FDA wins Court order restricting Lane Labs-Shark Cartilege for Cancer

[Guest guest]

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 (Schopick)- the FDA

strikes big!

Date:7/26/2004 12:10:00 AM Eastern Standard Time

From:S1573

To:S1573

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

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 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.

[Guest guest]

The owners of Lane Labs-USA, Inc. were convicted of civil

disobedience. The FDA will not dare make claims that the products don't

work because the courts would be flooded with testimonials and the judge

might waver. Instead the FDA attacks Lane for violating the agency's

administrative orders and then haughtily parades the court's decision as if

Lane committed fraud.

Lane was making a ton of money and this greatly bothered the FDA and their

megapharm advisory boards. Smaller companies often make very explicit

claims but the FDA doesn't bother them.

Last week an ex-Salabridad agent/physician [salubridad is the Mexican

version of the FDA] who now works as a consultant mentioned that she was

involved in shutting down one of the Tijuana cancer clinics. She said that

the US FDA demanded that Salubridad close down the clinic in spite of the

fact that this clinic was in full compliance with Mexican law. Internal

orders from Mexico City instructed the Tijuana agents to shut down the

clinic even if they had to plant something. Just so you know, the

treatments provided by this clinic weren't particularly effective, but that

is a different issue.

At 12:53 PM 08/01/04, you wrote:

>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

> 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 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.

>

[Guest guest]

Is there another product out there that would be a good equivalent of

MGN-3?

On Aug 1, 2004, at 6:52 PM, Gammill wrote:

> The owners of Lane Labs-USA, Inc. were convicted of civil

> disobedience.  The FDA will not dare make claims that the products

> don't

> work because the courts would be flooded with testimonials and the

> judge

> might waver.  Instead the FDA attacks Lane for violating the agency's

> administrative orders and then haughtily parades the court's decision

> as if

> Lane committed fraud.

Franceus | Absolute power doesn't corrupt. It reveals.

RABA Technologies | - Erwin Raphael McManus

paul@... |

[Guest guest]

I bet Big Pharma is real happy! They make me so sick to my stomache!

> Lane Labs has been selling Shark Cartilege for Cancer.