Company ordered to halt sales of unapproved drugs, reimburse buyers

A New Jersey judge has found that two products sold as dietary supplements and another touted as a cosmetic are unapproved new drugs under federal law because they were being marketed as treatments for cancer and HIV without FDA approval. The three products are BeneFin, a purported treatment for cancer, MGN-3, marketed as an HIV treatment, and SkinAnswer, promoted as a treatment for skin cancer. BeneFin is produced from shark cartilage, MGN-3 is a rice bran extract, and SkinAnswer is a skin cream.

On July 9, 2004, U.S. District Judge William G. Bassler permanently enjoined the defendants, Lane Labs-USA Inc. and its president, Andrew J. Lane, from distributing drug products unless they are first approved for marketing by the FDA or are distributed under an Investigational New Drug application for purposes of conducting a clinical trial. Bassler also ordered the defendants to pay restitution to all purchasers of the products since Sept. 22, 1999.

"Today's action by Judge Bassler sends a strong signal that the promotion and sale of unapproved drug products, especially for the treatment of cancer and other serious diseases, will not be tolerated," said Dr. Lester M. Crawford, Acting FDA Commissioner.

The FDA issued a warning letter to the company and Lane in September 1997. Nevertheless, the promotions of BeneFin, MGN-3, and SkinAnswer continued through mass mailings, Internet sites, and employee statements.

The government's request for a permanent injunction was based on the defendants' demonstrated unwillingness to comply with the law.