Xango juice drink not a cure-all, U.S. FDA warns

WASHINGTON (Reuters) - Xango, a tropical fruit beverage, is not proven to treat or prevent any diseases, despite its manufacturer's claims, U.S. health regulators warned after a review of promotional materials.

In a five-page letter to Xango LLC released on Tuesday, the Food and Drug Administration cited the company for asserting that the purple mangosteen fruit in the drink could prevent or treat cancer, depression, infection, Alzheimer's disease and other ailments.

Brochures for the beverage also claimed it was "a proven, natural COX-2 inhibitor," referring to prescription painkillers such as Pfizer Inc.'s Celebrex and Merck & Co Inc.'s withdrawn Vioxx.

Such medical statements are reserved for drugs, the FDA said in a Sept. 20 warning letter calling on the company to curb such promotions. Because the privately held company has not sought agency approval, its claims for Xango constitute illegal marketing, the FDA said.

The agency released the letter to the public on Tuesday and posted it on its Web site at http://www.fda.gov/foi/warning_letters/g6031d.htm .

The FDA gave Utah-based Xango LLC 15 working days to respond to the letter.

Dozens of similar FDA letters are sent to companies each year. In this case, 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..." the company said in one brochure on mangosteen juice obtained by the FDA.

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.

Representatives for Xango could not be immediately reached for comment.

While the FDA usually resolves most warnings without further action, it can levy fines, seize products and impose other civil penalties.