Consumers association for freedom of health
Vicolo di Monte del Gallo, 19/9 – 00165 Roma
Tel. 06 635884 – Fax. 06 632 196
e-mail: archimede@laleva.cc
sito web: http://www.laleva.cc

Presentation

La Leva di Archimede is an association of concerned individuals, consumers, practitioners and others interested in health and nutrition, formed in December 1998 in Rome, Italy. Its purpose is to advance and protect the freedom of choice of consumers in health matters through information, education and public campaigns.

Our principal areas of activity are nutrition and health, the freedom to choose alternative therapies, as well as information about known and suspected toxins in our food supply and in the environment.

We work through direct contacts with the authorities and the press and have also established a well-visited, popular website. The address of our site is:

http://www.laleva.cc

There is also a site that is news-oriented and open to contributions of users:

http://consumers.laleva.cc

We have established an on-line petition to legislators and administrators which, at this writing, has been signed by more than 26.000 consumers of natural and nutritional products from all over the world:

http://www.laleva.cc/petizione/english/intro_eng.html

What all these consumers are asking you is, in essence:

"Please preserve our freedom of choice in matters of health and nutrition; we depend on nutritional products for our health!"

President: Vitale Onorato
To contact us by e-mail: archimede@laleva.cc
Telephone: 003906 635884 - 0039 320 044 0948

Statistics about the safety of food supplements

The following statistics, elaborated by Ron Law in New Zeland on the basis of data from government and related sources, show that food supplements are the safest products available, even in countries where they are freely sold and are consumed by a large part of the population.

(2)	Dietary supplements are only responsible for 0,0002 % of all deaths.

(3)	Foods are about 390 times as dangerous as dietary supplements and 

(4)	Highly preventable adverse (medicinal) drug reactions are responsible for 2,4 % of all deaths. Pharmaceutical medicines are thus about forty-two thousand times more dangerous than supplements!

Considering that statistical data show a vastly superior safety profile for supplements over any other comparable product category, we must ask the question why these products should be regulated in the same or a similar way as pharmaceutical medicines, which are vastly more dangerous, despite having been subjected to such controls for decades!

To us such a step does not seem to make any sense at all!

A similar statistical elaboration of data from the USA is available in the internet at:

http://www.laleva.cc/petizione/english/ronlaw_eng.html
and
http://www.laleva.cc/petizione/ron_law_tables/tabella.html

Ref
(1)	1997, http://www.nzhis.govt.nz/stats/mortstats.html
(5)	1997, http://www.nzhis.govt.nz/stats/diseases/lung.html
(6)	1997, http://www.nzhis.govt.nz/publications/Suicide.html
(7)	1997, http://www.nzhis.govt.nz/publications/drugs.html
(8)	1997, http://www.nzhis.govt.nz/stats/diseases/cerebrovascular.html
(9)	1996 to 2000 http://www.ltsa.govt.nz/research/fatal5yr.html
(10)	1997, http://www.nzhis.govt.nz/publications/mortality97.pdf
(11)	1998, http://www.osh.govt.nz/hazards/stats/fatals/fatal1998.html
(12)	1997, http://www.nzhis.govt.nz/publications/Fetal.html
(13)	http://www.caa.govt.nz/publicinfo/towards-2005-media-rel.htm
(14)	http://www.watersafety.org.nz/index2.html
(15)	1999, http://www.msa.govt.nz/Publications/content/Accidents_1999-2000.pdf
(16)	1998, http://www.watersafety.org.nz/whatsnew/May01ds.pdf
(17)	http://dlg.wa.gov.au/pub/docs/Shark/report.pdf
(18)	http://www.mja.com.au/public/issues/171_11_061299/ohehir/ohehir.html
(19)	http://www.mja.com.au/public/issues/173_04_210800/mcgain/mcgain.html
(17)	1852-2000 Map of New Zealand Confirmed Unprovoked Shark Attacks ,
http://www.flmnh.ufl.edu/fish/Sharks/Statistics/GAttack/mapZE.htm
(20)	2000, http://www.transport.govt.nz/downloads/transport_overview.pdf
(21)	http://www.govt.nz/archives/MSA/chap5.htm
(22)	1997, http://www.nzhis.govt.nz/publications/fetal97.pdf
(23)	1997, http://www.moh.govt.nz/moh.nsf/49ba80c00757b8804c256673001d47d0/5b3ac5e4
40f6ccd7cc2569b8007e5e9f/$FILE/cervicalcancer.pdf
(24)	1997, http://www.moh.govt.nz/moh.nsf/Files/phot_89_99/$file/phot_89_99.pdf
(25)	1994, http://www.osh.govt.nz/hazards/stats/fatals/epidemology.pdf
(26)	1998, http://www.stats.govt.nz/domino/external/pasfull/pasfull.nsf/7cf46ae26dcb6800c
c256a62000a2248/4c2567ef00247c6acc256afd006cc9df?OpenDocument
(27)	1998, http://www.stats.govt.nz/domino/external/pasfull/pasfull.nsf/0/4c2567ef00247
c6a4c2568880078c4c2/$FILE/alltabls.xls
(28)	http://www.moh.govt.nz/moh.nsf/Files/section3/$file/section3.pdf
(29)	1998, http://www.moh.govt.nz/moh.nsf/49ba80c00757b8804c256673001d47 d0/d255c2525480c8a1c
c256b120006cf25?OpenDocument
(30)	http://www.lightningsafety.noaa.gov/
(31)	1997/98, http://www.acc.org.nz/about-acc/injury-statistics-2001/14.-fatal-entitlement-claim.pdf
(32)	1997, http://www.hillarysport.org.nz/sportfacts/factsfigs/topsports.shtml
(33)	http://www.sport.vic.gov.au/dir017/srvsite.nsf/pages/research_bussport4?OpenDocument
(34)	1999, http://www.cdc.gov/od/oc/media/pressrel/r990917.htm
(35)	1999, http://www.cdc.gov/ncidod/EID/vol5no5/mead.htm
(36)	2001, http://www.foodallergy.org/media.html
(37)	1999, http://www.anzfa.gov.au/mediareleasespublications/speeches/speeches1999/foodregulationinaust338.cfm
(38)	1998, http://www.dpc.vic.gov.au/domino/web_notes/pressrel.nsf/8033ad7c09aa5ebf4a2566c
c007e4f73/422ed71f890ade3c4a2566ce0083c734?OpenDocument
(39)	1996, Proposal to develop a national food hygiene standard ANZFA Sept 1996

The European Union's proposal for a food supplements directive

The following letter expresses our misgivings about the food supplements directive now under discussion.

(2)	Many consumers will lose access to vitamin and mineral supplements they are taking today, their freedom of choice will be severely limited.

(3)	Supplements, especially of higher doses, are often used in non conventional medicine, but the proposed directive does not consider this use and will remove from the market many of the more efficent and therefore most important means of  nutritional therapy.

(4)	Small and medium size enterprises (SMEs) comprise almost all of the European manufacturers, distributors and points of sale to the pubblic of food supplements. While the directive will favour the large pharmaceutical companies, many SMEs may suffer and eventually succumb to increased competitive pressure from "big pharma" as a result of the directive.

These are the salient points, but please read our letter for more detail.

Dear (member of the European Parliament)

La Leva di Archimede is an association of consumers aiming to protect the free choice of the individual, with particular emphasis on health matters and nutrition (http://www.laleva.cc)

We are writing to you as a member or substitute member of the Environmental Committee, but in any case as a member of the European Parliament. You will be asked, in the next few weeks, to deliberate and vote on a proposal for a directive regarding FOOD SUPPLEMENTS.

As you know, these are products that contain nutritive substances such as vitamins and minerals and other biologically active substances that are taken for their health - promoting properties.

The member States of the EU have arrived - after various compromises - at a "common position" for the text of the directive, however many doubts persist about the successive implementation of the control mechanisms it proposes to institute.

These mechanisms, such as the determination of maximum dosage limits and the approval of substances to be used as sources of vitamins and minerals, will be implemented by purely administrative action, without any possibility of intervention of the European or national parliaments or even of the governments of the Member States themselves.

Many consumers of these products are asking you and the other members of the European Parliament to intervene so as to safeguard the free availability of supplements with dosages and ingredients that are effective for the prevention of illness and are able to optimise health. These people are asking you to ensure that the products available today shall not vanish from the market as a consequence of the restrictive directive that is under consideration now.

You may have received a large number of e-mail messages from persons who are - not without reason in our view - concerned about the possibility to find themselves in the future without certain natural products which have saved their lives or have made their lives liveable, often after having tried without success to handle their health problems by means of allopathic medical interventions.

In addition to those consumers who write directly, many consumers have chosen to express their preoccupation by signing a petition posted in the internet on our association's site. This petition has already been signed by more than 25.000 consumers, many of them Europeans, and can be consulted directly at the following addresses:

http://www.laleva.cc/petizione/english/intro_eng.html
(in English)
http://www.laleva.cc/petizione/francais/intro_fr.html
(in French)
http://www.laleva.cc/petizione/deutsch/intro_de.html
(in German)
http://www.laleva.cc/petizione/italiano/intro_it.html
(in Italian)
http://www.laleva.cc/petizione/espagnol/intro_esp.html
(in Spanish)
http://www.laleva.cc/petizione/portugues/intro_pt.html
(in Portuguese)
http://www.laleva.cc/intro_gr.html
(in Greek)
http://www.laleva.cc/petizione/dansk/intro_dk.html
(in Danish)

A look at the directive

The directive as proposed by the Commission and accepted in principle by the Member States, will with all probability

- go against the interests of CONSUMERS by establishing restrictions on the availability of products that are very popular and are used to maintain good health;
- hinder the exercise of NON CONVENTIONAL MEDICINE by limiting the future availability of a very important preventive and therapeutical instrument - nutritional health products;
- be a DISASTER FOR PUBLIC HEALTH, because it is set to eliminate an important instrument of PREVENTION;
- have negative consequences for SMALL AND MEDIUM SIZE ENTERPRISES in Europe, which will find themselves in difficulty as the directive will slant market conditions in favour of the "big players";

and finally the directive will

- bring a windfall of PROFITS FOR THE PHARMACEUTICAL MULTINATIONALS, by creating market conditions in which they can easily outcompete the smaller companies.

These are serious allegations, which we are not making light-heartedly, and we shall explain below:

Restrictions on freedom of choice

Both the requirement for approval of all the sources of vitamins and minerals (see annexes to the directive) and the intention of establishing dosage limits (see article 5) will inevitably eliminate from the European market many perfectly safe products that are available today. Think only of the fact that there are currently more than three hundred vitamin and mineral sources that are excluded from the lists of allowed ingredients in the annexes of the directive.

Further more, the Scientific Committee on Foods (SCF), in the course of its work to fix maximum limits of non-toxicity for the various nutritive substances has already refused to set limits for some nutrients, not because of presumed toxicity but because it does not consider the setting of such limits necessary because, according to the SCF's reasoning, "there is no nutritional necessity" to supplement these nutrients above the level of the RDA. The SCF has also denied approval for some forms of mineral rich yeast as source of these minerals because, according to their reasoning, these minerals would then be "of too high bioavailability".

Certainly we cannot be confident that the right of consumers to freedom of choice will be respected after the directive passes into effect.

Non conventional medicine needs these products

The European Parliament itself, in its resolution A4 - 0075/97 on the status of non-conventional medicine has called on the Commission to "submit a proposal for a directive on food supplements which are frequently situated on the border between dietary and medicinal products. Such legislation should help guarantee good manufacturing practice with a view to consumer protection without restricting freedom of access or choice and ensure the freedom of all practitioners to recommend such products" (emphasis added).

According to our analysis, the proposal for a directive does not take into account the fact that in the exercise of non conventional medicine vitamin and mineral supplements are used often and with great success. The directive does not make any reference to the use of these products in non conventional medicine.

It is exactly the kind of products used in non conventional medicine (higher dosages and special formulations) that are going to be eliminated by the directive, interfering directly with the exercise of the alternatives to "official" medicine, which for decades has been completely dominated by a pharmaceutical paradigm.

We propose that the European parliament hear representatives of non conventional (nutritional) medicine to establish what would be the real impact the directive will have on their work and on the availability of the means of therapy.

Public health and vitamin supplements

It has been well known for years that many of the socalled "diseases of civilisation", including cancer and heart attacks, could be prevented with changes in nutrition. The health authorities of many member States are financing campaigns to raise public awareness ("eat several servings of fruit and vegetables a day", or "eat a healthy Mediterranean diet" etc.). For that reason, it seems to us that to limit access to nutritional substances by a directive that requires expensive "dossiers" for each substance and lowers available dosages of vitamins in health products, would be an action completely contrary to good sense as well as to our scientific knowledge of prevention and nutrition.

If on the one hand the European Union and its Member States go to great lengths to educate their citizens so as to take more responsibility for their health through their choice of food, it would seem counterproductive to limit, on the other hand, the choice of nutritional products available to those persons who already are interested and informed enough to integrate their food intake with certain nutrients!

Small and medium sized enterprises will suffer

Traditionally, nutritive and natural health products are produced by small and medium sized enterprises and they are distributed though a net of shops that specialise in the sale of natural health products, organic foods and so on. These are - in various countries - health food stores, dietetic products stores, Reformhaus, erboristeria, green pharmacies, and in more recent times even real "natural food centers".

Given that many products that are available today will be eliminated from the market and considering as well the rigidity of super controlled lists of ingredients almost certain to stifle innovation by making the formulation of new products extremely difficult, we must conclude that smaller producers will no longer be able to defend themselves against the competitive pressure of the multinational pharmaceutical producers.

It is already a fact that the multinational corporations are maneuvering to enter the market with such products as "nutraceuticals", "cosmeceuticals", and "functional foods".

The European Union's legislative procedures mandate new legislation to be considered in conjunction with a study of the impact of such legislation on small and medium sized Enterprises (SME). We are suggesting that such an SME impact study be conducted and made accessible to interested parties so as to properly assess the directive's impact on this part of the productive reality in Europe.

The enterprises concerned are local producers, distributors and shops that sell natural products in the EU. The number of jobs that are endangered by the directive might be relatively small if compared with its much greater impact on public health, but never the less we believe that these effects on the social tissue of production and commerce merit serious study.

The profits of the multinationals

The multinational pharmaceutical companies, in addition to establishing their own product lines, are entering the food supplements market in a serious way, buying up some of the more successful companies of that sector. The directive under discussion will boost this takeover campaign which ultimately aims to achieve complete market dominance.

The procedures for the approval of new ingredient substances to add to the lists in the directive's annex is best described as a "pharmaceutical evaluation". The costs for each substance to be approved are on the order of a hundred thousand Euro, too much for any but the largest companies to spend. Incidentally, the "basic lists" already annexed to the directive contain almost exclusively those forms of (especially) minerals, that have been utilised for decades as ingredients of pharmaceutical medicines. These types of ingredients may of course be used without any further costs to the large pharmaceutical producers in the formulation of supplements, while others will be forced to invest in defensive research.

The more recently introduced (by the health product industry) more advanced formulations are generally of greater bioavailability, but under the directive, those formulations will face substantial additional costs and even the possibility of not being approved for a variety of reasons any bureaucrat may dream up, much to the advantage of the multinational players.

Products containing higher dosages of vitamins and minerals are produced almost exclusively by small and medium sized companies. They are destined for a highly specialised market of well informed consumers and of persons who consult specialists in the field of non conventional medicines.

This kind of market will certainly vanish with the products simply "no longer available", in case the directive comes into force. This is such a highly specialised "niche market" that none of the large multinationals will agree to furnish the products, simply because there will not be enough request to justify their costly registration as a medicine.

Whether, as the ultimate result of the directive, a black market in popular high dosed supplement will spring up, remains to be seen.

Our question, at this point, is:
Is it true - as someone has said - that the European Union has been "made by the multinationals for the multinationals"?

We certainly hope that this is not the case and that the directive will not proceed in it's currently proposed form. To go ahead would mean to make a great gift to the pharmaceutical multinationals, rather than achieving any positive result for public health.

The food supplements market will be "well disciplined", that is true, but it will also fall into the hands of a pharmaceutical industry which has already demonstrated to be unable to stimulate PREVENTION, maybe because the greater part of its income depends on DISEASE.

We are hoping to hear from you and remain

Yours sincerely
La Leva di Archimede

Vitale Onorato
President

Our proposal for food supplements

The current text is of a very restrictive general outlook and does not take into account the use of supplements in non conventional medicine. It also completely ignores the freedom of choice of millions of citizens. We therefore do not believe that it is possible to salvage this current proposal by passing amendements.

Our suggension therefore is the following:

1) That the current text of the directive be rejected

2) That a new proposal for a directive regulating food supplements be worked out, consulting all relevant stakeholders early on in the process, i.e. when formulating the new legislative text, which should take into account the following:

(5)	the use of supplements in non conventional medicine;

(6)	the freedom of choice of the individual citizen;

(7)	the fact that a large part of the production and distribution of these products is the work of small and medium sized enterprises in the EU;

(8)	the golden opportunity of at once bettering pubblic health and drastically lowering public health ex penditure;

(9)	the necessity of abandoning the failing and prohibitively expensive pharmaceutical paradigm of health care;

(10)	other recent legislative experiences such as in the USA (1994) and Canada (still under development at this time)