FDA Warns XanGo Juice Maker
FDA Voices 'Serious Concerns' About Juice's Health Claims
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
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
Those claims include prevention of atherosclerosis (hardening of the
arteries), bacterial infection, glaucoma, cataracts, 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
The FDA has strict rules about health claims that can be used in marketing
The claims allegedly made by XanGo Juice can only be made by drugs, and
XanGo Juice isn't an approved drug, says the FDA.
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
XanGo Juice's web site says the juice contains phytonutrients called
"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."