XanGo Addressing FDA Health Claim Concerns

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."