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What I believe to be the Real 'STORY' behind the FDA Ruling against CS.

Bruce Marx, N.D., CS PRO Systems

On August 17, 1999, the FDA 'finalized' its ruling against all OTC (over the counter) Drugs containing colloidal silver ingredients or silver salts, to become effective within 30 days, as of September 16,1999.

On October 15, 1996 the FDA published the 'proposed' rule and gave the CS 'industry' until August 17, 1999 to provide the 'studies' demonstrating the 'claims' being made by the 'industry' relative to applications, uses, effectiveness, safety, etc. of colloidal silver, in its numerous forms and formulations. During this time frame the only thing that was produced and provided to the FDA were 251 responses, of which a small percentage were negative, and the balance being basically 'testimonials', with a very few 'studies' which were conducted on a small scale in uncontrolled conditions, some even by 'medical professionals'. However, nothing was presented in the 'format', and following the 'guidelines', required by the FDA to constitute a 'study' acceptable for consideration for approval. Therefore, with no 'proof' to the contrary, the FDA finalized the 'Rule'.

So how did all this come about? This is what I think, based on being in the business for nearly 10 years and 'observing' the increasingly sorry 'state of affairs' in the industry over this period.

Silver has been recognized for its antiseptic properties for centuries. Somewhere, way back, it was theorized that if the silver could be converted into something which could be administered internally it would be much more effective in fighting disease, so it was crudely ground into a powder form. The next stage was to get it into a 'liquid', whereby its usefulness could be much better utilized. This liquefaction was accomplished by dissolving the silver with powerful acids, such as nitric acid, which produced silver nitrate. Silver nitrate was used extensively by the medical community up through the mid 1900's, and is still in limited use in some areas even today. In the early 1900's it was discovered that silver could be reduced to small (comparatively speaking) particles by applying a DC electrical current through two silver electrodes suspended in water. This was the beginning of what we know today as "colloidal silver". Somewhere along the way, someone found that you could produce colloidal silver by putting a few batteries in series, and build a small, portable, colloidal silver 'generator'. Around the mid to late eighties this idea really caught on and the aggressive 'promotion' of colloidal silver began. Soon enterprising individuals began adding 'bells and whistles' to the little black boxes and bottling the DC colloidal silver, selling it extensively on the market. Of course there were no quality standards or controls, and very few producers had any idea what concentration they were making.

This began to attract the attention of the FDA. However, colloidal silver had been around for quite awhile before the FDA came into existence in 1938. So in 1991, someone got the FDA to write a letter basically stating that as long as 'it' (CS) was produced and marketed the same way it had been prior to 1938, it would be considered a 'grand fathered modality'.

At the same time, the internet was 'taking off'. Between the ability to market the product for next to no cost, the high price colloidal silver was bringing off the shelf in stores, and numerous 'MLM' operations, 'garage and basement operators' began showing up all over the place. First there were hundreds, and then thousands, of small CS producers, all over the internet, and the world. The famous 'FDA approval letter' was the rallying cry of these marketers; "FDA approved as a pre 1938 modality", and "CS is FDA approved", began showing up on many products and in nearly all advertisements for colloidal silver. About the same time the mysterious "List of 650 diseases which CS was 'known' to cure prior to 1938" was first mentioned. By the way, I have never seen, or been able to find, this supposed list, nor have any of my customers.

At this point, lets step back and take a look at the situation:

1. Discovering colloidal silver, seeing the average selling price, finding that the total cost to set up in the CS business is only a case of 9 volt batteries and some silver wire, and the only other costs are the 'water' and 'time', hundreds of people began going into the CS business, mostly in filthy garages, basements, or other unsanitary situation, part-time, and after their 'day job'.

2. We now have thousands of people producing 'who knows what' and selling it as colloidal silver, with FDA approval (?).

3. For the sake of 'marketing hype', CS products began appearing with various things 'added', such as 'protein', hyped as "MSP".

4. Some began adding other 'stabilizing' agents, so they can keep their particles in suspension longer, while neglecting to mention this on the label.

5. To achieve the touted 'golden yellow color', many were adding food coloring to their product, with no mention on the label.

6. Some of the less scrupulous were marketing CS products which had no silver at all, only food coloring.

7. AND, all of these products are being 'represented' as FDA approved! 8. Then came the 'list of 650', (unsubstantiated claims) for the effectiveness of CS in general, and hyped all over the place.

9. With all the commotion about CS, the 'big boys' (pharmaceuticals and medicos), knowing the 'potential' of CS and seeing that there is a popularity 'groundswell' which could potentially cut into their 'bottom line', are beginning to get concerned.

10. The FDA is casting a watchful eye on the colloidal silver industry in general, for their 'unethical' practices.

Where do we go from here? Well, in the midst of all the 'hoopla' the 'big boys' (pharmaceuticals and medicos) smell an opportunity. They procure an assortment of various CS products from the marketplace and have them analyzed. They find that virtually ALL of the products are 'mislabeled', claiming concentrations of silver (PPM) which are 'not' in the products. Many have 'stabilizers' added with no mention of this on the label. Some of the products have no silver content whatsoever (but possess a deep yellow color), and a few actually have bacteria growing in the CS(?). They see the 'state of the industry', the multitude of 'sub-standard' products, the 'unapproved' claims being made (including AIDS and cancer), and a potentially hazardous situation: products with 'bacteria' growing in them.

What an opportunity to get CS out of their hair!! So 'they' (or they had individuals do it for them) go to the FDA and file a series of complaints about CS, presenting this 'evidence'. At this point, the FDA is obligated to 'investigate'. They do, they find the same results, and begin drafting a 'rule' which they 'proposed' in October, 1996. The FDA gave the CS industry until August of 1999 to 'prove' (provide the studies for) their claims.

Therein lies the 'RUB'! Once within the realm of the FDA, the 'process' requires that 'studies' must be done and the results submitted to the FDA for 'approval'. The problem is, what applies to Peter also applies to Paul - there is NO 'double standard'. In other words, the 3 year, 'triple blind', 1500 subject, meticulously controlled, through numerous repetitions, precisely documented, and recorded study, that costs a pharmaceutical company 100's of millions of dollars to get a new 'drug' approved, would also be required of the CS industry, and would need to be in strict accordance with FDA 'requirements and guidelines'. The 'big boys' concluded that there was no organization, or individual, within the CS industry having the financial wherewithal to subsidize any such 'studies'. Without 'control' of the product, there is no possibility for a return on investment, and no one would put that kind of money into a 'guaranteed loss' situation. They were right! In fact, these 'study' procedures would need to be done for each 'individual manufacturers product', and separately for each 'individual claim' made. As an example, a colloidal silver manufacturer with a single product, wishing to submit studies for approval for only 10 claims, would need to conduct and submit 10 'individual studies' at a total expenditure of ONE BILLION DOLLARS! Welcome to the 'big league' CS'ers!

Needless to say, between 1996 and 1999, the 'proposed rule' was basically ignored by most producers, except to use it as 'marketing hype' to sell their product; "Get your CS today before the FDA takes it away - BUY NOW - BUY NOW"! Meanwhile, the 'snake oil salesmen', 'shysters' and the 'greedy ignorant' continued to flood into the market for the 'fast/easy' buck! The proliferation of 'junk CS' continued to increase at a phenomenal rate. The 'claims' were not only continued, but expanded! The products couldn't get much worse - there was just more of it! And the FDA was not sleeping while all this was going on!

So when the end came, and no one was able to produce the 'required studies' - for ANY CS products - the rule was finalized (August 17, 1999)! Additionally, since the 'proposed rule' was not only 'ignored', but used to support the "Buy Now" marketing ploy, the FDA had no reservations whatsoever in making the 'final rule' effective within only 30 DAYS (September 16, 1999) of finalization! Punitive punishment? I wouldn't doubt it!

Does the CS industry deserve this kind of treatment? YOU look at the situation and decide for yourself. Personally I have been watching, knowing for years that this would be the end result! Who do we blame? The FDA? Personally, I don't like the bureaucracy any more than the next 'patriot', but in this instance, I cast the blame on the greedy 'snake-oil salesmen' that inundated the CS industry for the sole sake of 'easy profit'! The FDA was merely 'doing their JOB' (and initially with some 'reluctance', it appears).

The FDA decision was announced via a short "FDA TALK LETTER", which only 'brushed over' the highlights of the entire 'rule'. In itself, the letter 'indicated' that the products in question were only those containing 'protein', and silver oxide. Those who go only by the 'Talk Letter' are 'cruising for a bruising'! They 'think' that the 'ruling' does not affect them, so they can continue to promote their 'junk' freely! Surprise! If one reads the entire 'Rule', basically anything with silver in it is included!

The only 'fortunate' thing is that the people responsible for this happening are inherently 'lazy' (EASY money) and they will not take the time or effort to do any research. To prove this point, look at the dearth of information which has been generated relative to CS! Over 80% is the same 'garbage', reshuffled, reorganized, and regurgitated in different formats! Another 10% is 'techno-gobbledygook' which the average consumer cannot comprehend or understand, 'insinuating' that the author MUST be 'correct' (?).

A little note here: In working with the FDA for 'approval', the topic of 'enforcement' came up, and I was advised, in no uncertain terms, that this rule was to be "VIGOROUSLY ENFORCED"! I am guessing at this, but I suspect $5000 per 'violation', and 'each bottle sold' being a single violation, will be a likely 'fine'! The cost of 'ignorance', or 'arrogance' could become very expensive, very quickly!

Unless CS producers invest in their own (approved and accurate) testing capabilities (most won't - too expensive and somebody has to operate it - 'techie wages'), or pay for 'certified analysis' on everything they make (which they won't - they proved that in the past), they WILL be caught for 'mislabeling'! Last year we analyzed over 30 different manufacturers products (off the shelf) and not a single one had even 50% of what they 'claimed' on their (mis) labeled bottle! Many of these were "(?) reputable(?)" bigger name products! It is very discouraging to me (as the 'layers' are removed, one by one), to see out how little even the 'bigger' distributors of CS know about the 'science' of what they are selling! This is what happens when 'marketing' (and profit motive) take control over 'basic science'. To their advantage, these 'bigger' organizations market a multitude of products, so dropping one product (when the pot gets too hot) doesn't hurt them that badly (compared to their 'exposure'), but it does affect the availability of CS to the consumer!

Was the FDA 'Talk Letter' a psychological 'coup'? I think so. I believe they KNOW the effectiveness and safety of CS, which is why they have ignored it for so long (until forced into action by the 'complaints'). I also believe that they knew that anyone 'seriously in the CS business', and producing a 'quality product', would read the 'entire rule', consult with the FDA, and act accordingly (they even provided 'us' with an 'OUT', buried within the rule). I'll bet they figured that the 'limited information' provided in the letter would keep the 'culprits' around long enough for them (FDA) to 'bust' them. This is the strategy I would use to separate the 'wheat from the chaff'!

Meanwhile, thanks to the greed of the aforementioned individuals, colloidal silver can no longer be sold as an 'OTC' drug (most CS products fit this classification). I have already had many contacts from people who have found CS 'missing' from the shelves of their local health food store, or have gone to the internet only to find a glaring notice that colloidal silver is "no longer available". Rest assured that CS PRO will do everything we can to continue to provide you with our 'quality' product.

I am not a 'supporter' of the FDA, or any other 'bureaucratic organization' (FBI, BATF, FEMA, etc.), but in this instance I don't see that they had any choice. Obviously, there cannot be a 'double standard', as the 'big guys' would exploit this to the hilt! The action was predictable, and 'mandated'. Manipulated? Perhaps you could say the 'complaints' were a manipulation. But in any case, the only ones we have to blame are ourselves (the CS industry), for allowing the 'infiltration' of the 'snake-oil salesmen'.

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