Tag: FDA

Huge victory for freedom of speech in America

Claus Hancke

May 5, 2011

The U.S. Food and Drug Administration (FDA) has suffered a stinging defeat in a lawsuit in Washington DC, where their tyrannical censorship of serious health claims have been found unconstitutional.

In the beginning was the word
“First Amendment to the United States Constitution” refers to freedom of expression as fundamental to the nation and is also the foundation of any civilized legal community today.

Without freedom of expression – no freedom
However, in civil services in many countries a tendency has crept in to promote their own political objectives by intimidation and over-management rather than under-management.

This is well known in Europe’s vast civil service, where no case is too small to rule from Brussels. And here in Denmark we know it as a tendency of the civil sevice to administer dietary supplements regulations in a far more restrictive way than it has ever been thought or spoken in the EU Food Supplements Directive, although this is much more restrictive than the equivalent in the U.S.
In other European countries like the Netherlands and England the same EU
rules are administered far more in consistent with people’s interests than is the case here in Denmark.

In the U.S. in 1996 the civil rights group “Citizens for Health” succeeded in implementing that a dietary supplement can only be banned if it is harmful.
Here in Denmark it will be prohibited if it is beneficial!

Lawsuit against FDA
It was the straw that broke the camel’s back to the “Alliance for Natural Health (ANH), and the organization sued the FDA in this matter in the District Court for the District of Columbia,” which recently ruled in the case.

The Court ruled that the FDA’s censorship of documented claims are contrary to the U.S. Constitution very first words about freedom of speech. The Court even allowed explicitly the following claims, which however was not about dietary supplements, but vitamins: “Vitamin C may reduce the risk of gastric cancer” and “Vitamin E may reduce the risk of bladder cancer”.

Denmark
Unfortunately we can´t expect Danish politicians in a foreseeable future to be awakened by a population who is surprised that there are health-promoting information, it may not get, even if it so desires.

One day, people will make politicians aware that this is contrary to the Article 10 of the European Convention on Human Rights in which one may not prevent people from information that they wish to receive.

This means that the authorities are on thin ice when they prohibit Internet sites that contain documented product information about diet or dietary supplements. The citizen performs however a independent active action when he or she click their way to a website; – thus accessing information on their own hand. But this is not allowed. It is not good for him to see how he can improve his health.

It must strike one with wonder, who might have an interest in restricting the population from such information.

A cry for freedom
Allow us here at Denmark’s Independence Day, May 5th to make below pious desire to promote general health in a free Denmark:
The Danish Vital Council believes that people should have free access to information about dietary supplements and free access to buy safe dietary supplement. This is the best guarantee to prevent accidents and to ensure that the consumer gets the best possible product to suit his needs.
This implies that:

1) The consumer must have free access to information
The Vitality Council believes that misinformation must be penalized.
Today we penalize information in Denmark. Not even pharmacies and doctors must be informed about the available scientific evidence concerning dietary supplements.
This should be changed so that consumers can get free access to accurate information.
2) The consumer must have free access to dietary supplements
The Vitality Council does not believe that it is in the public interest to have curtailed ones right to buy the dietary supplements, one may wish, when these are otherwise safe to consume.
The Vitality Council must therefore urge that no authority administratively hinder people’s access to dietary supplements whose safety can not be doubted.

By: Vitality Council

www.anh-usa.org/free-speech

American Authorities Wish for Better Information and Reporting about Dietary Supplements

Claus Hancke

April 12, 2004

Since 1994 liberal legislation in the United States has secured the American population full access to safe dietary supplements. 2½ year ago FDA asked the Institute of Medicine (IoM) to investigate the extent of harmful effects of supplements. The FDA received this report from IoM last week.

The conclusion is, among other things, that there are very few safety data for the 29,000 different dietary supplements sold in the United States, and the concern seems to be that this market grows by 25% a year, and today amounts to about 18 billion. dollars annually.

When the IoM was asked to do a safety assessment of the market, it was because there was growing concern about one supplement in particular, namely “Ephedra”, which was sold as a popular slimming and energy aid. The effect is somewhat reminiscent of the Danish, now banned drug, Letigen.

Ephedra does not exist in Denmark, and if it did, it would have to be registered as medicine, just as Letigen was in its time.

The FDA has now banned Ephedra as a dietary supplement after it caused 155 deaths and 16,000 cases of side effects. By comparison, over-the-counter arthritis medications (NSAIDs) cause 16,000 deaths in the United States each year.

The IoM also found products with wide variation in content, and products, particularly Chinese herbal preparations, which were contaminated with heavy metals and medicines. In some of the Chinese supplements, the medicine was actually added to promote the effect.

The IoM therefore proposes a “whistleblower” system with a central registration of side effects, similar to the Danish Side Effects Board, which is a fine idea. However, the IoM also writes that many side effects could be avoided if the consumer was sufficiently well informed.

This is a memento to the Danish system, where the Danish Food and Drug Administration prohibits information to both consumers and retailers of dietary supplements. Yes, not even doctors and pharmacists must be taught even the most factual information regarding dietary supplements.

This should be changed so that we increase security for the Danish consumer.

By: Vitality Council

Reference:
Special report: A health fad that’s hard to swallow, New Scientist Special Report, 12. April 2004.