Western Dietary Products will preliminarily halt Internet marketing claims that its black walnut, wormwood and clove tinctures treat and cure diseases such as cancer, diabetes and HIV/AIDS, the Federal Trade Commission says.

Western stipulated to entry of a preliminary injunction June 13 after FTC sued the firm in Seattle federal court for allegedly making false, deceptive and unsubstantiated health claims for supplements and medical devices over the Internet. Litigation with Western is ongoing, the commission said.

In a June 1 complaint, FTC challenges numerous statements on Western's Web site, www.curecancer.com, concerning its "herbal cure packages" and Zapper Electrical Unit. The company does business as Western Herb & Dietary Products.

Under the heading "The Cure For Organ Cancers," the site vows to show users "exactly which herbs are used to actually cure cancers. Our formulas have cured many people of cancer worldwide," the FTC complaint states. The site contends its products kill parasites that cause cancer and advises users to cancel surgery, radiation and chemotherapy, according to FTC.

Examples of prices listed on the site include $35 for the cloves tincture, $998 for the Cancer Cure Organ Package, and $1,297 for the Multiple Sclerosis Formula, the commission's filing states.

The complaint and preliminary injunction were among six enforcement actions announced jointly by FTC and FDA officials at a press conference in Washington, D.C. Initiated under Operation Cure.All, an ongoing campaign to combat health fraud, the actions targeted claims discovered by FTC staff surfing the Internet.

Although five companies reached consent agreements before Timothy Muris took over as FTC chairman June 4, the press conference was his first at the commission's helm and affirmed FTC's continued interest in ferreting out questionable supplement marketing claims, particularly those that prey on sick and vulnerable consumers.

"The FTC will step up its efforts to combat Internet health fraud," Muris announced. Calling the claims subject to the current enforcement actions "particularly egregious examples," he said: "we will send out, as we have in the past, news of these orders to Web sites that are making these kinds of claims."

"We will increase our efforts in this whole area," Muris promised. "This is a very important area for us."

Under separate consent agreements, Panda Herbal International, d/b/a Viable Herbal Solutions, and ForMor Inc., d/b/a ForMor International, must include a warning about potential Rx drug interactions and use by pregnant women on future advertising, promotions and labeling for St. John's wort supplements.

The warning states the botanical "can have potentially dangerous interactions with some prescription drugs. Consult your physician before taking St. John's wort if you are currently taking anticoagulants, oral contraceptives, antidepressants, anti-seizure medications, drugs to treat HIV or prevent transplant rejection, or any other prescription drug."

The statement continues: "This product is not recommended for use if you are or could be pregnant unless a qualified health care provider tells you to use it. The product may not be safe for your developing baby."

"In the event that the FDA issues a final rule requiring a warning on the labeling of products containing St. John's wort," the companies may substitute the agency warning for the disclosure required under the consent agreement, FTC says.

FTC alleges Panda's ad claims represented Herbal Outlook - a supplement containing St. John's wort, passion flower, gotu-kola and kava kava - as effective in treating HIV/AIDS, herpes simplex, tuberculosis and hepatitis B infections.

Claims on the Viable Herbal Solutions Web site said the product's ingredients "have no known contraindications or side effects," FTC says.

FTC cites ForMor Inc. for claiming St. John's Kava Kava is effective in treating HIV/AIDS, syphilis, tuberculosis and other conditions, and for representing the supplement has no serious drug interactions.

However, the commission notes St. John's wort "may reduce the effectiveness of drugs used to treat HIV/AIDS, as well as the effectiveness of cyclosporine (a drug used to prevent organ transplant rejection), the effectiveness of anticoagulants (such as warfarin) and the effectiveness of birth control pills."

"It's bad enough when someone with little or no evidence touts unproven medical remedies to vulnerable populations such as people infected with HIV or AIDS," said National AIDS Health Fraud Task Force Network Partnership Council Chair Walter Carr, who appeared at the press conference.

"It is even more frightening when they do so despite and without so much as a mention of emerging risks that those remedies pose to the very people to whom they are supposed to be pitching the sale. St. John's wort and protease inhibitors...do not mix," he said.

FTC developed the St. John's wort disclosure following discussions with FDA, which has been asked by the Consumer Healthcare Products Association to require supplements containing the botanical to carry a label warning about potential Rx interactions (¹ Also see "FDA Notices, Guidances Should Reflect St. John's Wort Interaction - CHPA" - Pink Sheet, 26 June, 2000.).

CHPA also has asked FDA to require pregnancy/nursing label statements on certain types of supplements. In its most recent "unified agenda," FDA targeted June for publication of a proposed rule on pregnancy warning statements for supplements.

ForMor and Robert and Lisa Spencer, d/b/a Aaron Co., agreed to settle FTC charges related to colloidal silver products. FTC asserts Aaron claimed colloidal silver "has been medically proven to kill over 650 disease-causing organisms in the body."

Colloidal silver products have been the subject of numerous "cyber" letters issued by FDA in recent months addressing illegal drug claims. The "cyber" letter program is part of Operation Cure.All (² Also see ""Cyber" Letters Lead To 15%-20% Web Site Correction Rate" - Pink Sheet, 26 March, 2001.)

MaxCell BioScience, also d/b/a Oasis Wellness Network, was cited for making anti-aging and disease treatment claims for its Longevity Signal Formula supplement containing DHEA. FTC says Michael Forrest, d/b/a Jaguar Enterprises of Santa Ana, claimed a combination known as Miracle Herbs cured cancer and other serious diseases.

Of the five firms that settled, four must offer refunds to purchasers on many of the challenged products, while MaxCell must pay $150,000 for consumer redress to FTC.

The five consent agreements will be subject to public comment until July 16, after which the commission must decide whether to make them final.

HIV/AIDS, Cancer Cure Supplement Claims Targeted In Six FTC Actions

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