Supplemental Information added 19th October 2007
The following is text from a press release issued by Harvard Health Publications as part of the Harvard Health Letter August 1, 2007. Click here to read the original press release from Harvard
Colloidal silver is peddled as a cold medicine, decongestant, all-around germ fighter, and a kind of cure-all.
Is there any legitimate reason for taking the dietary supplement? The short answer is no, and there may be some serious and strange side effects, reports the August 2007 issue of the Harvard Health Letter.
Silver has several uses in conventional medicine. Silver sulfadiazine is used to treat serious burns. Fabric impregnated with silver is sometimes used as a dressing for wounds or skin infections. And silver nitrate is occasionally used to treat warts and corns.
But there's no proof that taking colloidal silver by mouth has any benefits. As for harm, brain and nerve damage from silver exposure is rare, but colloidal silver can cause kidney damage, stomach distress, and headaches.
The most common problem associated with silver exposure is argyria: The skin turns a bluish gray as granules of silver accumulate in the body. The conjunctiva (the membrane that covers the eyes) and internal organs may also be affected. Once silver is deposited, there's no way to get it out, so the discoloration may be permanent.
Will the colloidal silver products currently on the market turn you blue? The Harvard Health Letter says if you use them for a short time and in recommended amounts, probably not. But some people overdo it. For example, a 59-year-old man was sent to the emergency room because he looked cyanotic—the bluish color that indicates you're not getting enough oxygen. It turned out he'd been taking a homemade version of colloidal silver whenever he felt a cold coming on.
Australian Therapeutic Goods Administration (TGA) Advisory, (Australia's regulatory agency for medical drugs and devices)
Regulation of colloidal silver and related products
Publication content last updated 26 March 2004
This information was last reviewed 20 April 2007
Web page last updated on 24 July 2007
In December 2002, an amendment was made to the Therapeutic Goods (Excluded Goods) Order such that products containing substances like colloidal silver, which make therapeutic claims, are no longer goods excluded from therapeutic goods legislation and must meet the requirements of other therapeutic goods. Colloidal silver products that are used in the purification or treatment of drinking water, and which do not make therapeutic claims, will remain excluded from therapeutic goods legislation.
In 1998, the Complementary Medicines Evaluation Committee (CMEC) was requested to provide advice to the National Drug and Poisons Scheduling Committee (NDPSC) on the efficacy of colloidal silver as a complementary medicine, to assist them in considering the use of the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) in providing safeguards in the use of this substance.
Following an investigation by the Therapeutic Goods Administration (TGA), the CMEC recommended that the NDPSC be advised that there are no current legitimate uses of colloidal silver and that the Surveillance Section of the TGA be requested to investigate the illegal availability of colloidal silver products because of concerns about their significant toxicity. The reasons for the recommendation were that:
- there is little evidence to support therapeutic claims made for colloidal silver products;
- the risk to consumers of silver toxicity outweighs the value of trying an unsubstantiated treatment, and bacterial resistance to silver can occur; and
- efforts should be made to curb the illegal availability of colloidal silver products, which is a significant public health issue.
Ongoing concerns over the safety of colloidal silver led the CMEC to recommend that action be taken by the TGA in regard to the safety risk posed by illegal or potentially illegal products containing colloidal silver. The Surveillance Section of the TGA subsequently advised that it was not able to take any action against colloidal silver products regardless of whether such products make therapeutic claims or not. This is because colloidal silver may be used in the purification or treatment of drinking water and such goods were excluded, by virtue of the Therapeutic Goods (Excluded Goods) Order (the Order), from the requirements of the Therapeutic Goods Act 1989 (the Act).
The TGA undertook action to change the Order so that all products which may have a use in the purification or treatment of drinking water but which are marketed with therapeutic claims are not excluded from the requirements of the Act.
The TGA consulted with the peak complementary medicine industry bodies, the water quality industry and relevant government agencies that might be affected by the proposed change. There was broad support for the TGA's proposal, with the proviso that the genuine use of colloidal silver for water purification purposes should not become captured under the Act.
A notice was published in the Gazette on 20 December 2002 which removed water purification substances, including colloidal silver, for which therapeutic claims are made from being excluded goods. Given the increased promotion of these products and the associated risk to public health, the change to the Order came into force on the date of gazettal.
The TGA contacted current and potential suppliers of products based on colloidal minerals for which therapeutic claims are made to alert them to the revised regulatory status of such products.
As of 20 December 2002, colloidal products which make therapeutic claims are classified as therapeutic goods under the Act. To date, the TGA has not approved any colloidal silver products for use as therapeutic goods in Australia. The TGA will take action to stop the supply of any unapproved colloidal silver products which make therapeutic claims.
Sponsors wishing to market colloidal silver products as therapeutic goods in Australia will need to submit an application, with relevant supporting data, to the TGA. This could be in the form of an application to have colloidal silver approved as a new Listable substance (on the basis of demonstrated safety and quality) or an application to have products containing colloidal silver included on the Australian Register of Therapeutic Goods (on the basis of demonstrated safety, quality and efficacy). As for all such applications, sponsors are encouraged to seek the assistance of a consultant familiar with TGA application processes and requirements.
For further information on this topic please contact the TGA Information Officer by telephone on 1800 020 653 or email to [email protected].
Colloidal Silver Products: Consumer Advisory from the National Center for Complementary and Alternative Medicine [NCCAM] - Part of the U.S. National Institute of Health (NIH)
Colloidal Silver Products
This fact sheet provides a general overview of colloidal silver products, discusses scientific research findings on their use for health purposes, and suggests additional sources of information.
- Colloidal silver products consist of tiny silver particles suspended in liquid. They are usually marketed as dietary supplements (see Question 1).
- Over-the-counter colloidal silver products are not considered by the U.S. Food and Drug Administration (FDA) to be generally recognized as safe and effective for diseases and conditions.
- The FDA has taken action against a number of colloidal silver companies (such as Web sites) for making drug-like claims about their products.
- Colloidal silver can cause serious side effects. One is argyria, a bluish-gray discoloration of the body. Argyria is not treatable or reversible.
- Tell your health care providers about any complementary and alternative practices you use. Give them a full picture of what you do to manage your health. This will help ensure coordinated and safe care.
1. What are colloidal silver products?
Silver is a metallic element that is mined as a precious metal. It has various industrial uses--for example, in jewelry, silverware, electronic equipment, dental fillings, photographic processing, and disinfecting water. People are commonly exposed to silver, usually in tiny amounts, through the environment (such as the air), drinking water, and food, and possibly their work or hobbies.1 Silver has no known biological function in living organisms.
Silver has had some medicinal uses going back for centuries. However, more modern and less toxic drugs have eliminated most of those uses. A few prescription drugs containing silver are still available. For example, silver nitrate can be used to prevent an eye condition called conjunctivitis in newborn babies and to treat certain skin conditions, such as corns and warts. Another drug, silver sulfadizine, can be used to treat burns. These drugs are applied to the body (i.e., they are not taken internally), and they can have negative side effects.
Colloidal silver products consist of tiny silver particles suspended in a liquid base. Sometimes other ingredients are added, such as proteins, coloring, etc. The products are usually taken by mouth (in which case the products are considered dietary supplements; see the text box below). Some other types are sprayed, applied to the skin, or injected into a vein.
About Dietary Supplements
Dietary supplements were defined in a law passed by Congress in 1994. A dietary supplement must meet all of the following conditions:
It is a product (other than tobacco) that is intended to supplement the diet and that contains one or more of the following: vitamins, minerals, herbs or other botanicals, amino acids, or any combination of the above ingredients.
It is intended to be taken in tablet, capsule, powder, softgel, gelcap, or liquid form.
It is not represented for use as a conventional food or as a sole item of a meal or the diet.
It is labeled as being a dietary supplement.
2. For what health purposes are colloidal silver products marketed?
Colloidal silver products are often marketed with various unproven health-related claims. Examples include that they benefit the immune system; kill disease-causing agents such as bacteria, viruses, and fungi; are an alternative to prescription antibiotics; or treat diseases such as cancer, HIV/AIDS, tuberculosis, syphilis, scarlet fever, shingles, herpes, pneumonia, and prostatitis (inflammation of the prostate).
3. Do colloidal silver products work?
Reviews in the scientific literature on colloidal silver products have concluded that2-5:
- Silver has no known function in the body.
- Silver is not an essential mineral supplement or a cure-all and should not be promoted as such.
- Claims that there can be a "deficiency" of silver in the body and that such a deficiency can lead to disease are unfounded.
- Claims made about the effectiveness of colloidal silver products for numerous diseases are unsupported scientifically.
- Colloidal silver products can have serious side effects (discussed further below).
- Laboratory analysis has shown that the amounts of silver in supplements vary greatly, which can pose risks to the consumer.
4. What are the risks of using these products?
Animal studies have shown that silver builds up in the tissues of the body. In humans, buildup of silver from colloidal silver can lead to a side effect called argyria. It causes a bluish-gray discoloration of the skin, other organs, deep tissues, nails, and gums. Argyria cannot be treated or reversed, and it is permanent. While it is not known how argyria occurs, it is thought that silver combines with protein, forming complexes that deposit in the skin and are processed by sunlight (as in traditional photography).6,7 Other side effects from using colloidal silver products may include neurologic problems (such as seizures), kidney damage, stomach distress, headaches, fatigue, and skin irritation. Colloidal silver may interfere with the body's absorption of the following drugs: penacillamine, quinolones, tetracyclines, and thyroxine.5
5. Does the Government regulate dietary supplements containing colloidal silver?
Yes, the Government regulates them, but differently than drugs. The Dietary Supplement Health and Education Act of 1994 places dietary supplements in a special category of foods. This category is regulated differently than other foods and than drugs. For example, manufacturers of dietary supplements, unlike manufacturers of drugs, do not have to prove their product's safety and effectiveness to the FDA before it is marketed. If the product is found to be unsafe after it is marketed, the FDA can take certain actions, such as removing it from the marketplace. The FDA issued a ruling in 1999 that no products containing colloidal silver are generally recognized as safe and effective. The FDA and the Federal Trade Commission (FTC) have sent warning letters to the operators of many Web sites that market colloidal silver with drug-like claims (i.e., that their product diagnoses, treats, cures, or prevents disease).
6. What should people do who are considering or using colloidal silver?
Tell your health care providers about any complementary and alternative practices you use. Give them a full picture of what you do to manage your health. This will help ensure coordinated and safe care. This is especially important if you are pregnant, nursing a baby, or considering treating a child.
- Agency for Toxic Substances and Disease Registry. ToxFAQs for Silver. Agency for Toxic Substances and Disease Registry Web site. Accessed at atsdr.cdc.gov/tfacts146.html on December 11, 2006
- Fung MC, Bowen DL. Silver products for medical indications: risk-benefit assessment. Journal of Toxicology. Clinical Toxicology. 1996;34(1):119-126.
- Gulbranson SH, Hud JA, Hansen RC. Argyria following the use of dietary supplements containing colloidal silver protein. Cutis. 2000;66(5):373-374.
- FDA bans colloidal silver products, cites lack of data. FDA Consumer. 1999;33(6). Accessed at fda.gov/fdac/departs/1999/699_upd.html December 11, 2006.
- Natural Medicines Comprehensive Database. Colloidal silver. Natural Medicines Comprehensive Database Web site. Accessed on December 11, 2006.
- White JM, Powell AM, Brady K, et al. Severe generalized argyria secondary to ingestion of colloidal silver protein. Clinical and Experimental Dermatology. 2003;28(3):254-256.
- Hori K, Martin TG, Rainey P, et al. Believe it or not--silver still poisons! Veterinary and Human Toxicology. 2002;44(5):291-292.