Bill falls found that this message from James A. was somehow corrupt in the archive. I checked, and for whatever reason part one of three doesn't come up.
Let's see if it shows up when I resend it now. In the meantime, Bill, you can capture this re-post for your use. Be well, Mike ------- Forwarded Message Follows ------- From: "James Allison" <[email protected]> To: <[email protected]> Date: Sat, 18 Sep 1999 11:45:44 -0700 Reply-to: [email protected] Subject: CS>1/3 - 21 CFR Part 310 [Federal Register: August 17, 1999 (Volume 64, Number 158)] [Federal Register: August 17, 1999 (Volume 64, Number 158)] [Rules and Regulations] [Page 44653-44658] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr17au99-6] ====================================================================== = ---------------------------------------------------------------------- - DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 310 [Docket No. 96N-0144] Over-the-Counter Drug Products Containing Colloidal Silver Ingredients or Silver Salts AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. ---------------------------------------------------------------------- - SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule establishing that all over-the-counter (OTC) drug products containing colloidal silver ingredients or silver [[Page 44654]] salts for internal or external use are not generally recognized as safe and effective and are misbranded. FDA is issuing this final rule because many OTC drug products containing colloidal silver ingredients or silver salts are being marketed for numerous serious disease conditions and FDA is not aware of any substantial scientific evidence that supports the use of OTC colloidal silver ingredients or silver salts for these disease conditions. DATES: This regulation is effective September 16, 1999. FOR FURTHER INFORMATION CONTACT: Bradford W. Williams, Center for Drug Evaluation and Research (HFD-310), Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855, 301-594-0063. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of October 15, 1996 (61 FR 53685), FDA published a proposed rule to declare that all OTC drug products containing colloidal silver ingredients or silver salts are not generally recognized as safe and effective, and are new drugs and misbranded within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(p)). Colloidal silver is a suspension of silver particles in a colloidal base. In recent years, colloidal silver preparations of unknown formulation have been appearing in retail outlets. These products are labeled for numerous disease conditions, many of which are serious diseases. The dosage form of these colloidal silver products is usually oral, but product labeling also contains directions for topical and, occasionally, intravenous use. FDA has not approved a new drug application (NDA) for any colloidal silver product. None of the silver salts evaluated as part of FDA's OTC drug review was found to be generally recognized as safe and effective for its intended use(s). FDA is not aware of any substantial scientific evidence that supports the use of OTC colloidal silver ingredients or silver salts for disease conditions. The agency invited any interested parties to collect and submit any existing data and information that support the safety and effectiveness of colloidal silver ingredients or silver salts for any of the uses not already evaluated under the OTC drug review. Interested persons were invited to submit written comments on the proposed regulation and on the agency's economic impact determination by January 13, 1997. In response to the proposal, the agency received 251 responses. Copies of these comments are on public display in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Additional information that has come to the agency's attention since publication of the proposal is also on public display in the Dockets Management Branch. Based on the information set forth in the proposed rule, and after consideration of the information submitted by the public comments (as summarized as follows), FDA is declaring that all OTC drug products containing colloidal silver ingredients or silver salts are not generally recognized as safe and effective, and are new drugs and misbranded within the meaning of section 201(p) of the act. Adequate safety and effectiveness data have not been provided to establish general recognition of the safety and effectiveness of colloidal silver or silver salt ingredients for any OTC drug uses. The data submitted did not include the required absorption, metabolism, tissue distribution, accumulation, excretion, and pharmacodynamics (effect of the drug at its action site) of silver in the body, both when taken internally and applied externally, and of the effect of the particle size of the silver on these systemic effects. FDA is amending subpart E of part 310 (21 CFR part 310) to add Sec. 310.548 for OTC drug products containing colloidal silver ingredients or silver salts. The agency has expanded proposed Sec. 310.548(a) to include some additional silver ingredients. II. Public Comments and the Agency's Response A. General Comments 1. Many comments agreed with the proposed rule. One of these comments cautioned against the dangers of using untested drugs and recalled that Laetrile misled unsuspecting people in search of a quick cancer cure. Another comment provided personal experience as a victim of argyria who had been disfigured for 40 years as a result of using colloidal silver. This comment included an excerpt from a book that recorded 114 cases of argyria compiled in the 1930's. The comment contended that many marketers of colloidal silver deny the potential for harm and often misquote or distort the historical articles dealing with these products. A physician, who was formerly a pharmacist, recounted his own experience in reviewing cases of argyria. The victims had ingested silver products in the 1940's and 1950's. The physician was concerned that a product that does not have any rational use would lead to the redevelopment of argryia as a clinical problem. Another physician/ ophthalmologist commented that colloidal silver is dangerous quackery. The agency appreciates these comments in support of its proposal. B. Comments on Safety and Effectiveness 2. One comment expressed concern that many different silver products being marketed are inferior products and are not even true colloids. Another comment stated that the vast majority of silver products being sold are fraudulent products. The comment noted that it had tested a number of these products and found that several actually had no silver content, one did not contain the silver particle size as stated on the label, and only one product exceeded all stated purity and stability claims found on the label. The comment added that many of the products were only duplicates of older colloidal silver products. The comment considered these ``newer'' products as having the same dangers, intermittent effectiveness, and lack of stability as the older products. The comment contended that the vast majority of the colloidal silver products it tested are totally useless, some were dangerous to ingest, and some were possibly a threat to life. The comment stated that it is a major problem to keep off the market these so-called ``colloidal silver'' products that contain significant amounts of silver ions and silver salts. The comment suggested a revision of the United States Pharmacopeia (USP) specifications for these products. Another comment stated that many of the colloidal silver products it analyzed are considered ``Bredig Sols'' (simple colloidal silver), referring to Bredig, Heidelberg, 1893. The comment added that a pure Bredig Sol is simply elemental silver in distilled water, while some Bredig Sols are mixed with saline to make them isotonic. The comment mentioned that the silver content in these products (a viable product could contain 0.005 percent silver) is many magnitudes less than the silver content of the products discussed by FDA in its safety and effectiveness evaluation (61 FR 53685 at 53686). The comment contended that the agency had not reviewed the Bredig Sols and disagreed with the agency's assumptions that there is an analogous comparison between colloidal silver proteins and other silver compounds to a simple Bredig Sol. END OF PART ONE Yours in health, James Allison Allisons Apothecary http://apothecary.hypermart.net Home of the $49.95 Colloidal Silver Generator [Mike Devour, Citizen, Patriot, Libertarian] [[email protected] ] [Speaking only for myself... ] -- 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] List maintainer: Mike Devour <[email protected]>
