Calcium & magnesium orotates

[Guest guest]

Terry,

Thanks for posting the report on calcium orotate. Although the kind of

advertising blurb that vendors carry on their websites has to be treated

with great caution, monographs like this one can be very useful and I

appreciate having them in full.

I had already noted that calcium and magnesium orotate (my supplement has

both) improve cartilage repair so it's good to have that confirmed, but

there are some drawbacks. I don't get the immune advantages that I get

from AEP and nor can I tolerate such effective doses. Also, the elemental

mineral is only 10% for calcium and 6.5% for magnesium, so you need to

take a lot and if Nieper's ideas are right, AEP should help the orotate

into the cell.

On a sombre note, the main UK manufacturer of orotates, Lamberts, has just

ceased production because all but the most basic supplements are being

banned under EU legislation. This is catastrophic and the US will be next

unless consumers there keep up the struggle. If you doubt this, study the

report below on Nieper's supplements from the FDA official website. The

pharmaceuticals are behind it but are they vindictive or what?

Seizers Keepers, Criminals Weepers

by Tamar Nordenberg

The maker of unapproved new drugs promoted for the treatment of cancer,

heart disease, diabetes, and other serious conditions lost its fight for

the return of $600,000 worth of illegal products seized at FDA's request.

In a March 1997 order, Judge Lloyd of the U.S. District Court for

the District of Nevada ruled that International Nutrition Inc. of Las

Vegas was not entitled to the return of the products sold under the Hans

Nieper label, even if the company intended to relabel the products and

remove the unsupported drug claims. The judge agreed with FDA that the

return of the goods would allow the company and its president, Gene

Sylvester Oden, to profit from their past illegal activities.

International Nutrition and Oden said they wanted the products back so

they could relabel them and sell them as dietary supplements. But FDA

stated in its brief to the court that the company " cannot plausibly argue

that a mere change in the labeling today will undo the effects of several

years of unsubstantiated therapeutic claims. "

The products were mostly orotates, which are made up of orotic acid and

various minerals, such as calcium, magnesium, zinc, potassium, and

lithium.

" Oden said that orotates were the best thing ever discovered for cancer

and other serious diseases, " says FDA investigator Chavarria of the

agency's Las Vegas resident post. " He said their unique transporter system

could carry nutrients through the cell wall faster than anything available

on the market. "

FDA received no reports of injuries from the Hans Nieper products made by

Oden. But, as Chavarria points out, the heavy promotion--and subsequent

use--of these products for serious ailments could endanger the public

health.

" For example, you could have a diabetic substituting these unproven

products for the insulin their body depends on, " he says.

FDA began looking into Oden's business practices after receiving reports

in 1992 and early 1993 from consumers and drug manufacturers about the

sale of unapproved Hans Nieper products in the United States.

Since 1987, FDA had been aware of fraudulently promoted products

manufactured in Europe by German physician Hans Nieper and sometimes

shipped into the United States. But FDA knew of no U.S.-manufactured Hans

Nieper products until FDA's Orlando district office traced some products

seen during a plant inspection to a manufacturing facility in Pahrump,

Nev. Based on this lead, Chavarria inspected Oden-owned Ramona

Manufacturing Inc. in Pahrump in March 1993.

" When I confronted Oden about the illegal manufacture of orotates, he

totally denied making them at his plant, " Chavarria says.

But two Ramona employees who were present during the inspection secretly

phoned Chavarria later and told him the plant did manufacture orotates.

The informants also told Chavarria that while he was inspecting the plant,

one employee ran out the plant's back door carrying boxes of orotates,

while another ran into the women's bathroom and hid the products' labels

behind a paper towel machine.

On April 30, 1993, an investigator with FDA's Minneapolis district office

placed an anonymous order for Hans Nieper products with International

Nutrition. Within two days, the district office received shark cartilage

and colamine phosphate drugs from International Nutrition, as well as

promotional literature with unsubstantiated medical claims sent by another

company owned by Oden, Papillon Botanicals Inc.

" To try to circumvent FDA's regulations, " Chavarria says, " Oden had set up

several companies besides International Nutrition to distribute the

literature with the medical claims. "

From June to August 1993, FDA investigators and U.S. marshals searched

seven Oden-owned facilities, including Ramona, Papillon, and International

Nutrition, and seized the unapproved drugs.

Both Oden and International Nutrition pleaded guilty in June 1995 to

selling unapproved new drugs across state lines. Oden was sentenced to

five years' probation and fined $5,000, and his company received five

years' probation and a $60,000 fine.

Almost two years later, FDA was in court with International Nutrition

again, this time opposing the company's bid to get back its seized

products. " Based on Oden's track record, we were very concerned that if he

got the seized items back, he would turn around and continue the criminal

enterprise he had been involved in, " Chavarria says.

The court, sharing FDA's concern, stated in its order denying return of

the products, " International Nutrition's request ... is akin to the

creator of a seized pipe bomb asking for the return of the pipe with the

promise that the pipe will be used for plumbing, or the manufacturer of

seized illegal firearms asking for the return of the metal with the

promise that it will manufacture the metal into legal firearms. "

The seized drugs will be crushed at a landfill, Chavarria says. To FDA's

knowledge, Oden has stopped manufacturing the illegal Hans Nieper

products. He still owns International Nutrition Inc., which he has

relocated to a town near El Paso, Texas.

Tamar Nordenberg is a staff writer for FDA Consumer.