FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
5600 Fishers Lane Rockville, MD 20857

FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.

T00-39                             Print Media:  301-827-6242
September 6, 2000                  Broadcast Media:  301-827-3434
                                   Consumer Inquiries:888-INFOFDA

FDA TAKES ACTION AGAINST FIRMS MARKETING UNAPPROVED DRUGS

The Food and Drug Administration is seeking a permanent injunction against the marketing of unapproved new drugs by three corporations and one individual.

The products, laetrile, in injectable and tablet form, and apricot seeds, are promoted and sold as cancer treatments by two Florida corporations, World Without Cancer, Inc. and The Health World International, Inc. of Bay Harbor Island, and one Arizona concern, Health Genesis Corporation, which also does business in Bay Harbor Island, Fla. In addition, the government's complaint names as defendant David E. Arjona, an officer of the three corporations.

In a complaint filed by the United States Department of Justice in the United States District Court for the Southern District of Florida on August 25, 2000, the government charged that the defendants unlawfully promote and market laetrile drug products for the treatment of cancer through their Internet web sites.

On September 1, 2000, United States District Court Judge Shelby Highsmith entered an Order of Preliminary Injunction that restrains the defendants from promoting and marketing laetrile products during the court's consideration of the case. The Order specifically enjoins the defendants from introducing or causing the introduction into interstate commerce of laetrile products, apricot seeds, or any other unapproved drug product as well as manufacturing, processing, packing, labeling, promoting, or distributing these or any other new drug.

In addition, the Order requires the defendants to modify their Internet web sites to cease using the web sites to promote the sale of or offer for sale their laetrile products.

The Order of Preliminary Injunction will remain in effect until the court orders a permanent resolution in the matter.

The complaint in the case asserts that FDA warned the defendants about the illegal nature of their promotion and marketing of laetrile in 1998 and that the defendants have continued promoting their products as remedies for cancer.

####