December 12, 1999
FDA Seeks Permanent Injunction Against Marketing
of BeneFin, SkinAnswer and MGN-3
Washington, DC (SafetyAlerts) - The Food and Drug
Administration has 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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and timely product warning notification visit: www.safetyalerts.com.
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