Food Supplements: Too Much Precaution May Be Bad For Your Health

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13 Oct 2005 17:36:35 -0000

Health Supreme Update: Food Supplements: Too Much Precaution

May Be Bad For Your Health

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Health Supreme Update: Food Supplements: Too Much Precaution May Be

Bad For Your Health

 

2005.10.13 19:36:32

 

http://www.newmediaexplorer.org/sepp/2005/10/13/food_supplements_too_much_precau\

tion_may_be_bad_for_your_health.htm

 

 

October 13, 2005

 

Food Supplements: Too Much Precaution May Be Bad For Your Health

 

 

After the passage, in 2002, of Europe-wide regulations for food

supplements, the Alliance for Natural Health has argued before the

European Court of Justice that vitamin and mineral supplements are

innocent - not to be condemned or worse eradicated by bureaucratic red

tape. The court decided in July 2005, surprisingly disregarding the

opinion of its own Advocate general, who had called for the directive

to be declared illegitimate, commenting that some of its regulations

have a degree of transparency comparable to that of a black box.

 

While there are important clarifications in the court's decision that

give hope for the future, many of the crucial decisions about the

destiny of nutritional supplements in Europe depend on how much

precaution will be exercised to protect us from the supposed hazards

of the safest products that can be found on the market today.

 

The EU Court, in its decision, cited the " precautionary principle " as

the reason why the restrictive European supplements law may stand.

Looking at the origin of the principle, which was formulated in the

face of toxic contamination and other threats to our survival, it

would seem somewhat out of place to apply such a rule to - of all

things - food supplements!

 

Perhaps the EU bureaucracy is still suffering from shell shock over

the outbreak of mad cow disease some years ago ... or perhaps the

watering-down of proposed rules to control toxic chemicals in the face

of industry opposition needs to be balanced by " action " in some other

field - the fact is the court quashed high hopes and confirmed a

monstrous piece of legislation, overriding the voice of reason

provided by its Advocate general.

 

Bert Schwitters has examined the court's sentence in detail. He tells

us what the decision means for supplements and how consumers of

healthy foods will likely end up ... in " no-choice-land " . Unless, of

course ... we find a way to make reason prevail and make the " risk

analysis " that is to be performed on supplements do its job properly,

including the initial evaluation: " Is there a problem at all? "

 

To quote Ron Law, risk assessment expert and policy consultant in New

Zealand:

 

" Consuming natural healthcare products " says Ron Law, " appears to

satisfy both the de minimis level of risk at a societal level (0.25

deaths per year on average; 1/120 th the de minimis level) and an

individual risk of 0.015 per million, or 1/67 th of the de minimis

risk level, and yet they have been reclassified via contentious

regulation [in Canada] as a subset of drugs which appear to be some

250,000 times riskier. There appears to be no evidential basis for

such regulation and regulating them in the same mindset as high risk

substances may well produce risks of its own, especially regarding

freedom of choice, and loss of benefits due to reduced product

availability. "

 

Bert Schwitters has put his money where his mouth is. He is sponsoring

a scientific research project, an evaluation of the available

legislative options for ensuring the safety of nutrients without

sending garlic and vitamin C to the gallows.

 

- - -

 

The `Framing' of Food Supplements in the EU

From the frying pan into the fire of `Precautionary Principle' and

`Risk Assessment'

 

by Bert Schwitters

12 October 2005

 

In this article, Bert Schwitters, Dutch author and businessman,

describes in intimate detail how the EU plans to remove some of the

most effective natural products from the market, through the misuse of

the Precautionary Principle. He uses his insight to the complex range

of scientific and legal issues that have developed following his

25-year sojourn with the European food supplements industry. During

the 1980s, Bert helped to lay the foundations for the Dutch

Association of Natural Products Manufacturers (NPN). His company,

International Nutrition Company (INC), sponsors the HAN Research

project, which is reviewing independently the entire framework of EU

and international food supplements regulation. INC, dedicated this

scientific research project to the Alliance for Natural Health. Bert

wrote this article for the Alliance on personal title.

 

On July 12, 2005, when millions of Europeans happily began their

holidays travelling through their frontier-less Europe or

" Schengenland " , the European Court of Justice gave its blessing to a

European Directive that would, had it applied to travelling, have

confined millions of law-abiding, legitimate citizens of some of the

Member States to their home country. The Directive, which concerns

food supplements, the products you know as nutrients in capsules or

tablets, professes to seek a " Schengen " type removal of the archaic

national frontiers that have always impeded the free movement of food

supplements in Europe, especially from Member States that permitted

liberal amounts of essential nutrients in such products, to European

states that applied more restrictive regimes. Now that the holidays

are over and we have all returned to our day-to-day reality, let's see

what that reality will bring Europeans in terms of vitamins and

mineral supplements.

 

Extra Visa for Baby-food nutrients

 

In " Schengen " terminology, by approving the framework and effects of

the Food Supplement Directive, the European Court of Justice did

indeed remove the national frontiers for a relatively small number of

predominantly synthetic forms of vitamins and minerals. In fact, the

nutrients that were selected for free movement by the makers of the

Directive had already been given " Schengen " status years before, be it

that they were allowed to cross Europe's old frontiers only when used

as additives in baby-foods. Baby-food and food supplements are

entirely different product categories, but the authors of the Food

Supplement Directive didn't mind. With the stroke of a pen they gave

the baby-food vitamins and minerals an extra " visa " permitting them to

now pass the old national barriers in food supplement form as well.

Sounds fine, one would be inclined to think, but by limiting the

" Schengenizing " of nutrients to baby-food additives only, all other

food supplement nutrients were sent to the guillotine. Thus, the

Directive, that came to be known as the Food Supplement Directive,

effectively knocked out a considerable number of safe food

supplements, even in the countries where they were once legitimately

sold. The old system prevented the free movement of safe and

legitimate products in Europe. The new system kills many of these safe

and legitimate products even in their countries of origin.

 

How could that happen? Why does a Directive that has harmonization and

free movement on its banner produce the contrary?

 

Directives are Orders

 

Most Europeans don't realize that their daily lives are already

governed by many thousands of " directives " written by the many

thousands of bureaucrats who occupy the many floors of the high rises

that mark the legislative horizon of our unelected European

Government. Most Europeans never consider the fact that the synonym

for " directive " is " an order issued by the government or a military

unit. " Every day, invisible, nameless and faceless bureaucrats issue

European Orders that influence the details of our daily lives. Indeed,

there is supposed to be some token gesture for democracy in the EU

law-making process. The European Parliament comprised of over 600

elected Members, must sign off. And so it did, when, on 10 June 2002,

it approved the European Food Supplement Order to make arrangements

for the free movement of food supplements.

 

And so, with Organized Industry well on board to make the best of it,

the train was set in motion, to criss-cross a frontier-less future. In

true Potemkin style, the wagons were clearly marked: FOOD SUPPLEMENTS.

And so, officials rushed the Food Supplements Train across European

borders to demonstrate their deep respect for the most essential

principle on which the Founding Fathers erected the European Union:

Free Movement. Where it stopped, there was fanfare and champagne. Yet,

it was a façade that hid the fact that although the FOOD SUPPLEMENT

wagons should have been filled to the brim with plenty of safe,

healthy and legitimately sold food supplements, the train was more or

less empty. It was a charade that left a few guessing about what was

really going on.

 

Nutrients are beneficial and life supporting

 

To put things in perspective, the Food Supplement Directive deals with

concentrated sources of nutrients and other dietary compounds that are

generally recognized as vital, beneficial, life supporting and safe.

That's why many millions of consumers around the world supplement

their daily diet with these nutritional basics which the body itself

cannot produce and modern food often lacks. These nutritional elements

are essential and you can't do without them. In their absence, minor,

major and life-threatening diseases are bound to occur. It is only in

their bountiful presence that we can enjoy a healthy life. That's why

the governments of countries such as the United Kingdom and Holland

allowed their citizens unlimited access to these vital compounds by

permitting them to be legitimately marketed. However, governments of

countries such as Germany are strongly opposed to that kind of

nutritional freedom and they installed and seriously enforced

restrictive regimes that ruled out certain nutrients and cut off the

supply of others at arbitrarily set levels.

 

Autobahn country

 

Those of you who don't live in " Autobahn " country may need some

explanation. While allowing unlimited speed on their motorways, the

German authorities have always appeared to be quite afraid that the

population might be overexposed to the nutrients that are seen as

healthy, safe and sound in countries such as Holland and the UK. In

Germany, influential high ranking scientists and authorities have a

tradition of wanting to dispense vitamins by the milligram or

microgram, preferably counting them one by one, so as to exclude the

risk of exposure. " Hmmm, let's see, Vitamin C, well, 68, 69, 70 .....

220mg, 221mg, .... 225mg ...., Mein Gott !, Halt !!! Pull over, here's

the Vitamin Polizei. Here's your ticket. You took 226 milligrams of

vitamin C today. That's 1 milligram too much. "

 

The 226th milligram of vitamin C

 

Fantasy? Read the reports " Verwendung von Vitaminen in Lebensmitteln "

and " Verwendung von Mineralstoffen in Lebensmitteln " , published in

2004 and produced under supervision of the head of the German Federal

Institute for Risk Assessment, Dr. Rolf Grossklaus. The Germans and

their Government have given Grossklaus and his fellow scientists the

watchdog task to count their vitamins under the Institute's motto:

" Recognize Risks, Protect Health. " The German authorities, who, as we

know, don't leave much to chance, perceive vitamins and many other

nutrients as hazardous and have them on their radar screens that

" recognize risk " . With radars bristling, the Institute picked up what

they perceived to be hazards of vitamin C. It " recognized " that at

226mg of vitamin C per day, taken in the form of a food supplement,

there is 1mg that produces a hazardous beep on the radar screen of

risks and that this particular beeping milligram of ascorbic acid may

therefore plunge the German population from glowing health into an

abyss of scientifically recognized risk and misery.

 

German science

 

According to Dr. Grossklaus' Institute, detecting hazardously beeping

milligrams of nutrients is pure science and what's more, it is this

" new " kind of " science " that permitted the Institute to undertake " a

comprehensive health assessment of the risks and benefits of vitamins

and minerals " ..... Thanks to this assessment, " so say the Germans,

" it is possible, for the first time, to derive maximum levels of these

substances for specific food supplements or fortified foods using

scientifically based risk assessment. "

 

According to the German scientists, they " used a uniform, standard

procedure when drawing up the proposals on maximum levels of the daily

amounts of a vitamin or mineral which can be additionally taken in

without any risk to health results .... " In case you missed it,

they're discussing the hazardous 226th, 227th, 228th and so forth

milligrams of vitamin C that might inadvertently be beeping in your

daily food supplements. Be careful.

 

Food Supplement Directive used as vehicle

 

The wise men (and I believe very few women were involved) who put the

Food Supplement Directive together used it as a vehicle in which to

install the German " Recognize Risks, Protect Health " approach. If

there is a recognized risk, we must act. Sounds logical and there's no

point arguing about it, unless, of course, there's no risk and there's

nothing to recognize. If there's a bomb threat, we shut the subway. In

spite of the fact that nutrients are generally and scientifically

recognized as essential to life and health, the Directive's authors

introduced a more German look at what's essential to life and took

great care to frame food supplements in terms as wonderful as " safety "

and " risk assessment. " In the hands of those who earn a living at the

German Federal Institute for Risk Assessment, risk assessment is

capable of providing authorities the tools to stop, restrict, limit

and ban nutrients arbitrarily and more or less at will. In this case,

the Directive and the provisional measures that were rigged to ban

safe and legitimately sold nutrients preceded, if not avoided, a

thorough, scientifically rational and unbiased risk assessment. These

are exactly the things that are missing with the Directive, which make

it fundamentally flawed.

 

Tummy aches

 

Just for the record, scientific risk assessment didn't play any role

at all in the bureaucratic removal of many food supplements. " Risk

assessment " was installed as a way to help set the maximum levels at

which the nutrients that survived the Directive may move freely

through the Community. In Dr. Grossklaus' vision, this is to stop the

226th milligram of vitamin C from reaching consumers in the European

Union in the form of a food supplement. So, it is not unimportant to

take a look at what the German " recognition " of the risks of nutrients

is worth, " streetwise " , so to say.

 

Well, their assessment, like any other, is as flawed as the data they

put into it, but then it is multiplied by the arbitrarily chosen

uncertainty factors they used to reach the calculated outcome. Who am

I to call the German method unfit and arbitrary? Well, suit yourself

and study the reports of Dr. Grossklaus to make your own judgment. Or,

let's compare the German findings to those presented in an English

scientific report titled " Safe Upper Levels for Vitamins and

Minerals " . It was produced in 2003 by the Expert Group on Vitamins and

Minerals under the direction of Dr. Michael Langman. The British

concluded that 1000mg of vitamin C per day is safe for each and every

English citizen. The English could not detect studies indicating any

adverse effects up to 3000mg per day. Adverse effect in this case

means that in the worst case scenario – and only with certain forms

the vitamin – some of you might get a tummy ache when taking vitamin C

in excess of 3000 mg per day, interestingly, while at the same time

deriving considerable benefits which are completely ignored by the

`risk assessors'.

 

Limeys and Krauts, who's wrong, who's right ?

 

Langman's English expert group recognized that there's no cause for

alarm whatsoever when people take 3, 4 ... 10 times in excess of that

" German " dosage. Langman and Grossklaus are both generally respected

and honorable scientists and their institutes are publicly funded by

democratically elected governments of Member States of the European

Community. Langman and Grossklaus explain in their reports what kind

of risk assessment methods they used, and, guess what, their

approaches are quite similar. When considering their nicknames,

" limeys " and " krauts " , one cannot deny that the British seem to differ

from the Germans in terms of nutritional and dietary preferences. So

do their health statistics and possibly even their genetics. However,

these nutritional differences are irrelevant in relation to nutrient

requirements and they are not capable of producing the striking

differences between Langman's and Grossklaus' recommendations.

 

When applied in Berlin, risk assessment science produces conclusions

that magically fit the German tradition of restricting vitamins as

hazardous, while the same science applied in London produces

conclusions that wonderfully match the Kingdom's tradition of a much

more fearless approach to the distribution and daily intake of

nutrients. There were times when that tradition served a higher

purpose than just keeping the population healthy. Wasn't it by giving

them lime that the Brits kept their sailors alive during the

intercontinental voyages between the various parts of the Empire ?!

Had it been up to Grossklaus, the limeys might have had less of a

chance to return home on winds " blowing southerly. "

 

The elasticity of " scientific " risk assessment

 

Scientific risk assessment, why is it so elastic ? Why is it not as

transparent, European, factual and universal as the word suggests ?

The reason is simple. Risk assessment not only involves the unbiased

collecting and assessment of data, information and research. It also

involves risk management and that's precisely where bias and arbitrary

viewpoints strip science from its transparency and universality. It

means that Dr. Grossklaus' 226th milligram of vitamin C is unsafe

because he holds the opinion that it is unsafe to let milligram No.

226 roam around freely in Europe. This, however, is not because he has

scientifically proven its lack of safety. Also, the fact that Dr.

Grossklaus is an honorable scientist doesn't make all his conclusions

and opinions scientific.

 

Removal of nutrients without assessment

 

In Article 5, the Food Supplement Directive royally paves the way for

Langman, Grossklaus and fellow scientists by introducing the terms

" upper safe levels, " " risk assessment " and " generally accepted

scientific data " as criteria to determine " maximum amounts of vitamins

and minerals present in food supplements. " Sounds fine, but apart from

the fact that the risk assessment approach used by both Langman and

Grossklaus precludes such incompatible and unworkable results, what's

there to assess when, by way of the " fait accompli " method, you have

already effectively removed most of the nutrients from the market

before their assessment. There was never an assessment of the alleged

risks of the indiscriminately banned nutrients. And what's more, there

wasn't even an assessment of the public health risks involved in the

removal of those safe and legitimately sold nutrients. In addition,

food safety regulations were already well in place in all the Member

States before the Food Supplement Directive was issued.

 

So, one might ask, what does all this have to do in a directive that

rose from the need to harmonize the European market and provide free

movement to legitimate and safe food supplements? Seems a bit out of

place, unless, of course, the objective was to install the management

tools that could help maintain the status quo by aiming at the very

existence of many " law-abiding " nutrients. If you can't stop them any

longer from moving around freely, then you might just as well remove

them by introducing and applying precautionary management tools such

as " provisional risk management measures. " You turn risk assessment

into risk management. And once you manage " by risk " but there's no

assessment of risk and you have no data, you call in the Precautionary

Principle. Not as a last, but as a first resort. When free movement

results in removal, the principle of free movement may still stand

unscathed and revered by all, but consumers are left bare handed

because there's nothing to move around any more!

 

EFSA and free movement

 

Understanding how all this worked and works in how the Food Supplement

Directive removed food supplements from the European market place,

requires going back to an earlier Directive, to the one that installed

on 28 January 2002 the European Food Safety Authority, better known

under its abbreviated name as EFSA. The EFSA Directive precedes the

Food Supplements Directive of 10 June 2002 by only a couple of months.

The EFSA Directive also solemnly professes to honour and strive for

the principle of free movement of foods and gives EFSA the task of

scientifically harmonizing food safety standards throughout the

European Community.

 

" Food law, " so states the EFSA Directive, " shall aim to achieve the

free movement in the Community of food ... " Because food supplements

fall under the European definition of food, EFSA became the scientific

authority that must assist the European Commission to further the free

movement of food supplements in the European Community. Wonderful. Put

the 2 Directives together and one might think that from there on, all

the safe and legitimately sold supplements to which British, Dutch and

other consumers always had unlimited access would now become available

to the deprived Germans. Sorry, that's not going to happen. The term

" free movement " suggest that there's something to move. Let's see what

nutrients the Food Supplement Directive left us un-removed.

 

Risk Assessment lingo

 

When EFSA speaks of " hazard, " they mean a " biological, chemical or

physical agent in, or condition of, food ... with the potential to

cause an adverse health effect. " When EFSA speaks of " risk

assessment, " they mean a " scientifically based process consisting of

four steps: hazard identification, hazard characterisation, exposure

assessment and risk characterisation. " And when EFSA speaks of " risk, "

they mean a " function of the probability of an adverse health effect

and the severity of that effect, consequential to the hazard. "

 

Putting the two Directives together, the Food Supplement Directive

tells EFSA to take a look at essential nutrients in terms of hazard,

risk and adverse health effects. EFSA must assist the European

government by assessing " the potential " of vitamins and other

nutrients " to cause an adverse health effect. " No doubt that food can

be hazardous when it contains poisons, chemicals, germs or infesting

bacteria. Certainly, foods pose hazards when they lack nutrients and

other vital compounds required to sustain a healthy life. But putting

vitamins, minerals and other safe and life saving compounds in the

category of hazards is ripping them out of their natural context and

misplacing them in the category of poisons and other ills. It's like

putting a Mozart symphony in the " heavy metal " section. It's like

installing an " Authority " that must assess the potential of Vermeer's

" Milk Maid " painting to cause an adverse effect on the mental health

of its admirers. It's like labelling law-abiding citizens " terrorists "

and locking them up until proven innocent.

 

Alliance for Natural Health

 

When a " last of the Mohicans " watchdog group called the Alliance for

Natural Health challenged in the European Court of Justice as

" disproportionate " the fact that the Food Supplement Directive would

indiscriminately ban a large number of food supplements, the European

Court replied that all was well. The Court asserted that the approach

taken by the European Commission was correct and that food supplements

could be placed " under orders " by applying a risk assessment principle

known in the inner circles of the risk assessment community under the

somewhat ominous term: " ex ante. " " Ex ante " is another piece of risk

assessment lingo. It means that in the absence of scientific data

about something, the public must not be exposed to that something.

Applied for example in the field of art, the " ex ante " principle means

that as long as a scientifically based process has not shown that

Vermeer's " Milk Maid " does not have an adverse effect on the mental

health of all of the museum's visitors, it shall be removed. In less

democratic situations, the " ex ante " principle is generally used as a

way to suppress freedom of speech and freedom of movement. Currently,

the Chinese government uses the " ex ante " principle to stop Chinese

citizens from accessing web-pages that contain words such as

" democracy " and " freedom. " Guilty and locked up unless proven

innocent, that's the game of " ex ante risk assessment. " Applied in the

field of traditional medicine, it is likely to mean that more than

half the world will be without the remedies that have cured their

ancestors over millennia.

 

" Ex ante " , where does it say so?

 

Although you won't find the term " ex ante " in the Directives, it's

there all right, when you read between the lines. The " ex ante "

approach is presented in the EFSA Directive's Article 7 as the

" Precautionary Principle " that must be applied to assure the " high

level of health protection. " The " ex ante " principle is not explicitly

found in the Food Supplement Directive, but because food supplements

are EFSA's turf, the Precautionary Principle applies just as well.

Here's the deal presented in Article 7: " In specific circumstances

where, " so warns the Directive, " following an assessment of available

information, the possibility of harmful effects on health is

identified but scientific uncertainty persists, provisional risk

management measures necessary to ensure the high level of health

protection chosen in the Community may be adopted, pending further

scientific information for a more comprehensive risk assessment. "

 

" Information " replaces science

 

In everyday language, this means that under the flag of health

protection, measures may be adopted without knowing the outcome of any

scientific process. The Precautionary Principle is the club that may

hit when " information " becomes available. Must that information be

specific and must it relate to a visible, factual, verifiable event?

The EFSA Directive doesn't tell. All they require is that the

information alludes to, suggests, perceives or simply evokes a

" possibility of harmful effects. " What's that?, you may ask.

" Possible " meaning " capable of happening, " the word " possibility "

opens up a field as wide as this universe. Must the source of the

" information " be known? Is it mere gossip, disinformation or

propaganda? Is it necessary that the supplier of the information

declares and explains how he or she obtained or observed the

information? Is the observed effect reproducible? The EFSA Directive

doesn't tell and there is no qualification of " information " in the

EFSA Directive. As long as the " information " is embedded in and

surrounded by " scientific uncertainty, " the Precautionary Principle

can hit and remain in force anywhere in the form of " provisional risk

management measures. "

 

The Law of the Land - Scientific Uncertainty

 

In a world where nothing is absolutely certain, what IS " scientific

uncertainty " ??? Things can be uncertain, but what if they are

" scientifically uncertain " ? Might it perhaps mean that scientists have

never studied something? But that in itself doesn't make something

uncertain. Might it mean that scientists differ in their opinions

concerning whatever they love to differ about? But that doesn't make

something uncertain. Or, might it mean that scientists haven't yet

made up their minds or that they used flawed or different methods to

arrive at different or contradictory outcomes. Could it be that we

have to endlessly stretch scientific testing to reach the unreachable

absolute certainty? Or, might it mean that as long as Grossklaus and

Langman have reached some kind of political compromise regarding their

significantly different conclusions about the hazards involved in

taking vitamin C, there is scientific uncertainty as to who's right

and who's wrong? Might it also mean that under the Precautionary

Principle we might have to settle for the most cautious approach, in

other words that of Grossklaus?

 

The question is; must we then, while the scientists are having their

publicly paid disputes, revert to " information " as a kind of

overriding super-uncertainty that provides the basis for activating

the Precautionary Principle? Does the Precautionary Principle install

powers in EFSA and the European Commission that permits them to

neglect or waive the work done by its own uncertain scientists, and

act upon information and belief instead? When " scientific uncertainty "

exists in the halls of EFSA's own scientific workgroups, can

information or belief set the Precautionary Principle in motion and

turn it into the law of the land? Yes. All this took place under our

very noses with the full consent of the European Court. The

Precautionary Principle is now in full force in the field of food and

food supplements.

 

Meteorites and food supplements

 

Food supplements are increasingly being forced, because of the

Precautionary Principle, into an ex-ante risk assessment

straightjacket, quite possibly it seems, by applying scientifically

flawed risk assessment methods, when they are among the very safest

things we are exposed to. Ron Law, a former biochemist and well known

New Zealand risk assessment scientist, has shown that in countries

like New Zealand or the USA, where food supplements have been used

liberally, there are almost no products that pose a risk lower than

that caused by `natural healthcare and therapeutic products'. In other

words, he found this group of products to be much safer than foods,

but also less risky than death by bee or wasp stings, lightning or

even shark attacks.

 

In fact, he only found one source of risk that was lower, and that was

the risk of being struck by a meteorite. With the negligable risk of

these food supplements and natural products being well below the level

at which we as a society should begin considering spending huge

resources regulating products, shouldn't we focus on the risks

involved in taking medicines, genetically modifed food, and what else

is new on the planet ! The hoops the natural products industry is

going to be forced to jump through over the coming years are not only

unnecessary, but they will undoubtedly result in many casualties and

many products falling foul of the system. Unless, of course, we do

something about it.

 

The bear's liver

 

" Yes, but " , some of you may think, " haven't I read somewhere that high

doses of vitamins can be dangerous, that vitamin A can kill you ! " Oh,

sure, long ago, an occasional hunter died when he hungrily devoured

the liver of a bear he had shot. The bear's liver was loaded with

vitamin A. And, yes indeed, one can reach levels of toxicity with

nutrients, especially with fat-soluble ones such as vitamin A.

Toxicity is a matter of dosage and quantity. There is no absolutely

toxic substance and there is no absolutely safe one. It's possible to

kill a man with an overdose of water.

 

But, the risk assessment and Precautionary Principle lingo used in the

Food Supplement and the EFSA Directives no longer straightforwardly

refers to the " good old " toxicity of substances, as established by way

of verifiable and reproducible scientific tests and examinations.

Since the days when straightforward and measurable toxicity levels

were the rule, the game has been completely changed. Those who manage

our lives today work out of the virtual reality of possibilities of

probabilities of adverse effects that may exist in the absence of

scientific certainty .... The word " probable " has been substituted by

the word " possible. " Doesn't the EFSA Directive give us guidance how

to assess the reality and certainty or probability of a perceived risk?

 

Oh yes, the EFSA Directive tells us that risk assessment shall be

" based on the available scientific evidence and undertaken in an

independent, objective and transparent manner. " Nevertheless, no such

scientific evidence seemed required when the European Commission

ruthlessly applied the Precautionary Principle to ban safe and

legitimately sold nutrients under the dictates of the " provisional

risk assessment measures " laid down in the EFSA Directive. In the wake

of this draconian violation of the principle of free movement, no

immediate, independent, objective and transparent scientific work was

undertaken by EFSA or by the European Commission, to fulfil all the

public health duties imposed on them by the Directives.

 

BAN = removal of legitimate products

 

If the Food Supplements (FS) Directive does ban a good number of safe

and essential vitamins and minerals, how is it then, you may wonder,

that you are still able to get all those good old food supplements you

used to buy ? Are these products now illegitimate ? Has the ban been

lifted or mitigated ? No, the ban has not been lifted, but its blade

may not have fallen yet on some of the banned nutrients. Up until

August 12, 2005, a so called " derogation procedure " enabled market

participants and interested parties to request a national grace period

for banned nutrients that were legitimately marketed in any of the

Member States before July 2003. Whether the grace period, which

definitely ends in December 2009, will eventually be granted will

depend on what EFSA has to say about the technical dossier that forms

part of the derogation papers. The mere fact that a derogation request

was filed is by no means a guarantee that the FS Directive may not,

before the ending of the year 2009, deprive you of the legitimately

sold products you may have been using for many years. And this is not

because all of sudden there's something wrong with these products. It

is not because risk assessment studies had revealed risk. No, it's

only because the European Commission placed nutrients " under orders "

by swinging the axe of the Precautionary Principle. What has happened

in the field of food supplements shows that the Precautionary

Principle is the ultimate and sacrosanct weapon in the hands of those

who don't like to be bothered by good science, sound reason and long

standing practices approved by national authorities. Embedded in

European Directives, the Precautionary Principle even ties the hands

of Judges and Courts.

 

Entitlement to existence denied

 

When they decided to not only strip legitimately sold food supplements

from their " entitlement to free movement " throughout the European

Community, but go a bit further and strip them from what I would call

their " entitlement to existence " in the Member States where they were

legitimately sold, the authors of the Directive must have figured that

an outright ban would be easily branded as disproportionate and

confrontational. So, they had to figure out an approach that would

withstand public opposition and eventually a legal challenge. They did

well. When the Alliance for Natural Health and two UK health trade

associations (who joined them in a bid to increase pressure against

the European regulators) argued before the European Court that the

Directive was disproportionate in that it would remove legitimate and

safe products from the shelves in the United Kingdom and elsewhere,

the Court took shelter under the umbrella of the Precautionary

Principle, stating that: " ... the authors of Directive 2002/46 could

reasonably take the view that an appropriate way of reconciling the

objective of the internal market, on the one hand, with that relating

to the protection of human health, on the other, was for entitlement

to free movement to be reserved for food supplements containing

substances about which, at the time when the directive was adopted,

the competent European scientific authorities had available adequate

and appropriate scientific data capable of providing them with the

basis for a favourable opinion, ... "

 

The accidental baby-nutrient

 

This means that food supplements that accidentally contain certain

forms of the vitamins and minerals selected for inclusion in

baby-foods survived the onslaught of the Food Supplement Directive

only because they happened to be in EFSA's baby-foods dossier. It also

means that all other nutrients were indiscriminately banned because

EFSA had never evaluated them. It doesn't mean that these nutrients

had never been evaluated at all, it simply means that EFSA never did.

Had EFSA ever been asked to evaluate them? Generally no. Had EFSA ever

done an exhaustive search of information to form an opinion about the

safety of the food supplements that were legitimately sold in many a

Member State? No. Had EFSA ever done an assessment of available

information? No.

 

As the European Court stated in its decision, EFSA's scientists lacked

" adequate and appropriate scientific data capable of providing them

with the basis for a favourable opinion. " So, EFSA was never in a

position of assessing available information because they had no

information. It doesn't mean that the information wasn't available. It

just means that EFSA didn't have it. Had EFSA ever transparently

identified, case by case, supplement by supplement, " the possibility

of harmful effects on health " of each and every individual food

supplement legitimately sold since many years in England, Holland and

elsewhere under the supervision of the relevant national health

authorities? No. Was there scientific uncertainty? No. Were there

unequivocal and uncontested scientific grounds for the provisional

risk management measure that the authors of the Directive used to

sweep numerous food supplements off the market? No.

 

Article 7, please read it again

 

Yet !!! The European Court boldly filled in the blanks and reorganized

history by implying that there had existed specific circumstances that

warranted the indiscriminate removal of each and every one of the

banned food supplements before or at the time of issuing the Food

Supplement. It worded its decision in a way that suggests, but does

not show, that all the conditions that must be fulfilled before the

European Commission may apply the Precautionary Principle, had in fact

been fulfilled. By implying fulfilment, the Court made it possible to

retrospectively grant the provisional powers to the authors of the

Directive by stating that " by virtue of Article 7 " of the EFSA

Directive, " ..., the Community legislature is entitled to adopt the

provisional risk management measures necessary to ensure a high level

of health protection and may do so whilst awaiting further scientific

information for a more comprehensive risk assessment, ... " That may be

true, but let's see what Article 7 says when you read it from the

beginning: " In specific circumstances where, following an assessment

of available information, the possibility of harmful effects on health

is identified but scientific uncertainty persists, provisional risk

management measures necessary to ensure the high level of health

protection chosen in the Community may be adopted, pending further

scientific information for a more comprehensive risk assessment. "

 

Reading backwards and deaf ears

 

So, to remove a product from the market by applying Article 7 of the

EFSA Directive, the circumstances must be specific. They must concern

a specific case or something and in each individual case an assessment

of available information must take place. Only then, when case by

case, a possibility of a harmful effect has been clearly described and

only when scientific uncertainty persists, may the EC take provisional

measures in the interest of public health. However, when you begin

reading Article 7 from the end and stop half-way, the " high level of

health protection " becomes a rather thin excuse for those who did not

comply with the requirement laid down in Article 7's opening words.

 

The fact that it was the European Court that read backwards doesn't

make the excuse any better. Had the Directive applied to the free

movement of persons, to travelling through the European Union, it

would have caused traffic jams, public protest and outrage, especially

because there wasn't any sign of a " clear and present danger " that

warranted a provisional measure to keep everybody home. Because the

measure hit " some nutrients " that were of interest to " some companies "

the case brought by the Alliance for Natural Health widely fell on

deaf ears. Even Organized Industry bashed at the Alliance. Still,

there was one highly placed European legal official who shared the

Alliance's opinion and for a short while, the Food Supplement

Directive was in deep trouble.

 

Geelhoed declares Directive invalid

 

Had the Alliance for Natural Health made outlandish claims about the

disproportionate nature of the ban? Were they really the fools and

strangers some want us to believe they are? Were they making stupid

and irresponsible moves that might upset the apple cart to which

Organized Industry had also given its blessing? I don't believe so.

Before the European Court makes a decision, it has the case, the

surrounding applicable cases and the circumstances evaluated by an

Advocate General. As one might expect, an Advocate General at the

European Court of Justice is not an inexperienced feather-weight legal

amateur and normally the Court places a great deal of confidence in

its " AG " and follows his or her Opinion. In the case that was brought

by the Alliance for Natural Health to test the validity of the Food

Supplements Directive, my fellow Dutch countryman, Advocate General

Geelhoed, prepared the Opinion for the Court.

 

In great detail AG Geelhoed exposed the Food Supplements Directive as

a scything and ill-wrought piece that causes enormous prejudice to

trade and consumers. Assessing the banning of legitimate food

supplements, Geelhoed wrote, " without calling in question the

substantive assessment made by the Community legislature, I must

conclude that it has seriously failed in its duty to design such a

far-reaching measure with all due care. " According to the Advocate

General, the " legislative technique applied here, " does not merit such

a title. And concerning the procedure offered by the authors of the

Directive to industry members who might want to undertake saving a

banned nutrient from certain death, " in so far as it (this procedure)

may exist and in so far as it may deserve this title, " it has " the

transparency of a black box: no provision is made for parties to be

heard, no time-limits apply in respect of decision-making; nor,

indeed, is there any certainty that a final decision will be taken. "

 

Geelhoed – Old Hat

 

With all due respect, I suspect that Advocate General Geelhoed still

lives in Pre-Precautionary-Principle times, when " individual

interested parties " such as, in this case, responsible companies

making, distributing and selling legitimate food supplements, still

deserved some basic form of protection against indiscriminate

bureaucratic bias and arbitrariness. " In order to ensure, " so

admonishes Geelhoed, " that these interests are taken into account in

the decision-making process in a manner which is open to judicial

scrutiny, the basic legislative act ought for that purpose to provide

for the minimal guarantee of an adequate procedure. " Meaning, a

procedure that companies should be permitted to follow prior to their

products being removed from the market.

 

Geelhoed found that the procedure proposed in the Directive " ... lacks

essential guarantees for the protection of the interests of private

applicants. " Respecting good old Pre-Precautionary-Principle

principles, Geelhoed continues: " the Community legislature in drafting

a legislative act may at least be expected to act with such care as to

make express provision for minimum conditions of prudent

decision-making in that legislative act. The fact that these

conditions were not included in Directive 2002/46 is in itself

sufficient to conclude that the Community legislature has failed in

this respect. The Directive does not comply with essential

requirements of legal protection, of legal certainty and of sound

administration, which are basic principles of Community law. Thus,

lacking appropriate and transparent procedures for its application,

the Directive infringes the principle of proportionality. It is,

therefore, invalid. " The underlining is mine.

 

Killing a frog ?

 

Prudent decision-making was not particularly what the authors of the

Directive can be accused of. They did not explore the best ways of

carefully combining the national procedures for product approval and

safety assessment traditionally applied by the competent authorities

in the Member States. They did not evaluate how these national

procedures could be combined, " approximated " is the technical term,

while paying respect to the principles of legal certainty and

protection that these procedures had always provided for industry

members and consumers alike. Instead, the Community's law makers

solved the problem by putting baby-food nutrients on two Positive

Lists (one that identifies the vitamins and minerals and one that

identifies the permitted forms of the listed nutrients), a manoeuvre

which effectively removed all other nutrients from the European market.

 

Sure, the banned nutrients were given an initial grace period, so that

they could survive until August 2005. And yes, industry was permitted

to file requests for " derogation " , so that, until the ending of 2009,

these banned nutrients could stay on the market in the Member State

where they were already legitimately sold. But that implied that

industry had to go way beyond the administrative requirements they had

already fulfilled in those Member States where their products had been

on the market since long. And then, even if one went through the

process of derogation, getting the product on the Positive List is an

entirely different matter. Industry members who wanted to go there

were left figuring out the best way through what the Advocate General

described as a " Black Box. " In the end, it all comes down to applying

the " killing the frog " system. Don't throw it into boiling water, it

will jump out. Just slowly raise the temperature until it boils. It

helps frogs, or people, adapt to the worst possible outcome: death. In

a follow-up article, I will explore how this frog may not only be

saved from imminent death, but may be kissed and turn into the prince

it was before the European Commission put its spell on it.

 

Killing a snake

 

As Geelhoed did point out, the Directive was and is an unworkable

piece of legislation. Organized Industry tried to cope and organize

things, but failed to take action against the fundamentally flawed

" legislative technique " and against the ruthless, inappropriate and

improper use of the EFSA Directive's Article 7. While all involved

were doing what they deemed fit, Advocate General Geelhoed tried to

shed some light in the procedural darkness of the Food Supplement

Directive. Doing so, he overlooked how the Precautionary Principle was

lurking in the Black Box' darkness and how this principle could tear

apart his well wrought Opinion that called for the prudent decision

making required of EU's lawmakers.

 

Had Geelhoed found the Precautionary Principle, he might have been

able to dismantle it, if only because there was no circumstance and no

reason in the first place to take provisional measures. An old saying

has it that when you think you've killed a snake you better make sure

that it's dead. Geelhoed found the Directive invalid, but he didn't

make sure it was dead. When the Court looked at it, it still found

some activity. It also found the venom for which there is no antidote:

The Precautionary Principle. And so, the Court ruled. The snake shall

live by virtue of its venom, not by virtue of its benefits. With the

help of the European Court, the Community legislature reaped the

fruits of the legislative technique that killed the one who tried to

kill it. The shrapnel is all over the place and with it came the Black

Box's true label: Pandora.

 

Organized Industry and Pandora

 

For reasons about which one can speculate endlessly, Organized

Industry took a pragmatic position and it never tried to stab the

beast the way the Alliance for Natural Health and Advocate General

Geelhoed did. Perhaps they saw the shadows on the wall, perhaps they

didn't. Perhaps they were told that saying " no " was not an option.

Perhaps, perhaps, ... Perhaps all the ills contained in Pandora's box

were not perceived as ills for certain players in the food supplement

industry. Mass market oriented companies who never planned to offer

consumers food supplements containing nutrients other than the ones

listed in EFSA's baby-foods dossier, all of a sudden saw markets

opened that had been closed before. Why bother about nutrients they

had no intention of selling anyway.

 

And, realistically speaking, the Directive effectively handled a

couple of innovative, progressive and more pioneering competitors who

were distracting consumers away from their mass market formulas by

offering more sophisticated special formulas containing orthomolecular

doses and more sophisticated nutrients that require a bit more work to

manufacture or extract, rather than the " run of the mill " ones that

have become commonplace in supermarkets and pharmacies around Europe.

Who knows. Fact is that most industry members have learned to live

with their competitors and with the obsessions of all kinds of

authorities and bureaucracies. Most likely they saw the Food

Supplements Directive as one of those things " we'll deal with when it

knocks at our door. "

 

Crawling out of a hole

 

Consumers and health practitioners face only one problem. Soon, many

of the food supplements they used to place their confidence in will

not be there anymore. The internet will lead them to American

suppliers who will have no problem whatsoever shipping their products

across the Atlantic. The European food supplement industry faces three

problems. Problem 1 is how to get a removed or new nutrient on the

Positive List. Problem 2 concerns the listed nutrients. How does one

realistically establish their maximum levels? And, is it necessary to

establish such maximum levels? Problem 3 concerns all other substances

fit to be presented in the form of food supplements: other nutrients,

enzymes, amino acids, phyto-nutrients, unsaturated fatty acids,

etcetera. Problem 3 will present itself in 2007, when the European

Commission must propose how it wishes to deal with those substances.

Looking at what has happened so far, one has to be an optimist not to

worry. Problem 2 brings us to making a choice between Grossklaus,

Langman or an even better approach. Problem 1 must be faced by the

lone ranger who has the guts to enter the Black Box.

 

There is actually a fourth problem for European industry. It has been

effectively removed from a position in which it was capable of

competing with American companies in the field of innovative products.

It is confronted with a bureaucratic monstrosity that not even the

American Food & Drug Administration (FDA) has been capable of

producing. And then, last but not least, there is a problem for Europe

in general. Its position in the field of health and nutrition has been

severely fractured and it remains to be seen what the long term

effects will be on public health. Innovation will be more difficult in

a legislative environment where the Precautionary Principle can stab

one in the back any time to bleed investments and intellectual effort

to death.

 

The HAN Research Project

 

The major obstacle in the whole process remains the unforeseen abuse

of the Precautionary Principle as the somewhat barbaric " technique "

that can unfairly upset prudent and appropriate risk management

techniques as well as innovative scientific and technological

developments. Now that lobbying, reasonable arguments and legal

efforts have failed, the only option that remains is to make a

scientific evaluation of risk assessment in the field of food

supplements. This is why, in June 2005, the Heidelberg Appeal

Nederland (HAN) Foundation and the Alliance for Natural Health started

a scientific research project to develop " ... a straightforward,

rational, transparent, and scientifically coherent benchmark

methodology to regulate food supplements cost–effectively within a

European (or even a global) level–playing field in which assessment

and management are explicitly linked. "

 

The research project will also focus on the problem that, so far, in

the field of food supplements, the desire for unconditional safety has

been approached by applying inappropriate pharmaco–toxicological

assessments used for medicines and toxic substances. " For food

supplements, " so write Dr. Jaap Hanekamp and Prof. Aalt Bast, the

scientists who will lead the research project, " this won't do. Risks

and benefits need to be evaluated equally within the context of

commended normal use ... " The safety of food supplements must be

evaluated in terms of risks and benefits rather than in terms of the

traditional pharmaco–toxicological approach.

 

The HAN Research Project will not only evaluate the risks of applying

the Precautionary Principle in the field of food supplements, but also

whether the continued application of this principle " will eventually

shift the locus of market control in the food supplement market in the

direction of the pharmaceutical industry and what the effects of such

a shift will be on product innovation and research. " After all, in a

world of risks, it is best to be precautious.

 

To be or not to be

 

In the meantime, there is little consolation for consumers,

practitioners, retailers and industry members who may now see many a

good supplement go up in bureaucratic smoke. Whether these legitimate

products will ever rise again from their ashes remains to be seen.

Often, justice delayed is justice denied. Even if the HAN research

eventually has an effect, it will be difficult and extremely time

consuming and costly to bring the lost supplements back to life.

 

In the meantime, the Precautionary Principle finds more followers to

conveniently attack nutrients. The French government is making an

effort to ban the very popular and widely used Co-Q10 phytonutrient.

Just out of precaution, so they say. Because the Precautionary

Principle is used to stab at the very existence of what's elemental in

life and health, the essential question for food supplements has

shifted toward: " To be, or not to be. " Those who fight for the

existence of the nutrients that were removed under the false premise

of " not existing " have no other option than to " take arms against a

sea of troubles, " as the great Shakespeare wrote. Instead of

protecting us against the " sea of troubles " that already surround us

in every day life, the Precautionary Principle adds oceans of troubles

when abused. Now that it has been applied to remove nutrients, the day

of reckoning will come. What will be gained in terms of public health,

costs, benefits? What will be lost? What do we need to fight for most?

The HAN Research Project will tell us.

 

 

For a PDF version of this article, go here.

http://www.alliance-natural-health.org/_docs/ANHwebsiteDoc_213.pdf

 

 

posted by Sepp Hasslberger on Thursday October 13 2005

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