent companies and

practitioners supplying appropriate supplements for nutritional purposes to

patients and consumers. Under the Human Medicinal Product Directive (HMPD)

and the Traditional Medicinal Products Directive TMPD) (a subset of the EU

Pharmaceutical Directive) due to come into force later this year, health

claims made on dietary products will be outlawed.

Restrictions on natural products are widely seen as an

encroachment on civil liberties and ultimately threaten some of the oldest

traditional health practices in the world, such as Ayurveda, Tibetan, Chinese

and tribal medicines, on which some eighty percent of the worlds’

population depend [9]. Codex guidelines on maximum dosages for vitamins and

mineral food supplements destroy effective remedies and give regulators the

power to choose which product they want to call a drug. Further

proposals restricting amino acids, essential fatty acids, enzymes, plant

extracts and probiotics are planned for an expanded EU FSD scheduled for

2007.

Corporate feudalism fuelled by patents and fees

A further concern is that restricting natural forms of

nutrients will encourage the use of synthetic alternatives and genetically

modified (GM) substances in food supplements. Pharmaceutical giants have been

buying up vitamin and mineral companies recently. For example Merck has

acquired Lamberts, while Wyeth, a global pharmaceutical and biotechnology

company, has bought Solgar.

In fact, the drug companies have gained control of food

supplements through PharmaPrinting, the result of collaboration between

PharmaPrint Inc and the University

of Miami [10].

Pharmaprinting is a technology that isolates and measures the bioactivity of

an active compound of any plant or natural remedy and replicates it in a

laboratory. These compounds are standardised as a pharmaceutical for

government approval. Patents are currently pending on pharmaceutical

versions of some of the most useful herbal remedies such as St s Wort,

(depression) Echinacea, (immune

function) Ginkgo biloba, (brain

booster) Saw Palmetto (prostate function) and Mistletoe (alternative cancer

treatment).

Under Good Manufacturing Practice in the US, Pharmaprinting carries out clinical

trials costing up to $6.5 million per product and patent protection costing

$0.5million that takes five years to complete. Investors are reluctant

to commit to such costs unless market exclusivity is assured. One way

of creating an exclusive market is to ban or remove natural remedies. The

existing US

healthcare market including health foods and drinks is estimated to be worth

$1.5 trillion. This staggering amount makes it a market worth

manipulating. Patented food supplements would also provide a royalty to

drug companies each time a patented product is purchased.

Foods are not

drugs

“Food as drugs” guidelines laid out by

Codex were adopted by Australia,

Denmark, Germany and Norway and many products have

been co-opted by pharmaceutical companies and repackaged as drugs. The

Health Protection Branch (Canada’s

equivalent to the US FDA) has already registered “natural

therapeutic” food products as drugs. Fish oil (lubricating

joints), cranberry capsules (for urinary problems) and hawthorn berries (for

the heart) have all been issued with a “Drug Identification

Number” (DIN), at a cost of $720 per product, plus annual fees [11].

This is a thoroughly disproportionate degree of “protection”

costs imposed on what are in effect harmless food items, especially when

conventional drugs kill six hundred hospital patients in Ontario every year, with a further ten

thousand deaths attributable to prescription drugs [12].

Box 1

The Alliance for Natural

Health’s key arguments were accepted and addressed by the European

Court of Justice. These are the two major validations on the Positive List:

1. The

ban on non-positive list of vitamins and minerals does not apply at all to

vitamins and minerals normally found in or consumed as part of the diet

which therefore are not banned as of 1 August 2005. 2. Where the FSD

does apply (which is to vitamins and minerals derived from “chemical

substances” i.e. not naturally derived) an application to have a

substance included on the positive list may be refused by the competent

authorities only on the basis of a full assessment of the risk posed to

public health by the substance, established on the basis of the most reliable

scientific data available and the most recent results of international

research

Full

documents available at:

http://www.alliance-

natural-health.org/_docs/ANHwebsiteDoc_190.doc

The

South African government is actively opposing Codex guidelines. They

highlight the role of vitamins and minerals in accordance with the World

Health Organisation, “Diet,

Nutrition, and Prevention of Chronic Diseases” (2003).

Dr Manto Tshabalala-Msimang, South African Health Minister has recently

allocated Rand 6 million to testing the

safety and quality of traditional medicines used as immune boosters by people

living with “Nutritionally Acquired Immune Deficiency Syndrome

(NAIDS)”, usually referred to as HIV/AIDS [12].

New

paradigm needed for health

In Unravelling AIDS, a new book from ISIS published later this year, we examine how numerous

essential nutrients are effective in preventing and treating NAIDS, HIV/AIDS,

and other chronic diseases [13]. The WHO and the United Nations (UNICEF)

appear to be backing the sole use of drug therapy at a time when drug

resistant strains of HIV are on the increase, and the toxicity of these drugs

are becoming more and more evident.

Jim

, the general counsel to The Weston A. Price Foundation, a charity that

disseminates knowledge on nutrition [14], believes that Codex and the EU

Directive on food supplements derive from the same basic reductionist model

of western science that argues that pharmaceuticals are the only answer to

health problems. World food experts refute this model by stating that

natural vitamin A supplements can offer developing countries thirty times as much

social improvement as one dollar of development aid.

recommends that vitamin and mineral guidelines should be evaluated by

nutritional science rather than the toxicological science used to evaluate

toxins. Codex categorically states that nutrients should be treated as toxins

and that foods and nutrients are not useful in treating disease and therefore

supplements are of little value.

Dr

Verkerk of the ANH agrees with s views [15]. He believes that a

new paradigm for safety/benefit analysis is needed specifically for nutrients

and has commissioned the Netherlands-based HAN Foundation to come up with a

new framework that could be used in the EU and internationally through Codex.

Bruce Guilmette, Ph.D.

Survive Cancer Foundation, Inc.

http://www.survivecancer.net