An FDA Warning Letter citing unapproved new drug claims for XanGo Mangosteen juice that XanGo said were made by a third party underscores the agency's position on the responsibility supplement manufacturers assume for unsubstantiated label statements.

Dietary supplement manufacturer XanGo does not dispute the statements in the recent warning letter, but the firm said it is not responsible for publishing the brochure in which the claims appeared.

In the Sept. 20 letter, FDA instructed XanGo to report how it would prevent "distributors from promoting your product in a manner that violates" labeling requirements of the Food, Drug & Cosmetic Act.

According to the letter, FDA officials used a telephone number provided in a XanGo distributor seminar to place an order for the "Mangosteen Brochure Combo Pack." The brochures the agency received include information promoting XanGo's Mangosteen juice "for use in the cure, mitigation, treatment, or prevention of disease."

Unapproved new drug claims specifically cited in the letter include statements that Mangosteen is "a proven, natural COX-2 inhibitor" that "prevents hardening of the arteries" and "lowers blood pressure."

XanGo said it is working to satisfy FDA's order, but declined to elaborate on how it will remove from circulation the information FDA said is non-compliant. The company did say, however, that it did not approve the information in the brochures FDA received.

The warning letter indicates "FDA believes that it ordered the literature directly from XanGo and that these materials are company-produced literature," said Craig Hale, XanGo's general counsel. "This is not the case, and we believe this fact will be important in resolving the issue."

"XanGo does not publish nor endorse any literature that makes health claims," Hale added. "Further, XanGo does not condone the use of non-compliant literature by its distributors, and makes every effort to educate distributors on the difference between compliant and non-compliant literature."

Whether XanGo produced the information is not the issue, according to FDA. Makers of FDA-regulated products or substances are responsible for the information distributed with those products, including brochures and other materials, the agency said.

Product makers often have other companies print their labels and other promotional materials; and distributors commonly handle printing labels and other information for products they offer. Such arrangements, however, do not relieve product manufacturers from complying with labeling requirements, FDA said (¹ Also see "FDA, CRN Say Proper Supplement Labeling Can Enhance Consumer Trust" - Pink Sheet, 22 May, 2006., p. 8).

In addition, court rulings give the agency "broad interpretation" of the term "accompanying labeling," FDA maintains. Circulars, booklets, books and article reprints "in functional proximity to the goods" are included within the definition of labeling information. Written, printed or graphic material that reaches customers with a product becomes part of its labeling, according to the agency.

"Their name is on the label as far as we're concerned," said Paul Boehmer, a Public Health Service compliance officer at FDA's Chicago office, which submitted the warning letter to Lehi, Utah-based XanGo.

"Whoever's name is on the label, that's who is responsible for the label," said Boehmer, who is not working on the XanGo case.

XanGo said it has distributors in Australia, Canada, Japan, Mexico and New Zealand as well as the U.S. It was the first U.S. firm to market mangosteen products and has a stated goal of $1 bil. in annual sales by 2009.

The field, however, has attracted multiple competitors, including AmerMed, California Academy of Health, Dynamic Health, Nexxus Nutrition, Genesis Today and Thai-Go. In addition, the Mangosteen MD division of Phytoceutical Research markets educational materials about the fruit.

Mangosteen, the fruit of a tropical tree found in Southeast Asia, contains xanthones - polyphenolic compounds researched for their role in immune, joint and intestinal health.

XanGo last month announced its juice had been cleared by the World Anti-Doping Agency from containing any banned substance, including masking agents and stimulants. Xango was tested by ConsumerLab for athletic performance-enhancing banned substances, along with Ajinomoto, Enliven International, Pharmanex, Tahitian Noni International and USANA, the company said (² 'The Tan Sheet' Sept. 18, 2006, In Brief).

- Malcolm Spicer

XanGo Brochures Draw FDA Warning Letter For Unsubstantiated Claims

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