XanGo and the FDA
XanGo, maker of an exotic mangosteen juice, claims to be the fastest-growing home-based seller of dietary supplements in history, going so far as to call itself the "iPod of the wellness revolution." Of course, Apple never peddled its hot-selling device by saying it prevents cancer.
According to the Food and Drug Administration, that's exactly what XanGo is doing in promotional brochures, violating U.S. law in the process.
The FDA, in a Sept. 20 letter to XanGo, said it has "serious concerns" regarding the promotion of the Lehi-based company's mangosteen juice concentrate, a dietary aid that sells for $35 a bottle and generates hundreds of millions of dollars a year in sales for XanGo.
The FDA obtained brochures promoting the health benefits of mangosteen juice through contact information provided at a XanGo recruitment seminar. Using a telephone number provided by seminar staff, the FDA ordered the "Mangosteen Brochure Combo Pack," according to the letter.
The brochures say mangosteen juice combats, among other diseases, Parkinson's, Alzheimer's, glaucoma, cataracts, cancer and viruses such as HIV.
The mangosteen, a tangerine-sized fruit grown in Southeast Asia, is filled with anti-oxidants called xanthones and has some documented health benefits.
But disease claims are reserved for FDA-approved drugs, and violators could face "enforcement action, including seizure and/or injunction," the FDA wrote in the letter to XanGo. "FDA approves new drugs on the basis of scientific data submitted by a drug sponsor to demonstrate that the drugs are safe and effective," added B. Belinda Collins, director of FDA's Denver district.
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 law.
XanGo agreed the materials cited by the FDA are problematic and possibly illegal. But the company insisted FDA is confused about who produces them, a point they plan to make in their response.
The brochures are published and sold by Sound Concepts of Orem, a third party that piggy-backs on the popularity of XanGo juice and other mangosteen supplements. Jared Frei, regulatory attorney for XanGo, said the two companies have a "symbiotic relationship," in that both prosper from the success of each other, but they are financially independent.
Sound Concepts produces materials related to network marketing and dietary supplements and shows up, uninvited, to workshops sponsored by XanGo, Tahitian Noni and other companies. It is possible FDA thought they were purchasing the brochures from XanGo, Frei said.
"And if that's the case, they have every right to be upset," he 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."
Under current law, drugs go through a rigorous screening and approval process by the Food and Drug Administration and can make claims that they are effective against certain ailments.
By contrast, supplements are regulated much like food products, have no pre-approval process and are restricted to more generalized claims. A supplement, for example, could claim to improve "well-being" or help some bodily function.
The more liberal regulations for supplements are the result of the 1994 Dietary Supplement Health and Education Act, written by Sen. Orrin Hatch. XanGo is one of Hatch's largest political contributors in recent years, giving $46,200 to the senator's campaign from 2001 to August of this year, according to the Center for Responsive Politics.
Hatch had this to say about FDA's warning: "XanGo's well-known in Utah and throughout the supplement industry for its quality products. I know they will take this seriously and work with the FDA to address these concerns."
If the FDA was confused about the source of the promotional materials, it's not hard to see why.
The materials sold by Sound Concepts include books by two of XanGo's favorite seminar speakers: J. Frederic Templeman, a physician who lives in Utah and lectures frequently on the healing properties of the mangosteen fruit, and David Morton, an assistant professor of neurobiology and anatomy at the University of Utah and brother to XanGo founders Joe and Gordon Morton.
Sound Concepts once sold XanGo's inhouse marketing materials in its catalog. And XanGo distributors often sell books and pamphlets, including those questioned by the FDA, on their Web site.
Frei said XanGo has beefed up its education and compliance program and, starting Oct. 1, only company-approved Web sites will be permitted.
Colby Olds, mangosteen marketer for Sound Concepts, said supplement makers like XanGo know his company is selling materials to their distributors. And they could boot his booths if they wanted.
Besides, Olds said, he's "convinced there is adequate science to back up" heath statements in his company's mangosteen brochures but added "there is room for improvement" in how those claims are couched.
"We're not out there trying to mislead people," he said.
Peter 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," Hutt said. "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."
See more about comments here.