From the Daily Herald: XanGo LLC, a Lehi direct seller of a mangosteen-based juice, on Thursday terminated several workers as part of what it called a “strategic reallocation process.” A XanGo official declined to specify how many workers were terminated, why the cuts occurred and whether this was the first time the privately-held company has downsized its work force after five straight years of consistent growth. Bob Freeze, vice president of public relations for XanGo, described the cuts as a “reallocation of resources, and not a layoff.”

But one employee with XanGo disagreed with the characterization, saying he himself was laid off on Thursday morning and believes there were at least 35 others terminated that same day. “This is very much a lay-off. I’d like to know where they’re reallocating me,” said the former employee who spoke to the Daily Herald on condition of anonymity. He said he was one of several workers escorted out of the XanGo corporate office in Lehi after a 15-minute meeting with senior management on Thursday morning. “There were three people in my department who were laid off, and one of them had been there for three years,” he said. “According to the security guard who escorted us out, there were at least 35 people laid off.”

The former employee said the layoffs occurred after Kent Wood, president of XanGo, sent out a companywide e-mail on Thursday morning saying he has had to make “tough decisions” after meeting with senior executives in the past few weeks. Freeze said the company was “reallocating corporate resources to align with its continued global expansion and provide premium service to its growing international markets.”

The former employee said he believes the layoffs were due to slowing sales in the U.S. market. Both the U.S. and Canada are XanGo’s biggest markets, accounting for more than 50 percent of total sales.

“Since the new year began, things have started getting more and more tight. Last week, the senior executives asked managers where they could cut budgets. This week, it’s personnel cuts. But XanGo still has many markets like Germany and Mexico where it’s growing and doing exceptionally well,” the former employee said. “Because XanGo only has one product, and the company has based all of its growth in the past five years on that one product, some people speculate that the product lifecycle of its mangosteen juice is starting on a downward trajectory,” he said. “The remedy would be to come out with new product lines like the new cosmetics line that’s being launched this November.”

XanGo also faces growing competition from more than two dozen rivals that sell fruit juices, powdered drinks and vitamin fizz tablets. That includes Tahitian Noni International Inc., which owns Pure Fruit Technologies, a Las Vegas company that markets exotic fruit beverages including MangoXan, a mangosteen-based drink. Not only does Pure Fruit underprice XanGo on MangoXan juice in health food stores, its parent, Tahitian Noni, also sold $2 billion worth of Noni juice in its first 10 years by 2006, according to an Associated Press report last month.

Associated Press reports on Xango.

“You’re not trying to sell the product; you’re sponsoring other people,” Gardner said. “Every distributor is a customer, and every customer is a distributor.” Jon Taylor, a one-time Nu Skin Enterprises Inc. distributor and trial consultant for disaffected distributors who analyzed XanGo’s multitiered compensation plan at the AP’s request, said it was little different from scores of other multilevel marketing ventures.

It’s a formula, he said, that makes money for the top 1 percent of distributors and leaves many other recruits stockpiling products they can’t sell. “The reason you lose money is you have to buy products every month to stay good with the company,” Taylor said. “That’s the rub.”

MSNBC reports on the $40 ’super fruit’ juice.

An independent lab test performed for The Associated Press shows XanGo’s antioxidant strength is no better than other readily available fruit juices, yet it costs nearly $40 a bottle. XanGo insists mangosteen contains other beneficial chemicals. “My big concern with XanGo is that the business has gone a long way without showing any benefit in human trials,” said Wayne Askew, director of the Division of Nutrition of the University of Utah’s College of Health. Others are skeptical, too.

“It’s a ‘Wizard of Oz’ story,” said Anthony Almada, president and chief executive of GENr8 Inc., a marketer of sports nutrition dietary supplements. “The industry is built on storytelling, and because they do it one-on-one, without advertising, they don’t incur the wrath of the FDA.”

Dietary supplements are a $22 billion largely unregulated business in the U.S. For the lab test, The Associated Press shipped a 750-milliliter bottle of XanGo to Oregon State University’s Linus Pauling Institute at Corvallis. The institute measured its antioxidant strength against store-bought juices that sell for a few dollars a bottle. On a scale of molecular weight, XanGo’s antioxidants measured 14,884 “micromoles” per liter — slightly higher than cranberry juice, but lower than black cherry and less than half the power of blueberry juice. Apple juice finished last in this test.

Source: Sydney Morning Herald
You’ve heard of the goji berry, “the most powerful food on the planet”, they reckon. It’s for sale on the Internet, in health food shops, via your hairdresser and at your door. It is urged upon you by workmates and peddled towards you by friends. It stops cancer, blindness, arthritis, baldness, impotence, death and the runs. It can make you live for 500 years, and it scrubs up a treat in cocktails (so they tell me). It hails from Tibet, the Himalayas, Mongolia, or somewhere in China - just not from here, or anywhere in dumb, stupid, ignorant America. There is only one drawback with the magical goji: bullshit. Unhappily, this particular element constitutes a significant percentage of the goji’s active ingredient.

There is no such botanical creature as a “goji berry” anymore than there is an actual “bindi eye”. What passes for goji is most commonly Lycium barbarum, or “wolfberry”. This stuff can be picked up for a song at your local Chinese herbal shop and, I’m reliably informed, is as revered in the Chinese medicinal sphere to about the same degree as the ginseng root. The Chinese call it “Gou Qi Zi” - their word for “lycium”, the “Qi” pronounced “chi” - which, when phonetically shoehorned into English, becomes “goji”. Where the goji can be found depends very much on who you ask, but you won’t readily be told the truth - that it grows all over the world, though most abundantly in China. The people who flog it to you will tell you there is only one ‘true’ goji - theirs - and that it thrives in bountiful quantities in special places among “the unpolluted hills” of Tibet and the Himalayas.

In December last year, Simon Parry, a journalist for the South China Morning Post, actually went to Tibet in search of the goji, to the very region advertised as the font of the berry by the Tibet Authentic company. The folk at Tibet Authentic (whose website describes getting a prescription from a certified medical doctor, rather than drinking goji juice, as a “quick fix”) refused to take Parry to their goji or tell him where he might find it, so he asked around: Tibetan medicine stores in Lhasa had never heard of Tibetan goji berries; a traditional medicine expert in Nyingtri, while confirming that berries grew in the region, declared it “impossible” that they could be exported on such a scale; an elderly nomadic couple, who had spent 60 years wandering the mountain valleys, did not recognise the goji berries when shown a picture of them.

“A pig farmer who guided us there,” wrote Parry, “was perplexed at our interest. ‘Sometimes, if there are many berries, we pick them and sell them in the town,’ said Penba Niyama, 42. ‘But Tibetan people don’t buy them … we just leave them for the birds to eat.’ When I told him people in the west paid the equivalent of 140 yuan for a small bag of the berries, he shook with laughter. ‘People there must be very strange,’ he said.”

Why Tibet might be chosen by western marketeers as the geographical seat of goji is no mystery. Despite being home to one of the more miserable peoples of Earth - an average life span of 60, one in three families hosting at least one disabled family member, an infant mortality rate of more than 1-in-10, an appalling adult literacy rate and an exiled spiritual leader so chosen because he lucky dipped the right toys as a kid - Tibet is still the “alternative” culture of choice in the eyes of dopey westerners who see it as some kind of advanced plateau of uncorrupted knowledge, its hillsides steeped in all manner of ancient wisdom apparently lost to its own wretched people. It is entirely possible that the modern obsession with Tibetan wisdom and longevity is based less on fact than on the 1933 James Hilton novel, Lost Horizon (indeed, the real-life Shangri-La, through which thousands of backpacking bozos stampede each year, was actually named after the fictitious place in the book).

But goji isn’t confined to the Tibetan Plateau, rather the entire Himalayas and their immediate surrounds, the general inaccessibility of the region tailor-made for anyone selling something the root of which they do not wish to be found. Like Earl Mindell.

The father of the modern goji cult, Dr Earl Mindell is a Canadian-American who describes himself as “the world’s leading nutritionist”, but who actually scored his PhD from an unaccredited online university (the same “diploma mill”, in fact, from which the Honourable Marcus Einfeld ‘graduated’). Mindell, who published Goji: The Himalayan Health Secret in 2003, and who also happens to sell “goji” juice through multi-level marketing group, Freelife International, recently claimed during a Canadian television interview that “goji” was a cure for cancer, as had been proved, he said, by a study from the prestigious Memorial Sloan-Kettering Cancer Centre in New York, when in fact, according to the Sloan-Kettering website, no such study has taken place there at all. Almost everything else “Dr” Mindell has said about goji juice appears to be complete bunk.

In fact, for all the claims that riddle “goji” literature insisting that “studies have proved” this or that, there appears to be not a shred of credible evidence that “goji” is anything but a regular antioxidant, the legend of its magical properties existing exclusively on “goji” advertising material, which is equal parts hearsay, folklore, flaky testimonial and flat out lies.

Take http://www.goji-berry.com.au/, for example: “They contain 500 times the amount of vitamin C, by weight, than oranges making them second only to camu camu berries as the richest vitamin C source on earth.”

Not so. According to wikipedia - which notes its references and can at least be trusted for the fact it is selling nothing - the vitamin C content of wolfberry is “actually comparable to many citrus fruits and strawberries” and “is considerably lower than for numerous other fruits and berries, such as the Australian Kakadu ‘billy goat’ plum”. The website continues:

“In several study groups with elderly people the berry was given once a day for 3 weeks, many beneficial results were experienced and 67% of the patients T cell transformation functions tripled and the activity of the patients white cell interleukin-2 doubled.”

Really? What are these studies, where were they conducted, and by whom? One would think that those who so easily quoted from them would be able to supply a link or at least an annotation. Unless, of course, these studies don’t exist. And again:

“The famed Li Qing Yuen, who apparently lived to the age of 252 years (1678-1930), consumed Goji berries daily. The life of Li Qing Yuen is the most well-documented case of extreme longevity known.”

Bullshit. Li Qing Yuen’s existence is no more “well-documented” in the real world than the life of Clark Kent. In 1933, TIME magazine made mention of this dubious character of folklore, noting somewhat cautiously that “to skeptical Western eyes he looked much like any Chinese 60-year-old”. Assuming the old bugger actually existed at all, and that he was telling the truth if he did, the secret to his long life, according to ‘the man’ himself, was: “Keep a quiet heart, sit like a tortoise, walk sprightly like a pigeon and sleep like a dog” - no mention at all of pigging out on “goji”. The only “documented” ‘evidence’ of Li Qing Yuen and goji berries together occurs in Earl Mindell’s Goji: The Himalayan Health Secret, this unique history dutifully repeated nowhere else but on goji merchant website after goji merchant website. Anywhere else, and the “250-year-old man” is generally regarded an urban legend.

At the website for Goji Australia (http://www.gojiaustralia.com.au/) is a real whopper:

“Would you believe the average woman in the Himalayan Hunza tribe lives to be 100? Their secret? The berry of the goji (pronounced Go-jee) vine.”

Bollocks. Though the Hunza do not keep birth certificates, making it difficult for anyone to ascertain their ages, the highest credible average estimate on record is 90, and their secret, well-known to all who’ve studied them, is apricots. Still, this nonsense is perpetuated as goji profiteers breed like rats.

And then there is this, from a flyer left fluttering from my letterbox recently:

“The Biggest Discovery in Nutrition in the Last 40 Years!” - TIME Magazine reveals the “Breakout Superfruit of the Year”.

Pretty impressive. Surely a journal as respected as TIME wouldn’t write such a thing if it weren’t true. Well, it’s isn’t, and TIME didn’t. This appears to be a complete rebuilding of a quick mention goji berries scored in TIME on July 16 last year, a wrap-up of the 52nd Summer Fancy Food Show in New York in which goji was described as “this year’s breakout” of the “so-called superfruits” section of the show. The only other mentions of goji in TIME have been in an October 9, 2006 cover story about bogus supplements and in a response to a letter on the popular “Ask Dr Weil” column of September 6, 2006, in which Dr Weil replied to a reader’s query by asserting that goji berries “offer no special benefits that pomegranates and more familiar berries do not”. But I wouldn’t bother calling the number on the flyer - you’ll get a recorded message telling you to leave your details so someone can flog you some goji juice.

Which is not to say the goji berry has not received some positive press - just about every brainless magazine in the country has gushed about goji in the last 12 months, almost always quoting directly from goji marketing material - even The Daily Telegraph using goji promotional websites as references for nutritional information. When reading magazines, it’s important to bear in mind that they exist not primarily to bring you information, but simply to meet their own print schedules, the staff - crumby ‘journalists’ and eager work experience kids, mostly - finding a ready-made slab of illustrated advertorial irresistible in those frantic, empty-paged hours before deadline.

The goji experience is actually an excellent example of how the internet is not so much an “information super-highway” as a bullshit mega-sewer, with apparently credible websites set up to support fraudulent information disseminated by others.

“Tibetan Goji berries are not Chinese wolfberries and it is not correct to call the Chinese wolfberry ‘Goji’,” lies the website for The Tibetan Goji Berry Company. “Local harvesters are careful to distinguish the ‘Goji’ berry from its distantly related offspring, the Chinese Wolfberry (Lycium barbarum) … See the ‘Goji’ research pages for more information.” Ignoring for the moment the vendor’s own curious use of ironic quotation marks, a click to the “research pages” takes one to studies that certainly prove their point, conducted at The Tanaduk Botanical Research Institute, an establishment that sounds credible enough, but turns out to have no physical presence on planet Earth. A Whois search reveals that gojiberry.com and tanaduk.com are run by the same person, the “founder” of the Tanaduk Botanical Research Institute, Bradley Dobos, presumably the same as mentioned in this story:

“Julia Dobos and her husband, Bradley Dobos, a nutritionist, started importing Gojis about six years ago and selling them online.”

Julia and Bradley Dobos are, in fact, The Tibetan Goji Berry Company.

It seems that, no matter how deeply one wants to descend into the goji juice well, there will always be bullshit waiting to meet you. Even the consumer information panel on a bottle of the stuff tells you that much. At first, the percentage looks good - 27 mls of goji juice for every 30 mls of what’s in the bottle - but look closely and you see that’s 27 mls of “Goji Juice Blend”. Even if there are any magical properties to the goji berry, you have no way of knowing how much of the stuff you are getting in your “blend”. And to find out, of course, you’d have to go to the Himalayas, ‘cos they sure don’t bottle it here.

It’s a matter of common sense. There are no clinical trials that can’t be linked to a merchant. There are no “amazing facts” on websites that aren’t selling something. For a magical “superfood” that is taking the Australia by storm, there are precious few goji outlets, or known goji offices, or bricks-and-mortar establishments that one might approach when one has a complaint. Almost exclusively, goji products are sold by folk with mobile phone numbers, PO boxes and websites - nothing that can’t be deserted quickly when the heat is felt around the corner. And that heat will come, when thousands of people realise they’ve spent a fortune on fruit juice, or when someone who abandoned their chemotherapy for the magical powers of a fairy-tale berry decides to sue the manufacturer for their own imminent death.

Goji juice, it appears, is fruit juice, nothing much more and a good deal less. If it’s not, the people who are selling it will sue me for saying so. But they won’t, because then they’d have to stand up in court and tell us what it is they’ve been peddling.

A brilliant article by Frederic Patenaude provides an insight into the world of Mangosteen Juice and talks about the scam practices involved. Here’s what Frederic has to say;

Today, I’d like to get a few things off my chest that have been bothering me for a while, namely the greed and abuse of consumers credibility of many companies that are selling outrageously expensive products for their so-called “anti-oxidant” power.

I’m going to first crush a few obvious ’scam’ products, not because I those are necessarily the worst ones out there, but simply because these products get pitched all the time and I know that a lot of honest health-seekers are wasting a lot of their hard-earned cash on them.

Then after I’m done with this rampage, I’m going to give a last uppercut to these greedy empires by showing you some of the best anti-oxidant packed foods you can incorporate in your diet on the cheap.

Xango Juice: or the Art of Abusing Credulity

I’ve never told you that, but a long time ago (over 12 years) — I briefly attempted to succeed in the “network marketing” world. For almost a year, I was involved in one such company, selling “premium dog food”, believe it or not!

So I got a lot of insights into the world of “network marketing.” While it’s certain that there are many good companies that operate under this model, there’s definitely also a whole lot of bad ones.

When I first joined this MLM (Multi-Level Network) company, the big guru told us that MLM was the future of the world. That in ten years 80% of the products would be distributed that way (which obviously hasn’t happened, 10 years later… not even close).

He also told us that because MLM bi-passes the “big distribution network”, it allowed the distribution of higher quality products at a lower cost.

My experience with many Multi-Level-Networking companies I have encountered proves this to be wrong. Generally, the products they sell are very high-priced. Unless you actually join as a distributor, you literally pay several times the actual market value of the product.

I’ve also found that while there are a few good MLM companies with good products, most companies are selling suspect items to gullible consumers. Many of these products have actually very little value, and are 90% hype, marketing and exaggerated claims. Of course, they always have a cute little story to back it up.

How the founder of the company had a “vision” and a “dream” to improve the nutrition of the entire world, and how he founded his company to fulfill his higher mission. I particularly like how they talk about this one “scientist” from Japan (ever noticed they’re all from Japan?) who found the fountain of youth in some ancient plant, and wants to share it with the western world.

Let’s talk about this Mangosteen Juice

The company Xango sells their exotic fruit drink made with mangosteen. This fruit is not related to the “mango”. When I was in Bali, I ate mangosteens by the kilo, and they were very inexpensive. In Asia, the mangosteen is regarded the “queen of the fruit” for its delicate taste.

Xango sells their mangosteen juice as a “miracle cure”. Actually, what they sell is some mangosteen product mixed with the juices of about eight other fruits. And at $32.50 per bottle, this fruit juice better be good!

Actually, if you start to believe their marketing literature, this juice is nothing short of a miracle cure. According to Xango, there are more than 20 “human health benefits” to their mangosteen juice, from “anti-microbial” to “anti-cancer”.

Supposedly, we should drink their juices because of “xanthones”, a “powerful antioxidant” that “may help maintain intestinal health, strengthen the immune system, neutralize free radicals, help support cartilage and joint function, and promote a healthy seasonal respiratory system.”

However since they don’t have any serious research to back this claim up, Xango adds this disclaimer as a footnote: “These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease”.

Xango is in the business for the bux

Anyone who knows network marketing knows how the system works. Independent distributors are selling the products but mainly recruiting other distributors in order to get a percentage off their sales.

Generally the motivated network marketer will aggressively sell the products to his own friends, relatives and neighbors. (I remember when I was in this “dog food” company and I phoned the entire list of names from my high school year, in order to pitch them the dog food product!)

With this system, the more distributors a person can recruit, the more money they can make. And the company itself provides all of the marketing material they need to generate as much buzz as possible.

Like all similar products sold through the same kind of system, Xango has some kind of resemblance of scientific truth that they exaggerate to the extreme to sell their product. Many of their claims are completely exaggerated and unsubstantiated. For a neutral perspective on Xango, read the Wikipedia page on the subject.

Countless Other Products

The marketing, the claims, and the suspicious research behind Xango’s success resembles mysteriously to a lot of other similar products we’ve seen marketed over the last few years. I’m referring to:

• Noni fruit juice
• Goji Berry juice
• Aloe Vera juice

The same story here, the same scam, with a different product. In fact, I’ve found that both the Chief Financial Officer AND the president of Xango worked previously for Tahitian Noni International, another company selling their own miracle cure.

When I look at a $35 bottle of “anti-oxidant-rich” mangosteen juice, I can’t help to laugh and think to myself, “what kind of idiot would spend that kind of money (plus shipping) for a bottle of fruit juice?”

Let’s not forget what these companies are after. A few years ago, more than one person wanted to take advantage of my “big mailing list” to sign me up as a Xango distributor. They tried to convince me that I would make “so much money” if I used the power of my mailing list to sell this product, and recruit other distributors.

I didn’t consider for a single second to do that and never gave replied to those requests (one came from a friend of mine). What’s interesting is that everyone who came to me to tell me about mangosteen juice spent more time to explain how much money I could make with it, rather than try to convince me it was a really good product. It’s almost as if the product is irrelevant, as long as the rest is in place.

Some Anti-Oxidant Rich Foods: Cheap Alternatives

Okay, now that I feel a little better to have expressed my truth about this mangosteen juice, let me give you some quick tips that these companies certainly don’t want you to know.

1- Berries — Berries are by far the one of the richest sources of antioxidants, particularly wild blueberry. I suggest having as many berries as you can. Plus they are particularly enjoyable to eat. When wild blueberries are in season, freeze them in ridiculous quantities and use them throughout the year.

2- Pomegranate Juice — Pomegranate Juice is a very high source of cancer-fighting anti-oxidants. You can either purchase fresh pomegranates and make the juice yourself, or purchase pomegranate concentrate (which is still a high source of anti-oxidants). The good thing is that even a big jug of pomegranate juice will only cost you about $7, so 5 times less than the mangosteen juice (which is made mostly with other juices). And best of all, you can find it in most health food stores.

3- Prunes — According to recent studies, prunes rank really high on the “anti-oxidant” score. Good thing, because they are also very delicious.

4- Greens — Dark green leafy vegetables are also an excellent source of anti-oxidants. But not just that. Greens contain more nutrition than any other foods! For the full story, sign up for the Green for Life Program.

5- Mangosteen — Finally, you can also get the health benefits of mangosteen… by trying them out fresh. They are very delicious. You can find them in many Asian markets. Even at $5 a pound, you’re still going to get a better deal than you would get on the Xango juice. And if you ever travel to Costa Rica in September, or Asia in the winter, you’ll get all of the mangosteens you can eat, at dirt cheap prices.

In a future issue, I’ll go deeper into this fascinating topic of anti-oxidants.

Know that next week, for less than the price of two bottle of mangosteen juice (I think I’ll start talking like that for a while…), you can join me in a powerful, truly “results-oriented” Green Cleanse — one of my most popular and effective diet detox. There’s a few spaces available, and the cleanses starts on June 4th. Sign up here.

Source: Consumer Affairs
Marketers of XanGo, a drink made with mangosteen juice that costs $35 for a 25-ounce bottle, claim it may improve joint function and strengthen the immune and respiratory systems.

However, the company’s scientific advisor admits that the only study of mangosteen juice in humans was conducted in Singapore in 1932 to treat dysentery.

Mangosteen, found in tropical climates, is known as the “queen of fruits” in Asia, but fresh mangosteen is rare in Western countries.

Source : Herald Extra
The signs and behavior of TNI, indicating that they are suffering both financial and resource problems, are clearly an ingredient in the settlement with Xango over a three year legal dispute over the intellectual property right. Sources inform us that no money was exchanged as part of this settlement.

Why has TNI and their army of snake-oil salesmen been claiming for several years that they would “own Xango” or would otherwise “spend millions to bury Xango”.

Distributors of TNI must feel like they have egg on their face after beating their war drums while making bold statements about how TNI was going to destroy Xango. Then again, TNI distributors are known for making bold statements without substantiation.

Source: Noni World Wide Warning
“But perhaps the most memorable example of a network marketing stampede is noni juice, a once totally obscure Polynesian fruit that became the basis of a huge industry.” and “This is the sort of performance that makes get-rich-quick artists drool”.

“The mangosteen phenomenon is a reprise of the aloe vera, gingko biloba, and especially the noni juice story, complete with exaggerated claims for the health benefits of an exotic fruit. It should come as no surprise that both the President and the Chief Financial Officer of Xango once worked for Morinda (now called Tahitian Noni International)”.

Source: Discussion
Whats up with Mormons and Network Marketing (MLM) companies? Xango Founders and every other MLM company in Utah are Mormons! Has anyone looked at the site http://noni.worldwidewarning.net and here PDF At the bottom there’s a section on Mormons starting up MLM schemes. Seems like another way for the church and its members to get rich. interesting?

Source: Scam.Com
One contributor wrote: The people behind the company have big questions hanging over them. They were terminated by Morinda (TNI) for Industrial Espionage!

That lawsuit is still ongoing and Morinda have hired the best lawyers in the State of Utah! Their Pay Plan is crap for e.g. one of their reps who is turning over a monthly volume of 20,000 is only earning $400 but even worse they have a rep turning over 1,000,000 in volume each month and his cheque is only $9,000.

That’s REALLY Pathetic in MLM! And now that their Patent has been made Invalid they have a lot of trouble brewing! I would not hang my hat there and that’s for sure!!

Source: Cycling Forums
When I wrote “Cancer Therapy” in the early 1990s, I had the bright idea of putting my mailing address in the book in the hope that some readers would send me information on new treatments. Little did I imagine that such communication would become a torrent of proposals. Today, hardly a day goes by without my being made aware of some new “cure.” Would that a fraction of these panned out as well as proponents claimed!

One of the latest in this long line is an exotic fruit drink called mangosteen, or XanGo. Mangosteen should not be confused with mango, an entirely different plant. It is part of a group known as the Guttiferae, a family of mainly tropical trees and shrubs that secrete an acrid yellow resinous juice. Mangosteen’s scientific designation is Garcinia mangostana (Campin 2004). It is reputedly named after a French explorer, Jacques Garcin (1673-1751). In Europe and North America, the most recognizable member of this family is the popular herb, St. John’s wort.

No one knows exactly where and when the mangosteen was first cultivated. One botanist, Julia F. Morton, believes it originated in the Moluccas and the Sunda Islands. Yet there are also wild mangosteen trees in the forests of Malaya. Some experts say the trees were first domesticated in Thailand or Burma. But in the 19th century, botanists brought seeds to Europe and America. Valiant attempts were made to cultivate the 18-foot high trees in Africa, the Caribbean and central America. But the plant is considered “ultra-tropical” and sensitive: nursery seedlings die at 45º F. In fact, there are few if any mangosteens growing in the continental US. A lone American tree in Florida was said to have yielded a single fruit…and then died. That was the beginning and end of the American mangosteen “industry.”

But attempts continued to bring mangosteen to Europe and America as a food. “Despite the oft-repeated Old World enthusiasm for this fruit,” says Morton, “it is not always viewed as worth the trouble to produce. In Jamaica, it is regarded as nice but overrated; not comparable to a good field-ripe pineapple or a choice mango.”

The mangosteen fruit is the size of a small apple, purple colored, with a hard rind. Inside there are typically five to seven seeds surrounded by a sweet, juicy cover (or aril). The pulp, which is said to resemble a pineapple or peach in taste, is reputed to be a very delicious food - in Asia it is sometimes called the queen of fruits in honor both of its flavor and its economic importance.

Uses in Traditional Medicine

For many years dried mangosteen fruits have been shipped from Singapore to Calcutta and then on to China for medicinal use. As to its many uses in folk medicine, here is what botanist Julia Morton has written:

“The sliced and dried rind is powdered and administered to overcome dysentery. Made into an ointment, it is applied on eczema and other skin disorders. The rind decoction is taken to relieve diarrhea and cystitis, gonorrhea and gleet [a watery discharge, ed.] and is applied externally as an astringent lotion. A portion of the rind is steeped in water overnight and the infusion given as a remedy for chronic diarrhea in adults and children.”

“Filipinos employ a decoction of the leaves and bark as a febrifuge and to treat thrush, diarrhea, dysentery and urinary disorders. In Malaya, an infusion of the leaves, combined with unripe banana and a little benzoin is applied to the wound of circumcision. A root decoction is taken to regulate menstruation. A bark extract called ‘amibiasine’, has been marketed for the treatment of amoebic dysentery.”

Morton also writes that “[t]he rind of partially ripe fruits yields a polyhydroxy-xanthone derivative termed mangostin, also beta-mangostin. That of fully ripe fruits contains the xanthones, gartanin, 8-desoxygartanin, and normangostin. A derivative of mangostin, mangostin-e, 6-di-O-glucoside, is a central nervous system depressant and causes a rise in blood pressure.” A more complete listing of constituents is given at ethnobotanist Dr. James Duke’s informative and useful Phytochemical and Ethnobotanical Databases (Duke 2004). We can conclude then that mangosteen has many uses in folk medicine, and as such, it can join a fairly long list of plants that can be considered as promising sources of new medicines.

XanGo on the Go

In this age of frenzied commercialism, entrepreneurs are always on the lookout for ways to make it big in the natural medicines market. Under such conditions, however, new medicines of botanical origin cannot be developed or tested in an orderly way.

A common feature of the way in which natural medicines such as mangosteen are promoted is the use of network marketing. This involves the retailing of products through the use of independent distributors. These distributors are then encouraged to build and manage their own sales force by recruiting, motivating, supplying, and training others to sell products. Compensation in such arrangements includes the distributor’s own sales as well as a percentage of the sales of his or her entire “downline” (i.e., all those people signed up by an individual, who in turn go on to become salespeople). The term network marketing is virtually synonymous with the older but now somewhat disreputable term ‘multi-level marketing’ (MLM).

Network marketing turns mere consumers into determined marketers who aggressively sell their product, often to their own friends, relatives and neighbors. The more people they can recruit into the growing network the more money they themselves make. A sophisticated marketing blitz, including books and pamphlets, seemingly objective newsletters, press releases and chattering websites, inflate the importance of a product, creating a buzz that only dies away when the huge supply of potential customers and salespeople is finally exhausted. Or when, as it has on occasion, the government finally steps in. But the essential requirement for a successful MLM operation of this sort is a kernel of promising-sounding scientific evidence, coupled with a credible and compelling story, a compliant doctor willing to underwrite the concept, and finally some patients (who may themselves be distributors) willing to testify that the product led to astounding cures.

Aloe vera, colloidal minerals, gingko biloba and ginseng were all popularized in this way. But perhaps the most memorable example of a network marketing stampede is noni juice, a once totally obscure Polynesian fruit that became the basis of a huge industry. Tahitian Noni International, formerly called Morinda, last year claimed to have passed the two billion dollar sales mark! This is the sort of performance that makes get-rich-quick artists drool.

The techniques of network marketing, honed through decades of trial and error, are now being used by a Utah-based company to position mangosteen as the latest “miracle cure” craze. The price of their XanGo mangosteen juice is currently $37 per bottle (or four for $100). You have to ask yourself: who on earth would pay that much for a bottle of fruit juice, no matter how delicious it might be? The reason the marketers can succeed in selling juice at this price is obvious: when people are suffering from medical conditions for which there does not appear to be much hope, or for which the orthodox medical recommendations are too toxic or expensive, they will actively seek alternatives. And then someone, oftentimes someone they trust, such as a friend or neighbor, convinces them to give some new product a try. Products such as mangosteen exploit humanity’s understandable desire to discover simple and painless solutions to intractable problems.

Now that the commercial ball is rolling an increasing number of mangosteen brands are reaching the market. But for the time being the market leader is XanGo (www.myxango.com). A visit to their website triggers an audio webcast from a very pleasant sounding young lady, who assures us that “by integrating the Internet, teamwork, and personal mentoring, MyXanGo.com provides you a vehicle to improve the areas of your life that are most important to you, and we do it for FREE.”

I listened in amazement to her polished spiel and the brazen intrusiveness of this message. I was particularly amused when she said, “You should know that this message is not about selling.” Right. “It’s not about false claims and outlandish statements.” Sure. “It’s about sharing facts to help you decide if now is the right time in your life to consider XanGo.” Really.

The rhetoric gets even more effusive. A March 2004 press release from one seller proclaims: “Mangosteen is now on an unstoppable march to conquer the world” (Goss 2004). Put this way it sounds rather ominous.almost like a cross between Osama bin Laden and the Attack of the Killer Tomatoes.

Xanthones

As stated, one requirement for a successful network promotion is that there be at least a kernel of scientific truth around which exaggerated claims can be assembled. As with noni juice, mangosteen is not entirely without scientific documentation. The problem, as usual, is that the claims for mangosteen are inflated till they far outpace what has been established through careful experimentation.

Some mangosteen promoters have mined James Duke’s famous ethnobotanical database for confirmation of their product’s value. And, indeed, Dr. Duke confirms that the plant contains several interesting components. But so do thousands of other plants in his voluminous database. For most of the chemicals contained in this fruit (such as beta-mangostin, catechins, cis-hex-3-enyl-acetate, gamma-mangostin, gartanin, garcinones) the database lists NO particular biochemical activities. Only the compound called “mangostin” seems to have some scientific backing for its antibacterial, antiseptic and fungicidal properties (Recio 1989). Yet scores of mangosteen websites now cite Duke’s database as scientific justification for this product. In reality, Dr. Duke has absolutely nothing to do with any mangosteen distributor and is not particularly enthusiastic about the product.

Much is made of the xanthone connection. According to the MyXanGo.com website: “There are over 200 xanthones in nature. Each xanthone can have specific effects on the body. What’s remarkable about the mangosteen is that there are over 40 xanthones identified in the pericarp, or rind, making it the single most xanthone-rich source in the world..Only six of the xanthones have been studied in depth. While we don’t know fully why the mangosteen works on such a wide variety of physical conditions, we know it has to do with being the world’s most potent source of xanthones. Each xanthone has its own effect, and when combined, they take on a synergistic quality that supports the health of the entire body.”

But all of this is speculative. It is undoubtedly true that there are many xanthones (a kind of antioxidant) in mangosteen. In fact, according to the Merck Index (11th Ed., p. 5613) the first scientifically defined substance to be derived from mangosteen was the xanthone mangostin. This was isolated by a German scientist named Schmid in 1855. In 1979, mangostin was found to have significant anti-inflammatory and anti-ulcer effects in rats (Shankaranarayan 1979). Yet although mangosteen’s xanthones have been known for almost 150 years, there are still only 19 PubMed articles on these xanthones and none of these articles concerns the use of xanthones in the actual clinical treatment of human disease. So I would say the jury is still out on their effectiveness in treating anything.

The main XanGo website also claims that the antioxidant ORAC (oxygen radical absorbance capacity) value of mangosteen is the highest of all edible plants. “It is so potent that literally I know of nothing else in the supplement market that can possibly come even close to it,” says J. Frederic Templeman, MD, a Georgia family practitioner who is interviewed at the MyXanGo website. Many other XanGo-promoting websites repeat the claim that while the previous champion, prunes, have an ORAC value of 7,000 per ounce, mangosteen has an ORAC value of 17,000 to 24,000.

Yet XanGo sites claim that “a new champion” has been born in the worldwide contest for ORAC supremacy. But where in the scientific literature is the ORAC value of XanGo published? The source of these numbers is hard to track down. For instance, the Sunsweet prune website states that 100 grams (3.5 ounces) of prunes have an ORAC value of 5,770. While the ORAC values for most fruits and vegetables have been determined by standard laboratories and published in scientific journals, this is not so for mangosteen. I have not seen independent confirmation of these confidently promulgated claims. However, even if we assume for the sake of argument that the figures cited are indeed accurate, it must be pointed out that merely having an astronomically high ORAC value does not in and of itself confer any particular advantage. Not all antioxidants that are confirmed as present in the laboratory can be absorbed by human beings. And there is a limit to how much we can benefit from an inc reased intake of antioxidants.

According to Dr. Ronald Prior of the US Department of Agriculture Research Service at Tufts University, Boston, Massachusetts, “a significant increase in antioxidants of 15 to 20 percent is possible by increasing consumption of fruits and vegetables, particularly those high in ORAC value.” However, in order to have a significant impact on plasma and tissue antioxidant capacity one can only meaningfully increase one’s daily intake by 3,000 to 5,000 ORAC units. Any greater amount is probably redundant. That is because the antioxidant capacity of the blood is tightly regulated, says Dr. Prior. Thus there is an upper limit to the benefit that can be derived from antioxidants. Taking in 25,000 ORAC units at one time (as reputedly occurs with mangosteen) would be no more beneficial than taking in a fifth of that amount: the excess is simply excreted by the kidneys.

Marketers of the drink have widely claimed that XanGo has exceptional health-giving properties based on its very high ORAC score. (ORAC stands for oxygen radical absorbance capacity - a measure of the antioxidant value of a substance.) But having a high ORAC value does not necessarily confer any health advantage.

According to Dr. J. Frederic Templeman, a Georgia family practitioner who has written a small book on mangosteen, and who is widely quoted by XanGo marketers, if you take these antioxidants “you aren’t going to probably have a heart attack as fast as someone who doesn’t take them” and consuming them could therefore constitute “literally the difference between life and death.” Although I myself have written a book on the subject of the benefit of antioxidants (Antioxidants Against Cancer), I would say it is a tremendous stretch to claim that antioxidants are predictably going to save anyone’s life. Good health is achieved through a combination of many factors, hereditary as well as environmental.

Effects on Cancer

At the XanGo website, a company spokesperson interviews Dr Templeman on the subject of mangosteen’s beneficial effect on cancer. They both agree that a single test tube experiment is proof of the anticancer value of the juice: Dr. Templeman: “That’s striking.” XanGo spokesperson: “It’s incredible.” At various other websites devoted to XanGo (and there are now over 21,000 of them!) we read in glowing terms about both the supposed quantity and quality of scientific research on this previously obscure fruit.

Reality Check

So it is high time for a reality check. Has mangosteen really been thoroughly studied in terms of its effect on cancer and a host of other diseases? Or is this simply a wild extrapolation driven by strong commercial motives? Dr. Templeman refers to 44 scientific publications on this topic but there are just 29 articles on the topic of Garcinia mangostana in PubMed, the US National Library of Medicine database of 14+ million citations. A total of four of these studies relate to cancer. In one test tube experiment it was shown that a xanthone found in mangosteen kills cancer cells as effectively as many chemotherapeutic drugs. It also appears (on the basis of limited data) that compounds found abundantly in mangosteen can inhibit the harmful Cox 1 and Cox 2 enzymes, and can also induce programmed cell death (apoptosis) in aberrant cells (Ho 2002). Mangosteen thus joins a fairly long list of naturally derived compounds that might potentially have some anticancer activity.

These 29 articles do not constitute a wealth of data. For example, by contrast, PubMed lists over 2,300 articles on the topic of vitamin C and cancer, 125 of which refer to clinical trials. There are a similar number of studies on vitamin E and cancer. There are 835 studies of melatonin and cancer, and a truly impressive 16,000 on polysaccharides and cancer, including 536 clinical trials and 277 randomized controlled trials (RCTs).

Yet, we’re to believe that four test-tube experiments constitute - to quote the aforementioned Dr. Templeman - “mountains of evidence” on the benefits of XanGo. According to the promotional website of one of XanGo’s many “independent distributors” at http://bjsbytes.com/Xango/Questions.htm: “…much of the science behind xanthones is predominantly available to those in the medical community until recently. Many of the clinical studies on xanthones have been done in universities and testing facilities throughout Asia and have recently started to catch the attention of Western researchers.”

But is this true? Reputable researchers the world over, including those in Asia, publish in PubMed-listed journals. For example there are over 63,000 articles on cancer in PubMed in the Japanese language. Yet despite the website’s misleading talk about “clinical studies,” PubMed does not contain a single clinical trial of mangosteen in the treatment of cancer, or any other disease. Perhaps these promoters don’t realize that a clinical study is not something done in a laboratory, but a study that by definition is carried out on living patients. Laboratory studies on cell lines or even animals do not qualify for the title ‘clinical study’. Thus, despite what you may read at any one of those 21,000 promotional websites, very little scientific evidence exists concerning mangosteen’s anticancer activity in humans.

In my opinion, what we have here is simply an overpriced fruit drink. Fruit drinks are often healthful beverages. But the only reason I can see that the promoters of mangosteen can get away with charging $37 for this product is that they are playing on patients’ hopes and fears in a cynical way. Without the health claims, open or implied, the product could only be sold for at most $5 or $6 (which, for example, is the cost of antioxidant-rich pomegranate juice).

The mangosteen phenomenon is a reprise of the aloe vera, gingko biloba, and especially the noni juice story, complete with exaggerated claims for the health benefits of an exotic fruit. It should come as no surprise that both the President and the Chief Financial Officer of Xango once worked for Morinda (now called Tahitian Noni International).

Compounds found in plants have long been of great interest to cancer researchers. We must never forget that about one-fifth of all chemotherapeutic agents (including Vincristine, Vinblastine, Etoposide, Teniposide, and Taxol) are ultimately derived from plant sources. Many of these took a long time to pass through the regulatory process, since serious research into botanical medicine often goes begging for financial and intellectual support. Starved of funds in this way, the riches of the natural world are often neglected by mainstream science, only to be plundered by less scrupulous organizations. The patient loses twice - by not having the fruits of serious research and by being deceived by slick operators posing as friends and benefactors. Some may even opt for unproven miracle juices in lieu of more certain therapies that might save their lives. When it comes to cancer, we truly live in a topsy-turvy world.

References: (see full list here)

Source: Powerpilates
There are several juices on the market looking to squeeze extra cash out of consumers with their bold claims of health benefits. Is there any science backing these claims? Should you incorporate these juices to achieve optimum wellness?

Health claims made by these products on the internet will have you believing that $35-$40 per bottle will cure whatever ails you!

I will outline three juices based on information provided by the November Nutrition Action Healthletter (author David Schardt), their claims and pitfalls so you can decide what is best for you and your wallet!

Mangosteen: People in China, Malaysia and India have been using this fruit and the bark of the Mangosteen tree to help treat eczema and diarrhea for decades.

It is sold via a multi-level marketing network that posts websites, recruits other sellers, and markets to family and friends.

At each steps, sellers are getting a commission from the company XanGo located in Utah (this company is also linked with Tahitian Noni).

Despite that the company cannot make claims that the juice fights specific disease, local juice sellers boast that the juice cures cancer, diabetes, migraine headaches, Alzheimer’s and more.

The juice does contain xanthoes or antioxidants that may help improve intestinal health and neutralize free radicals.

David Morton, scientific advisor to XanGo and University of Utah anatomist claims that the “Science on Mangosteen is still very early”. There are no studies scheduled on humans because so much more needs to be done in the lab first.

Source: FDA
Mr. Gary Hollister, CEO, Xango LLC, International
3098 Executive Parkway, Lehi, Utah 84043, Ref # - DEN-06-22

Dear Mr. Hollister :

This letter is to advise you of serious concerns that the Food and Drug Administration (FDA) has regarding the promotion of Xango, your mangosteen-juice product. Labeling used by distributors of your product promotes your product for use in the cure, mitigation, treatment, or prevention of disease. Products intended for such uses are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. 321(g)(1)(B)).

FDA obtained brochures promoting the health benefits of mangosteens and mangosteen juice through contact information provided at a seminar at which representatives of your firm, David and Joe Morton, made presentations designed to recruit distributors for Xango. By using a telephone number provided by staff at the seminar, FDA ordered the “Mangosteen Brochure Combo Pack.” FDA subsequently received a packet of brochures that included ten copies each of nine different brochures promoting the health benefits of mangosteens and mangosteen juice. The packet also included brochures aimed at recruiting distributors for your product.

Under the Act, “labeling” is not limited to labels on the immediate container for your product. “Labeling” is defined in section 201(m) the Act [21 U.S.C. 321(m)] as “all labels and other written, printed or graphic matter upon any article . . . or accompanying such article.” The brochures we received as a prospective distributor of your product meet the definition of “labeling” in section 201(m) of the Act. Examples of some of the claims in the brochures include:

From “Tame the Flame”

• “For several decades, relief from inflammation has been available through nonsteroidal anti-inflammatory drugs (NSAIDS) like aspirin and ibuprofen. Mangosteen is just that - a proven, natural COX 2 inhibitor.”
• “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-inflammatory-Significantly reduces inflammation in the body targeting neck, back, and knee pain. Proven to significantly reduce nerve pain as well.”
• “Anti-Parkinson, Anti-Alzheimer and other forms of dementia”
• “Anti-depressant.”
• “Prevents bacterial infections (Anti-bacterial)”
• “Prevents and arrests fungus (Anti-fungal)”
• “Viral fighters and prevention of infections (Antiviral). Mangosteen has been used for centuries to treat skin disorders such as dermatitis, infections from wounds, ringworm, acne, and so forth.”
• “Prevents gum disease (Antiperiodontic)”
• “Lowers fevers (Anti-pyretic)”
• “Eye care - prevents glaucoma and cataracts (Anti-glaucomic and Anti-cataract)”
• “Weight Loss - helps and prevents obesity (anti-obesity)”
• “Lowers blood fat (Anti-lipidemic) Dr. Templeman says, ” . . .the degree of the lowering of LDL equals or exceeds that obtained with some commercial drug preparations . . without the serious side effects of the anti-cholesterol drugs.”
• “Anti-Tumor benefits”
• “Cancer: Mangosteen helps in the prevention of cancer with its powerful anti-oxidants . Six Xanthones according to a preliminary study were capable of killing cancer cells.”
• “Lowers blood pressure”
• “Blood sugar lowering”

From “An Introduction to Xanthones”

• “The thick mangosteen rind is used for treating . . .cystitis (inflammation of the urinary bladder), dysentery, eczema (a skin disease), fever. . . .”
• Teas of the mangosteen bark are known for treating genital and urinary infections as well as stomatitis (inflammation of the mouth).”
• “anti-inflammatory”,”anti-microbial”, “anti-fungal”, “anti-viral”, “anti-cancer”, “anti-tumor”, “anti-ulcer”, “anti-hepatotoxic”, “Is anti-rhinoviral”, “anti-allergic”
• “In addition, the anti-inflammatory activities of natural xanthones found in the mangosteen plant are significant. In particular, one recent study confirmed that gamma mangostin, a xanthone derivative, is a potent COX inhibitor. Suppressing the cellular production of cyclooxygenase, or “COX,” is an important factor in reducing inflammation, pain and fever.”

From “Mangosteen and the Hormone Balancing Act”

• “Another way mangosteen keeps the cells and glands of the endocrine system working properly is by fighting off infection.”
• “Scientific investigation has shown that mangosteen has strong antimicrobial properties. Anti means against; microorganisms are tiny organisms like bacteria, viruses, yeasts, and molds. Studies report mangosteen stops the growth of Staphylococcus, common bacteria that causes infections if not controlled. Another study done in Thailand found that a mangosteen extract stimulated the phagocytic cells to kill the bacteria Salmonella enteritidis. Other research shows mangosteen to be effective in stopping various types of fungal growth.”
• “By drinking mangosteen, you may help prevent infections . . . .”

From “Xanthones and the Chiropractic Connection”

• “Because of the amazing results I have had with XanGo, I am now drug free and virtually pain free for the first time in 21 years. The .research I have performed on this product has led me to believe that it helps restore liver function, breaks down insulin resistance, and can turn around chronic conditions of inflammation in the cells of the body.”
• “Its delicious taste and medicinal qualities not only put dessert on the table but keep the people free of such ailments as dysentery, infections, inflammation, diabetes, and pain, to mention a few.”

From “Why Healthy People Drink Mangosteen Juice”

• “Traditionally, mangosteen was used to help with ailments such as diarrhea, eczema, thrush, urinary infections . . . . Currently, many people use mangosteen to help prevent disease by lowering their risk factors for disease . . . .”
• “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 two separate studies, researchers proved that the xanthones in mangosteen prevented the growth of as many as six different dangerous fungi.”
• “Polysaccharides are incredibly potent anti-cancer and anti-bacterial plant compounds . . . . Japanese scientists isolated several polysaccharides from mangosteen that helped decrease murine tumors (a cancerous tumor in mice).”
• “Another study that looked at the polysaccharides from mangosteen found that they were effective against intracellular bacteria (such as Salmonella enteritidis) . The study results showed that the mangosteen’s potent polysaccharides killed all of the bacteria in the culture.”

From “The Xanthone Effect” - David A. Morton, Ph.D

• “Science supports the idea that xanthones found in the mangosteen fruit are an effective remedy for diarrhea and dysentery, mainly by inhibiting the action of the COX-2 enzyme (mechanism of action).”
• “They discovered that some mangosteen xanthones had been reported, ‘to produce analgesic and anticonvulsant effects.’ They also stated that the mangosteen xanthones were ‘found to produce significant anti-inflammatory effects.’ An interesting sidenote is that some mangosteen xanthones did not ’cause aggravation of gastric ulcers . . . mangostin produces significant antiulcer activity in experimental animals.”
• “They concluded that, ‘gamma-mangostin serves not only as a new attractive pharmacological tool for studying the molecular mechanism underlying inflammation but also as a new lead compound for drug development for the prevention and/or treatment of inflammation and brain diseases.”

From “Mangosteen [and IBS, and Constipation] An Abdominal Surgeon’s Perspective”

• “Two of the conditions that I have found the mangosteen useful in treating are constipation, and IBS (irritable bowel syndrome), which I will deal with in this brochure.”
• “Supplementing with mangosteen should enable you to reduce or eliminate the use of steroids in your treatment. . .”

These claims cause your product to be a drug, as defined in Section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] . Because this product is not generally recognized as safe and effective when used as labeled, it is also a new drug as defined in Section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the United States without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)] . FDA approves new drugs on the basis of scientific data submitted by a drug sponsor to demonstrate that the drugs are safe and effective.

The introduction or delivery for introduction into interstate commerce of an unapproved new drug is prohibited under the FD&C Act [21 U.S.C. 331(d)] and may lead to enforcement action, including seizure and/or injunction. Please advise this office in writing, within 15 working days of receipt of this letter, as to the specific steps you have taken or will be taking to prevent your distributors from promoting your product in a manner that violates the Act. Your reply should be directed to the attention of Regina Barrell, Compliance Officer, Food and Drug Administration, at the address shown on the letterhead above.

Sincerely,
B. Belinda Collins
District Director