XANGO and FDA

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FDA Slaps Juice Maker XanGo For Cancer Claims

By Gehrke and Fantin

The Salt Lake Tribune http://www.sltrib.com/ci_4419210?source=rss

Posted: 7:34 PM- WASHINGTON - The Food and Drug Administration has

admonished XanGo International for claiming its exotic juice can prevent

a variety of diseases, including cancer and the virus that causes AIDS -

assertions reserved for FDA-approved drugs.

XanGo, however, says the criticism should be aimed at the publishing

company that produced and sold the materials and piggy- backs off the

popularity of XanGo.

In a Sept. 20 letter to XanGo, FDA said it has " serious concerns "

regarding the promotion of XanGo's mangosteen juice concentrate, a

dietary aid that generates hundreds of millions of dollars a year in

sales for the Lehi-based company and is among the hottest-selling

supplements.

In the letter, FDA quotes several mangosteen-related brochures the

agency obtained through contact information provided at a XanGo

network-marketing seminar. Examples of claims made in the brochures are

that mangosteen juice:

- prevents hardening of the arteries.

- deters Parkinsons' Disease, Alzheimer's and " other forms of

dementia. "

- acts as an anti-depressant.

- prevents gum disease.

- prevents glaucoma and cataracts.

- helps in the prevention of cancer with its powerful anti- oxidants. "

- is effective in inhibiting bacteria " and viruses (such as HIV-1). "

" These claims cause your product to be a drug " under the law, wrote

FDA's B. Belinda , director of the agency's Denver district office.

" FDA approves new drugs on the basis of scientific data submitted by a

drug sponsor to demonstrate that the drugs are safe and effective. "

Selling unapproved drugs is prohibited by law, wrote, " and may

lead to enforcement action, including seizure and/or injunction. "

XanGo says the criticism is misdirected. The promotional brochures,

which are not affiliated with a single company, were published and sold

by Sound Concepts of Orem.

Frei, regulatory attorney for XanGo, said the companies have a

" symbiotic relationship, " in that when XanGo prospers, so does Sound

Concepts, but there is no financial or administrative connection.

Sound Concepts independently produces materials related to network

marketing and dietary supplements and shows up, uninvited, to workshops

sponsored by XanGo, Tahitian Noni and other companies.

Frie suspects FDA is confused about who sold them the brochures.

" I assume FDA thought they were calling XanGo, and if that's the case,

they have every right to be upset, " Frie said. " But we, as a company, do

not publish any materials that make [drug-related] health claims. We say

nothing about a disease or symptom of a disease ... We take FDA

compliance very seriously. "

Colby Olds, mangosteen account manager for Sound Concepts, said he's

" convinced there is adequate science to back up " heath statements in his

company's mangosteen brochures. But when pressed to substantiate claims

that mangosteen juice prevents glaucoma, cancer and HIV, Olds said

" there is room for improvement " in how those claims are couched.

The FDA gave XanGo 15 days to notify the agency what steps it had taken

to keep distributors from " promoting your product in a manner that

violates the Act. " Frie said XanGo is working on a response that will

" clear up the confusion " involving Sound Concepts.

Barton Hutt, a former general counsel at the FDA, said there is an

exception in the Dietary Supplement Health and Education Act for third

party documents, but it is limited.

" It cannot mention the name of the product and it must be part of a

fairly balanced presentation of material, " said Hutt. " Any time that FDA

sees a claim for cancer or HIV they take it far more seriously than

anything else and I don't think that's surprising and I think you or I

would want it that way. " " Those are trigger words, " Hutt said.

Check Nutrition at my site:

Nutrition.teach-nology.com

Ortiz, RD

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