Lane Labs has been selling Shark Cartilege for Cancer. They had some studies
supporting it, but probably could not make a cancer claim.
arnold
-----------------
Forwarded Message:
Subj:Sent to my friends and colleagues -- by Julia (Schopick)- the FDA
strikes big!
Date:7/26/2004 12:10:00 AM Eastern Standard Time
From:JuliaS1573
To:JuliaS1573
FDA NEWS
FOR IMMEDIATE RELEASE
P04-64
July 13, 2004
U.S. District Judge Issues Permanent Injunction Against Lane
Labs-USA, Inc. and Orders Firm to Refund Money to Purchasers
of Illegally Marketed Unapproved Drugs
The Food and Drug Administration today announced that Judge
William G. Bassler of the United States District Court for
the District of New Jersey, has found that three products
sold by Lane Labs-USA, Inc. and its president Andrew J. Lane
(the defendants) as dietary supplements and a cosmetic -
Benefin, MGN-3 and SkinAnswer - are, in fact, unapproved
new drugs under federal law because they were being mar-
keted as treatments for cancer, HIV, and skin cancer with-
out FDA approval. In addition, Judge Bassler permanently
enjoined the defendants from distributing BeneFin, MGN-3,
and SkinAnswer unless the products are first either approved
for marketing by the FDA or distributed pursuant to an
Investigational New Drug (IND) application for purposes of
conducting a clinical trial. Judge Bassler also ordered
the defendants to pay restitution to all purchasers of
BeneFin, MGN-3 and SkinAnswer since September 22, 1999.
'Today's action by Judge Bassler sends a strong signal that
the promotion and sale of unapproved drug products, espec-
ially for the treatment of cancer and other serious diseases,
will not be tolerated,' said Dr. Lester M. Crawford, Acting
Commissioner of Food and Drugs.
'Moreover, the court's decision ordering the defendants in
this case to refund money to all purchasers of the unlaw-
fully marketed products is particularly significant, because
it puts promoters of such illegal products on notice that
they cannot profit from this type of exploitation,' added
Dr. Crawford.
FDA issued a warning letter to the defendants in September,
1997. Nevertheless, the defendants continued promoting
BeneFin, MGN-3, and SkinAnswer as treatments for cancer and
other diseases through such means as mailings, Internet web
sites, and employee statements. BeneFin, produced from
shark cartilage, was promoted as a treatment for cancer.
SkinAnswer, a glycoalkaloid skin cream, was marketed as a
treatment for skin cancer. MGN-3, a rice-bran extract, was
promoted as a treatment for cancer and HIV, the virus that
causes AIDS.
The government's request for a permanent injunction was
based on the defendants' demonstrated unwillingness to
comply with the law."
COMMENT FROM BILL HENDERSON, WHO HAS A CANCER NEWSLETTER:
SO, YOUR GOVERNMENT WORKS TO PROTECT YOU
This type of action by the FDA and FTC is almost always
the direct result of a complaint from a pharmaceutical
company. Any natural substance which appears to have
promise of treating a disease for which there are huge
profits to be made from pharmaceutical drugs gets put
down. If this doesn't help you vow to take charge of
your own health care, I'm not sure what will.
