posted October 05, 2004 05:23 PM         

"Making Conscious, Compassionate, and Informed Choices for Our Children"

The following is written by a colleague of GSMC's doctors, Jonathan V.
Wright, M. D., to inform the public of the organized threat to the
availability of nutritional supplements. If you value your right to make
your own healthcare decisions, we ask that you read it in its entirety,
forward it to any others you think may be concerned about this imminent loss
of freedom, and then, take action.

Sincerely, Dr. Wilson and Dr. Wright

Flash forward to the year 2007. You've taken supplements for years. You're
out of vitamins C and E. You go to your natural food store, but you can't
find the kind you want on the shelf. You ask a clerk to find them for you.
She says you can't get your vitamin E as mixed tocopherols (the best natural
form) anymore, and asks if you like your vitamin C in the 100 or
200-milligram size. The 1,000-milligram size, you say.

"Where have you been?" she asks. "Asleep since 2004? It's 2007 now! The
types and sizes of vitamins you just asked for have been declared illegal by
the Dispute Settlement Body of the World Trade Organization!"

"Wait!" you reply. "This is America! Our President says we're fighting for
American freedom--and you're telling me that the World Trade Organization
can dictate what size vitamin C I can take, and forbid me from taking mixed
tocopherols?"

The sales clerk sighs, and reaches for a piece of paper. "It's a little
complicated," she says. "A few years back, the European Commission passed
the European Food Supplements Directive..."

You feel your blood pressure rising. "What does the European Commission and
its Directive have to do with me? If Europeans want bureaucrats to tell them
what to do, that's their business. I'm a free citizen of these United
States!"

"Now, now, dear, your blood pressure will go up, and you can't get calcium
citrate, magnesium aspartate, CoQ10 or L-arginine or anything else natural
to help regulate it anymore."

"What? This goes beyond the FDA's wildest dreams!"

"That's not a tenth of it, dear. While you were distracted by the war
overseas for American freedom, here at home we lost our right to buy any
amino acids at all-no arginine, no carnitine, no tryptophan, nothing. I
can't sell you any essential fatty acids either-no DHA or EPA. And no
beta-carotene, no mixed carotenoids, no MSM, no boron...The list goes on and
on."

"So what can I buy?" you ask.

"Let's see...those 100 and 200 milligram vitamin Cs. Vitamin B6 maximum 4.2
milligrams, vitamin B1, 2.4 milligrams. Oh, here's a better one: You can get
niacin at 32 milligrams."

"Enough! I'm getting sick! How did this ever happen in these United States?"

"As I was saying, the European Directive..."

"I heard you. But what about America's Congress, America's President?

"Oh, they signed us up for this in the 1990s, when they made us members of
the World Trade Organization. According to the Congressional Research
Service: 'As a member of the World Trade Organization, the United States
does commit to act in accordance with the rules of the multilateral body.
The United States is legally obligated to ensure national laws do not
conflict with World Trade Organization rules.'"

"Our President and Congress send troops overseas to fight for freedom, but
let the WTO tell us what to do with our vitamins? There must be something we
can do."

"Actually, we did have a chance or two to reverse this in 2004, but it's
going to be incredibly difficult now."

"But I really need my mixed tocopherol vitamin E. And my mother with
congestive heart failure depends on CoQ10."

"I'm not unsympathetic, especially to your poor mother, dear." She looks all
around, and then lowers her voice. "I can give you some sources downtown."
She whispers a few names.

"But those people deal dangerous drugs! Now they're selling vitamins, too?"

"That's freedom in America in 2007, dear."

Think it can't happen? Think again.

The FDA's wildest dream-and our worst nightmare-is about to come true. Two
years ago, I told you about the passage of the European Union (EU) Directive
on Dietary Supplements. This directive, which is part of a larger form of
legislation called Codex Alimentarius, severely restricts access to natural
health products in Europe. At the time, it probably seemed a long way off:
After all, the law wasn't to go into effect for several years following the
initial passage.

Unfortunately, that several years is up, and the EU Directive is on track to
take full effect in August 2005-less than a year from now--and by 2007, the
scene described above will certainly be a reality for many, many people.
Obviously, this is devastating news for Europe. But thanks to some
pre-existing international agreements made by the U.S., the EU Directive
will be just as devastating for the natural health community here. The main
difference is that while the Directive has been big news in Europe for some
time, it's been virtually ignored by U.S. media, which means that the severe
restrictions it calls for will sneak up on most people and rob us all of our
freedom to choose natural alternatives before we even know what's happening.
That's why I and many of my colleagues in the health publishing world have
done our best to keep you informed of the Directive's developments-and their
consequences for the U.S.-over the years. And why we've decided to make a
big push in our September newsletters by covering it in-depth.

Simply put, we're down to the wire, and if we don't act immediately, we will
be facing the same fate as Europeans. There are steps you can take to get
the word out and, hopefully, to diffuse this ticking time bomb. But first,
let's take a few minutes and recount some of the specifics included in the
Directive so that you know exactly what it is we're fighting against.

5,000 products set to disappear

The EU Directive classifies vitamins and minerals in Europe as "medical
drugs" rather than dietary supplements, which means that they're subject to
government regulation in terms of dosage and availability. It gets worse:
There are many nutrients known to be vital to optimal health that are not on
the government's RDA nutrient list including chromium picolinate, lysine,
and selenium. Under the Directive, these types of supplements are banned
from over-the-counter sale. Put simply, it will be illegal to buy them
without a prescription.

The supplements that will be available will be restricted to multi-vitamins
containing no more than 100 percent of the established RDA amounts, which
are usually useless, trivial quantities--and they'll be far more expensive
than what we have now.

This Directive, for all intents and purposes, makes it illegal for people to
keep themselves healthy by supplementing with essential nutrients.

Plus, the Directive only allows supplements to be made from a list of 15
minerals and 13 vitamins. That leaves out at least 40 minerals important in
human metabolism and forbids the use of the most bio-available forms of
vitamin complexes. In essence, it means that all nutritional supplements
will be virtually the same-the specific combinations might vary, but the
types and amounts of nutrients will be identical-no matter what product
they're formulated into.

So, for instance, a middle-aged woman in Liverpool, England, who has a
dangerously elevated homocysteine level will no longer have the option of
reducing her risk of heart disease with a vitamin B dosage of her own
choosing. If she's currently taking 5 mg of folic acid daily, under the new
Directive she will be legally restricted to a prescription of 1 mg per day.
If she's taking a 100 mg dose of B6, she'll be restricted to 10 mg. And her
pantothenic acid (B5) intake of 500 mg will drop to 200 mg. These maximum
dosage levels have been chosen to "protect" her (so we're told), when in
fact the protection she needs the most will be unavailable.

In addition to these essential B vitamins, low maximum dosage levels have
also been set for vitamin C, niacin, and vitamin E. But at least they made
it on the list of allowed nutrients.

Approximately 350 supplement ingredients are missing from the list. If they
are not added to the list by June 2005, they will be deemed illegal
throughout the European Union. Supplement manufacturers may submit
"technical dossiers" to support applications for the inclusion of individual
elements or formulations on the so-called "positive list." But the EU has
made this process so expensive and time consuming that many manufacturers
simply can't afford the costs involved. As a result, around 5,000 safe
formulas and nutrients that have been on the market for decades will soon be
banned.

Saving us from ourselves

Of course, these regulations were all passed under the guise of "protecting
the public." According to the World Health Organization, popular alternative
medicines are often "misused" and may "harm patients." They point out that
the "incorrect use" of alternative therapies has caused deaths in wealthy
countries where more and more patients rely on them.

You could also argue that the incorrect use of kitchen knives, water-skis,
and even plastic bags have all caused deaths! Not to mention the use of
AMA-sanctioned medical procedures and FDA-approved drugs. The key phrase
here is "incorrect use."

The WHO could do everyone a service by first addressing the incorrect use of
accepted mainstream therapies that have caused far more widespread death and
adverse reactions than natural medicine therapies ever have or ever will.

Although they are few and far between, there are mistakes and fatalities
associated with alternate therapies, supplements, and herbal remedies. It's
always important to keep in mind that many of the compounds and herbs used
in natural medicine treatments are very powerful. They have risks and
potential side effects, which is why I always recommend that you work
closely with skilled natural medicine practitioners whenever you use these
therapies. But even with their cautions, natural remedies are far, far safer
than prescription drugs, and one reason might be the users themselves. An
article published in the journal Psychologist noted that people who seek out
natural and alternative treatments are generally more health conscious than
non-users, and believe that by making sound lifestyle choices they can
influence their own health. But not if the EU has anything to say about it.

Where's the "fight for freedom" when you need it?

You'd think that such blatant abuse of power to restrict people's personal
liberty would have our own self-proclaimed freedom-loving government up in
arms (literally). But there's an even darker side to all this, and it has
little--if anything-- to do with health or looking out for people's best
interests.

Even if the American government didn't want to go along with the regulations
imposed by the EU Directive, we really wouldn't have a choice. In fact, the
United States never has acknowledged or stated any form of acceptance for
the EU Directive. But hard as it is to believe, this "Directive" can
actually over-ride United States law if it isn't stopped in Europe.

As a member of the World Trade Organization (WTO), the U.S. will be bound by
any finalized standards put forth in the Directive.

If we choose to ignore the regulations our WTO-affiliation binds us to, we
would face severe trade sanctions with other WTO countries, which could
potentially cripple part of our economy. And there's no way that our already
anti-natural-medicine government is going to let that happen over access to
vitamins and minerals. So the best way to ensure it doesn't get to that
point is to do everything we can to stop it now--before it happens.

Protect your rights with these 3 steps

There are three actions to take. The most urgent is to support a case
brought by the British Alliance for Natural Health to overturn the European
Food Supplements Directive. In January 2004, the Alliance's attorneys (a
firm which has successfully had another European Directive overturned) won
the first round in the High Court of Justice in London; the appeal was
referred to the European Court of Justice. Please visit the Alliance's
website, www.alliance-natural-health.org
<http://www.alliance-natural-health.org/> , read about their case, and most
importantly, make a donation to support their efforts to protect everyone's
supplements, including yours. Even a few dollars will help; a few dollars
from each of us will add up. If we can help them overturn this food
supplement dictatorship in Europe, it won't ever come here.

The second action I urge you to take is to write, call, and e-mail your
state's Senators and Congressmen. Tell your Senators to oppose S.722, the
Dietary Supplement Safety Act, and tell your Congressmen to oppose H.R.
3377, the Dietary Supplement Access and Awareness Act. These two bills put
the wheels in motion for restrictions similar to those outlined in the EU
Directive to become U.S. law, which would be even more threatening to us
than just an inter- national code of standards. These extremely dangerous
and misnamed proposals would allow the FDA to "roll back" most of the small
amount of health care freedom you and I re-gained with the 1994 "DSHEA" law
we all fought so hard for. Even if we're successful in helping the Alliance
for Natural Health defeat the European Food Supplements Directive, if these
bills are passed into law, our supplement choices will shrink dramatically
anyway.

The final step to take is to tell your U.S. Senators and Congressmen to
support U.S. Representative Ron Paul's H.R. 1146, the American Sovereignty
Restoration Act. This accurately named (for once) legislation would make the
Constitution of the United States the supreme law of the land again, and
restore law-making and judging power to our elected representatives and
American courts, respectively. Please don't leave this off your list; in the
long run, it's the most important action of the three.

Please make a donation-of any size-to the Alliance for Natural Health as
soon as you can. Then, please write, call, fax, and e-mail your U.S.
Senators and Representative as often as you can, telling them to oppose S.
722 and H.R. 3377, and to support American freedom by voting for H.R. 1146.

For further information on the European Union Directive on Dietary
Supplements and on the Codex Alimentarius legislation, contact the American
Holistic Health Association (www.ahha.org <http://www.ahha.org/> ), the
Alliance for Natural Health (www.alliance-natural-health.org
<http://www.alliance-natural-health.org/> ), or the International Advocates
for Health Freedom (www.iahf.com).

posted October 06, 2004 12:31 PM         

Harpyr, if you were still in the PNW, I'd love to buy you a beer.

I'm torn between wishing you were still here and being glad you're not. Torn because you are truly one of us PNW-ers and I wish you were here, and glad that you're out there being your fabulous self... changing lives

I find it quite interesting how so many of your posts go uncommented upon (especially in GU). I'm quite positive their read (I sure read most of 'em).

posted October 06, 2004 01:15 PM         

your place in lindaland is beloved and necessary.

posted October 06, 2004 01:32 PM         

It's always nice to hear that one's presence is appreciated and the both of you should also know that you are integral parts of this community. I always enjoy both of your postings.

LS, I wish I'd met you when I still lived in P-town. I would definetly take you up on the offer for drinks. We'd have fun, I'm sure. lol

posted October 06, 2004 03:37 PM         

but i love to partake of lindaland's offerings, even if i can't always jump right in....

posted October 06, 2004 09:43 PM         

We are in a battle right now with the European Directives and what they would mean to ordinary people like us. They want to take away our right to buy natural supplements and re-classify them as medicines. Just so we are CLEAR about this. This means ANYTHING that changes, restores, corrects or modifies physiological function in the body. Just think about this one moment...

It means everything natural.

Homeopathy
Bach
Aromatherapy
Vitamins
Minerals
Herbs

The list is endless.....

The directives say (article 5)from the year 2005, the following bio-available supplements will not be permitted. That means NATURAL SUPPLEMENTS.

Calcium
Vitamin E
Selenium
Magnesium
Vitamin C

WATCH OUT USA!!!!

It's coming your way too. The American Medical Association has a history of prosecuting anyone whose practices they disagree with. No matter how successful the treatment maybe or inspite of evidence based solid scientific research.

Did you think it ended with Wilhelm Reich?
I thought it had too. We were wrong!

In 1993 a woman called Sharon Smith was diagnosed with cancer. It had metastasised to the bone. She went to a well known alterantive practioner Dr.Lawrence H Taylor
based in San Diego for treatment using alternatives. Within a few months, xrays showed her cancer had stopped spreading. She gained weight, she was no longer in pain, was more active. Her oncologist watched her carefully and was amazed. In March 1994 the police raided Dr Taylor's office, seizing his medicines because they were not FDA approved for the treatment of cancer. All requests by Sharon's lawyers and her oncologist were refused. A few months later Sharon died. Dr. Taylor was no longer able to help anybody.

The Codex Alimentarius Commission is fighting for us. We need to act now. Start writing letters folks. Start fighting back because you know that good nutrition is fundamental to good health.

Gia

--------------------------------------------------------------------------------

posted October 07, 2004 11:48 AM         

Is your government doing enough to protect you from! the dangers of vitamin supplements? The absurdity of that question would be comical if it weren't the basis of an international drive to severely limit our access to dietary supplements.
In yesterday's e-Alert I gave you some background on the "European Union Directive on Dietary Supplements" that will become law in August of 2005. Among the 25 European Union (EU) nations (representing more than 450 million people), this directive reclassifies vitamin supplements as "medical drugs," mandates low dosage levels, and outlaws many supplement ingredients that are currently widely available. Created to "protect" consumers, the directive will do exactly the opposite by denying consumers access to natural therapeutic supplements.

But don't think you're off the hook if you live outside the EU. Plans are already underway to bring these extreme regulations to the U.S. and many other countries.

---------! ---------------------------------------------------------------
Try ing to stay positive
------------------------------------------------------------------------

Under the EU directive, a "positive list" has been created to mandate which dietary supplements will be allowed for sale. The list does not include about 350 supplement ingredients, such as boron, a mineral that helps manage symptoms of menopause.

So if you're a supplement manufacturer in an EU country, and you produce a supplement that contains boron, you'll be required to remove it from the supplement by August 2005. But there is another option. You can submit a "technical dossier" to argue the case that a particular ingredient (such as boron) should be included on the positive list. Ah, but there's a catch: The European Commission has made this process so expensive and time consuming that many manufacturers simply can't afford the costs involved. As a result, many safe formulas and nutrients that have been on the ! market for decades will soon be banned.

-------------------------------------------------------------------------
But wait... it gets worse
-------------------------------------------------------------------------

The positive list isn't really as positive as it sounds.

For instance: Vitamin E made it on the positive list. Sort of. As HSI Panelist Allan Spreen, M.D., has made clear in several e- Alerts, there are a number of different vitamin E forms, and the synthetic form should be avoided for internal use. But according to Euromonitor International, the ONLY form of vitamin E on the positive list is the synthetic form.

And then there's selenium. Besides the fact that selenium has excellent antioxidant properties that have been shown to help increase insulin efficiency, selenium also enhances the effect of vitamin E, making it a perfect match for any vitamin E regimen.
But the only two forms of selenium that made the positive list are - yep - synthetic forms.

Wondering why the positive list emphasizes synthetics? I'll answer that question with another question: What sort of company specializes in manufacturing synthetic forms of natural treatments?

You already saw it coming, didn't you? The answer: pharmaceutical companies. Large drug companies can easily produce synthetic ingredients at low cost. So the positive list will certainly be positive for drug companies, while many small manufacturers of natural supplements will be forced out of business.

-------------------------------------------------------------------------
Decoding Codex
-------------------------------------------------------------------------

The outlook for the future of dietary supplements in Europe is decidedly gloomy. But if you're a U.S. citizen you might be wondering how all of this will affect you. In fact, the 2005 implementation of the EU directive won't directly affect consume! rs outside the EU. But the U.S. and the EU are both members of a much larger club.

The U.S. is one of the 165 member countries of the Codex Alimentarius Commission - an international food standards program created by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO). One of the purposes
of the Codex Commission is to "harmonize" international food trade. And here are a few key elements of that harmonizing:

* WHO regards all dietary supplements as "drugs" * The Codex Commission has made it clear that it wants to limit over-the-counter sales of dietary supplements while reclassifying others as pharmaceuticals, available only through a pharmacist

* The U.S. has one vote on the Codex Commission. The European Union represents 27 votes on the commission: the 25 votes of its member countries and 2 votes of the 2 EU candidate countries

* Under World Trade! Organization (WTO) rules, Codex decisions override decisio ns of individual countries

* Member countries (including the U.S.) that refuse to "harmonize" with WTO directives may be subject to restrictive trade sanctions

* The European Union is the United States' largest trade and investment partner, with a yearly two-way trade in goods and services that is estimated to be nearly $600 billion

"Harmony" never sounded so awful.

--------------------------------------------------------------------------
Securing the Homeland
--------------------------------------------------------------------------

The remarkably harsh restrictions of the EU directive on Dietary Supplements have met with an enormous protest from people who correctly see this process as an infringement on their right to make their own health care choices. This past February, the High Court in London ruled that a case challenging the directive should be referred to the European Court - the only court with the authority to challenge EU directives. Exactly when that court will hand down a ruling is not known. What is known is that the decision will have a profound effect on the availability of dietary supplements in Europe and beyond.

Meanwhile, back on the other side of the Atlantic, many congressmen and pro pharmaceutical organizations have been calling for more restrictive regulations of supplements. So there's no time to waste in letting our legislators know that we don't want to see any form of the EU directive taking effect in the U.S.

A complete list of government e-mail and postal addresses is available at a web site called Congress.org.

Send a message to your congressmen and let them know that we want no part of international "harmonizing" that restricts our access to supplements. And most importantly, tell them that you don't need any government or international organizations to "protect" you from your personal health care choices.

posted October 07, 2004 11:49 AM         

I've been telling some of my friends and family about this and they are always shocked and appalled that such a thing could happen. And they call this the land of the free!? riiiiight. I'm calling my congressman for dang sure.. we need to let our lawmakers know we won't stand for this!

posted October 07, 2004 11:59 AM         

I don't think most people of this country realize we've essentially forfeited our sovereignty on matters such as these.. It really boggles my mind the way some people can't stand the idea of the US being apart of the U.N. for this very reason and yet didn't bat an eye when we gave up our right to make our own laws when we signed up for the WTO....

posted October 07, 2004 12:24 PM         

August 2003

Diverging views on the EU Directives

Manufacturers, suppliers, retailers, practitioners and consumers in Europe have received a very wide range of sometimes conflicting messages about the likely impact of the EU legislation (see Box 1 for summary). Information filtering across the Atlantic is even more inconsistent. With so much confusion, many companies are doing nothing.

Box 1: Summary of key EU Directives

 
The reality is that a clutch of EU legislation is making its way through the EU law-making pipeline covering the full spectrum of dietary supplements, including herbal products, so-called ‘borderline products’, fortified foods, sports nutrition. In addition new EU regulations on health claims have recently been proposed and these are more or less identical to those just proposed in the US. For many it is the combined effect of all the EU laws that is of greatest concern.

Fortunately, only one directive has so far been passed in to EU law and EU member country legislation, this being the Food Supplements Directive. There is therefore still considerable scope to amend and shape the other legislation, assuming European and international interests get behind the appropriate campaigns.

One of the reasons the Food Supplements Directive managed to scrape through the European Parliament is that major international and European trade associations advised their member companies that the directive was going to be generally beneficial for the industry and they should plan ahead to comply with it. In contrast, it has been consumer, retailer and practitioner groups, especially in the UK, Sweden and Ireland, that have consistently claimed that the legislation could be catastrophic for particular sectors.

Since the directive’s passage in to EU law, many of the leading companies and associations with interests in the innovative sector of the European dietary supplement industry have come together under the umbrella of the pan-European and international Alliance for Natural Health (www.alliance-natural-health.org).

A detailed look at the legislation suggests that the primary reason for discrepancies in view over the Food Supplement Directive’s impact is the difference in impact of the legislation on different sectors of the industry. Innovator suppliers and those who are dependent on their products will inevitably be hardest hit. Companies manufacturing or selling relatively low-dose, synthetic vitamins and inorganic minerals will actually be set to gain considerably from the legislation, benefiting from the single market conditions across the 15 EU member countries (soon to be enlarged to 25) set by the directive, its primary intended purpose.

But, for others, the loss of many food-state vitamins (e.g. mixed tocopherols, tocotrienols, natural carotenoids, methylcobalamin (a form of B12), a range of minerals such as sulphur, boron, vanadium, silicon and many chelated or plant-derived forms is of great concern. Since the Food Supplements Directive is incremental in its effects, with even the bans on nutrient forms not coming in to force until 1 August 2005, many detractors argue that future effects could cumulatively have catastrophic impacts on innovators, independent retailers and practitioners.

Food Supplements Directive: key concerns

In summary there are four primary concerns about the Food Supplements Directive. These are:

Limited range of nutrient forms allowed on the ‘positive list’ (Annex I & II of FSD). The UK Food Standard Agency has determined that there are at least 270 ingredients (nutrient forms) that are presently used in the UK that are not included on the positive list. The National Association of Health Stores has in fact determined that this is an understatement, the real figure being in excess of 300 ingredients. These ‘missing’ ingredients are included in some 5000 products just on the UK market. The Irish Association of Health Stores has determined that around 85% of vitamin/mineral products in Irish health stores contain one or more missing nutrient form and would require reformulation to comply with the directive. One of the greatest concerns of the Alliance for Natural Health (the leading pan-European group working to positively shape the legislation) is that many of the missing forms are food-forms that are more bio-available (and generally safer) than the synthetic or inorganic forms included on the positive list.

Difficulties and costs in submission of dossiers (Article 4.6) to allow derogated use of off-list nutrient forms. The key issue here is that most supplement companies are in fact formulation companies who buy in products from a limited number of raw ingredient manufacturers or producers. If these manufacturers choose not to put in dossiers, then the formulation company would not be able to use it. However, if one manufacturer submits (and has approved) a particular dossier, any formulator can use that ingredient (at least until 31 December 2009). Costs for dossiers vary greatly according to the amount and nature of existing data: but estimates vary from €20,000 to over €300,000, depending on the ingredient. In addition, because the time frames are limited (12 July 2005), there may not be sufficient time to generate all the data for some ingredients.

Reductions in Maximum Permitted Levels via unnecessarily low Upper Safe Levels (USLs), being developed by the SCF/EFSA without a procedure that allows open consultation with outside scientists or other experts. The Alliance for Natural Health Expert Committee has determined that some of the science being used by the SCF is flawed and it appears that it is being used in order to justify very low maximum levels of nutrients in food supplements (the consequence of this is that higher levels will still be regarded as drugs and can therefore only be administered by doctors as is currently the protocol in many of the countries with less permissive legislative regimes) (Article 5).

Future restrictions on nutrients other than vitamins and minerals as of 2007, such as amino acids, fatty aids, phytonutrients, enzymes, fibre, probiotics, etc. These restrictions could be brought in via a positive list system (Recitals 6 & 8, Article 4.8).

It seems that the intended purpose of the FSD is to protect the simplest, low-dose, food supplements, of the type typically sold in European supermarkets and pharmacies. The more specialist forms, particularly those using food-form nutrients will only be able to remain on the market after August 2005 if dossiers for their ingredients are submitted and accepted, with all the contingent difficulties.

For many companies there is simply not enough time to conduct the necessary safety studies, given that there has never been any incentive or reason to do this work for a large proportion of the food-form nutrients. For others the task is too expensive. Take for example, selenomethionine, the most common form of selenium found in foods and well known as a very important antioxidant mineral: this form of selenium was rejected by the European Food Safety Authority (EFSA, formerly the Scientific Committee on Food [SCF]) in 1999 because long-term safety studies had not been conducted. Instead, EFSA has allowed use of two inorganic forms of selenium (sodium selenate and sodium selenite) that are both more toxic and less beneficial as antioxidants. For many consumers this is very confusing, as they hear on one hand that we should increase our consumption of Brazil nuts which contain high doses of selenomethionine, yet the EU Commission does not approve on its positive list use of this safe form of selenium simply because the studies are not available. Are food manufacturers being asked to provide safety data on natural products? Who for, example, has been required to prove via clinical trials that fruits and vegetables are safe?

Legal challenge of the Food Supplements Directive

The ANH is working with its scientific Expert Committee, outhouse lawyers, public affairs and media specialists to either annul or positively shape key EU legislation set to otherwise severely impact the innovative supplement industry and its beneficiaries. Although there is plenty that can still be achieved by effective lobbying on the amendments to the Pharmaceuticals Directive and the Traditional Herbal Medicinal Products Directive, and ANH is hard at work on this, options are far fewer for the Food Supplements Directive.

There is still some room to influence the maximum permitted levels and positive lists for nutrient groups other than vitamins and minerals, but the directive has already passed into European law and gets its full teeth once the directive is implemented fully in EU member states 2 years after its transposition in to their laws, in August 2005.

So, on behalf of innovators and practitioners, the ANH is proposing to challenge the validity of this directive later this year, and is working on this case with its out-house lawyers who are among the most experienced European lawyers in the EU.

Challenging the directive would make no sense unless there were reasonable grounds and probabilities of success. The ANH has retained the only legal team to ever have overturned an EU Directive – and after a detailed examination of the FSD, this team has given the ANH a green light to proceed (www.alliance-natural-health.org; see Latest News, 8 August 2003). The case is being built on a number of grounds, but of particular importance are EU constitutional grounds which suggest that there is a real chance of annulling the directive.

In addition, it appears that the effects of the directive can be challenged on grounds of proportionality, based on the fact that that it will impact on certain sectors of the industry, notably those associated with innovative products, in a disproportionate manner. The challenge was mounted on 13th October 2003, but this is just the start of it. Legal, scientific and commercial experts remain hard at work on the case to strengthen the already solid foundations of the case. Interestingly, if the directive is annulled, all national laws reliant on the directive are likely to be invalid.

Dr Robert Verkerk, Executive Director of the ANH, said, “the case will allow the real science of nutrients to be showcased to the Commission, to the Parliament and to the public generally. People will understand that supplementation of a good diet with high quality nutrients is a valid and effective way towards optimum health. There is no scientific rationale for accepting synthetic vitamins and a limited range of inorganic mineral forms while rejecting the plethora of naturally occurring vitamins and minerals. Winning the case will pave the way to a very bright future for the industry. We are not suggesting that there should be no directive at all, but the existing directive needs to be replaced with a re-worked version that allows for high quality, effective supplements across the whole of Europe. It’s about harmonising to good standards, not bad ones.”

It is now time for all manufacturers, suppliers, retailers and practitioners who believe their businesses are at risk to join the ANH campaign – and support the legal challenge. Contact Henrietta Lee, the ANH Campaign Manager on info@alliance-natural-health.org or phone + 44 1252 371 275 to find out how you can join the campaign and be part of the ANH’s rapidly expanding Support Base (see www.alliance-natural-health.org). Support is needed NOW.

The other Directives

The two key EU directives that will regulate basic supplements will be the FSD (but only those containing ingredients on the positive list or for which dossiers have been approved) and the amended pharmaceutical directive (PD) (Directive 2001/83/EC), of which the traditional herbal medicinal products directive (THMPD) is a part. So if a product is not able to be controlled under the FSD, it will default to the PD. If it falls under the PD, it will either require a full drug license (with the very substantial data requirements and costs required for drug approvals) or, if appropriate, botanically-based products can be classified as ‘medicinal herbs’ and benefit from a ‘fast-track’ licensing scheme. This ‘fast-track’ THMPD procedure requires that the applicant can demonstrate 30 years safe, traditional use is used in lieu of safety data (the major component of data required for market authorization as a drug).

The THMPD is passing through the European regulatory process now and one particularly contentious issue is the requirement in the EU Commission’s proposed legislation for 15 years EU use, out of the total 30 years traditional use. The Alliance for Natural Health, along with several other organisations have tabled amendments and are campaigning to allow 30 years demonstrated safe use form anywhere in the world. They argue that limiting non-EU use will prevent interesting and beneficial herbs discovered in parts of the world with very strong herbal cultures (e.g. China, India, South East Asia, South Africa, South America) from being brought in to Europe and it will therefore strongly impact future innovation. The legislation would essentially have the effect of freeze-framing the industry in the early 1990s.

In addition to this, further directives are being prepared by the EU Commission on sports nutrition and fortified foods, and draft Health Claims Regulations were tabled in Brussels in July of this year.

Conclusion

The US dietary supplement industry has flourished in the face of what must be regarded relatively as very liberal laws. There are clearly steps being taken by the FDA and others to alter this, but it seems the industry together with its huge consumer support base has so far defended itself very well against unnecessarily restrictive legislation. The current US campaigns against Durbin’s Bill S722 is a good example of how a diverse range of interested parties can work together.

The US industry is without question the world leader in this field, and there is growing evidence that nutrients in dietary supplements may be used very successfully in the prevention or even treatment of diseases.

Owing to the trends towards global harmonization, and in particular increased pressure towards trans-Atlantic harmonization, the EU Directives have a direct influence on the shape of future US laws. In addition to this, many US companies have substantial and growing markets in Europe, which will, following enlargement in two years time, have a population of some 450 million people.

The Alliance for Natural Health developed initially as a diverse range of largely European interests who were not against legislation per se, but were concerned about legislation that would potentially kill off innovation in the future. It has now developed an increasingly strong support base across Europe as well as in the US. The joint international committee of the NNFA and AHPA in July unanimously put forward a motion that supported the ANH’s legal action against the Food Supplements Directive. Some have gone as far as suggesting that the EU Directives are an even bigger threat to the US industry than the original proposal for DSHEA which was positively amended in 1994 following huge protests in Congress.

Time is of the essence – and every company or individual with interests in the future of the dietary supplement industry, both in Europe and the US, should now very seriously consider whether they want to accept the Food Supplements Directive, or be part of the potentially ground-breaking challenge that could pave the way to a very bright future for the industry.

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I'm busy writing my letters even now, and I stumbled upon this when I followed this link: http://www.alliance-natural-health.org/.
I also found this in case anyone would like some tips on writing to Congress: http://hea-www.harvard.edu/~ehooper/gov_pol/udall.html

It really is quite informative and simple. Now all you need to do is find the contact info for your senators and representatives and get writing.