XanGo Addressing FDA Health Claim Concerns

10/2/2006 8:48:44 AM
ARTICLE TOOLS

LEHI, Utah--XanGo LLC, a multilevel marketer of mangosteen beverages, received a warning letter from the Food and Drug Administration (FDA) regarding the company's promotional materials. In reviewing company brochures supplied at a meeting and via mail, FDA found what it considers to be claims promoting the product for the "cure, mitigation, treatment or prevention of disease", thereby positioning the product as a drug in the eyes of the agency. FDA considers the brochures "labeling" under the Federal Food, Drug and Cosmetic Act (the Act).

Among the claims seen in the brochures were:

* "One study showed mangosteen extract was a more potent anti-inflammatory agent than several prescription anti-inflammatory medications currently used for arthritis and gout."

* [From "22 Reasons to Drink Mangosteen Juice"] "Prevents hardening of the arteries (atherosclerosis)", "Anti-Parkinson, Anti-Alzheimer and other forms of dementia", "Anti-depressant", "Mangosteen helps in the prevention of cancer with its powerful anti-oxidants" and "Lowers blood pressure".

* "Another way mangosteen keeps the cells and glands of the endocrine system working properly is by fighting off infection."

* "The xanthones in mangosteen have been shown to inhibit both bacteria (including strains of the staphylococcus bacteria that were antibiotic resistant) and viruses (such as HIV-1)."

In its warning letter, FDA noted the claims position the product as a drug, and as such, it has not been approved; marketing of an unapproved new drug can lead to enforcement action. XanGo was given 15 working days from the Sept. 20 warning letter to detail the steps it will take to "prevent your distributors from promoting your product in a manner that violates the Act."

Craig Hale, general counsel for XanGo, noted the company is working to resolve the situation with FDA. "XanGo recently received a warning letter from the FDA related to some mangosteen materials it obtained through a third-party publishing company," Hale said. "While it is unclear from the letter, it appears that the FDA believes that it ordered the literature directly from XanGo and that these materials are company-produced literature. This is not the case, and we believe this fact will be important in resolving the issue. ... From its beginnings, XanGo has been committed to complying to the federal regulations that govern both the natural products and direct sales industries. XanGo does not publish nor endorse any literature that makes health claims. Further, XanGo does not condone the use of noncompliant literature by its distributors and makes every effort to educate distributors on the difference between compliant and non-compliant literature. XanGo is confident that we will shortly reach an appropriate resolution."

Comments

1

Anne Van Brussel 10/09/2008 17:25

i have been drinking xango for over 13 months and this juice has stopped my throbbing feet that i have had for 15 years, completely rid me of migraines which were an absolute nightmare, given me the softess skin i have ever had, rid me of acne, rid me of my allergies, all of my extremely painful arthritis is gone, i had 2 bulging discs in my back which had me in the most aweful pain - not being able to walk, sit, stand, nothing - and now i am pain free - and...i was pain free after just a month of drinking it, rid me of sciatic nerve pain - which would put me on the floor, stopped dental pain almost immediately, and there is so much more....no more monthly cramps, bloating...none of my children have been sick in 13 months and none of us have to take tylenol, ibuprofen or nothing anymore! this is the absolute best thing i have ever seen...if you are not drinking it, i suggest you do!!!!
2

Wendy Martin 04/13/2008 11:24

It doesn't make sense that Xango company would put out literature making claims that it cures when everyone knows that when they do such things it (in the eyes of the FDA) would make it a "drug" and therefore allow the drug companies to get their hands on it and make billions off of it when if it's presented as a network marketing company it gives back to those who will want to sell it and get others involved. In other words it puts some of the money back into the hands of the people who are willing to work hard for themselves.
3

Marlene Castelluccio 01/12/2008 08:48

I am a Wholistic Practioner and have been a Xango Distributor for almost 2 years now. I did all my Due dilligence and research prior to risking my reputation by promoting Xango, it is repulsive how the FDA has targeted XanGo specifically that we have to say Mangosteen Juice rather than XanGo - there is a huge difference. Before finishing one bottle of XANGO my husband had a lump under his nipple. I was 75% gone and he no longer required surgery to remove it. I have had a TUMOR in my uterus for 20 some odd years. Since drinking the XANGO it has shrunk 3 cm ( I have both radiological and MRI's to prove both) Any claims that I have read in Xango Marketing material is supported by medical researched which can be accessed by the general public at Pubmed.com
I know the truth-so should everyone else.
4

Mary Klein 10/10/2007 15:27

I have never observed Xango - an amazing Company with a unique and unparalled product - make claims of cure, treatment and so forth.  As with any other company in the industry, these problems arise when 'individual' distributors step outside their boundaries. In fact, I have been more than impressed by the high standards the Company has set.  As for the product, I have witnessed many stunning results, both personally (within our family) and with consumers.  There is nothing but good that can be said about this company.
5

Crush 09/01/2007 21:39

I took Xyango over a two day period. Third day I became violently ill, threw my guts out (All xango juice). I felt weak as well. My wife also had a reaction the very same day as intake of the product. What happened. I had nothing else in my system to cause such a reaction. Also, if I were to continue to seek such a product for health reasons, it makes sense to go with the other product that contains more then 50 times the nutrient level then xango. No wonder they didn't talk about the products nutrient aspect at one of the "Training meetings" I attended.
6

marty r. sandidge 03/30/2007 21:31

I would like to tell you that xango is a very amazing juice. Did you notice, that I said "Juice?" I do know my dad was given  a year to live in 67. I myself was born in 69. He is still alive today with his medical condition known as croans disease. He has had pollops tumors and ulsers  for 30 plus years. After being on Xango for about 2 years, His doctor has told him that he is sqeaky clean. Its all gone and wanted to know what he is doing to achieve such results. My dad told him and now he is checking into it. That is enough proof for me.They also told my dad he would never weigh more than 120 lbs the rest of his life . He weighs about 160 or more. I rest my case.
7

LoraLee 10/18/2006 21:39

I have been on Zango for over a year.. I was diagionsed with Fiber Myalga not the correct spelling but I can now walk because of the MangoSteen Fruit.. it really works.. how about all of the medicine that kills you.. I think what God Created heals the body not medicine... I take God over mans invention any time...
8

Marleen Bauer 10/13/2006 10:47

Hats off to your insightful note, Randy Hall, 10-3-06!  Yes, it's true doctors kill 300,000 people a year because of a misdiagnosis, or simply the misplacement of a decimal point...yet so many put their faith in them.  Medications do not cure or prevent.  They simply offer a "band-aid."  Rest assured, once you begin, you'll be taking them for life.  The best remedy is education!  There are so many other healthy alternatives.


Marleen 


Cancer survivor, through education, and awesome  supplements....No chemo, no radiation.

9

cyndy 10/09/2006 15:16

I have been taking Xango for 3 years and I love it, I tore my rotator cuff 3 years ago and I never took a pain killer, I have not had acid reflux since and am off my previcid, I made it into a paste and applied it on a barnacle of old age for 10 days and this growth disappeared. I dont' sell it anymore but I won't be without it. It is expensive and I wish I could find a more inexpensive product but it is the best and you pay for that.
10

Ann O. 10/04/2006 17:11


Is it Vemma or New Vision that charges $350.00?  That does seem a little pricey.           



 I have a friend that signed up for a Xango distributorship for $35.00, seems reasonable for a distributorship and some pain relief as well..Seems like, if it works for you, then you are blessed to have found it...FYI     Ann

11

Lance 10/04/2006 10:51

Xango patent is under reeaxamination, these reexaminations almost always favor the patent, in the mean time, however the patent still holds, it has not been taken away. Further more NU-VISION use of the mangosteen in its products is under question. If XanGo hype about mangosteen is just that then why boast about in other products. There were no other products using the whole fruit mangosteen until Xango and there are still no other products using the whole fruit mangosteen. Xango is not competing in the mangosteen market, they are the market of the original mangosteen fruit juice. knock offs use extracts of the pulp, this is clearly not the whole fruit. Check the ingredients in these other products.
12

Vitamin Queene 10/04/2006 07:44

It's too bad that the corp. Xango people are not standing behind the the training/literature/info that is dished out thru the distributor pyramid.  What about all the promotion by Dr. Tempelman?  The distributors don't just dream up the health claims.  They are taught that thru the literature, seminars, etc.  Where is the company integrity?
13

Melinda Pace 10/03/2006 15:19


Xango reps are notorious for hyping up their medical claims about their product and are still promoting their "so unique, it's patented" product even though that patent was revoked by the USPTO(Patent Office) over a year ago! I spoke with several people who were told that New Vision and Vemma would be out of business as a result of it. It takes 14 bottles of Xango to equal one bottle of New Vision or Vemma's Mangosteen Vitamin product. Hmmm, $350 distributor cost or $30, which would you choose? Sounds like some pretty pricey hype to me!

14

Darin 10/03/2006 14:21


Figuring out how to apply the Dietary Supplement Health and Education Act’s (DSHEA) meaning of the use of third-party literature to promote dietary supplements can be a challenge. This is especially true for companies selling their products through the direct sales channel like XanGo.




 



According to the DSHEA, a third-party article is defined as “an article, a chapter in a book, or an official abstract of a peer-reviewed scientific publication that appears in an article and that was prepared by its author or the editors of the publication…” (DSHEA 403B (a) 1994). These publications must be printed in their entirety and meet each of the following five criteria:




 




1.      


“It may not be false and misleading;”

(DSHEA 403B (a) 1994). For example, does the information represent the truth? It is not sufficient to rely on the opinion of the author alone, even if they have a M.S., Ph.D., or M.D. after their name. Is the information accurate and can it be supported by good, quality scientific studies? If it is truthful and can be supported by science, it meets this criterion.




 





2.
      





“It may not promote a particular manufacturer or brand of a dietary supplement;”

(DSHEA 403B(a) 1994). For this criterion, neither the name of the company nor the name of the company’s product can be mentioned in the literature. Third-party information should focus on the benefits of individual ingredients rather than the benefits of a particular product.







 







3.
      





“It must be displayed or presented with other such items on the same subject matter, so as to present a balanced view of the available scientific information on a dietary supplement;”

(DSHEA 403B (a) 1994).
This criterion suggests that third-party information should provide a balanced perspective. For example, if there are five studies that demonstrate that the herb Ginkgo biloba helps improve mental acuity, but there are also two studies that have shown no effect on mental acuity, then the results of all the studies should be presented. A balanced view will offer a summary of the totality of scientific evidence, not just one vantage point in favor of the positive.







 






4.      


If displayed in an establishment, it must be physically separate from the dietary supplements; “

(DSHEA 403B (a) 1994).” While this criterion seems to directly relate only to a retail store establishment, it does have implications for direct selling businesses as well. For example, by linking to a third-party article on another company’s web site, a virtual physical separation should be created. This can be done by having an intervening page that lets the web viewer know they are leaving the

15

Daniel 10/03/2006 13:49

I do not know that much about Xango, but I love a product called Ziwi that VivaTRU sells. It has fucoidan in it which really does have like 600 clinical studies backing it. It is used in most cancer clinics in Japan as well.
16

Randy Hall 10/03/2006 12:56

Is the FDA under a gun? How many commercials (DTC) do we see a day about drug manufacturing properly prescribed drugs that kill more than 106,000 people a year. These drugs are FDA approved. Pharmaceutical companies are often in violation. They overstate drug benefits and camouflage with deceptive pictures and do not show data from clinical trials.  The FDA should ban this misleading statement: " LET FOOD BE YOUR MEDICINE"   Hippocrates


If claims of cure are being pulished they should be shut down. If claims of prevention are being claimed maybe some real science and medical Journals should be scrutinized as well.


Randy

17

Cindy 10/03/2006 11:00

I work in a retail setting, and sell a product that "competes" with XanGo.  I'm amazed at how many people have asked me if it's true that if you drink a bottle of Xango a day that it can cure cancer, that if you follow the Xango directions and take 3 oz twice a day, you can cure your diabetes, high blood pressure, osteoarthritis, etc.  When I ask where they got their info from, it is always "(so & so) who sells it and wants me to sigh up to be a distributor"so they can get it cheaper.  They talk about the Xango literature given out by the distributors and seem to be amazed at what all Xango will cure.


So much for can't cure, diagnose, treat or prevent!!

18

Deborah Linton 10/03/2006 10:26

I have been seriously ill with Rheumatoid Arthritis for 2 years (my RF level was 700 times maxium and ESR 3 times maximum).  I stopped all but 1 medication prescribed by my Rheumatologist as the cancer medication made me ill.  In the interim I started Xango and within 3 months I am in remission and have been ever since, (only 30% of RA patients go into remission).  My Rheumatologist is very surprised and elated.  Cudos to Xango.  I am a believer.
19

Jim 10/03/2006 09:46

I have been to two Xango meetings where there were pleanty of these so called third party brochures, books and cd's being sold in the same room.  There was a speaker who said he was a distributor and Doctor who spoke and said he was a distributor and his CD Fighting the Fatal Five Diseases was on the table for sale.
20

Atticus Killough 10/02/2006 13:35

From what I've read, the only questionable marketing materials were created by third party vendors.  Every quote you cite is from these third-party pamphlets and brochures.  None of the marketing materials created by XanGo are in violation of FDA regulations.

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