Washington, Oct. 3 - The Food and Drug Administration has warned the maker of tropical fruit drink XanGo over claims the beverage can prevent or treat cancer, depression, infection, Alzheimer's disease and other ailments.
In a Sept. 20 letter to XanGo LLC, released Tuesday, the FDA said brochures for the purple mangosteen beverage also asserted it was "a proven, natural COX-2 inhibitor," referring to painkillers such as Pfizer Inc.'s Celebrex and Merck & Co Inc.'s withdrawn Vioxx.
The FDA said such medical statements are reserved for drugs and constitute illegal marketing without agency approval. It gave Utah-based XanGo 15 days to respond and called on the company to curb such promotions.
XanGo General Counsel Craig Hale said the company did not publish or endorse any literature making health claims.
"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," Hale said in a statement.
The FDA letter said agency staff attended a distribution recruitment seminar and later ordered a packet of brochures using a number provided by two company representatives.
"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 ..." said one brochure on mangosteen juice obtained by the FDA.
While the FDA usually resolves most warnings without further action, it can levy fines, seize products and impose other civil penalties. Dozens of similar FDA warning letters are sent to companies each year.
According to the Nutrition Business Journal, XanGo is a multimillion-dollar company that is expected to reach $1 billion in annual sales by 2009. The company moves its beverages through thousands of distributors in 13 global markets, the journal said last year.