It is my understanding that non drug products cannot make cure claims, so anything mentioning the actual way to use it would not be allowed. This letter was trickily written. It actually does not say it is dangerous. It just says the limitations on labelling. I am unsure on what the US rules for dosage are, but I think what they are saying is that dosages need to be clearly marked. In Canada many things will have dosage recommendations at a level that will not harm anyone, but for those people doing their own research, they will take however much they want. If necessary, warnings can also be included to indicate if, for example, a rash or stomache ache occurs to discontinue use. Here in Canada, there is no way you could possibly figure out how to use products unless you obtained the information in a different spot than the bottle. Here, those 2 things cannot legally exist together. That is why we often see one site with product info that does not really tell us how much to take and when. The light warning against argyria looks like just a scare tactic without actually lying. The abuse that is required to cause it is so way beyond even most radical users, but they just "gotta" throw that in there. Wouldn't it be interesting to see this type of warning on every drug, food, and OTC medicine. No one would leave there house!! We'd all be scared to death!!
Thora -----Original Message----- From: bob smith [mailto:rresm...@comcast.net] Sent: Monday, February 16, 2004 2:33 PM To: silver-list@eskimo.com Subject: CS>Emailing: ANS00971 I just came across this article. I had never heard of these restrictions on CS. My understanding was that they did not find it harmful. But there could be no claims made as to its benefits. Bob Smith FDA TALK PAPER Food and Drug Administration U.S. Department of Health and Human Services Public Health Service 5600 Fishers Lane Rockville, MD 20857 FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. T99-39 Print Media: 301-827-6242 August 17, 1999 Consumer Inquiries: 888-INFO-FDA FDA ISSUES FINAL RULE ON OTC DRUG PRODUCTS CONTAINING COLLOIDAL SILVER The FDA has issued a Final Rule declaring that all over- the-counter (OTC) drug products containing colloidal silver or silver salts are not recognized as safe and effective and are misbranded. Colloidal silver is a suspension of silver particles in a colloidal (gelatinous) base. In recent years, colloidal silver preparations of unknown formulation have been appearing in stores. These products are labeled to treat adults and children for diseases including HIV, AIDS, cancer, tuberculosis, malaria, lupus, syphilis, scarlet fever, shingles, herpes, pneumonia, typhoid, tetanus and many others. According to the Final Rule, a colloidal silver product for any drug use will first have to be approved by FDA under the new drug application procedures. The Final rule classifies colloidal silver products as misbranded because adequate directions cannot be written so that the general public can use these drugs safely for their intended purposes. They are also misbranded when their labeling falsely suggests that there is substantial scientific evidence to establish that the drugs are safe and effective for their intended uses. The indiscriminate use of colloidal silver solutions has resulted in cases of argyria, a permanent blue-gray discoloration of the skin and deep tissues. Colloidal silver ingredients and silver salts include silver proteins, mild silver protein, strong silver protein, silver chloride, and silver iodide. The dosage form of these colloidal silver products is usually oral, but product labeling also contains directions for topical and, occasionally, intravenous use. In reaching its decision, FDA considered all of the information described in the proposed rule (October 15, 1996) and submitted by the public in response to that proposal, the Final Rule becomes effective on September 16, 1999, 30 days after publication. #### -- The Silver List is a moderated forum for discussing Colloidal Silver. Instructions for unsubscribing are posted at: http://silverlist.org To post, address your message to: silver-list@eskimo.com Silver List archive: http://escribe.com/health/thesilverlist/index.html Address Off-Topic messages to: silver-off-topic-l...@eskimo.com OT Archive: http://escribe.com/health/silverofftopiclist/index.html List maintainer: Mike Devour <mdev...@eskimo.com>
