American Authorities Wish for Better Information and Reporting about Dietary Supplements

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

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

“Amateur-like” Statement from the Organization Anti Doping Denmark

October 27, 2003

In October 2003 one could read pretty harsh warnings against the combination of dietary supplements and sports in several Danish newspapers. The medical doctor, Rasmus Damsgaard, from Anti Doping Denmark was the originator of these judgmental statements.

Damsgaard is quoted for several bastant announcements – among others: “Dietary supplements do not work – Basto”. And he calls it quite amateurish when respected coaches like Ulrik Wilbæk, give supplements to their players.

By: Vitality Council

(No references)

Press Release from the Danish Society for Orthomolecular Medicine (DSOM)

November 12, 2002

The Danish Society for Orthomolecular Medicine (DSOM):
Rumours that antioxidants should have no general effect on secondary prevention of heart disease originates from The Heart Protection Study published in July 2002 in the magazine The Lancet. The study was financed by e.g. the pharmaceutical companies Merck & Co. and Roche Vitamins.

The purpose of the study was, among others, to investigate Merck’s cholesterol lowering drug Zocor’s effect on various parameters such as blood clots in the heart and heart disease, etc. The study included 20,536 high-risk patients – ie. patients with known cardiovascular disease or dispositions for this – eg. diabetes.

The patients were randomized to 4 groups, of which 5000 patients received 600 mg vitamin E, 250 mg Vitamin C and 20 mg betacarotene. 5000 patients received both Zocor and vitamins. 5000 patients received Zocor only and 5,000 patients served as a joint control group. This means that the part of the study containing the vitamin group plus a joint control group comprised 10,000 people and not 20,536 persons as stated elsewhere.

Not surprisingly, the main result of the study showed that Zocor had a positive effect even at very low cholesterol values, which undoubtedly significantly increases the indication range for Zocor.

However, there are several criticisms, apart from the fact that the number of trial participants is exaggerated:

  • Dosage of vitamin E and vitamin C are not proportional to each other. The two vitamins are closely linked in the antioxidant protection of the cell. If there is an excess of one vitamin, it can have a pro-oxidant effect.
  • One will usually not give more than 100 – 200 mg of Vitamin E. Vitamin C should be given several times a day or as a prolonged-release preparation.
  • Vitamin C, as a single dose in a dose of 250 mg will only have an effect for a few hours. The half-life of vitamin C is approx. 4 hours, i.e. that from a daily dose alone you can not expect an effect at all – rather the opposite.
  • Beta-carotene has previously been tried alone in a major trial for lung cancer and smokers. Here, it appeared that this vitamin had a prooxidant effect with a prevalence of lung cancer in smokers as a result. The Heart Protection Study has not been able to confirm such an effect of an incorrectly unbalanced dosage.

The results of the study also coincide with the results found in the HOPE study, namely that there was no secondary preventive effect when consuming individual vitamins.

  • You can not study the effect of individual vitamins on diseases that have taken decades to develop. Vitamins act as co-factors and as antioxidants, they are involved in a complicated interaction with the body’s own enzymatic antioxidants in a way that we do not yet fully understand.
  • Individual vitamins or random combinations of two or three individual vitamins should not be perceived as a medicine that cures a disorder in the traditional sense, but as a method that can strengthen the body’s own antioxidant defenses.
  • You cannot simplify and define 3 different vitamins in an illogical mutual dosage for antioxidants generally. The antioxidant system reduces oxidized molecules. This is done according to the thermodynamic laws. The individual steps in this process, of which there are many, depend on the redox potential of the individual molecule. For example, urate is part of this chain. Urate is not an antioxidant in the traditional sense in everyday speech but possesses antioxidant properties just like albumin. A generalization is therefore completely incorrect.
  • The individual may have several or individual nutrient deficiencies. It is therefore not correct to study the effect of individual vitamins on chronic diseases.

Only in the last year has it become common knowledge that a substance such as Homocysteine (indicator of low B vitamins) has the greatest significance for risk and heart disease.

The content of the B vitamins: B12, B6, and folic acid in our food has decreased significantly since the Danish Ministry of Food began systematic studies of these in 1993. Thus 24% to 50% of the male population is at risk of deficiency diseases. Despite the private Nutrition Council’s stubborn adherence to the opposite, the Ministry of Food, Agriculture and Fisheries in Denmark is aware of this, but states that they are simply keeping an eye on developments.

The iron content of e.g. oatmeal has been reduced by 10% within just the last 5 years. The website of the British Ministry of Agriculture reports a 50% drop in selenium intake compared to 1983 and today.


By: Per Tork Larsen, M.D., DSOM

(No references)

Nutritional Council’s Negative Statements Against Dietary Supplements

12 November 2002

One again the media have been misled by the Nutritional Council’s warnings against dietary supplements.

In the news channel TV2, they stated: “Knockout for Q10 and Selenium”. This is severe disinformation of the population.

The Nutrition Council has via Steen Stender MD, reintroduced an article in The Lancet from July 6, 2002, which among others found that small doses of vitamin E, C and beta carotene had neither a beneficial or harmful effect on a risk group of cardiac patients. Q10 and Selenium are not mentioned at all in this study.

The media have uncritically settled with only listening to one party in this controversial field. -and they have not even discovered that this is a purely Danish news story. They have not wondered why this English study is not mentioned in foreign media at all.

By Vitality Council.

(No references)