A recent decision of the European Court of Justice has delineated the borderline between food and medicine in a case involving a German pharmaceutical importer and the administrative authorities. The Lueneburg district's administration had challenged Hecht-Pharma that their product called "Red Rice" was a medicine by function, and that it could not be legally sold in Germany. A "medicine by function" is a product presented and sold as a food, that is determined to really be a medicine because its function is that of "restoring, correcting or modifying physiological functions in human beings".

Hecht-Pharma, which operates a wholesale pharmaceutical business, marketed in Germany a product composed of fermented red rice under the name ‘Red Rice 330 mg Kapseln [capsules]’.

The capsules were marketed in plastic bottles which stated on their labels, inter alia: ‘Red Rice 330 mg, food supplement with fermented rice. One capsule corresponds to 1.33 mg of monacolin k’. The recommendations for use read as follows: ‘As food supplement, 1 capsule 1 - 3 times daily’.

The Niedersächsisches Oberverwaltungsgericht (Higher Administrative Court of Lower Saxony) held that the legislation on medicinal products was applicable on the ground that the product in question could come within the scope of the definition of a medicinal product by function. It contained significant levels of monacolin k. That active substance is synonymous with lovastatin, an inhibitor of cholesterol synthesis which is contained, as an active substance, in a number of prescription medicinal products.

The Niedersächsisches Oberverwaltungsgericht concluded that the product at issue in the main proceedings was liable to lower excessively high cholesterol levels and therefore contribute to the realisation of a therapeutic objective. It added that inhibitors of cholesterol synthesis could also have serious, undesirable side-effects on the muscles and kidneys.

Hecht-Pharma appealed on a point of law against the judgment of the Niedersächsische Oberverwaltungsgericht. During the course of the appeal, the Bundesverwaltungsgericht (Federal Administrative Court) decided to stay the proceedings and to refer the certain questions to the European Court of Justice for a preliminary ruling.

The decision of the EU Court, which no doubt will be greeted with some relief by European supplement manufacturers as well as consumers, sets down a firm marker that helps us understand where the borderline between food [supplements] and medicinal products is to be drawn. A recent revision of European medicines directives had left considerable confusion and uncertainty in that respect. The court intends to limit the application of pharmaceutical law to only those products sold with claims of prevention or cure of illness, and to products which, by their composition, are scientifically proven to be effective in modifying physiological functions.

The full text of the EU Court of Justice decision is available here on the eur-lex site.

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ADHD Drugs: Hallucinations Not Uncommon

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Sott.net
Health & Wellness
Salynn Boyles
WebMD
January 26, 2009

Treatment-related hallucinations and other psychotic symptoms in children with attention deficit hyperactivity disorder (ADHD) may be more common than previously thought, FDA officials report in the latest issue of the journal Pediatrics.

In an earlier investigation, FDA researchers identified more than 850 separate incidences of hallucinations and other psychotic episodes among children taking stimulants used to treat ADHD.

The investigation prompted federal officials to require new labeling on the drugs, including Ritalin LA, Concerta, Adderall XR, Focalin, Focalin XR, Metadate CD, Daytrana, and Strattera, warning of possible psychiatric side effects.

An estimated 2.5 million children and teens take these and other stimulant-based medications to treat ADHD symptoms.

Nearly half of the cases of hallucination and other psychiatric side effects reviewed by FDA researchers involved children younger than age 11. And in more than nine out of 10 cases, the children had no reported history of psychiatric events.

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OpEdNews
January 26, 2009
By Sally Stride

Sixty-four years ago, on January 25, sodium fluoride was poured into Grand Rapids, Michigan's public water supply to prove that fluoridation reduces children's tooth decay. Five years into the experiment, things weren't going as expected. Cavities declined equally in the non-fluoridated control city of Muskegon, too. So, to blur the truth or prove their expectation, Muskegon was fluoridated also.

So what's happening today?

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The Liberty Voice
Greenpeace
January 13, 2009


corn-condom-216x300.jpgIndia — New research from Austria shows that a commercial strain of Monsanto-made GE corn causes mice to have fewer and weaker babies. What is this doing to human fertility?

Regulators around the world said Monsanto’s GE corn was as safe as non-GE strains.

It has been approved in many countries and regions including the US, the EU, Argentina, Japan, Philippines and South Africa.

China approved the GE corn for animal feed back in 2005.

Until this research, under the Austrian Ministries for Agriculture and Health, none of the regulators had seriously questioned the safety of Monsanto’s GE corn.

The biotech industry is playing a game of genetic roulette with our food and with our health.

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Medicinal plants on verge of extinction

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Rob Edwards
New Scientist
January 12, 2009

The health of millions could be at risk because medicinal plants used to make traditional remedies, including drugs to combat cancer and malaria, are being overexploited. "The loss of medicinal plant diversity is a quiet disaster," says Sara Oldfield, secretary general of the NGO Botanic Gardens Conservation International.

Most people worldwide, including 80 per cent of all Africans, rely on herbal medicines obtained mostly from wild plants. But some 15,000 of 50,000 medicinal species are under threat of extinction, according to a report this week from international conservation group Plantlife. Shortages have been reported in China, India, Kenya, Nepal, Tanzania and Uganda.

Commercial over-harvesting does the most harm, though pollution, competition from invasive species and habitat destruction all contribute. "Commercial collectors generally harvest medicinal plants with little care for sustainability," the Plantlife report says. "This can be partly through ignorance, but [happens] mainly because such collection is unorganised and competitive."

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Associated Press
January 8, 2009

Anti-psychotic medications reduce symptoms, but at a high cost, study says

LONDON - Anti-psychotic drugs commonly used to treat Alzheimer's disease may double a patient's chance of dying within a few years, suggests a new study that adds to concerns already known about such medications.

"For the vast majority of Alzheimer's patients, taking these drugs is probably not a worthwhile risk," said Clive Ballard, the paper's lead author, of the Wolfson Centre for Age-Related Diseases at King's College London.

"Would I want to take a drug that slightly reduced my aggression but doubled my risk of dying? I'm not sure I would," Ballard said.

The research was published Friday in the medical journal, Lancet Neurology.

Alzheimer's disease is the most common cause of dementia and causes symptoms including aggression, delusions and hallucinations. Previous studies have shown anti-psychotic drugs, which can help control the aggression and hallucinations for a few months raise the risk of death in older patients with dementia. There are other side effects, including respiratory problems and stroke.

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Fluoride Alert.Org
January 11, 2009

Editor's note: You don't have a right to choose what type of water to drink or use. The majority of drinking water in the U.S. is adulterated with fluoride. The dentists make the decision and lobby the state and local governments to add the chemical into your drinking water because they say it's good for your teeth. But just because they say fluoride is good for the teeth does not mean they have the right to force you to drink it. If fluoride is indeed good for the teeth, people can use supplements or whatever anytime. But why this chemical, which has been found to pose a health risk such as bone cancer in boys, should be added to in the public drinking water systems? Something fishy, but the answer is obvious.

Up until the 1990s, no research had ever been conducted to determine the impact of fluoride on the pineal gland - a small gland located between the two hemispheres of the brain that regulates the production of the hormone melatonin. Melatonin is a hormone that helps regulate the onset of puberty and helps protect the body from cell damage caused by free radicals.

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tv.mpp.org

December 25, 2008

As we say goodbye to the Bush Administration, we’d like to take this opportunity to give the outgoing President and his Drug Czar their final grades.

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Posted by Xeno on January 9, 2009

First the frogs started disappearing. Then the bees started disappearing. Now, according to the Seattle Times, its birds:

Pelicans suffering from a mysterious malady are crashing into cars and boats, wandering along roadways and turning up dead by the hundreds across the West Coast, from southern Oregon to Baja California, Mexico, bird-rescue workers say.


200901090949.jpg Frogs and bees are so different from people that they are easier to ignore. But birds are larger, more complicated, warm-blooded animals, and thus closer to us biologically.

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NewsWithViews.com
By NWV News Director, Jim Kouri
December 22, 2008

While most Americans were bombarded with news coverage regarding the presidential race without end, President George W. Bush almost silently signed a senate bill that would change America forever.

S.1858 allows the federal government to screen the DNA of all newborn babies in the United States. According to the legislation, the new law must be implemented within 6 months of Bush's bill signing in April 2008.

According to police experts, this infant DNA collection is now being carried out by individual states and sample DNA is being submitted to the feds. Congressman Ron Paul states that this bill is the first step towards the establishment of a national DNA database.

The rational for the Newborn Screening Saves Lives Act of 2007 is that it represents preparation for any kind of natural or man-made emergency or disaster. The bill states that the federal government should "continue to carry out, coordinate, and expand research in newborn screening" and "maintain a central clearinghouse of current information on newborn screening... ensuring that the clearinghouse is available on the Internet and is updated at least quarterly." Sections of the bill also make it clear that DNA may be used in laboratory experiments and tests.

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