Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
Southwest Region

 

Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087

September 20, 2006

WARNING LETTER

VIA FEDERAL EXPRESS

Mr. Gary Hollister
Chief Executive Officer
Xango LLC, International
3098 Executive Parkway
Lehi, Utah 84043

Ref # - DEN-06-22

Dear Mr. Hollister :

This letter is to advise you of serious concerns that the Food and Drug Administration (FDA) has regarding the promotion of Xango, your mangosteen-juice product. Labeling used by distributors of your product promotes your product for use in the cure, mitigation, treatment, or prevention of disease. Products intended for such uses are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. 321(g)(1)(B)).

FDA obtained brochures promoting the health benefits of mangosteens and mangosteen juice through contact information provided at a seminar at which representatives of your firm, David and Joe Morton, made presentations designed to recruit distributors for Xango. By using a telephone number provided by staff at the seminar, FDA ordered the "Mangosteen Brochure Combo Pack." FDA subsequently received a packet of brochures that included ten copies each of nine different brochures promoting the health benefits of mangosteens and mangosteen juice. The packet also included brochures aimed at recruiting distributors for your product.

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.

Examples of some of the claims in the brochures include:

From "Tame the Flame"

From "22 Reasons to Drink Mangosteen Juice"

From "An Introduction to Xanthones" -

From "Mangosteen and the Hormone Balancing Act" -

From "Xanthones and the Chiropractic Connection" -

From "Why Healthy People Drink Mangosteen Juice" -

From "The Xanthone Effect" - David A. Morton, Ph.D -

From "Mangosteen [and IBS, and Constipation] An Abdominal Surgeon's Perspective" -

These claims cause your product to be a drug, as defined in Section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] . Because this product is not generally recognized as safe and effective when used as labeled, it is also a new drug as defined in Section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the United States without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)] . FDA approves new drugs on the basis of scientific data submitted by a drug sponsor to demonstrate that the drugs are safe and effective.

The introduction or delivery for introduction into interstate commerce of an unapproved new drug is prohibited under the FD&C Act [21 U.S.C. 331(d)] and may lead to enforcement action, including seizure and/or injunction. Please advise this office in writing, within 15 working days of receipt of this letter, as to the specific steps you have taken or will be taking to prevent your distributors from promoting your product in a manner that violates the Act. Your reply should be directed to the attention of Regina Barrell, Compliance Officer, Food and Drug Administration, at the address shown on the letterhead above.

Sincerely,

/s/
B. Belinda Collins
District Director

This page was posted on October 2, 2006.

Links to Recommended Companies