XanGo

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XanGo, LLC, an international multi-level marketing company based in Lehi, Utah, was founded in 2002^[1]. Its sole product is a multi-fruit beverage called XanGo Juice promoted as a dietary supplement^[2]. Priced up to $37 per bottle, the juice is made using a proprietary formula containing an unspecified amount of mangosteen juice which includes extracts of xanthones from the fruit's rind^[3].

In May 2004, the company was granted a United States patent^[4] which was revoked by the United States Patent and Trademark Office in April 2005^[5]. The company is appealing the revocation^[6][7].

Contents 1 Company operations 2 Health benefits 3 US FDA warning letter 4 Supporters 5 Critical assessments 6 References

[edit] Company operations

Privately held and founded in October, 2002^[2], XanGo, LLC International sells XanGo Juice mainly using a nine-layer multi-level marketing structure ^[8].

The company has stated that its 2003 sales were $40 million, increasing to $150 million in 2004^[9]. In February 2006, the company reported 2005 sales more than twice those of 2004^[10].

In June 2006, the company said it had 350,000 distributors in 13 markets, with a goal to have $1 billion in annual sales by 2009^[11]. In July, the company told the Federal Trade Commission that there were "roughly 500,000 distributors worldwide"^[2], and in November, it reported having more than 600 employees at its Lehi headquarters and more than 500,000 independent distributors in 15 international markets^[1].

In November 2006, the company became the official corporate sponsor of the Real Salt Lake, a MLS soccer team based in Salt Lake City, Utah for four years, at a cost of between $500,000 and $1 million per year.^[12] Also in 2006, XanGo made a 5-year, $1 million grant to an Orem, Utah arts council for renovating and operating what is now called the "XanGo Grand Theater".^[13]

The company said in July 2006 that it gives 5 to 7 percent of its net profits to charity.^[2]. (As a privately held company, it does not publish its financial statements.)

[edit] Health benefits

XanGo Juice is a blend of mangosteen aril juice with those of eight other fruits: apple, pear (juice and purée), grape, blueberry, raspberry, strawberry, cranberry and cherry^[14].

Marketing materials used to promote XanGo juice indicate more than 20 human health benefits, among which are "anti-inflammatory," "anti-microbial," "anti-fungal," "anti-viral," "anti-cancer," "anti-ulcer," "anti-hepatotoxic," "anti-rhinoviral," and "anti-allergic"^[15]. Promotional literature for the product cites antioxidants from the inedible rind of the fruit as providing health benefits. None of these claims, however, has scientific proof established by rigorous peer-reviewed research and human clinical trials, as discussed below.

In mid-2005, the American Cancer Society profile of mangosteen juice said that there was no evidence that any part of the fruit is effective as a treatment for cancer in humans, but preliminary laboratory studies showed some promise for treating acne. The profile mentioned laboratory studies indicating need for further research ^[16].

On its website, after stating that "Research shows xanthones (a component of XanGo juice) possess potent antioxidant properties 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", the company adds an obligatory 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"^[17].

The company's scientific advisor, David A. Morton, PhD^[18][19](whose brothers, Joe and Gordon, helped found the company^[20]), stated in 2006 there is "emerging evidence that mangosteen has anti-inflammatory, antioxidant, and anti-microbial properties"^[18], yet acknowledged the only study of humans consuming mangosteen juice was conducted as a test of dysentery therapy in Singapore in 1932^[21][18]. "I don’t think there are plans to study mangosteen in humans in the near future," Dr. Morton said in 2006, because "there’s much too much that still needs to be studied in the lab"^[18].

[edit] US FDA warning letter

On September 20, 2006, the United States FDA issued a warning letter[2] to XanGo LLC International itemizing the company's extensive health claims.

If XanGo Juice were to have such health effects, said the FDA letter, then the claims “cause XanGo to be a drug” (paraphrased, see Letter[3]) which has not been subjected to the same human research and scientific scrutiny for safety and efficacy as other marketed drugs.

As new drugs can not be sold for interstate commerce in the US without approval of the FDA, the letter warned XanGo LLC that enforcement was imminent, including seizure and/or injunction of products.

Jared Frei, XanGo's regulatory lawyer, said the materials collected by the FDA were published and sold by Sound Concepts of Orem, a separate company that is financially independent of XanGo. Frei said that "we, as a company, do not publish any materials that make [drug-related] health claims. We say nothing about a disease or symptom of a disease. . . . We take FDA compliance very seriously." Frei said XanGo had beefed up its education and compliance program.^[20].

Under FDA drug labeling rules, XanGo LLC, as manufacturer, is responsible for satisfying scientific criteria to make health claims on its product labels and all marketing materials [4].

As of February 16, 2007, the case remains under review.

[edit] Supporters

Dr. David Morton and J. Frederick Templeman, MD, who are part of a company called Phytoceutical Research, LLC ^[22], have written a number of editorials, available at their website, about the benefits of XanGo Juice. They criticize authors who made negative comments about the purported benefits of mangosteen juice. For example, in his latest editorial dated October 2005, Dr. Templeman specifically accuses XanGo Juice critics, Drs. Andrew Weil and Ralph Moss of "deceitful misdemeanor". ^[23]

Drs. Templeman and Morton sell books, brochures, audio CDs and video DVDs about mangosteen juice therapy, such as Mangosteen: the X-Factor, fifth edition, at their website ^[24] . Some of their books are also sold by Sound Concepts of Orem, a company closely linked with XanGo International LLC^[20].

[edit] Critical assessments

The Mayo Clinic said in October 2005 that "there are no published clinical trials showing evidence that either the fruit or its juice — marketed under the name XanGo juice — is an effective treatment for arthritis, cancer or any other disorder in humans."^[25]

In February 2006, the U.C. Berkeley Wellness Newsletter, sponsored by the University of California at Berkeley, said that "Mangosteen marketers make farfetched and unsubstantiated claims for their products." The newsletter notes that "there are no clinical trials, and what happens in a test tube or animal may not occur in a human. Any reported benefits in humans have been anecdotal. No one even knows if the processed fruit juice and capsules retain the potentially beneficial compounds. What’s more, the juice is typically a mix of fruit juices — with an undisclosed amount of mangosteen in it." ^[26]

Dr. Ralph Moss, author of several natural remedy books, has said of mangosteen juice:

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).^[27]

In an article published in February 2007, Paul M. Gross, PhD (physiology), and Ian Crown, a mangosteen grower, said, "As mangosteen's supposed health claims are not supportable by sufficient nutrient density or a complete research process allowing conclusions about human health benefits, it has not met standards to be a superfruit. Research on xanthones is only at a preliminary stage from which no conclusions regarding lowered disease risk are valid at this time." ^[28]

[edit] References