I sent an email to [email protected] with the accompanying article: Mr. Bela Berkes P.O. Box 445 Solano Beach, CA 92075
Dear Mr. Berkes: It is our understanding that some of your distributors and customers have recently been asking questions about the safety of silver in your product based on a recent advance notice of proposed rule-making by the Food and Drug Administration. Recent comments contributed by this institute to the FDA in response to its proposed rule-making point out that silver is a dietary supplement under the meaning of 21 U.S.C. Section 321 (ff), if it is labeled as a dietary supplement and not labeled for therapeutic use. Under this section of the Food, Drug and Cosmetic Act, known as the dietary Supplement Health and Education Act of 1994, a dietary supplement, including a mineral, intended to supplement the diet, and intended for ingestion, and labeled as a dietary supplement may not be prohibited from being marketed unless the product "presents a significant or unreasonable risk of illness or injury" when consumed in accordance with its recommended or suggested labeling or under ordinary conditions of use. In this regard, you should be advised that we recently completed an extensive review of the scientific literature on the safety of silver, especially as it relates to its one known potential side effect, namely, Argyria. Argyia is an irreversible discoloration of the pigment (skin) caused by excessive silver intake or chronic exposure to silver by certain tissues. The amount of silver required to develop Argyria is estimated to be 3.8 grams per day. By comparison standard 10 ppm colloidal silver contains silver in amounts equaling less than 1 milligram of silver (1,000 micrograms = 1 milligram; 1,000 milligrams - 1 gram), which therefore represents an amount approximately 1/500th to 1/1000th of the amount of silver considered to be a risk in the development of Argyria. Most cases of Argyria reported in the medical literature over the last 100 years involved chronic intravenous or intramuscular use of the silver preparations, most often involving a silver drug prescribed by physicians which in most cases contained silver nitrate. Other cases of Argyria reported in the medical literature involve application of silver preparations used for many months or years in the treatment of the eye or vagina for certain diseases. We could not locate a single case of orally consumed colloidal silver manufactured in the last 25 years causing Argyria in our review of the literature. This is probably due to the low levels of silver contained in such preparations, since only very small amounts of silver are needed for its antiseptic effect. Humans consume approximately 100 micrograms of silver every day in the diet. Additional amounts within this range would be considered safe by all reasonable estimates, especially if the amount needed to develop Argyria would be equivalent of 380,000 micrograms (or 3.8 grams) of silver a day. As for the efficacy of silver preparations, we found considerable scientific evidence published over the last 75 years that a number of silver compounds can be effective germicidal (antiseptic) agents against several hundred pathogenic organisms. However, silver is not termed an antibiotic as some have claimed because an antibiotic by definition is derived from a living organism. I hope this information is of assistance. We appreciate the concerns expressed at this time by some of your distributors and customers based on the recent proposed rule-making of the FDA. However, that rule-making seems directed at OTC drug-like silver preparation, products that contain magnitudes of silver greater than might be found in a normal colloidal silver product. Sincerely, Alexander G. Schauss, Ph.D. Director, Life Sciences Division John Hopkins University Dr. Alexander Schauss, Ph.D. Alexander G. Schauss, Ph.D., is the Director of the Life Sciences Division of the American Institute for Biosocial Research, Inc. in Tacoma, WA. He is a member of the Government's Commission on Dietary Supplements. He holds joint faculty positions as Associate Professor of Research and Senior Director of Research and Development at the Southwest College of Naturopathic Medicine and Health Sciences, in Tempe, AZ. And, as Associate Professor of Behavioral Sciences at the National College of Naturopathic Medicine in Portland, OR. Dr. Schauss is an Emeritus Member of the New York Academy of Sciences, former Chairman of the Food Policy Council of the National Council for Public Health Policy, Founding Member of the British Society of Nutritional Medicine, Emeritus Executive Director of the American Preventive Medical Association, Emeritus Executive Director and current President of Citizens for Health, and a member of the American Public Health Association and the American Association for the Advancement of Science. _______________________________________________________ Do You Yahoo!? Get your free @yahoo.ca address at http://mail.yahoo.ca -- The silver-list is a moderated forum for discussion of colloidal silver. To join or quit silver-list or silver-digest send an e-mail message to: [email protected] -or- [email protected] with the word subscribe or unsubscribe in the SUBJECT line. To post, address your message to: [email protected] Silver-list archive: http://escribe.com/health/thesilverlist/index.html List maintainer: Mike Devour <[email protected]>
