Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
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T99-56 Print Media: 301-827-6242 December 10, 1999 Consumer Media: 888-INFOFDA
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:
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.