COLLOIDAL SILVER BANNED IN EUROPE - PART II
“A rash of European laws are being foisted on Europe's 500 million strong population through undemocratic means, by unelected bureaucrats in the European institutions, which attempt to sideline natural treatments once and for all.”
by Dr Robert Verkerk
According to the international health freedom organization Alliance for Natural Health (ANH), colloidal silver has now been banned throughout the European Union.
This is a major defeat for global colloidal silver community and it may well ultimately spell disaster for North American colloidal silver users too, particularly as moves to “harmonize” North American food supplement regulations with European Union regulations continue.
A Brief Overview of the Global Battle Against Colloidal Silver
“There are moves all round the world, not just in Europe, to make it difficult to sell silver as a food supplement because it directly competes with the antibiotic market.”
-- Meleni Aldridge, Executive Coordinator, Alliance for Natural Health Int’l
I’ll cover the European Union ban on colloidal silver in just a moment. But first, let me give you a brief overview of the global battle now raging against colloidal silver.
I’ve been warning for years that the battle to ban colloidal silver is, in reality, a worldwide battle, with anti-colloidal silver forces operating on multiple fronts, in multiple countries, using a variety of political bullying and media propaganda tactics in attempts to ultimately deprive consumers of their rights to use the world’s most powerful natural antibiotic.
Here in the U.S., the FDA tried to ban colloidal silver throughout the 1990’s, at the behest of the major pharmaceutical companies. After spirited consumer opposition, they finally admitting in June 1999 that they could find no legitimate reason to ban its sale.
Instead, they implemented their infamous “Final Ruling” on colloidal silver, stating that it was not considered to be “safe or effective” for treating any disease or condition, and therefore no health claims could be made for it in advertising or on product labeling.
Afterwards the FDA embarked on a campaign to prevent colloidal silver manufacturers and vendors from telling the public about the powerful, infection-fighting qualities of the substance, by issuing numerous threats in the form of official regulatory warnings against offending colloidal silver vendors.
Pseudo-medical proxy groups like Quackwatch and a number of others who shill for the FDA and AMA, have also been used to publicly denigrate colloidal silver. And sensationalistic television and print media campaigns have been launched to scare the public into believing colloidal silver is “unsafe,” “toxic” or otherwise harmful.
Then, in 2009 a coalition of radical environmental groups operating globally with funding from several major pharmaceutical companies picked up the anti-colloidal silver baton and sued the Environmental Protection Agency in an attempt to force them to regulate silver-based products – including colloidal silver – as “pesticides” and ban them until manufacturers could prove their products posed no threat to “ecologically sensitive microorganisms” in the environment.
This tactic unleashed a flood of opposition from thousands of angry colloidal silver users who called, faxed, emailed and wrote the EPA, expressing their displeasure at the proposed regulations. This massive outpouring of citizen displeasure appears to have at least temporarily forced the EPA to back down.
The EPA has been tight-lipped since that time, neither confirming nor denying whether or not their classification of silver as a “pesticide” will ultimately affect dietary colloidal silver supplements.
(Side note: When I recently spoke with EPA’s Director of the Office of Science and Coordination, Joseph Bailey, and point blank asked him whether or not the EPA intended to regulate colloidal silver, he said “Probably not, because it’s a nutritional supplement and it’s not being used for pesticidal purposes.” Knowing that “pesticidal” is the EPA’s euphemism for “anti-microbial” in regards to all matters concerning silver, I then said, “But we all know colloidal silver is sold and used for the specific purpose of killing microbes.” He replied, “Under those circumstances, then, I suppose we’d have to regulate it.”)
Interestingly enough, the environmental groups attempting to force the EPA to more stringently enforce their “pesticide” laws against silver-based products have in the interim repeatedly called for colloidal silver to be banned as an environmental toxin and a danger to human health and well-being.
What’s more, all of this has coincided with the advent of the global “Swine Flu” threat, which saw the FDA step in to repeatedly threaten colloidal silver vendors against telling consumers that colloidal silver is effective against viruses by accusing them of committing consumer fraud if they do.
Those are the kind of strong-arm tactics being used here in the U.S. to keep colloidal silver out of the hands of consumers, and to keep consumers in the dark regarding its remarkable, infection-fighting qualities.
And of course, it’s all done for the protection of the major global pharmaceutical companies who want no competition from natural products against their basically useless and potentially dangerous flu drugs, and potentially deadly vaccines.
In Australia, the same kind of thing is happening.
The Australian Therapeutic Goods Agency (TGA) ruled back in 2002 that there were “no legitimate medical uses for colloidal silver and no evidence to support its marketing claims.” They concluded that "efforts should be made to curb the illegal availability of colloidal silver products, which is a significant public health issue."
The Australian TGA has now apparently banned all colloidal silver products from being sold in Australia if the manufacturer or vendor makes health claims.
Indeed, the only exclusion allowing legal colloidal silver sales in Australia is if the product is sold for use as a “water disinfectant” and if no claims whatsoever are made for it.
That of course hasn’t stopped some Australian colloidal silver vendors from illegally marketing their product as an oral nutritional supplement and infection-fighting agent. Nevertheless, the handwriting is on the wall, and the laws are in place in Australia for a complete ban.
I am told the same thing is happening in New Zealand, South Africa and other countries.
Even our neighbors to the north are not immune. In 2007 Canada’s Health Canada agency began issuing “unauthorized product” warnings against colloidal silver vendors, and simultaneously began soliciting “adverse reaction reports” against specific colloidal silver products.
Of course, as we’ve publicly noted, the Canadian health authorities have no evidence whatsoever that colloidal silver products are unsafe or harmful. They are simply trying to manufacture evidence by goading their citizens into making adverse reaction reports, apparently as a means of justifying planned regulatory actions against colloidal silver manufacturers in the future.
The European Ban on Colloidal Silver
Okay. Here’s the scoop on the European ban on colloidal silver, which took effect on January 1, 2010.
The story actually begins back in 2003. That’s when the European Food Safety Authority (EFSA) brought into force their infamous Food Supplements Directive (2002/46/EC) (FSD), which dramatically limited the number of types of nutrients that could be sold throughout the 27 member nations of the European Union encompassing most of western Europe and some eastern European nations.
This action essentially removed several hundred nutrient ingredients -- including silver – from the marketplace in one fell swoop, making it illegal to sell thousands of different food supplement products containing those ingredients.
Fortunately, the Directive had a derogation clause under Article 4(6) that allowed unapproved nutrient types that were already on the market at the time the Directive came into force in 2003 to continue to be sold until the end of the derogation phase on 31 December 2009.
Because of the derogation clause, a complete ban on thousands of nutritional supplement products containing unapproved ingredients – including colloidal silver -- was temporarily forestalled.
False Sense of Security
Unfortunately, the extra time granted by the derogation clause apparently gave European nutritional supplement manufacturers and vendors a false sense of security.
Nutrient manufacturers throughout Europe were supposed to use the extra time to conduct clinical studies and submit dossiers to the European Food Safety Authority demonstrating the safety, efficacy and bioavailability of the unapproved ingredients being used in their products, in accord with the EFSA’s stringent regulatory requirements.
Unfortunately, many European nutritional supplement manufacturers were either completely unaware of the requirements to conduct safety, efficacy and bioavailability studies, and submit the results to the EFSA, or they could not afford the expensive and time-consuming scientific testing required.
In the end, they blissfully continued manufacturing and selling products containing the unapproved ingredients, without submitting the proof demanded by the EFSA.
In some cases, some colloidal silver manufacturers who admit to having known all along about the regulations have personally complained to me that the required clinical studies were so onerous, stringent and costly that they simply could not be met.
Others have complained to me they could not obtain the proper study protocols from the EFSA. They felt it was ridiculous of the EFSA to require studies costing as much as hundreds of thousands of dollars, but refuse to spell out the protocols for acceptable results.
Some EU colloidal silver manufacturers have even complained that it appeared the regulatory requirements were purposefully designed to assure that as few unapproved ingredients as possible could survive the approval process.
Silver – the primary active ingredients in colloidal silver -- was apparently one of those unapproved ingredients the European health authorities wanted to keep off the market at any cost. As Anders Sultan, owner of Sweden’s largest colloidal silver manufacturing firm Ion Silver recently told me:
“Conducting a bioavailability study was a must in order to have even a slim chance of keeping an unapproved ingredient like silver on the market.
A study like this is basically the same as a Phase I drug study, costing in the range of $120,000 U.S. dollars or more.
This study wouldn’t be all that’s required, as it only addresses bioavailability. The EFSA also requires proof of safety and efficacy.
So you can see that many hundreds of thousands of dollars in testing would have to be spent, and even after that there was no guarantee the EFSA would approve the ingredient for use in nutritional supplements.”
When I mentioned that someone must have at least tried to conduct the studies needed to keep colloidal silver on the market in Europe, Sultan replied:
“Natural-Immunogenics, who as you know is a large and well-known colloidal silver manufacturer based in America, also sells their product in Europe.
My understanding is that they had set out to conduct a bioavailability study in accord with EFSA requirements. But they apparently never got a final conclusive study off the ground because they couldn’t get the EFSA to cooperate with them.
The EFSA apparently failed to give them formal guidelines explaining how the study needed to be conducted in order for the results to be accepted as evidence on silver’s behalf.”
I can only surmise that Natural-Immunogenics didn’t want to spend over $100,000 conducting a bioavailability study, only to be told afterwards that their study protocols didn’t meet the EFSA’s requirements.
A news article published on the NutraIngredients.com web site back in December 2008 explains that the EFSA was apparently unhappy with the initial data submitted by Natural-Immunogenics on behalf of their “silver hydrosol” product. The EFSA appears to have kept upping the ante until the required documentation was simply too onerous to produce.
In short, it appears the EFSA didn’t deal in good faith with Natural-Immunogenics, to say the least, a sentiment echoed privately to me by other European colloidal silver vendors in regards to their own efforts.
Indeed, many European food supplements manufactures now privately complain that unfair roadblocks were put up in order to prevent supplements containing unapproved ingredients like silver from being transferred to the Positive List. In many ways, European colloidal silver vendors tell me, the deck was simply stacked against silver and other “unapproved” ingredients from the start.
What’s more, even major European health freedom organizations such as the Alliance for Natural Health – who oppose the inclusion of colloidal silver on the banned list -- have complained that they were “not among the interests who were invited to submit comment” regarding changes to the European Commission draft regulations covering food supplements.
It was these draft regulations that ultimately resulted in the EU-wide ban on the sale of common minerals supplements such as colloidal silver.
This apparently purposeful exclusion of the Alliance for Natural Health from the public portion of the regulatory process was likely because they had, back in 2005, successfully challenged the EU Food Supplements Directive through the European Court of Justice, resulting -- much to the chagrin of the EFSA -- in some key regulatory reversals benefitting nutritional supplement manufacturers. This included getting natural sources of vitamins and minerals (such as food) eliminated from regulatory overview.
The ANH is now fighting the 2010 food supplement ban on the basis that it may well contravene EU law. And they may soon be helping EU supplement manufacturers pursue legal action against EU “health claims” regulations on the basis that they violate freedom of speech and thereby infringe on consumer welfare by preventing them from learning more about the qualities of nutritional supplements.
What the Alliance for Natural Health Says About the European Silver Ban
We asked the Alliance for Natural Health (ANH), which has been described as Europe’s foremost health freedom organization, to give us a better understanding of the colloidal silver ban. Here’s what they wrote:
It is unfortunately true that silver, in all forms in food supplements, has become illegal to market in Europe from the 1st January 2010.
This is because the Food Supplements Directive (2002/46/EC) (FSD), which came into force in 2005, had a 4 year derogation phase built into it, where forms of vitamins and minerals not on the Positive List of approved forms would be allowed to be sold until 31st December 2009.
Silver is one of the forms of minerals that has been unsuccessful so far in gaining a positive approval to be allowed for ongoing legal sale and this means that all silver products should have been removed from the shelves at the beginning of this year. This is Europe-wide and not just in the UK.
Whilst we have been trying very hard to alert companies and consumers to the loss of many supplement products in 2010, we understand that there are many people who still are not aware of what is happening.
This political technique, called ‘gradualism’, is effective in lulling people into a false sense of security because the widespread bans predicted when the FSD came into force didn’t happen immediately. However, they are happening this year and there are now only 181 approved forms of vitamins and minerals for sale in Europe. All others are technically illegal.
It isn’t just silver that will be going off the shelves, there are many others too e.g. vanadium. If you’ve read the press release, then you’ll have access to the Draft Regulation via a link at the end. Here you’ll be able to view the Positive List in Annex I and Annex II (http://www.anhcampaign.org/news/anh-press-release-food-supplement-ban-in-2010-may-contravene-eu-law).
I’m not sure if you’re signed up to receive our eBlasts, but they are a good way to stay abreast of what is happening (http://www.anhcampaign.org/user/register).
The good news is that the Positive List remains permanently open so companies/manufacturers are able to make another application for silver to be added to the list. The other side of the coin, however, is that there are moves all round the world, not just in Europe, to make it difficult to sell silver as a food supplement because it directly competes with the antibiotic market. Although, the official line is that there is insufficient data regarding safety and this is a consumer protection issue!
… We don’t intend to let this one lie and hope in particular to support a manufacturer with a dossier application for silver. The application would ideally need to be completed by a manufacturer given the requirements for scientific data proving safety, efficacy and bioavailability.
I hope this helps to clarify the legislative situation regarding silver in the EU for you and we will keep our supporters posted with any changes.
Alliance for Natural Health International, The Atrium, Curtis Road, Dorking, Surrey RH1 1XA, United Kingdom
Additional Confirmation from the ANH
We thank Meleni Aldridge and the ANH for that great overview, and urge readers to learn more by following through on the links provided.
In a recent ANH press release, they further confirm the EU ban on numerous nutritional supplement ingredients, including silver:
The natural products industry in the UK, as well as in other EU Member States, has been asked to approve changes even before the draft Regulation amending the EU Food Supplements Directive of 2002 has been ratified in Europe. The reason given for the rush is the desire to stick to the date given in the 2002 Directive, which states that the derogation phase expires on 31 December 2009.
This means that any vitamin or mineral forms not complying with the new list of approved forms, as given in the draft Regulation as proposed by the European Commission, will be banned as of 1 January 2010.
The draft Regulation adds just 69 additional vitamin and mineral forms to the previous list of 112 forms. All other vitamin and minerals forms will be banned, this affecting hundreds of products that have been selling freely, under the derogation, in more liberal Member States such as the UK. Amongst the casualties are all food supplements containing vanadium or silver, as well as many mineral amino acid chelates.
Coming Soon to America
As ANH Director Dr. Robert Verkerk has stated:
“Europe is emerging as the epicenter of the problem when it comes to disproportionate legislation on natural products and claims as to their benefits.
But how contagious is this approach? Very, it seems.
Indeed, the push for global harmonization of European-style natural health laws is gaining serious momentum.
Now, the ultimate bastion of free speech, the USA, is seriously threatened by precisely the same process that is well underway in the European Union.
Here's a link to the draft regulations explaining which vitamin and mineral ingredients can now legally be added to foods and food supplements in the European Union. You’ll note that silver is not on the list of approved supplement ingredients:
This is all part of the looming one-world plot to “harmonize” all nutritional supplement laws on a global basis, and dramatically restrict your rights to use natural substances like colloidal silver as you see fit.
It’s called Codex Alimentarius, which simply means “food law” or “food code.”
And while the looming Codex agreement consists chiefly at this point of thousands of pages of rules and regulations creating new uniform global standards for such things as pickling cucumbers (yes, there are 11 pages of stringent regulations in the Codex for pickling cucumbers), the real threat to health freedom comes in the sections of the Codex governing nutritional supplements.
Are Your Supplements Actually “Toxins”?
You see, under the Codex regulations most nutritional supplements will be labeled as “toxins” and either banned or have their dosage levels strictly limited to “non-toxic” levels.
This of course is merely a ploy by the global medical bureaucrats to make sure therapeutic levels of nutrients are simply not available to consumers, except through a doctor’s prescription.
All “approved” nutrients will be given “Nutrient Reference Value Upper Daily Intake Limits,” which severely restricts the amount of each active nutrient ingredient that supplement manufacturers can put in a capsule or tablet. These new daily intake limits are so low they are incapable of preventing nutritional deficiencies much less healing illness or disease.
For example, under the draft regulations made public so far, only 5 ug daily of Vitamin D will be allowed in any supplement (most people take 500 ug to 1,000 ug or more daily). Only 45 mg. of Vitamin C will be allowed (most people take 500 to 5,000 mg. or more daily). And only 1.5 mg. of Vitamin B-6 will be allowed (most people take up to 100 mg. daily for cardiovascular health, for example).
Other supplements such as colloidal silver will likely be outlawed altogether, on the premise there is no “scientific consensus” for their effectiveness or no evidence of their “safety.”
The beneficiary of all of this Codex pseudo-science is, of course, the global pharmaceutical industry – aka Big Pharma – which has waged war for decades now against nutritional supplements in general, and colloidal silver in particular.
As Congressman Ron Paul, an ardent health freedom fighter, has stated:
“Soon, all European Union countries will unify their food supplement laws to conform with rules established by a United Nations commission called Codex Alimentarius, which calls for strict regulatory control of dietary supplements. Under the Codex rules, Europeans will need a doctor’s prescription to obtain even basic levels of vitamins. Americans may soon find their supplements similarly restricted in an attempt to harmonize the regulatory playing field between the U.S. and Europe.”
Already Happening in the U.S.
Congressman Paul is correct. But what’s already happening here in the U.S. is much more subtle and underhanded than what’s happening in Europe.
You see, here in the U.S. the bureaucrats are quietly re-categorizing supplements into a variety of regulatory categories they’ve never before been under.
For example, one of the most active forms of Vitamin B-6, pyridoxamine, was recently re-categorized as a “drug” by the FDA, even though it’s been sold as a nutritional supplement since the 1980’s. With the stroke of a pen, pyridoxamine was simply banned from ever being sold as a nutritional supplement again.
You probably didn’t realize it, but moves are now afoot to re-categorize weight loss claims as “disease claims.” Why? So weight loss supplements can also be re-categorized and regulated as “drugs.”
What’s more, there’s a growing move afoot to re-categorize supplements that contain finely “micronized” particles for better absorption. The medical bureaucrats want to call them “nano substances.” Why? So they can be treated as “unapproved new drugs” rather than nutritional supplements!
The EPA and Their Drive to Re-Categorize Silver as a “Pesticide”
What does this have to do with colloidal silver? As we’ve been reporting in online blog posts and in printed newsletters since February 2009, the Environmental Protection Agency is now being pressed by a coalition of radical environmental groups to re-categorize products containing silver – including colloidal silver – as “pesticides” so they can be regulated as potential environmental threats.
Indeed, here in the U.S., the Environmental Protection Agency (EPA) is meeting regularly to consider the fate of all silver-based products, including colloidal silver.
We firmly believe these efforts to re-categorize nutritional supplements is nothing more than a backdoor approach to harmonizing U.S. supplement laws with the proposed global Codex regulations.