Colloidal Silver -FDA Issues A Warning Letter

Colloidal silver is peddled as a treatment for hepatitis C, if not a cure, according to the recent April 11th FDA warning letter  sent to International Institute of Holistic Healing, Inc., Colloidal silver is recommended and sold online for treating AIDS, Cold Sores, Liver Disease, Genital Herpes, Genital Warts, and HIV.
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As a mother I was repulsed at the claim listed in the FDA Warning letter by the Company/Institute for the use of the product in children.
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"For Children's Immune System Health and Infections: Viruses, Bacteria, Fungi, Candida, Parasites, Allergies
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Thymus extract and colloidal silver are sometimes marketed for the treatment of hepatitis C, but there is currently no research to support their use for this purpose.
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As far back as 1999 the FDA issued a ruling that no products containing Colloidal Silver are recognized as safe and effective for treating any kind of disease or condition.
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Colloidal silver can cause brain and nerve damage, such as seizures, kidney damage, stomach distress and headaches.  The product is available in many forms, it can be taken by mouth, some products are either sprayed directly on the skin, or injected into a vein.

One of the most common health problem associated with silver exposure is argyria: What happens in that the skin turns a bluish grey as granules of silver accumulate in the body. The membrane that covers the eyes and internal organs may also be affected. 
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Claims made by distributors such as a "deficiency" of silver in the body which can lead to disease are unfounded. Silver is not an essential mineral supplement or a cure-all and should not be promoted as either.
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(for more information, see the NCCAM fact sheet Colloidal Silver Products).
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From Mayo
Brent A. Bauer, M.D.
Colloidal silver isn't considered safe or effective for any of the health claims manufacturers make. Nor is it an essential mineral, as some sellers of silver products claim.
Colloidal silver products are made of tiny silver particles suspended in a liquid — the same type of precious metal used in jewelry, dental fillings, silverware and other consumer goods. Colloidal silver products are usually marketed as dietary supplements that you take by mouth. Colloidal silver products also come in forms to spray, to apply to your skin or to inject.
Manufacturers of colloidal silver products often claim that they are cure-alls, boosting your immune system, fighting bacteria and viruses, and treating cancer, HIV/AIDS, shingles, herpes, eye ailments and prostatitis. However, no sound scientific studies to evaluate these health claims have been published in reputable medical journals. In fact, the Food and Drug Administration has taken action against some manufacturers of colloidal silver products for making unproven health claims.
It's not clear how much colloidal silver may be harmful, but it can build up in your body's tissues over months or years. Most commonly, this results in argyria (ahr-JIR-e-uh), a blue-gray discoloration of your skin, eyes, internal organs, nails and gums. While argyria doesn't pose a serious health problem, it can be a cosmetic nightmare because it's not reversible, even when you stop taking silver products.
Rarely, excessive doses of colloidal silver can cause possibly irreversible serious health problems, including:
  • Seizures and other neurological problems
  • Kidney damage
  • Skin irritation
Colloidal silver products also may interact with medications, including penicillamine, quinolones, tetracycline and thyroxine medications.


The FDA recently sent this warning letter to
International Institute of Holistic Healing, Inc.
 (excerpted: click here for complete text)

UNITED STATES OF AMERICA
FEDERAL TRADE COMMISSION
BUREAU OF CONSUMER PROTECTION
WASHINGTON, D.C. 20580
DEPARTMENT OF HEALTH
AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
WASHINGTON, D.C. 20740

April 28, 2011

WARNING LETTER

Dr. Aundrea Adams
International Institute of Holistic Healing, Inc.
1730 Cordova Drive
Mesquite, TX 75150-6825

P.O. Box 944
Lancaster, TX 75146

2331 Gus Thomasson
Suite 115
Dallas, TX 75228

Dear Dr. Adams:

This letter is to advise you that the United States Food and Drug Administration (FDA) and the United States Federal Trade Commission (FTC) have reviewed your web site at the internet address, http://www.doctorajadams.com/1. The FDA has determined that your firm's marketing of the products Colloidal Silver 500 ppm (Liquid), Essaic Tonic Liquid Drops, and Oil of Oregano P73 Physician's Strength, which are offered for sale on your website, violates the Federal Food, Drug, and Cosmetic Act (the Act). As described in more detail below, Colloidal Silver 500 ppm (Liquid), Essaic Tonic Liquid Drops, and Oil of Oregano P73 Physician's Strength are unapproved new drugs in violation of sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)] and are misbranded under sections 502 and 502(t)(1) of the Act [21 U.S.C §§ 352 and 352(f)(1)]. These products are further misbranded under section 502(j) of the Act in that they are dangerous to health when used in the manner recommended or suggested in their labeling.

UNAPPROVED AND MISBRANDED NEW DRUGS

Labeling statements on your website and in sample labeling include, but are not limited to, the following:

Colloidal Silver 500 ppm (Liquid):

• "Colloidal Silver Uses ... AIDS ... Cold Sores ... Genital Herpes ... Genital Warts ... HIV ..."

"Research States That Colloidal Silver Has Been Used For:
Acid Reflux [Caused by Intestinal Candida], Acne, Allergies, Athletes Foot, Bad Breath, Bladder Infections [Cystitis], Bleeding Gums, Severe Bums, Blood Parasites, Boils, Colitis, Canker Sores, Chronic Fatigue, Colds, Conjunctivitis, Cornea Injury, Dandruff, Dermatitis, Diarrhea, Digestive Aid, Dysentery, Ear Infections, Eczema, Enlarged Spleen, Entamoeba, Enteritis, Fibrositis, Flu, Gastritis, Gingivitis, Gonorrhea, Gum Recession, H Pylori [Helicobacter Pylori], Halitosis, Hay Fever, Hemorrhoids, Impetigo, Keratitis, Lymphagitis, Meniere's Disease, Moles, Natural Decongestant, Ophthalmology, Pruritis, Psoriasis, Rheumatoid Arthritis, Ringworm, Skin Rashes, Rhinitis, Rosacea, Seborrhea, Sinusitis, Sore Throat, Tonsillitis, Tooth Decay, Trench Foot, Ulcers, Vincents Angina, Warts, Whooping Cough, Yeast Infections, Other Infections [Bacterial, Viral, Fungal, Parasitic]"


• "The Colloidal Silver really helped my daughter recover from Mononucleosis."

• "My bladder infection is almost gone! Colloidal Silver worked wonders."

• "I want to let you know that your brand of colloidal silver along with the P73 Orgeno [sic] Oil are 2 very potent remedies for microbes, and they have nearly cleared up a very, very strong infection - certainly one of the worst infections I've ever had in my life."

.....Essaic Tonic Liquid Drops:

• "Other Suggested Uses for Essiac: ... AIDS and HIV infections Blood Sugar Problems Type II Diabetes ... Genital herpes viral infections Hepatitis liver disease Virus Infections; Recurrent viral, bacterial or parasitic infections"

• "Protect, Repair, and Detox Liver and All Other Major Organs With This Miraculous Herbal Formula Used for Cancer, Diabetes, Thyroid Disorders, Tumors, Cysts, Growths, Immune Disorders, AIDS, HIV, Kidney Disorders, All Chronic Illnesses ... "

• "In addition to its reputation for reversing cancer, it has since proven itself to be an effective remedy for many infections, inflammatory conditions, immune disorders [sic] other ailments as well."
Oil of Oregano P73 Physician's Strength:

• "Natural Support for Immune Health, Lungs, Cancer, Growths, Bacteria, Viruses, Fungi, Parasites, All Infections and Inflammations, With Oil of Oregano P73 Physician's Strength!"

• "Oil of Oregano Uses ... AIDS ... Anthrax ... Anti-Viral ... Cancer Cold Sores ... Genital Herpes ... Genital Warts ... Gonorrhea ... Heart Disease Herpes ... HIV ... Kidney Infection ... Meningitis ... SARS ... Skin Cancer ... Syphilis ... Tuberculosis West Nile Virus ..."

• "For Herpes: the oil completely destroyed herpes viruses...."

• "Oregano oil has been tested against a variety of microorganisms [infections] and is found to exert a high degree of anti-fungal, anti-parasitic, anti-viral and antibacterial actions."

• "Oregano is such a potent anti-fungal agent that it is capable of destroying even resistant fungal forms, such as the mutated fungi which result from antibiotic therapy."

• "[o]ne of the testimonials given in the book states that a woman's genital herpes completely disappeared after only 1 month, after having it for several years."

• "The oil of oregano is helping my shingles."



Also A Warning Letter Sent on 4-25 to Natural Path / Silver Wings, LLC 
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Warning From The FDA On Oct 2009
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October 6, 2009
The Food and Drug Administration (FDA) is advising consumers about the risk of permanent skin and mucous membrane discoloration, known as argyria, associated with the use of dietary supplements that contain silver, including colloidal silver. Argyria is a permanent and irreversible grayish or bluish discoloration of the skin, conjunctiva (the clear membrane that covers the white part of the eye), nails, and gums. Although argyria is not dangerous to physical health, some patients with argyria may experience significant negative psychological or social consequences as a result of the condition. In addition, the use of silver-containing dietary supplements may interfere with the body's absorption of some drugs, such as quinolone antibiotics [ciprofloxacin (Cipro), norfloxacin (Noroxin), ofloxacin], tetracycline antibiotics, thyroxine, and penacillamine (Cuprimine).

Argyria may develop quickly with the use of products that contain large amounts of silver or may develop gradually over time with the use of products that contain small amounts of silver. Based on the available scientific information, FDA is not able to advise consumers of a dose or use restrictions that would minimize or eliminate the risk of argyria. However, the Environmental Protection Agency (EPA) has established a chronic oral Reference Dose (RfD) of 5 micrograms (µg) of silver per kilogram (kg) of body weight per day (5 µg/kg/day) based on a review of 70 cases of argyria that were associated with oral and other uses of silver compounds. For a 70 kg person (or about 154 pounds body weight), this would be about 350 µg of silver per day. Ingesting silver in amounts close to or above the EPA RfD may put a consumer at risk of developing argyria. If you are using or considering using a dietary supplement that contains silver and have questions or concerns about its safety for you in your particular circumstances, you should discuss those concerns with your health care provider.

Silver ingredients may be identified on the label of a dietary supplement as "colloidal silver" (a liquid suspension of tiny silver particles), "colloidal silver protein," "ionic silver," "native silver," "silver," "silver alginate," "silver protein," "mild silver protein," and "true colloidal silver."

Argyria is usually permanent. There are no effective non-surgical medical treatments, and surgical procedures have limited effectiveness and are not suitable in all cases. The exact mechanism of how argyria occurs is not known, but it is believed that silver combines with protein to form deposits in the skin. Silver also can increase the body's production of melanin, which causes the skin to get darker when exposed to sunlight.

Silver is present in the environment, and therefore people are normally exposed to it. However, silver is a nonessential mineral that has no known physiological functions or benefits when taken orally.
Silver has some appropriate medical uses, such as medicines, bandages, and dressings used to treat burns, skin wounds, or skin infections, and as medicines used to prevent the eye condition called conjunctivitis in newborn infants. However, there are no legally marketed prescription or over-the-counter (OTC) drugs containing silver that are taken by mouth.

FDA regulates dietary supplements under a different set of standards than those that apply to drugs. For example, FDA does not approve dietary supplements or their labels before they are sold. It is unlawful for a manufacturer to represent a dietary supplement containing silver as able to prevent, diagnose, mitigate, treat, or cure any disease.

FDA urges consumers and health care professionals to report any cases of argyria or other side effects that may be related to the use of silver-containing dietary supplements. Adverse events associated with the use of dietary supplements should be reported as soon as possible to FDA's MedWatch program by calling their toll-free number (1-800-332-1088) or through the Internet (http://www.fda.gov/medwatch1).

FDA will continue to review applicable research and investigate the relationship between silver-containing dietary supplements and the occurrence of argyria or any other side effects. FDA will alert consumers, and if warranted, take additional action as more information becomes available.

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