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....

1 comment:

  1. I bet the promotional video will be taken down by the company after they see this. I love the girls. Thanks great info