COLLOIDAL SILVER

Is it FOOD or is it a DRUG?

What's the real Definition of a Disease?

     Herbs and spices used in foods can provide such excellent benefits to our bodies that they become classified as "drugs" according to the FDA when claims are made about their efficacy.  When we were kids and someone got a cold in our house the first thing we got from Mom was a hot lemonade with honey, a garlic sandwich, a few Vitamin C tablets, a zinc tablet and a warm turtle neck sweater with some essential oils on the chest, throat and nostrils.  Our colds generally didn't last too long when we hit them will the full arsenal.  A lot of people know that this type of thing "loosens up" a cold and provides a faster recovery time.  But if someone were to try to package this idea and sell a packaged lemonade with honey, vitamin C and Zinc which said, "Cold Remedy" on the label, it would then be considered a drug.

     We know that everything our bodies need to beat of disease is found in herbs, spices and all sorts of foods.  We also know that food today isn't what it used to be 50 years ago, this is well documented by Private and Government studies.  We know that all forms of nutrition are important for the body to regenerate itself.  Herein also lies a challenge with the labeling of Colloidal Silver.  Colloidal Silver is a simple product found in nature and available in our natural food and water supplies.  Even in very small quantities Colloidal Silver has been found to kill many forms of bacteria.  A compendium study on water  done at University of British Columbia Canada showed that silver levels in water had a dramatic effect on maintaining healthy water for mammalian life.

     Common sense would also tell us that either God or if you believe in Evolution caused Silver to be there for good reason.  How many things would Scientists say are redundant in nature?  How many elements on earth are truly redundant?  It doesn't appear as too many intelligent people would stand up and say anything is redundant to some aspect of life, and isn't important in the big picture.  The complexity of the Natural world is astounding, and the definitions and applications of terms and definitions is a formidable challenge that all regulatory bodies, business and consumers face alike.  Here are some excepts of various discussions regarding this matter provided from FDA dockets that you may find of value.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

PUBLIC MEETING ON REGULATIONS ON SUPPLEMENTS MADE FOR DIETARY SUPPLEMENTS

     FDA policy must require structure/function claims to be supported by solid scientific substantiation.  Nowhere does the law exempt structure/function claims from the requirement that they be truthful and non-misleading.

     You can apply the misbranding provisions of the FD&C Act to start with and then consider anti-deception concepts in the FTC Act.

     We have no doubt that there are problematic claims for which even the most basic substantiation files could not exist because the scientific literature is silent on the claim's structure or function effect.  A few well-targeted warning letters in these instances would be very effective in sending the message that folklore is not substantiation and the statutory disclaimer does not provide a carte blanche.

     We would like to have a definition that has clarity, consistency, accuracy, and common sense in the definition of disease, accuracy meaning that it's true, consistency meaning that when it's used by multiple people it's used in the same way, clarity meaning that most of us could understand it, and common sense, which unfortunately is often lacking in a lot of these regulations, would mean that it coheres with the thoughts that most people would understand when they bring to this issue.

     Given this goal, unfortunately, it seems to me unlikely that we'll be able to achieve all of these different qualities for several reasons.  First of all, the history of supplement regulation, and this is just how things have evolved and the context in which we find ourselves now in having to kind of contort our positions to ally with past history.  For instance, nutritional diseases obviously are diseases by any definition and yet they're specifically excluded because of historical matters and the way this came up.

     Secondly, the activities and the desires of the folks who manufacture these products to market them effectively, right up to and some would say beyond the limits of the law and common sense in making claims.

     Thirdly, the very great difficulty that we have and the confusion and sort of hair-splitting distinctions between diseases and symptoms and where does one begin and one end.  As some of the materials that were distributed before point out, what conceivable difference could one make between seizures, which are a symptom, and epilepsy, which is a disease; between wheezing, which is a symptom, and asthma, which is a disease.

     The proposed rule, having its problems--all definitions have their problems--is better since it includes signs, symptoms, laboratory measurements in that definition of disease.

      Sixth, FDA should insist that any dietary supplement making even a statement of nutritional support, i.e., structure/function claim, let alone a disease claim, adhere to standards of quality, safety, efficacy, and purity commensurate with those required for pharmaceuticals.

     Seven, DSHEA was intended to create parity between dietary supplements and foods, not between supplements and drugs.  A statement of nutritional support must be just that.  It must be limited to the nutritional value of the supplement and not its pharmacological activity.  This will allow for better and more informed consumer choice about the difference between drugs and dietary supplements.

     The FDA should consider adopting various kinds of regulatory disclaimers to help understanding in the food supplement label area rather than looking at how to prohibit statements.  Not only did they say they should do that, they said they are required by the Constitution to do that.

     The only way that something can be prohibited is if it's an inherently misleading claim that has no substantiation.  If it's not an inherently misleading claim, other avenues besides prohibition need to be looked at...  to read the entire docket click on link:

http://www.fda.gov/ohrms/dockets/dockets/98n0044/tr00001.doc

Food and Drug Administration  FDA Consumer  June 1981

The Long Struggle For The 1906 Law

     Many forces combined to create the need for the 1906 Food and Drugs Act. James Harvey Young traces the history of the law and the conditions that led to its enactment. The author is professor of history at Emory University and is the author of many books and articles on food and drug regulatory history.  ...read more http://www.cfsan.fda.gov/~lrd/history2.html

     It is the goal of our company to best serve the needs of our customers and to do this we share our experiences with Colloidal Silver and that of customers who have written us to tell their experience.  It must be clearly understood that no two people will necessarily have equal results with our products.  We simply cannot and will not guarantee this and we never have made these guarantees.  We do offer an extremely high quality product and we do offer a refund when a customer has legitimately tried our product as recommended and believes they receives no benefits.  We make no claims that are misleading or inflated in order to garner sales, the information on our site is from public domain sources or from customer testimonies.

     Our product is 20 parts per million (ppm) Colloidal Silver which is not considered by either Homeopaths or Allopaths to be of a highly potent strength.  We provide a product that replicates what might have once been found in Natural food and water sources. People have been drinking well water for millennia which has been found to contain very high Total Dissolved Solids (TDS) 100-500 parts per million or more, and some well water contains metals like arsenic, lead, cadmium that are known to be dangerous for humans.  In comparative terms, Colloidal Silver at 20 ppm is extremely low of a dosage and is non-toxic at these low concentrations, but provides bacterial killing power.  Common sense would tell us there is good reason to drink Colloidal Silver Water, and replenish the amounts of Natural Silver that our bodies require for good health.

     How many benefits a person receives because of taking the Colloidal Silver is a question that can only be answered on an individual basis, we are delighted to reports that come in and welcome your comments and input about any of our products.

Warm regards,

Baruch (Bruce) Gorovenko

President/Founder

Rapha Laboratories