Colloidal Silver: Risk Without Benefit

Stephen Barrett, M.D.

Colloidal silver is a suspension of submicroscopic metallic silver particles in a colloidal base. Long-term use of silver preparations can lead to argyria, a condition in which silver salts deposit in the skin, eyes, and internal organs, and the skin turns ashen-gray. Many cases of argyria occurred during the pre-antibiotic era when silver was a common ingredient in nosedrops. When the cause became apparent, doctors stopped recommending their use, and reputable manufacturers stopped producing them. The official drug guidebooks (United States Pharmacopeia and National Formulary) have not listed colloidal silver products since 1975.

Dubious Ads

In recent years, silver-containing products have been marketed with unsubstantiated claims that they are effective against AIDS, cancer, infectious diseases, parasites, chronic fatigue, acne, warts, hemorrhoids, enlarged prostate, and many other diseases and conditions. Some marketers claim that colloidal silver is effective against hundreds of diseases.

During 1997 and 1998, Changes International, a Florida-based multilevel company, stated:

Our colloidal silver contains 99.99% pure silver particles suspended indefinitely in demineralized water that kills bacteria and viruses. It can be applied topically and/or absorbed into the blood stream sub-lingually (under the tongue), thereby avoiding the negative effects of traditional antibiotics that kill good bacteria in the lower digestive tract.

An all natural antibiotic alternative in the purest form available. The presence of colloidal silver near a virus, fungi, bacterium or any other single celled pathogen disables its oxygen-metabolism enzyme, its chemical lung, so to say. The pathogens suffocates and dies, and is cleared out of the body by the immune, lymphatic and elimination systems.

Unlike pharmaceutical antibiotics which destroy beneficial enzymes, colloidal silver leaves these beneficial enzymes intact. Thus colloidal silver is absolutely safe for humans, reptiles, plants and all multi-celled living matter.

It is impossible for single-celled germs to mutate into silver-resistant forms, as happens with conventional antibiotics. Also, colloidal silver cannot interact or interfere with other medicines being taken. Colloidal silver is truly a safe, natural remedy for many of mankind's ills. Colloidal silver can be taken indefinitely because the body does not develop a tolerance to it [1].

Seasilver International, a California-based multilevel company, had claimed that American are suffering from "silver deficiency." Although silver is not an essential nutrient, product information posted on the company's Web site several years ago stated:

The depletion of minerals in our soil has left us deficient of silver, one of our most essential trace minerals, causing a drastic increase in immune system disorders in our society in the last decade. Research has taught us that all disease is allowed to manifest itself because of a weakened immune system. In over 20 years of worldwide research on Colloidal Silver, numerous interviews with government agencies, health care practitioners and their patients, no other nutrient, herb or drug (prescription or over-the-counter) is as safe and effective against all known forms of unfriendly virus, bacteria, and fungus. Additionally, while it is generally known that most antibiotics kill only perhaps 6 or 7 different disease organisms, reports have shown that Colloidal Silver has been used successfully in the treatment of over 650 diseases! Furthermore, strains of disease organisms fail to develop in the presence of Colloidal Silver. Colloidal Silver's greatest attribute is its unique ability to function as a superior second immune system in the body! [2]

The ad below is from the July 1996 issue of Alternative Medicine Digest.

Critical Studies and Case Reports

In 1995, an herbal distributor named Leslie Taylor tested nine commonly marketed colloidal silver products available at health-food stores and concluded:

Of course, the fact that a product inhibits bacteria in a laboratory culture doesn't mean it is effective (or safe) in the human body. In fact, products that kill bacteria in the laboratory would be more likely to cause argyria because they contain more silver ions that are free to deposit in the user's skin.

FDA laboratory studies have found that the amount of silver in some product samples has varied from 15.2% to 124% of the amount listed on the product labels. The amount of silver required to produce argyria is unknown. However, the FDA has concluded that the risk of using silver products exceeds any unsubstantiated benefit [3]. So far, eleven cases of argyria related to silver products have been reported:

  • A 58-year-old man who treated a presumed kidney infection with a home-brewed colloidal solution 12 times a day for 4 days developed argyria about 4 weeks later [9].
  • A 38-year-old man developed argyria after ingesting approximately 16 ounces of 450 ppm colloidal silver three times a day for 10 months to treat his arthritis and other conditions. He made the solution with a simple battery-operated chamber that leached silver from pure silver wire. He had obtained the plans from information on the Internet [10]. The photograph to the right shows how his skin color compares to that of normal skin.
 

Enforcement Actions

Between October 1993 and September 1994, the FDA issued warning letters to five colloidal silver marketers::

In October 1996, the FDA proposed to ban the use of colloidal silver or silver salts in over-the-counter products [11]. A Final Rule banning such use was issued on August 17, 1999 and became effective September 16th. The rule applies to any nonprescription colloidal silver or silver salt product claimed to be effective in preventing or treating any disease [12]. Silver products can still be sold as "dietary supplements" provided that no health claims are made for them. During 2000, the FDA issued warnings to more than 20 companies whose Web sites were making illegal therapeutic claims for colloidal silver products.

In 2000, the Federal Court of Australia banned Vital Earth Company Pty Limited and its director Darryl John Jones from falsely representing that the colloidal silver produced by their "Vital Silver 3000 Zapper," "Vital Silver 2000 Automatic" and "Vital Silver 2000":

The company was also ordered to pay AUS$9000 in costs and to provide refunds [13].

In 2001, the FTC obtained consent agreements with two companies:

In 2002, the FTC obtained a consent agreement with Kris Pletschke, doing business as Raw Health, agreed to stop making unsubstantiated claims that its colloidal silver product could treat or cure 650 different diseases; eliminate all pathogens in the human body in six minutes or less; and is medically proven to kill every destructive bacterial, viral, and fungal organism in the body, including anthrax, Ebola, Hanta, and flesh-eating bacteria [15].

In 2002, the Australian Therapeutic Goods Administration amended its rules so that water-treatment products containing substances like colloidal silver for which therapeutic claims are made must meet the requirements of medicines included in the Australian Register of Therapeutic Goods. This means that such products can no longer be legally marketed without proof that they are safe and effective for their intended purpose. The amendment was based on clnclusions that:

References

  1. Product brochure. Changes International, 1997. Downloaded in 1998.
  2. Seasilver International Product Information, accessed October 12, 1998.
  3. Fung MC, Bowen DL. Silver products for medical indications: risk-benefit assessment. Journal of Toxicology and Clinical Toxicology 34:119-26, 1996.
  4. Gulbranson SH and others. Argyria following the use of dietary supplements containing colloidal silver protein. Cutis 66:373-374, 2000.
  5. Hori K and others. Believe it or not—Silver still poisons! Veterinary and Human Toxicology 44(5):291-292, 2002.
  6. Blue Is the color of my candidate's skin. Associated Press, Oct 2, 2002
  7. Cohen LE and others. Effects of Internet quackery: Argyria in the silver state. Federal Practitioner 21(4):9-17, 2004.
  8. Wickless SC, Schwader TA. Medical mystery—The answer. New England Journal of Medicine 352:2349-2350, 2004.
  9. Brandt D. Argyia secondary to ingestion of homemade silver solition. Journal of the American Academy of Dermatology 53:S105-107, 2005.
  10. Wadhera A, Fung M. Systemic argyria associated with ingestion of colloidal silver. Dermatology Online Journal 11(1):12, 2005.
  11. Federal Register 61:53685-53688, 1996. (To access this document, search the 1996 volume for "colloidal silver.")
  12. FDA. Final rule: Over-the-counter drug products containing colloidal silver ingredients or silver salts. Federal Register 64:44653-44658, 1999. Download PDF version
  13. Refunds for buyers of alternative therapy devices. News release, Australian Competition and Consumer Commission, May 5, 2000.
  14. "Operation Cure.All" wages new battle in ongoing war against Internet health fraud. FTC news release, June 14, 2001.
  15. FTC announces first two enforcement actions against purveyors of bioterrorism defense products. FTC news release, Feb 27, 2002.
  16. Regulation of colloidal silver and related products. Therapeutic Goods Administration Web site, Aug 19, 2003.

For Further Information

Rosemary Jacobs, an argyria victim, has made a detailed study of the colloidal silver marketplace and is willing to answer questions.

This article was revised on August 17, 2005.