Showing posts with label Colloidal silver. Show all posts
Showing posts with label Colloidal silver. Show all posts

Sunday, June 9, 2013

The FDA Warning Letter, Noni Juice and Dancing Girls

Hawaii Grass Skirt Pin Up Girl
The FDA Warning Letter, Noni Juice and Dancing Girls

Its a lovely Sunday here in Michigan, how I love the weekend.

Today on the blog we have a FDA warning letter, a few liver toxicity case studies linked to Noni juice, insight into selling the juice and a video with dancing girls.

We begin..........

Not too long ago the FDA identified an emerging trend where over-the-counter products, frequently represented as dietary supplements, were found to contain harmful hidden active ingredients. A majority of the products were marked as sexual enhancement, bodybuilding and weight loss products. The agency has a RSS feed to warn consumers quickly about tainted products marketed as dietary supplements.

This year a study published in JAMA Internal Medicine found 273 recalls of dietary supplements between 2004 and 2012 - containing hidden ingredients that could cause "serious adverse health consequences or death."

The New York Times reported in 2011;

Many millions more are also being spent annually on black-market products, particularly those marketed for weight loss, bodybuilding and sexual enhancement. Some of these products, according to the F.D.A., contain amphetamines, synthetic steroids, laxatives and compounds like the active drug in Viagra. Officials say such products can cause heart attacks and strokes, and can damage the kidneys and liver. A few people in the United States, they say, have died after taking them.

According to Nutrition Business Journal, a trade publication, in 2009 Americans spent $26.7 billion on supplements. These dietary supplements are purchased on the Internet, at grocery stores, drug stores and health food stores.

One such product, I call vacation in a bottle, better known as - Noni juice, received a warning letter last month from the FDA. The warning letter was issued to Matrix Health Products, Inc., citing unproven therapeutic claims found on their website.

This product is sold as a dietary supplement in the United States. Unlike drugs (which must be tested before being allowed to be sold), the companies that make supplements are not required to prove to the Food and Drug Administration that their supplements are safe or effective, as long as they don't claim the supplements can prevent, treat, or cure any specific disease. 

To protect the public and stop these sites from enticing consumers into buying unproven products through the use of false claims the FDA steps in by issuing a warning letter. If that doesn't work the agency then initiates an enforcement action. These warning letters are publicly posted on the FDA's website.

So what is Noni?

The noni or morinda plant is a tropical evergreen tree that grows to about 10 feet tall in Tahiti and other Pacific Islands, as well as in parts of Asia, Australia, South America and the Caribbean. The tree can grow to as tall as 10 feet and bears a fruit about the size of a potato which starts out green and ripens into yellow or white. The juice, fruit, bark, and leaves are used in herbal remedies and Polynesian folk medicine.

Is It Safe?

Recently, a case of severe drug-herb-induced liver injury in a 38-year-old woman was reported (Case Reports in Gastroenterology) after 7-day consumption of a herbal preparation (noni juice).

The patient developed acute liver injury associated with noni juice consumption on a long-term (9 months) anticonvulsant therapy. Clinical presentation and liver biopsy were consistent with severe, predominantly hepatocellular type of injury. Both agents were stopped and corticosteroids were initiated. Five months later the patient had fully recovered. Although in the literature the hepatotoxicity of noni juice remains speculative, sporadic but emerging cases of noni juice-associated liver injury address the need to clarify and investigate potential harmful effects associated with this supplement. 

The full 2013 article is available here. 

In the 2011 issue of ”Journal of Pediatric Gastroenterology and Nutrition” a case study involved a 14-year-old boy who developed liver toxicity from consuming noni juice. In “Digestion” a case of hepatitis was reported from drinking noni juice over a four week period,  in the “World Journal of Gastroenterology” two cases of liver damage from noni juice were studied, one required a liver transplant.

According to the U.S. National Library of Medicine;
Noni is POSSIBLY SAFE when taken in food amounts. But there is concern that taking noni in medicinal amounts is POSSIBLY UNSAFE. Noni tea or juice might cause liver damage in some people. There are several reports of liver damage in people who drank noni tea or juice for several weeks. But it is not known for certain if noni was the cause.

Special precautions & warnings:

Pregnancy and breast-feeding: Don’t take noni if you are pregnant. Historically, noni has been used to cause abortions. It’s also best to avoid noni if you are breast-feeding. Not enough is known about the safety of taking noni during breast-feeding.

Kidney problems: Noni contains large amounts of potassium. This can be a problem, especially for people with kidney disease. There is one report of a person with kidney disease developing high levels of potassium in the blood after drinking noni juice. Don’t use noni if you have kidney problems.

Liver disease: Noni has been linked to several cases of liver damage. Avoid using noni if you have liver disease.

The Health Claims

According to the latest FDA warning letter the product is promoted to treat the following conditions:

- Noni . . . turned pre-cancer cells back into normal cells”

“Noni reported to stimulate T-cells and NK cells in our immune systems”

“Improvements in AIDS patients”

A table on the website, (which is now gone) describes conditions that are “Reported to respond to noni” and the “% [people] Helped”:

“Cancer, lessened symptoms”
“Heart disease, decreased symptoms”
“Diabetes, Types 1 and 2”
“Obesity, lost excess weight”
“High blood pressure, decreased”
“Smoking, stopped”
“Arthritis, lessed [sic] symptoms”
“Pain, including headaches, decreased”
“Depression, lessened symptoms”
“Allergy, decreased symptoms”
“In some situations, noni can allow other medications to act more efficiently. You should tell your health professional that you are taking noni as your physician might want to decrease the dose of the medication prescribed.”

Who Sells Noni?

From what I understand, people just like you and me can make money by selling the miracle juice or capsules, this is how it works.

The manufacturer, which in this case is Tahitian Noni International is in need of distributors, so they promote the opportunity to sell their product. You, become an independent distributor, the startup kit is purchased for $40. However, you must also commit to purchasing a minimum amount of their product each month at wholesale prices, which you turn around and sell at retail prices. But the real money is made after you recruit new distributors. Once this is accomplished you make residual commissions from their monthly purchases and sales. It works somewhat like a pyramid scheme, in that participants begin to really make money by recruiting more members. A phone call to Uncle Bill, recruiting the next door neighbor, are all profitable for you - the independent distributor. I'm not insinuating anything is illegal, just telling you how its done folks.

Promotional Video From "Tahitian Noni International"

Titled : Tahitian Noni International home office days

Business and product training
Build your own vision, Expand your business
See the product up close and  personal
Check out the girls!

The Warning Letter
Colloidal Silver is also included in the FDA Warning Letter, as is Tahitian Organic Noni Juice, Tahitian Original Noni Juice, Tahitian Pure Noni Juice, Hawaiian Noni Juice and Hawaiian Noni Juice Capsules.

Colloidal Silver

“Among the conditions colloidal silver has controlled are severe burns, . . . boils, . . . yeast infections, . . . digestive problems and colitis, ear and sinus infections, herpes, shingles, lupus, malaria, viral and fungal infections, blood parasites, rheumatoid arthritis, and ringworm.”
“It (silver) kills even antibiotic-resistant strains and also works on fungus infections, cures the most stubborn infections of all kinds and bacteria . . . ”
“Silver is emerging as a wonder of modern medicine. An antibiotic kills some half-dozen disease organisms, but silver kills some 650 and resistant strain fails to develop.”
“Because silver has been found to exert anti-fungal properties, . . . silver supplementation in our diets could be vital in protecting our immune system.”

Under the heading “Colloidal Silver Frequently Asked Questions”

“Doctors and medical journals have long advocated the use of silver for infection, viruses, bacteria, fungus and a wide variety of disease organisms.”
“Silver has been shown to possess antiviral, antibacterial, and antifungal properties.”
“Silver has been used . . . because of its disease-resistant properties . . . Silver continues to be a versatile disease-fighting agent because it is effective against antibiotic-resistant bacteria and a much broader range of disease organisms than antibiotics.”

Continue reading....

A Warning

As consumers we have no idea the extent of illness caused by dietary supplements, only the worst cases attract attention, less serious incidents many slide under the radar and go unreported. The FDA estimates that less than 1 percent of the severe adverse effects linked to dietary supplements are ever reported. In some cases health problems can arise because of either the supplement’s hidden ingredient or a drug interaction with other medications. Drug interactions continue to be a concern for clinicians, last year an article appeared in "Alternative and Complementary Therapies" outlining the dangers.

Herbal, dietary, and energy or nutritional supplements can have harmful and even life-threatening effects when combined with commonly used medications. Clinicians need to educate their patients about the potential risks of mixing supplements and therapeutic agents, since their interaction can diminish or increase drug levels

 Read the article here.....

The Bottom-line

Dietary supplements or Herbs could have unknown side effects. In many cases, there is poor quality control and the supplements may even come from questionable sources. Research has shown eating
a well-balanced diet will provide all the nutrients and vitamins a person needs.

As for curing disease? I point you back to the FDA

Unlike drugs, supplements are not intended to treat, diagnose, prevent, or cure diseases. That means supplements should not make claims, such as "reduces arthritic pain" or "treats heart disease." Claims like these can only legitimately be made for drugs, not dietary supplements.  
Dietary supplements are not approved by the government for safety and effectiveness before they are marketed. If the dietary supplement contains a NEW ingredient, that ingredient will be reviewed by FDA (not approved) prior to marketing — but only for safety, not effectiveness. 
The manufacturers and distributors of dietary supplements are responsible for making sure their products are safe BEFORE they go to market. Manufacturers are required to produce dietary supplements to minimum quality standards and ensure that they do not contain contaminants or impurities, and are accurately labeled. 
Manufacturers are required to report all serious dietary supplement related adverse events or illnesses to FDA as of December 2007. 
FDA can take dietary supplements off the market if they are found to be unsafe, adulterated, or if the claims on the products are false and misleading.

Read more here....

Monday, May 16, 2011

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.
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.
"For Children's Immune System Health and Infections: Viruses, Bacteria, Fungi, Candida, Parasites, Allergies
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.
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.
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. 
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.
(for more information, see the NCCAM fact sheet Colloidal Silver Products).
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)


April 28, 2011


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, 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.


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 
Warning From The FDA On Oct 2009
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 (

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.