Webmaster Note: Please copy and distribute these two FDA articles far and wide. You should especially copy and distribute Dr. Flick's silver bibliography below. Sending multiple copies to the FDA and your elected public servants is important since the FDA (to whom we pay untold millions to research and investigate) alledges: "FDA is not aware of any substantial scientific evidence that supports the safe and effective use of colloidal silver ingredients or silver salts for any animal disease condition." ('animal' includes humans?) and "FDA is not aware of any body of data that supports the use of colloidal silver for the various conditions listed in the labeling used with currently marketed products." They apparently have not investigated the scientific and medical research referenced in the following bibiography. If the FDA is unaware of this medical and scientific research as they say they are - WHAT HAVE THEY BEEN DOING WITH OUR MONEY? It is of further interest that the FDA promises to investigate and prosecute any silver colloid maker/seller/distributor on the basis of LABELING (marketing; i.e., via commerce clause) alone. Therefore silver colloid is a non-issue whether one uses it or not - especially since extensive medical and scientific research data really does exist supporting the product.


prepared by Dr. A. Bart Flick
1. Addicks, L. et al.: Silver in Industry, Reinhold Pub. Corp., NY 401-450, 584-597 (1940). Extensive bibliography on silver for water purification.
2. Akiyama, H. and Okamoto, S., Prophylaxis of indwelling urethral catheter infection: clinical experience with a modified Foley catheter and drainage system, J. Urol., 121, 40, 1979.
3. Avakyan, Z.A., Comparative toxicity of heavy metals for certain microorganisms, Microbiology, 36, 366, 1967.
4. Baenziger, N.C., Description of the structure of three silver-containing drug complexes, First International Conference on Gold and Silver in Medicine, Bethesda, MD, May 13-14, 1987.
5. Barranco, S.D. and Colmano, G., Electrical Inhibition of Staphlococcus aureus, Virginia Medical, 646, 1976.
6. Barranco, S.D., Spadaro, J.A., Berger, T.J., and Becker, R.O., In vitro effect of weak direct current on staphlococcus aureus, Clinical Orthopaedics, 100, 250, 1974.
7. Becker, R.O., Electrical treatment of osteomyelitis, Surgery of the Musculoskeletal System, Churchill Livingstone, New York, 1983, 4, 10- 197.
8. Becker, R.O., The effect of electrically generated silver ions on human cells, First International Conference on Gold and Silver in Medicine, Bethesda, MD, May 13-14, 1987.
9. Becker, R.O., Effect of anodally generated silver ions on fibrosarcoma cells, Electro- and Magnetobio., 11, 57, 1992.
10. Becker, R.O. and Esper, C., Electrostimulation and undetected malignant tumors, Clin. Orthop., 161, 336, 1981.
11. Becker, R.O. and Spadaro, J.A., Treatment of Orthopedic Infections with electrically generated silver ions, J. Bone Jt. Surgery., 60-A, 871, 1978.
12. Benvenisty, A.I., Tannenbaum, G., Ahlborn, T.N., Fox, C.L., Modak, S., Sampath, L., Reemtsma, K. and Nowygrod, R., Control of prosthetic bacterial infections: evaluation of an easily incorporated, tightly bound, silver antibiotic PTFE graft, J. Surg. Res., 44,1, 1988.
13. Berger, T.J., Spadaro, J.A., Chapin, S.E., and Becker, R.O., Electrically generated silver ions: quantitative effects on bacterial and mammalian cells, Antimicrob. Agents Chemother., 9, 357, 1976.
14. Berger, T.J., Spadaro, J.A., Bierman, R., Chapin, S.E., and Becker, R.O., Antifungal properties of electrically generated metallic ions, Antimicrob. Agents Chemother., 10, 856, 1976.
15. Block, Seymour, Ed.: Disinfection, Sterilization and Preservation, Chapter 18; Lea & Febiger & Co., Philadelphia, 3rd Ed (1983). Extensive bibliography.
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18. Bragg, P.D. and Rainnie, D.J., The effect of silver ions on the respiratory chain of Escherichia coli, Can. J. Microbiol., 20, 883, 1974.
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25. Carr, H.S., Wlodkowski, T.J., Rosenkranz, H.S., Silver-sulfadiazine: in vitro antibacterial activity, Antimicrob. Agents Chemother., 4, 585, 1973.
26. Chu, C.S., McManus, A.T., Okerberg, C.V., Mason, A.D., and Pruitt, B.A., Weak direct current accelerates split-thickness graft healing on tangentially excised second-degree burns, J. Burn Care Rehab., 12, 285, 1991.
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28. Chu, C.C., Tsai, W.C., Yao, J.Y., and Chiu, S.S., Newly made antibacterial braided nylon sutures. 1. In vitro qualitative and in vivo preliminary biocompatibility study, J. Biomed. Mater. Res., 21, 1281, 1987
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30. Collinge, C.A., Goll, G., Seligson, D. and Easly, K.J., Pin tract infections: silver vs. uncoated pins. Orthopedics, 17, 445, 1994.
31. Colmano, G., Medical Applications of monomolecular films of silver, gold and other metals, International Conference on Gold and Silver in Medicine, Bethesda, MD, May 13-14, 1987.
32. Colmano, G., and Barranco, S.D., Inhibition of staphlococcus aureus on a contaminated electrode in the femur of the rabbitt by low electrical current and its relation to stress, Biophys. J., 15, 28a, 1975.
33. Colmano, G., and Barranco, S.D., Staphlococcus aureus inhibition by low direct current on silver electrodes in the femur of rabbits. Fifty- third Annual meeting of the Virginia Academy of Science, Harrisonburg, VA, May 6-9, 1975.
34. Colmano, G., Edwards, S.S., Lesch, T.E., and Barranco, S.D., Control of Staphlococcus aureus osteomyelitis by microampere activation of metal ions in monomolecular films on stainless steel pins, Fifty-Third Annual Meeting of the Virginia Academy of Science, Harrisonburg, VA, May 6- 9,
35. Colmano, G., Edwards, S.S., and Barranco, S.D. Activation of antibacterial silver coatings on surgical implants by direct current: preliminary studies in rabbits, _., 41, 964, 1980.
36. Colmano, G. , Edwards, S.S., Fainter, L.K. and Barranco, S. D., Electronmicrographs of silver and stainless steel surgical implants coated with silver compounds to control S. Aureus by direct current activation, Twenty-eighth Annual ORS, New Orleans, LA, January 19-21, 1982.
37. Colmano, G., Edwards, S.S. and Barranco, S.L., Effects of low direct current on monomolecular layers of metal stearates coating electrodes in bacterial cultures and surgical implants, Symposium URSI "Ondes Electro-magnetiques et Biologie", Jouy-en-Josas, Juillet, 1980, 149.
38. Colmano, G., Fainter, L.K., Edwards, S.S., and Barranco, S.D., SEM of S. aureus on current-activated surgical pins coated with silver and silver stearate monolayers, Second Annual BRAGS, Oxford, U.K., Sept. 20-22, 1982.
39. Cowlishaw, J., Spadaro, J.A., Becker, R.A., Inhibition of enzyme induction in e. coli by anadoc silver, J. Bioelectricity, 1, 295, 1982.
40. Crannell, M.Y., Silver in Medicine, Silver-Economics, Metallurgy and Use, ed. Butts, A., Krieger, Huntington, NY, 1975, 227.
41. Cullen, J.M. and Spadaro, J.A., Axonal regeneration in the spinal cord: a role for applied electricity, J. Bioelectricity, 2, 57, 1983.
42. Danscher, G., Rytter Norgaard, J.O., and Baatrup, E., Autometallography: tissue metals demonstrated by a silver enhancement kit, Histochemistry, 86, 465, 1987.
43. Deitch, E.A., Marino, A.A., Gillespie, T.E., and Albright, J.A., Silver-nylon: a new antimicrobial agent, Antimicrob. Agents Chemother., 23, 356, 1983.
44. Deitch, E . A. , Marino, A. A . , Malaleonok, V. , and Alb richt, J . A . , Silver nylon cloth: in vitro and in vivo evaluation of antimicrobial activity, J. Trauma, 27, 301, 1987.
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48. Ellerman-Eriksen, S., Rungby, J., and Morgensen, S.C., Autointerference in silver accumulation in macrophages without affecting phagocytic, migratory or interferon-producing capacity, Virchows Arch., B. 53, 243, 1987.
49. Ersek, R.A., and Navarro, J.A., Maximizing wound healing with silver impregnated porcine xenograft, Today's OR Nurse, 12, 4, 1990.
50. Ersek, R.A., and Denton, D.R., Cross-linked silver-impregnated skin for burn wound management, J. Burn Care Rehabil., 9, 476, 1988.
51. Ersek, R.A., Gadaria, U., and Denton, D.R., New natural wound dressing, Phys. Ther. Forum, 5, 1, 1986.
52. Ersek, R.A., and Denton, D.R., Silver-impregnated porcine xenograft for damaged or missing skin, Contemp. Surg., 23, 83, 1983.
53. Ersek, R.A., and Denton, D.R., Treatment of skin graft donor sites using silver-impregnated porcine xenograft, Contemp. Orthop., 12, 27, 1986.
54. Ersek, R. A. and Denton, D . R. , Silver-impregnated porcine xenografts for treatment of meshed autografts, Plast. Surg., 13, 482, 1984.
55. ErsekR.A. and Lorio, J., The most indolent ulcers of the skin treated with porcine xenografts and silver ions, Surg. Gynecol. Obstet., 158, 431, 1984.
56. Ersek, R.A., and Denton, D.R., Rhinophyma: treatment with electrocautery and silver-impregnated porcine xenograft, Plast. Reconstr. Surg., 74, 269, 1984.
57. Ersek, R.A., and Hachen, H.J., Porcine xenografts in the treatment of pressure ulcers, Ann. Plast. Surg., 5, 464, 1980.
58. Ersek, R.A., and Denton, D.R., Nail bed avulsions treated with porcine xenografts, J. Hand Surg., 10A, 152, 1985.
59. Ersek, R.A., Denton, D.R., Surak, G.M., and Peters, C.W., Treatment of spider bites with silver-impregnated porcine xenografts, Texas Med., 81, 32, 1985.
60. Falcone, A.E., and Spadaro, J.A., Inhibitory effects of electrically activated silver material on cutaneous wound bacteria, Plast. Reconstruc. Surg., 77, 455, 1986.
61. Flick, A.B., Clinical application of electrical silver iontophoresis, First International Conference on Gold and Silver in Medicine, Bethesda, MD, May 13-14, 1987.
62. Flowers III, R.H., Schwenzer, K.J., Kopel, R.F., Fisch, M.J., Tucker, S.I., and Farr, B.M., Efficacy of an attachable subcutaneous cuff for the prevention of intravascular catheter-related infection. JAMA, 261, 878, 1989.
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66. Furst, A., Schlauder, M.C.: Inactivity of Two Noble Metals as Carcinogens; Jour. Environmental Pathology and Toxicology, 1, 51-57
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93. Madden, M.R., Nolan, E., Finkelstein, J.L., Yurt, R.W., Smeland, J., Goodwin, C.W., Hefton, J., and Staiano-Coico, L., Comparison of an occlusive and semi-occlusive dressing and the effect of the wound exudate upon keratinocyte proliferation, J. Trauma, 29, 924, 1989.
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154. Spadaro, J.A., Webster, D.A. and Chase, S.E., Direct current activation of bacteriostatic silver electrodes, Third Annual BRAGS, San Francisco, CA, Oct. 2-5, 1983.
155. Spadaro, J.A., Webster, D.A., and Becker, R.O., Silver polymethyl methacrylate antibacterial bone cement, Clin. Orthop. 143, 266, 1979.
156. Spadaro, J.A., Webster, D.A., Kovach, J. and Chase, S.E. Antibacterial fixation pins with silver: animal models, 30th Annual ORS, Atlanta, GA, Feb. 7-9, 1984, 335.
157. Tarr, R., Luck, J.V., Snyder, S. and Mills, B., Laboratory experiences with silver electrode bone stimulation, 29th Annual ORS, Anaheim, CA, March 8-10, 1983, 253.
158. Taubes, G., An electrifying possibility, Discover, 7, 23, 1986.
159. Thibodeau, E.A., Handelman, S.L. and Marquis, R.E., Inhibition and killing of oral bacteria by silver ions generated with low intensity direct current, J. Dent. Res., 57, 922, 1978.
160. Thurman, R.B., and Gerba, C.P.: The Molecular Mechanisms of Copper and Silver Ion Disinfection of Bacteria and Viruses; CRC Critical Reviews in Environmental Control, Vol 18, Issue 4 (1989). Extensive bibliography.
161. Tsai, W.C., Chu, C.C., Chin, S.S. and Yao, J.Y., In vitro quantitative study of newly made antibacterial braided nylon sutures, Surg. Gynecol. Obstet., 165, 207, 1987.
162. Vince, D.G. and Williams, D.F., Determination of silver in blood and urine by graphite furnace atomic absorption spectrometry, Analyst, 112, 1627,
163. Vince, D.G. and Williams, D.F., Systemic distribution of metals following implantation, presented at Biointeractions'87, Cambridge, U.K., July 6-8, 1987, 40.
164. Wataha, J.C., Hanks, C.T. and Craig, R.G., The effect of cell monolayer density on the cytotoxicity of metal ions which are released from dental alloys, Dent. Mater., 9, 172, 1993.
165. Watts, S.H., The silver bolt as a means of fixing ununited fractures of certain long bones. Johns Hopkins Hospital Bulletin, April 1904, 135.
166. Webster, D.A., Spadaro, J.A., Kramer, S., and Becker, R.O., Silver anode treatment of chronic osteomyelitis, Clin. Orthop., 1961, 105, 1981.
167. West, H.D., Johnson, A.P., and Johnson, C.W.: The Use of Radioactive Silver for the Detection of Abscesses and Tumors; Jour. Lab. and Clinical Medicine, 34, 1976-1979 (1949).
168. Whalberg, Vivian: The Crede Prophylaxis; Acta Paediatrica Scandinavica, Supplement 295, Stockholm 1982.
169. Williams, D.F. The biocompatibility of silver, First International Conference on Gold and Silver in Medicine, Bethesa, MD, May 13-14, 1987.
170. Williams, D.F., Definitions in Biomaterials, Essevier, Amsterdam, 1987.
171. Williams, D.F., and Doherty, P.J. and Oliver, C., The analysis of inflammatory exudates in the assessment of biocompatibility, presented at Biointeractions '87, Cambridge, U.K., July 6-7, 1987, 22.
172. Williams, R.L., Doherty, P.J., Vince, D.G., Grashoff, G.J. and Williams, D.F., The biocompatibility of silver, Critical Reviews in Biocompatibility, 5, 221, 1989.
173. Williams, R.L. and Williams, D.F., Albumin absorption on metal surfaces, Biomaterials, 1988.
174. Williams, R.L. and Williams, D.F., The spatial resolution of protein absorption on ogeneous metallic biomaterials, J. Biomed. Mater. Res., 23, 339, 1989.
175. Williams, R.L. and Williams, D.F., The effect of albumin on the wettability of pure metal and metal oxide surfaces, J. Colloid Interface Sci., 126, 596, 1988.
176. Wlodkowski, T.J. and Rosenkranz, H.S., Antifungal activity of silver sulphadiazine, Lancet, 1972, 739.
177. Wysor, M.S. and Zollinhofer, R.E., On the mode of action of silver sulfadiazine, Pathol. Microbiol., 38, 296, 1972.
178. Wysor, M.S. and Zollinhofer, R.E., Silver phosphanilamidopyrimidine, Chemother. 18, 342, 1973.
179. Wysor, M.S. and Zollinhofer, R.E., Reactivity of silver sulfadiazine and the silver uracils with the glucose oxidase of Aspergillus niger, Enzyme, 14, 185, 1972-73.
180. Wysor, M.S. and Zollinhofer, R.E., Deoxyribonucleic acid repair replication in Pseudomonas aeroginosa after sublethal doses of silver sulfadiazine, Path. Microbiol. 39, 434, 1973.
181. Wolcott, L.E., Wheeler, P.C., Hardwicke, H.M. and Rowley, B.A., Accelerated healing of skin ulcers by electrotherapy: preliminary clinical results, Southern Med. J., 62, 795, 1969.
182. Zimmerman, R.L., Piezoelectricity and biological materials, J. Bioelectricity, 1, 265, 1982.
183. Zmener, O. and Dominguez, F., Silver accumulations in periapical granulomas: report of five cases using the scanning electron microscope, the electron microprobe and other complementary methods, Oral Surg. Oral Med. Oral Pathol., 65, 94, 1988.

Federal Register Vol. 61, No. 200 Tuesday, October 15, 1996 Proposed Rules 53685


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: Proposed rule.

SUMMARY: The Food and Drug Administration (FDA) is proposing to establish that all over-the-counter (OTC) drug products containing colloidal silver ingredients or silver salts for internal or external use are not generally recognized as safe and effective and are misbranded. FDA is issuing this proposal because many 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: Written comments by January 13, 1997; written comments on the agency's economic impact determination by January 13, 1997. FDA is proposing that any final rule that may issue based on this proposal become effective 30 days after its date of publication in the Federal Register.

ADDRESSEES: Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration,12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

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.


I. Background

Colloidal silver is a suspension of silver particles in a colloidal base. Historically, a number of colloidal silver/silver colloidal salts have been marketed in the United States. Some of these colloidal silver products were recognized as official articles in the United States Pharmacopeia (U.S.P.) and the National Formulary (N.F.). Colloidal silver iodide (Ref. 1) contained not less than 18 percent and not more than 22 percent silver, with the product diluted for local use to concentrations from 0.05 to 10 percent. Strong silver protein (Ref. 1) contained not less than 7.5 percent and not more than 8.5 percent silver, with the product diluted for local use to concentrations from 0.5 to 10 percent. The 10th edition of the N.F. had a cautionary note for these products that stated: "Caution: Solutions of Colloidal Silver Iodide should be freshly prepared and should be dispensed in amber-colored bottles," and "Caution: Strong Silver Protein Solutions should be freshly prepared and should be dispensed in amber colored bottles."

Mild silver protein (Ref. 2) contained not less than 19 percent and not more than 23 percent silver, with the product diluted for local use to concentrations from 0.1 to 5 percent. The 12th edition of the N.F. had n cautionary note which stated: "Caution: Solutions of Mild Silver Protein should be freshly prepared or contain a suitable stabilizer, and should be dispensed in amber colored bottles."

Ammoniacal silver nitrate solution (Ref. 2) contained 28.5 to 30.5 percent silver, was made extemporaneously, and was used locally without dilution. Silver nitrate solution (Ref. 3) was made extemporaneously and was used locally at strengths from 0.1 to 10 percent.

None of these formerly recognized colloidal silver preparations has been official in the U.S.P. or the N.F. since 1975. Moreover, of the silver salts evaluated as part of the agency's OTC drug review thus far, none was found to be generally recognized as safe and effective for its intended use(s). These included silver nitrate as an astringent (58 FR 27636, May 10,1993) and as a smoking deterrent (58 FR 31236, June 1, 1993) and mild silver protein as an ophthalmic anti-infective (57 FR 60416, December 18, 1992). Silver acetate was also evaluated as a smoking deterrent and found not to be generally recognized as safe and effective (58 FR 31236).

II. Recent Developments

In recent years, colloidal silver preparations of unknown formulation have been appearing in retail outlets. These products are labeled for numerous disease conditions, including human immunodeficiency virus (HIV), acquired immune deficiency syndrome (AIDS), cancer, tuberculosis, malaria, lupus, syphilis, scarlet fever, shingles, herpes, pneumonia, typhoid, exanthematic typhus, tetanus, variola, scarlatina, erysipelas, rheumatism candida, staphylococcus and streptococcus infections, tonsillitis, parasites, fungus, bubonic plague, cholera, chronic fatigue, acne, warts, Meniere's disease (syndrome), whooping cough, enlarged prostate, perineal eczema, hemorrhoids impetigo, ringworm, recurrent boils, burns, and appendicitis.

Several marketers of these products use a labeling brochure that refers to colloidal silver as a treatment or cure for 650 diseases (Ref. 4). Some colloidal silver products have been promoted using reprints of articles, taken from magazines and newspapers, that make claims of extensive health benefits for colloidal silver, similar to the claims listed above. The articles have also been shipped with colloidal silver products, when the products were ordered through the mail (Ref. 5). The dosage form of these colloidal silver products is usually oral, but product labeling also contains directions for topical and, occasionally, intravenous use.

In October 1994, FDA issued Health Fraud Bulletin #19 (Ref. 6) to address the emerging marketing of colloidal silver products offered for serious disease conditions. In that bulletin, the agency stated that it was "not aware of any substantial scientific evidence which demonstrates that any OTC colloidal silver solution is useful to prevent or treat any serious disease condition." The bulletin explained that FDA has not approved a new drug application (NDA) for a colloidal silver product. In addition, the bulletin stated no data or information has been submitted to FDA to document an exemption from the new drug provisions of the Federal Food, Drug and Cosmetic Act (the act) under the 1938 or 1962 grandfather provisions. The bulletin referred to 21 CFR 314.200(e)(2), which sets forth the type of evidence necessary to support an exemption under a grandfather provision.

III. The "Grandfather" Exemption

Some marketers of various colloidal silver preparations claim their products are exempt from the "new drug" provisions of section 201(p) of the act (21 U.S.C. 321(p)) under the "grandfather" provisions of the 1938 act and the 1962 amendments to the act. The marketers frequently claim that their products were marketed before 1938, that only insubstantial changes have been made in product formulation and labeling since that time, and that the products' current labeling contains the same representations for use as those contained in the labeling used before 1938.

To qualify for exemption from the "new drug" definition under the 1938 "grandfather" clause, the drug product must have been subject to the Food and Drugs Act of 1906, before June 25, 1938, and at such time its labeling must have contained the same representations concerning the conditions of its use (section 201(p)(i) of the act). Under the 1962 "grandfather" clause, a drug product that, preceding October 9,1962 (1) Was commercially used or sold in the United States, (2) was not a "new drug" as defined in the 1938 act, and (3) was not covered by an approved NDA under the 1938 act, would not be subject to the added requirement of effectiveness "when intended solely for use, under conditions prescribed, recommended, or suggested in the labeling with respect to such drug." (Pub. L. 87-781, sec. 107(c)(4), 76 Stat. 788, note following 21 U.S.C. 321.)

FDA does not believe that any of the currently marketed products qualify for the exemption, because the currently marketed silver products do not appear to be the same as the silver products marketed in the early 1900's. Unlike the silver preparations that were once compendial articles, these new colloidal silver preparations, based on their labeling and/or product analysis, appear to contain less silver than the products marketed historically. Many of the products FDA has sampled lack an ingredient declaration. Samples of some products analyzed by FDA laboratories contained as little as 0.01 percent silver. Analyses showed potency varied from 15.2 percent to 124 percent of the amount of silver declared on the labels. However, FDA has not analyzed the majority of the products on the market and, thus, is unable to state their actual silver content.

Any person seeking to show that a drug comes within a grandfather exemption must prove every essential fact necessary for invocation of the exemption. (See United States v. An Article of Drug * * * "Bentex Ulcerine," 469 F.2d 875, 878 (5th Cir. 1972), cert. denied,412 U.S. 938 (1973).)

Furthermore, the grandfather clause will be strictly construed against one who invokes it. (See id.; United States v. Allan Drug Corp., 357 F.2d 713, 718 (10th Cir.), cert. denied, 385 U.S. 899 (1966).) A change in the composition or labeling of the product precludes the applicability of the grandfather exemption. (See US V Pharmaceutical Corp. v. Weinberger, 412 U.S. 655, 663 (1973).)

IV. Evidence of Safety and Effectiveness

FDA is not aware of any body of data that supports the use of colloidal silver for the various conditions listed in the labeling (Refs. 4 and 5) used with currently marketed products.

The 1939 book, "Argyria, The Pharmacology of Silver" (Ref. 7), discussed the history and pharmacophysiologic effects of silver administration. It included a summary chapter on the negative effects of argyria, a permanent ashen-grey discoloration of the skin, conjunctiva, and internal organs, resulting from the silver salts. The book also included an index that listed proprietary silver compounds marketed at that time.

Goodman and Gilman described colloidal silver use in earlier editions of The Phannacological Basis of Therapeutics (Refs. 8 and 9). But in the 1980 edition (Ref. 10), Goodman and Gilman stated:

Claims that mild silver protein penetrates tissue at the site of application because chloride ion does not precipitate the silver are misleading. The large-carrier protein molecule penetrates poorly. Fortunately, the colloidal silver preparations are now in a deserved oblivion.

Goodman and Gilman (Ref.10) also stated that the indiscriminate use of colloidal silver solutions, especially in the prophylaxis and treatment of respiratory tract infections, probably does more harm than good. They mentioned that there is no acceptable evidence that the routine use of silver solutions for the prophylaxis of colds is at all efficacious, and cases of argyria have resulted from this practice.

Remington's Pharmaceutical Sciences (Ref. Gland The Dispensatory of the United States of America (Ref. 12) state that long-term use of silver preparations could lead to argyria. Concerns about the side effects of argyria may have contributed to reduced medical usage of colloidal silver products.

The Dispensatory of the United States of America (Ref. 12) also stated that there is no justification for the internal use of colloidal silver either theoretically or practically.

Recently, Fung and Bowen (Ref.,13) reviewed the basic chemistry, pharmacokinetics, pharmacology, clinical toxicology, and case reports of adverse events of OTC silver-containing medicinal products, including colloidal silver proteins. They concluded that silver has no known physiologic function and that the risk of using these products exceeds any unsubstantiated benefit.

Fung and Bowen reported that, after ingestion, up to 10 percent of silver salts may be absorbed. Silver is deposited in many organs. The highest concentrations are found in the skin, liver, spleen, and adrenal glands, with lesser deposits in the muscle and brain. Argyria is the most commonly reported adverse event and results from accumulation of silver deposits in the skin below the epidermis. Argyria is effectively irreversible.

As noted in section I. of this document, a number of silver salts were evaluated as part of FDA's OTC drug review, and none was found to be generally recognized as safe and effective for its intended use(s). Accordingly, FDA concludes at this time that no colloidal silver ingredients or silver salts are generally recognized as safe and effective for OTC use.

V. The Agency's Proposal

FDA is proposing to declare all OTC drug products containing colloidal silver ingredients or silver salts as not generally recognized as safe and effective, misbranded, and new drugs within the meaning of section 201(p) of the act. FDA proposes to amend subpart E of part 310 (21 CFR part 310) by adding new ¤ 310.548 for OTC drug products containing colloidal silver ingredients or silver salts. The agency invites 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. Safety data should be in accord with ¤ 330.10(a)(4)(i) (21 CFR 330.10(a)(4)(i)) and effectiveness data in accord with ¤ 330.10 (a)(4)(ii). The agency will evaluate these data and determine if any colloidal silver ingredients or silver salts should not be included in new ¤310.548.

VI. References

The following references have been placed on display in the Dockets Management Branch (address above) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

1. National Formulary, 10th ed., pp.517 and 520, Rockville. MD,1955.

2. National Formulary, 12th ed., pp. 354355, Rockville. MD, 1965.

3. The Pharmacopeia of the United States, 16th ed.. pp. 643444, Rockville, MD, 1960.

4. Labeling brochure for "Colloidal Silver."

5. Reprints of articles and labeling that accompanied samples of colloidal silver shipped through the mail.

6. Food and Drug Administration, Health Fraud Bulletin #19, "Colloidal Silver," October 7, 1994.

7. Hill. W. B., and D. M. Pillsbury, Argyria, The Pharmacology of Silver, The Williams & Wilkins Co., Baltimore,1939.

8 The Pharmacological Basis of Therapeutics, Goodman and Gilman, 4th ed., p. 1050, 1970.

9 The Pharmacological Basis of Therapeutics, Goodman and Gilman 5th ed., pp. 930, 931, 999, and 1000, 1975.

10 The Pharmacological Basis of Therapeutics. Goodman and Gilman, 6th ed., pp. 976-977, 1980.

11. Remington's Pharmaceutical Sciences, 16th ed., pp. 351, 727, and 1111,1980.

12. The Dispensatory of the United States of America, 25th ed., pp. 1234- 1236, 1960.

13. Fung, M.C.,and D. L. Bowen, Silver Products for Medical Indications: Risk-benefit Assessment," Clinical Toxicology, March 1996.

VII. Analysis of Impacts

FDA has examined the impacts of the proposed rule under Executive Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety and other advantages; distributive impacts and equity). The agency believes that this proposed rule is consistent with the regulatory philosophy and principles identified in the Executive Order. In addition, the proposed rule is not a significant regulatory action as defined by the Executive Order and so is not subject to review under the Executive Order.

Under the Regulatory Flexibility Act, if a rule has a significant impact on a substantial number of small entities, an agency must analyze regulatory options that would minimize any significant impact of a rule on small entities. Early finalization of the regulatory status of colloidal silver ingredients and silver salts will benefit consumers by the early removal from the marketplace of products for which safety and effectiveness have not been established. This will result in a direct economic savings and public health protection to consumers. In addition, other approved products may be available to treat the conditions. This particular rulemaking for OTC colloidal silver and silver salts drug products is not expected to pose a significant impact on small business because only a limited number of products, the agency estimates fewer than 30, would be covered by this rulemaking. A number of silver ingredients have already been covered in earlier rulemakings in the OTC drug review, and none were found safe and effective for OTC human use. Under the Regulatory Flexibility Act (5 U.S.C. 60s(b)), the Commissioner of Food and Drugs certifies that this proposed rule will not have a significant economic impact on a substantial number of small entities. No further analysis is required.

The agency invites public comment regarding any substantial or significant economic impact that this rulemaking would have on OTC drug products containing colloidal silver ingredients or silver salts. Comments regarding the impact of this rulemaking on OTC drug products containing colloidal silver ingredients or silver salts should be accompanied by appropriate documentation. The agency is providing a period of 90 days from the date of publication of this proposed rule for comments on this subject to be developed and submitted. The agency will evaluate any comments and supporting data that are received and will reassess the economic impact of this rulemaking in the preamble to the final rule.

VIII. Environmental Impact

The agency has determined under 21 CFR 25.24(c)(6) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

IX. Request for Comments and Data

Interested persons may, on or before January 13,1997 submit to the Dockets Management Branch (address above) written comments and data in response to the proposed rule. Written comments on the agency's economic impact determination may be submitted on or before January 13,1997. Three copies of all comments or objections are to be submitted, except that individuals may submit one copy. Comments and data should be identified with the docket number found in brackets in the heading of this document and may be accompanied by a supporting memorandum or brief. Received comments and data may be seen in the office above between 9 a.m. and 4 p.m. Monday through Friday.

List of Subjects in 21 CFR Part 310

Administrative practice and procedure, Drugs, Labeling, Medical devices, Reporting and recordkeeping requirements.

Therefore, under the Federal Food Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 310 be amended as follows:


1. The authority citation for 21 CFR part 310 continues to read as follows: Authority: Secs. 201, 301, 501, 502, 5o3, 5o5, 506, 507, 512-516, 520, 601(a), 701, 704 705, 721 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 357, 360b-360f, 360j, 361(a) 37l, 374, 375, 379e); secs. 215, 301, 302(a) 351, 354-36OF of the Public Health Service Act (42 U.S.C. 216, 241, 242(a), 262, 263b-263n).

2. New ¤ 310.548 is added to subpart E to read as follows: ¤ 310.548 Drug products containing colloidal sliver Ingredients or sliver salts offered over-the-counter (OTC) for the treatment and/or prevention of disease. (a) Colloidal silver ingredients and silver salts have been marketed in over-the-counter (OTC) drug products for the treatment and prevention of numerous disease conditions. There are serious and complicating aspects to many of the diseases these silver ingredients purport to treat or prevent. Further, there is a lack of adequate data to establish general recognition of the safety and effectiveness of colloidal silver ingredients or silver salts for OTC use in the treatment or prevention of any disease. These ingredients and salts include, but are not limited to, silver proteins, mild silver protein, strong silver protein, silver chloride, and silver iodide.

(b) Any OTC drug product containing colloidal silver ingredients or silver salts that is labeled, represented, or promoted for the treatment and/or prevention of any disease is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act (the act) for which an approved application or abbreviated application under section 505 of the act and part 314 of this chapter is required for marketing. In the absence of an approved new drug application or abbreviated new drug application, such product is also misbranded under section 502 of the act. (c) Clinical investigations designed to obtain evidence that any drug product containing colloidal silver or silver salts labeled, represented, or promoted for any OTC drug use is safe and effective for the purpose intended must comply with the requirements and procedures governing the use of investigational new drugs set forth in part 312 of this chapter. (d) After (date 30 days after date of publication of the final rule in the Federal Register), any such OTC drug product containing colloidal silver or silver salts initially introduced or initially delivered for intro into interstate commerce that is not in compliance with this section is subject to regulatory action.


Wm. K. Hubbard

Ass. Commissioner for Policy Coordination


The following article found at: http://www.cvm.fda.gov/fda/infores/updates/silver.html

February 12, 1997

FDA has received reports that products containing colloidal silver are being promoted for use in the treatment of mastitis and other serious disease conditions of dairy cattle, as well as for various conditions of companion animals. For example, FDA's Center for Veterinary Medicine has received reports from the Agency's regional milk specialists and State inspectors that colloidal silver products have been found on some dairy farms. Also, recent articles in some farm newspapers and journals promote the use of colloidal silver in treating mastitis and claim that no milk discard is needed.

FDA is not aware of any substantial scientific evidence that supports the safe and effective use of colloidal silver ingredients or silver salts for any animal disease condition. Also, in the October 15, 1996 Federal Register, FDA proposed to establish that all over-the-counter human drug products containing colloidal silver ingredients or silver salts for internal or external use are not generally recognized as safe and effective and are misbranded.

Use of colloidal silver ingredients in food-producing animals constitutes a potentially serious public health concern because of the possibility of residues in milk or meat. According to several scientific publications mentioned in the October 15, 1996 Federal Register proposal, the human consumption of silver may result in argyria -- a permanent ashen-gray or blue discoloration of the skin, conjunctiva, and internal organs.

In addition to the possible human health concerns, use of these products to treat a serious illness in animals (including pets) could potentially endanger the health of the animal by delaying timely, appropriate treatment.

Colloidal silver-containing products have not been approved by FDA for use in any animal species. Promoting the use of colloidal silver for treating animal diseases causes such products to be misbranded veterinary drugs under the Federal Food, Drug, and Cosmetic Act (the Act). Labeling colloidal silver products to treat animals causes such products to be new animal drugs which are adulterated under the Act.

FDA has taken action against colloidal silver products, and is continuing to investigate the promotion and use of colloidal silver products in dairy and other animals. If necessary, FDA will take further appropriate regulatory action.


Date sent: Tue, 9 Nov 1999 22:55:00 -0600
From: <bhohles@AIRMAIL.NET>

Reprinted from The Resister

Feeling a Little Stupid Lately?

THE UNITED NATIONS World Health Organization (WHO) actively promotes the use of fluoride in water purification, beverages, toothpaste, mouthwash, topical gels, dietary supplements and food. If the WHO advocates fluoride that is reason enough to avoid any products containing fluoride. But the medical journal, Neurotoxicology and Teratology Vol 17, No.2, 1995 provide urgent compelling reasons.

Researchers Phyllis J. Mullenix, Department of Toxicology, Forsyth Research Institute, Boston; Ann Schunior, also of Forsyth; Pamela K. Denbesten, Department of Pediatric Dentistry, Eastman Dental Center, Rochester, New York, and William J. Kernan, Veterinary Diagnosis Laboratory, Iowa State University asserted that "There have been reports from Chinese investigators that high levels of fluoride in drinking water (3 to 11 ppm -- parts per million) affect the nervous system directly without first causing physical deformations from skeletal fluorosis." [Emphasis added.]

" One study of adult humans," states their report, "found attention affected by sublingual drops containing 100 ppm of sodium fluoride [NaF], an exposure level potentially relevant to humans, because toothpastes contain 1000 to 1500 ppm and mouth washes contain 230 to 900 ppm fluoride. Also," they continue" effects on behavior were related to levels of fluoride found in plasma and in different regions of the brain." The observers found that it was fluoride levels in plasma, not fluoride levels of exposure, which best predicted effects on behavior. They observed that "similar plasma fluoride levels... have been found in humans ingesting 5 to 10 ppm fluoride in drinking water...."

The authors point out that theirs is the first laboratory study to demonstrate that the central nervous system's functional output is vulnerable to fluoride and that fluoride accumulates in brain tissues. Speaking of the conclusions drawn from their study of fluoride use and toxicity levels the authors state, "A generic behavioral pattern disruption as found in this study can be indicative of a potential for motor dysfunction, IQ deficits and/or learning disabilities in humans."

Dr. Frank Bertrand of Stilfontein, South Africa, commenting on the Neurotoxicology and Teratology study notes: "Fluoride is a very strong oxidizing agent and wiII destroy vitamin E and other anti-oxidents... but most dangerous of all is probably the fluoride gel used in dental surgery. The WHO recommends a 2.72% NaF [also known as acidulated phosphate fluoride]." That is 12,300 ppm! "Fluoride in an acid medium," continues Dr. Stilfonrein, "tends to produce the very corrosive hydrofluoric acid, which will attack and eat its way through glass.

Dental gel delivered to surgery in acid resistant plastic containers is left in the mouth for four minutes. Some of this highly concentrated NaF is swallowed. Dr. S. Gibson, Research Physician, Glasgow Homeopathic Hospital, states that fluoride reacts with hydrogen bonds in biological molecules to form HF (hydrofluoric acid) bonds, with adverse physiological effects at very low concentrations, well below 1 ppm. Dr. Stilfonein further notes that cancers usually attributable to cigarette use (i.e., lung and mouth) were, for all practical purposes, absent before fluoridation of water in Britain in the early 1950s, then increased exponentially several years after fluoridation was introduced.

[Try this little experiment. Go to your local water purification plant and inquire how to purchase, oh, say, one ounce of pure NaF (sodium fluoride.) Tell them you have a well and wish to treat your water for your children's "oral wellness." When you get out of the federal slammer after being indicted under various nuclear non-proliferation treaty acts for soliciting the sale of nuclear "byproducts" and one of the most toxic neurological poisons known to man, write us a letter and let us know how it went. Editor.]

Adopted from:
The Ada Parker Newsletter
PO Box 91059
Auckland Park
South Africa

Steve Wingate


Where's the FDA as the bodies pile up?

From: Bob Compton [mailto:bob.compton@excite.com]
Sent: Thursday, January 20, 2000 8:58 AM
To: mesaleas@cts.com
Subject: Startling Statistics...

Some Startling Statistics...

Number of physicians in the U.S..............................700,000
Accidental deaths caused by physicians per year..............120,000
Accidental deaths per physician................................0.171

Number of gun owners in the U.S...........................80,000,000
Number of accidental gun deaths per year (all age groups).....1, 500
Accidental deaths per gun owner............................0.0000188

Therefore, doctors are approximately 9,000 times more dangerous than gun owners!

This only counts full kills. How many were maimed, crippled and lives ruined by "medicine"? Licensed to practice medicine is a license to kill? Move over 007!