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Analysis of Suzanne Harris, JD, The Law Loft of the Codex Threat as it existed in August 2000 after the Codex meeting in Berlin Note that her dire predictions are coming true- she was worried that the EU would pass the Vitamin Directive.... It DID on March 13, 2002 see Harris correctly notes that passage of the EU Vitamin Directive threatens to set up passage of a finalized Codex vitamin standard. By sheer numbers, the EU can and will dominate this way at Codex- so there is no way the USA can stop a finalized Codex vitamin standard from being developed at Codex- UNLESS we can help our European allies to do following: A) Stop the Medicines Directive, B) Stop the Traditional Medicines (Herbs) Directive C) Successfully Sue the European Commission Over the Vitamin Directive to Reverse It D) Put massive pressure on Congress to hold ANOTHER Oversight hearing on the Codex vitamin issue since they whitewashed the first one E) Show the need for the supplement industry to back legislation intended to remove the US from the WTO and fromm the UN in order to protect DSHEA. (See Last Section: What We Must Do Now!!)


The European Union is positioned to get there first. That's spells trouble for the dietary supplement industry and for consumers

The Codex Committee on Nutrition and Food for Special Dietary Uses started out with a bang this year. Demonstrators congregated outside as delegates tried to make their way inside past guards armed with submachine guns and at border crossings that looked like they were taken right out of an old World War II movie. While what happened outside the meeting may be good for us in the sense that it drew attention to consumer concerns about Codex, what happened inside was bad news indeed.

Why it's too early to uncork that champagne:

At first blush the result at Codex looks like a good deal. There was so much disagreement about where to go from here on the revised German proposal that the entire proposal got downgraded from Step 4 to Step 3 where it will remain until the next meeting of the Codex Committee on Nutrition and Food for Special Dietary Uses until next year.

That's good news, right? After all we didn't't want that nasty German proposal making its way through Codex to the Commission level where it could be adopted and then influence and ultimately overcome US and Canadian law.

While all of these statements are true, the conclusion that we are now better off isn't. Here is why:

Everything that's traded is subject to international jurisdiction one way or another:

Unless the current international trading system is torn out by the roots and replaced with something else, everything that is traded is subject to international jurisdiction one way or another. Dietary supplements are going to be regulated at the international level either as foods or as drugs. If classified as foods they will end up under Codex jurisdiction. If classified as drugs, they will end up under World Health Organization jurisdiction. While Codex may be bad, the WHO is worse. When viewed in comparison to other international organizations, Codex is a pretty open place that is showing early signs of opening up even more in the future. Codex meetings until this one where the Germans were frightened by e-mails that they read as a threat to the meeting, have been open to the press and open to the public. Some international NGO's that appear to be consumer based are certified as observers at Codex. And this meeting saw a shift in the composition of several country's delegations from lobbyists toward increasing the present of genuine consumer groups. While these are small steps, many other important international meetings have been closed to both the public and the press. So while not a good place to be, given the available international choices, Codex is the best choice available.

The first issue on the table is whether dietary supplements will be traded as food or as drugs:

When Agenda Item 5, dietary supplements came up for discussion, the first question on the table was whether dietary supplements should be discussed at all. Several delegations spoke out strongly that dietary supplements are drugs and not food and therefore are outside Codex jurisdiction all together.

A majority lead by the United States, Germany,the EU, the Netherlands, South Africa and others argued successfully that dietary supplements should be regulated as foods by Codex.

Bangkok made a difference:

More good news came as a result of the influence of the FAO/WHO expert consultation in Bangkok in 1998. The Law Loft argued at Codex as early as 1995 that it is wrong to assume that today's ordinary diets necessarily contain enough essential nutrients. Since the Bangkok expert consultation made the same point in 1998, it was easier for the US and Canada achieve a consensus to revise the preamble to the proposed Codex guideline to reflect the fact that ordinary diets may not always contain enough essential nutrients. That's an important point because it supports the view that dietary supplements should be available to consumers in international commerce as foods.

Now for the bad news: Upper Limits:

But bad news quickly followed. Nations could not agree on how to establish upper limits for dietary supplements. No nation took the position that we don't need upper limits on dietary supplements. Instead the conflict was between those who believed that upper limits should be set based on risk assessment (which would establish the highest levels for upper limits) and those who believed that upper limits should be established based on multiples of RDI's (reference daily values.) Even within the RDI position there was lots of disagreement. Some countries believe that upper limits should be set at 100 per cent of RDI's (which would limit dietary supplements to very low potency levels.)

It was in part due to this disagreement that the decision was taken to set the dietary supplement proposal back to Step 3.

Still more bad news, the EU will get there first:

The above wouldn't't be such bad news if the European Union weren't't poised to get their first. As things now stand, it is almost a certainty that the European Union will approve a new directive on dietary supplements before Codex writes an international guideline. That's really bad news.

A quick look at the background behind the EU's decision to write a new dietary supplement directive:

The European Union has sustained several shocks in recent years. The European public is now deeply concerned about food safety. The first scare was Mad Cow Disease but contamination scares and dioxin scares followed in rapid succession. European regulators got another shock at Codex where the US and Canada outmaneuvered them and passed a pro-beef hormone guideline and then took the Europeans to court at the WTO based on that guideline and won again.

It became clear to European Union that to prevail at Codex and at WTO it was going to have to revise its food laws to make them harmonious, consistent, streamlined and more science based. The EU began this process with a green paper (discussion paper on food law) in April of 1997. It quickly followed with another white paper (discussion paper on dietary supplements.)1 Since that time we have all been waiting for the other shoe to drop.

On May 8, 2000. the Commission of the European Union issued a new proposed directive in food supplements. And it's bad news indeed.

What the proposed European Union directive says:

While it's hard to read and contains lots of rather obscure references, and this reading isn't the final one, we can say that the preliminary reading of the proposed directive on dietary supplements is dangerous and very bad news. Here's part of what we have deciphered so far:

While purporting to take dietary supplements out of the straight jacket imposed by the definition of medicinal products contained in 65/65 EEC, the proposed directive would create restrictions that are almost as bad.

Under current EU law as stated in 65/65 EEC and as defined by the European Court of Justice, dietary supplements can be classified as drugs ("medicinal products") based on either their presentation (looks like a duck, walks like a duck, quacks like a duck,therefore is a duck) or upon functional criteria. The exact language of 65/65 EEC says that products may be classified as drugs if they "may be administered to human beings to restore or correct physiological functions." Since even a glass of water fits that text, some truly absurd and restrictive case law has been generated. For example, an herbal tea with no medicinal claims was classified as a drug because it invited consumers to contact a third party which made claims.2

The one good thing about 65/65 EEC was that it was interpreted and applied differently in different member countries of the EU. But by 1997, even that was changing as more liberal countries like the UK started moving toward the more restrictive interpretations.

The proposed directive states that neither labeling, nor presentation, nor advertising of a dietary supplement can claim 'the property of preventing, treating, or curing a human disease' either expressly or by implication.

While the sophisticated consumer may not care much about claims, manufacturers do because claims are linked to sales. The proposed limitations would severely restrict both direct and indirect forms of advertising and label claims. While its an improvement over 65/65 EEC, that improvement is slight.

The proposed directive is limited to vitamins and minerals and to combinations of those vitamins and minerals.

While the preamble to the proposed directive suggests that herbs and other products may be treated under a food directive in the future, for now the directive is limited to vitamins and minerals. Thus there is no relief on the near horizon for amino acids or herbal products.

The proposed directive creates a positive list of vitamins and minerals. The list is restrictive, that is, no vitamin or mineral not on the list may be traded under this directive.

Not only does the EU list, list fluoride as a proper dietary supplement ingredient but more importantly, the list is proscriptive. No vitamin or mineral not on the list can be sold as food without passing through a pre-approval process at the EU commission level.

The proposed directive sets out a list of approved chemical formulations for dietary supplements. Only those formulations can be traded as food supplements.

This could be good if it kept genetically modified dietary supplements off the market. The trouble is it may not. The EU is considering another directive to allow labeling of GMO free foods.

The proposed directive will set upper limits and minimum content for dietary supplements through an administrative process with 'mixed signals' as to how to make those determinations.

Under the Proposed Directive the European Commission with the assistance of the Standing Committee for Foodstuffs will set upper limits and minimum content. Setting minimum content is probably a good idea. Who wants to buy an empty tablet? Setting maximum levels, upper limits, is a problem. In making its decisions the Commission is to be guided by three factors:

1) safe upper levels established by scientific risk assessment

2) safe upper levels set through reference intakes where reference intakes are close to safe upper limits

3) and by reference to intakes of vitamins and minerals from other dietary sources.

Point one in this formula taken alone is probably the best we could get given the political picture as demonstrated at the meeting in Berlin. Point two, multiples of reference intakes in close cases where toxic effects occur at fairly low doses might be ok depending on how toxic effects are defined. But, point three 'intakes from other dietary sources' opens the door even wider to scientific chicanery. In fact, there is little reliable data on what people really eat and its nutritional content. The studies necessary to make those determinations are costly and won't be done in the near future. Just setting upper limits based on theoretical dietary intakes coupled with an undefined basis for setting toxic effect levels could be a recipe for disaster.

Mandatory labeling: labels must contain a warning against exceeding recommended intakes. Labels must say that dietary supplements are not a substitute for a diversified diet. Labels must say "This is not a medicinal product" where the presentation [packaging] is similar to a pharmaceutical form.

Cautionary labeling won't deter long time users but in many parts of Europe, dietary supplements sold as foods will be new to the consumer.

Why do we care? Count the votes!

We in North America care about what happens in Europe. Given the new state of international politics, what happens to them heavily influences what happens to us. If the parliament and council of the EU adopt this proposed directive, EU member states will come to Codex with one voice and many votes. Let's count the votes.

The EU has 15 votes. When the European Union joins Codex in its own right which it plans on doing next year that adds another vote for a total of 16.

The EU will control the votes of the 3 EU candidate countries because they won't want to vote against a system that's part of their accession package.

The EU will control 9 more votes of the candidate in waiting countries.

The EU will effectively control many more votes in the form of former colonies of member states in Africa, Asia and the Caribbean who enjoy trade preferences granted to their products at the EU and still more votes in the Maghreb and along the Mediterranean due to the new EU-Mediterranean free trade zone set to be established in 2010.

When you consider that under Rule 6, Codex votes can be taken on guidelines based on a majority of those present at a meeting, its easy to see the EU winning, forcing a variation on its directive on the entire Codex membership.3

We are in trouble here, what do we do?

The European Union has announced the opening of its decision making processes to more foreign and grassroots in-put. That means:

We can force Canada and the US to lobby directly at the EU for a more health freedom oriented directive

We can make our opposition to the proposed EU directive known to candidates for parliament and for Congress. This is an election year.

We can present our positions directly at the EU through international grassroots groups now being formed and through continued presentation of position papers at the EU.

We can and should support efforts by Europeans to establish genuine grassroots groups within their own countries

How long have we got?

Although the final effect on us isn't close, in every war there are significant battles that turn the tide. The battle at the EU is one of these battles. If the EU stays on schedule, the European Parliament and Council will approve the proposed directive by March 2001. We haven't got that long to get organized here. If we wait the key battle will be over before we even get started.


Where do dietary supplements stand? The bullet point summary:

  • The German proposal re: dietary supplements was returned from Step 4 to Step 3 at the CCNFSDU meeting in Berlin.
  • The current text of the German proposal continues to contain square brackets in key areas reflecting important areas of disagreement among delegates.
  • A new preamble acknowledging that ordinary diets may not provide sufficient nutrients has been added to the text.
  • A majority of delegates agreed that dietary supplements should be considered at Codex which means that the majority of delegates believe that an international guideline for dietary supplements as food is needed.
  • Under the present international system, we cannot escape some entity taking jurisdiction over dietary supplements at the international level. Given the presently available choices, we are better off at Codex with all of its flaws than ending up under World Health Organization jurisdiction with dietary supplements classified as drugs.
  • Negotiations broke down at Codex over a series of important questions about how dietary supplements should be regulated as foods.
  • On the plus side, for the first time, several delegations at Codex contained grassroots pro-dietary supplement activists. There is evidence at Codex that several governments want for the first time to include consumer in-put in the crafting of their official positions. The US Congress is showing a renewed interest in Codex as well. There are indications of interest within the Canadian Senate too.
  • But at this stage, the bad news outweighs the good because timing is important. Bogging down at Codex and failing to advance a pro-dietary supplement guideline is bad news not good news because lets the European Union go first.
  • The European Commission of the European Union came out with a new proposed directive on dietary supplements as food on May 8th.
  • Unless stopped or modified, that proposed directive on food supplements is scheduled for adoption by the European Parliament and the European Council in March of 2001.
  • The new EU proposed directive on dietary supplements contains good news and bad news. However, on balance it is a dangerous development.
  • The good news is that for the first time, the EU proposes considering dietary supplements consisting of vitamins and/or minerals as foods. If adopted, this directive would block most efforts by EU member countries to prohibit sale of dietary supplements that are covered by the proposed directive. The proposed directive suggests that in the future other nutrients like herbs could be added to the food category too.
  • The bad news is that: proscriptive positive lists of vitamins and minerals are created. In other words unless a vitamin or mineral is on that list (or is later approved for inclusion on that list by the European Commission) it cannot be traded as food in the EU.
  • More bad news: chemical formulations for vitamins and minerals are listed as well. But it doesn'tt look like these lists will protect against genetically engineered content.
  • Still more bad news, the proposed directive will allow the European Commission to set upper and lower limits on the content of vitamin and/or mineral supplements. Setting lower limits might be good as a precaution against empty capsules. But setting upper limits is dangerous especially under the formula contained in this proposed directive.
  • The three part formula for setting upper limits is vague, ambiguous and has great potential for abuse.
  • No label, presentation or advertising will be allowed that attributes to food supplements the property of preventing, treating or curing human disease.
  • Under the proposed directive, no label shall state or imply that an adequate and diversified diet cannot provide appropriate quantities of nutrients.
  • Mandatory labeling includes: a warning of health risks if recommended portions are exceeded, and a statement that food supplements should not be used as a substitute for a diversified diet.
  • Where presentation resembles a drug, the label must state: : This is not a medicinal product.
  • Timing is important. If the EU adopts its directive ahead of Codex establishment of a new guideline, the EU will be in position to heavily influence the content of the final guideline adopted at Codex. This is so for several reasons.
  • Right now, the EU countries are divided. Once an EU directive has been adopted, they will become a united voting block.
  • Experience has shown that once the member states of the EU agree to a collective position, the EU can be a very potent voting block at Codex. The EU will soon control 16 votes directly and another 12 almost directly. Still more votes are very heavily influenced by the EU through preexisting and newly emerging trade relationships.
  • Since at Codex votes on new guidelines can pass based on a majority vote of those in attendance, the EU will be in a position to not only heavily influence but dominate the result at Codex.
  • Codex guidelines once adopted have international level legal and political effects. They will influence the character of domestic legislation on dietary supplements in every WTO member state, including the US and Canada.
  • The dietary supplement industrys calculated effort to force market access at the EU through vote gathering at Codex has backfired or at least misfired. Industry had hoped to pry open the EU marketplace by adoption of a new dietary supplement guideline at Codex ahead of changes as the EU. In this way, industry hoped to influence the resulting legal framework within the EU via Codex instead of vice versa.
  • The dietary supplement industry is in danger here and so are consumers. While there are inherent conflicts of interest between the goals of the dietary supplement industry and consumers, there are also areas of convergence. Neither consumers nor industry are winners of the EU adopts an anti-dietary supplement directive.
  • The US position at Codex has been dominated by industry. The US government may not be able to muster the leadership or have the sustained political will to counter the EUs new moves.

We can only save dietary supplements if:

  • We firmly resolve to take matters into our own hands trusting neither governments nor industry to do the job for us;
  • We tell our governments exactly what we want them to do for us and demand that they do it;
  • We must create a pro-consumer strategy that keeps abreast of changes at home and abroad as they occur and that modifies its tactics to meet those changes.
  • We must be prepared to offer concrete positive demands and not simply criticize without offering solutions.
  • We must engage the process within the EU. That means: supporting the development of EU based consumer groups, presenting our positions to the EU in a timely manner and uniting European and North American grassroots groups in international umbrella organizations.
  • We must recognize that while this war may take years, critical battles, the battle at the EU and the battle to shape the Third Category in Canada, face us right now;
  • This is an election year in both the United States and Canada. We need to make Codex and the developments at the EU an issue in this election.
  • We must convince both the United States and Canadian governments to take a pro-consumer position at Codex and in other fora and not just blindly follow industrys lead.
  • We must convince both the United States and Canada to aggressively lobby the EU for a more dietary supplement friendly position.
  • Right now there are indications within both governments of a new interest in making contact with grassroots based consumers and in taking grassroots interests into greater consideration in crafting official government positions.
  • We can win this war, we can save dietary supplements but we will have to work hard and with intelligence to do it.

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