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Oct. 4, 2006 -- The FDA has warned the makers of XanGo Juice to stop making health claims about the juice, voicing "serious concerns" about those claims.
But XanGo, which makes the juice from a tropical fruit called mangosteen, says it didn't produce the promotional materials containing those claims.
In a letter posted on the FDA's web site, the FDA gave XanGo Juice 15 days to tell the FDA how it has stopped or will stop those marketing claims.
The FDA's letter includes a long list of health claims the FDA says it found in nine brochures promoting the health benefits of mangosteen and mangosteen juice.
Those claims include prevention of atherosclerosis (hardening of the arteries), bacterial infection, glaucomaglaucoma, cataractscataracts, and gum disease.
The FDA says the brochures also claim that the juice has "antitumor benefits" and is "anti-Parkinson, anti-Alzheimer, and other forms of dementiadementia," and "antidepressant."
The FDA has strict rules about health claims that can be used in marketing products.
The claims allegedly made by XanGo Juice can only be made by drugs, and XanGo Juice isn't an approved drug, says the FDA.
Company's Response
WebMD contacted XanGo for a response to the FDA's letter.
Bob Freeze, XanGo's vice president of public relations, emailed the following statement by Craig Hale, XanGo's general counsel, to WebMD:
"XanGo recently received a warning letter from the FDA related to some mangosteen materials it obtained through a third-party publishing company. 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 currently working to resolve this issue, and is confident that we will shortly reach an appropriate resolution."
XanGo Juice's web site says the juice contains phytonutrients called xanthones.
"Research shows xanthones 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," states XanGo Juice's web site.
That sentence comes with this footnote: "These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease."
SOURCES: FDA: "Warning Letter, Sept. 20, 2006." XanGo.com: "XanGo Juice."