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T99-56						Print Media: 301-827-6242
December 10, 1999				
                   				Consumer Media: 888-INFOFDA

FDA TAKES ACTION AGAINST FIRM MARKETING UNAPPROVED DRUGS

The Food and Drug Administration today stepped up its efforts to protect the public against unproven claims for unapproved drugs by seeking a permanent injunction against the marketing of three unapproved drug products being illegally promoted as treatments for cancer and other diseases by a New Jersey corporation and its top officer.

The products, called BeneFin, SkinAnswer and MGN-3, are promoted and sold by Lane Labs-USA, Inc., in Allendale. In addition to Lane Labs-USA, Inc., the complaint names as defendant its President, Andrew J. Lane.

The government's complaint, filed by the United States Department of Justice in the United States District Court for the District of New Jersey, charges the individual defendant and his company with unlawfully promoting and marketing three products for the following diseases:

BeneFin, which is produced from shark cartilage, as a treatment for cancer and other diseases;
SkinAnswer, a glycoalkaloid skin cream, as a treatment for skin cancer;
and MGN-3, a rice-bran extract, as a treatment for cancer and HIV, the virus that causes AIDS.

BeneFin is being studied as a potential cancer therapy under an Investigational New Drug application reviewed by the FDA. As such, it can be distributed for use in clinical trials. Like the other two products, however, it may not be promoted and marketed until its safety and effectiveness are demonstrated, and FDA reviews and approves the sponsor's marketing application.

Today's action against the BeneFin brand of shark cartilage does not affect brands of shark cartilage that are not intended for use in the treatment of disease and that are otherwise lawfully marketed as dietary supplements.

FDA began warning the defendants about the illegal nature of their promotion in June, 1997. Nevertheless, the defendants have continued promoting BeneFin, SkinAnswer, and MGN-3 as remedies for cancer and other diseases through such means as books, articles, Internet web sites, and employee statements.

The governmentís request for a permanent injunction is based on the defendantsí demonstrated unwillingness to comply with the law. The government's action seeks an injunction against, among other things, the defendants' distribution of the three unapproved drugs unless the products are either approved for marketing by FDA or are distributed pursuant to an Investigational New Drug application solely for purposes of conducting a clinical trial.

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FDA TALK PAPER

FDA TAKES ACTION AGAINST FIRM MARKETING UNAPPROVED DRUGS

FDA
TALK PAPER