The FDA’s complaints about XanGo concern brochures for the product, some of which were designed to be given to distributors rather than consumers. XanGo, which relies of multi-level marketing for distribution, places significant emphasis on attracting sellers, not just customers.
The warning letter reflects FDA’s view that “labeling” is not just the label on the bottle, it’s anything printed that’s given out about the product as well. As the letter says:
Under the Act, “labeling” is not limited to labels on the immediate container for your product. “Labeling” is defined in section 201(m) the Act [21 U.S.C. 321(m)] as “all labels and other written, printed or graphic matter upon any article . . . or accompanying such article.” The brochures we received as a prospective distributor of your product meet the definition of “labeling” in section 201(m) of the Act.
FDA alleges that the claims for XanGo referenced in the letter are drug claims, and a quick review seems to bear that out. Many of the claims reference specific diseases and conditions that XanGo claims can be treated with xanthones found in mangosteen juice.
Will the FDA take this further? Who knows. Also worthy of note, XanGo executives have been the largest contributors to Utah Sen. Hatch’s reelection campaign.