Compromise on EU Vitamins and Minerals

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31 Aug 2005 13:36:57 -0000

Compromise on EU Vitamins and Minerals

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ISIS Press Release 31/08/05

 

Compromise on EU Vitamins and Minerals

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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 http://www.i-sis.org.uk/full/CFV.php.

Details here http://www.i-sis.org.uk/membership.php

 

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 Robert 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 Paul 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 Johns 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/ANHwebsiteDo

c_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 Turner, 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.

 

Turner 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 Robert Verkerk of the ANH agrees with Turners 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.

 

 

 

 

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