Risk Assessment Model for Supplements

Yet another major threat to your health freedom comes via a group led by Dr Rolf Großklaus (Chair of the Codex Committee on Nutrition and Foods for Special Dietary Uses).  It has just produced a "risk assessment model" for deducing maximum safe levels of nutrients provided in supplements and fortified foods.

New German report claims that food supplements are unsafe

A newly-established German institution, the Federal Institute for Risk Assessment (BfR), released a 341-page report on risk assessment of nutrients used in food supplements.  The report makes recommendations for maximum levels for dietary supplements that are well below those that are commonly present in vitamin and mineral supplements sold in health stores in the UK, Ireland, Sweden, other EU countries, the USA and elsewhere.  Many people might understandably assume, as a result of this report, that commonly available food supplements are unsafe.

The Alliance for Natural Health (ANH), a pan-European body of interests in the natural healthcare field, strongly contests the science used by the German institute.  Good science and good law underpin all of the ANH's work, and the scientific reports produced by the ANH are endorsed by many of the world's leading doctors and scientists working in the field of nutritional medicine.

The report, for example, recommends a maximum level of vitamin C of 225 mg in food supplements, when many health stores sell 1000 mg tablets, and significant numbers of people safely consume 2000 mg or more per day.  Maximum recommended dosages for vitamin B6 have been set at 5.4 mg, against 25 mg or more commonly found in UK and US supplements, while vitamin B12 has been set at an astonishing 9 mcg, compared with over 300 mcg in many supplements.

For years, many European countries have regarded multi-vitamin/mineral supplements containing the Recommended Dietary Allowances (RDAs) for nutrients a means of assessing safety, but this approach has been found to be scientifically unjustifiable as RDAs are minimum levels that guard against the development of deficiency diseases that are uncommon in modern, western societies, such as scurvy, beri-beri, pellagra and rickets.  Scientific risk assessment is the recently-acclaimed approach that will replace RDAs for evaluation of safety, having been endorsed both by the European Union in its Food Supplements Directive, set to come into force in August of 2005 (barring its being overturned in the European Court of Justice), and the United Nation’s Codex Alimentarius, which develops global guidelines for food safety.

Dr Robert Verkerk, executive director of the Alliance for Natural Health says:

The maximum levels for vitamins and minerals proposed by BfR are in many cases far lower than those required for optimum health.  They have used what is purportedly a scientific method to produce data that is meaningless for the majority of the population.

The problem is that the poor science used in this report will be viewed seriously by EFSA — the European Food Safety Authority — that is developing maximum levels for use in food supplements in Europe, and Codex Alimentarius, which is setting global guidelines on vitamins and minerals.  In the worse case scenario, the science could be adopted by EFSA lock stock and barrel, and that would be catastrophic for the leading edge of the natural products industry in Europe, as well as US innovative suppliers, practitioners and consumers of these products.

In December 2004, the Alliance for Natural Health submitted a ground-breaking critique of risk assessment methods to the FAO/WHO of the United Nations in response to a consultation on the subject.  The ANH report demonstrated the flawed nature of existing scientific risk assessment methods used by the EU's Scientific Committee on Food, in turn used as the baseline for upper levels by BfR.  BfR have gone on, as proposed in the EU's Food Supplements Directive, to reduce further the already unnecessarily low "upper safe levels" by taking into account dietary intakes and susceptible population groups, and ended up with meaningless, unreasonably low maximum recommended levels for food supplements.

The ANH's landmark case against the EU's proposed ban on 75% of vitamin and mineral forms currently on the UK market was heard in the European Court of Justice in Luxembourg on 25 January.

Grossklaus's team arrived at their conclusions after "assessing data from population studies, assessing current intakes of all of the vitamins and minerals from the 'typical diet'" (whatever that's supposed to be).  These are then subtracted  from the upper safe levels for these nutrients established by European & other scientific committees.

(Note that Grossklaus's team has been influenced heavily by the infamous conclusions of the Nordic Ministries Council — the folks who have already destroyed consumer access to high potency vitamins in Denmark and Norway.)

See the whole story.

The final "recommended maximum levels for food supplements", as recommended by Dr. Großklaus and his team, are as follows:

Vitamins
Beta-Carotene: 2-4 mg
Vitamin D: 5-10 µg
Vitamin E (equivalent): 15 mg
Vitamin K: 80 µg
Vitamin B1 : 4 mg
Vitamin B2 : 4.5 mg
Niacin: 17 mg
Vitamin B6: ?5.4 mg
Folic acid: 400 µg
Pantothenic acid: 18 mg
Biotin: ?180 µg
Vitamin B12: 9 µg
Vitamin C: 225 mg

Minerals
Sodium: 550 mg
Chloride: 830 mg
Potassium: 2000 mg
Calcium: 1200 mg
Phosphorus: 1250 mg
Magnesium: 400 mg
Iron: ?15 mg
Iodine: 200 µg
Fluoride: 3.8 mg
Zinc: 10 mg
Selenium: 70 µg
Copper: 1500 µg
Manganese: 5 mg
Chromium: 100 µg
Molybdenum: 100 µg

These are ridiculously low standards; far below what is needed for any serious therapeutic support for a whole range of health conditions that respond well to nutritional therapy.

And keep in mind when you read this that the entire American supplement industry is being led blindly to the cliff from within by the NNFA's pharma-dominated law firm, Sidley, Austin, Brown and Wood, LLP.

---

In the article below, the UK-based Alliance for Natural Health skewers a recent German report calling for mindless restrictions on allowable potency levels of vitamins and minerals.

Risk model on supplement levels prompts concern for EU law

1/20/2005 — The first attempt in Europe to set maximum safe levels for nutrients in supplements and fortified foods demonstrates that numerous products could be declared unsafe, if the same approach is adopted across the European community.

Scientists at Germany's Federal Institute for Risk Assessment (BfR) gathered data on dietary habits in Germany and nutrient levels in the current food supply, and substracted these from the upper safe levels (USL) of nutrients determined by the EU's Scientific Committee on Food.  Their conclusions, published in a 341-page report, suggest that supplements should contain a maximum level of 225 mg vitamin C, 5.4 mg of vitamin B6 and 9 mcg of vitamin B12.  All of these vitamins are sold at considerably higher dosages — up to 1000mg for vitamin C and 300 mcg for B12 — in supplements on several European markets.

While the report is designed for review by German food authorities, it is also likely to be considered by European regulators charged with developing maximum safe levels for nutrients under both the 2002 Food Supplements Directive and a proposed regulation on fortified foods.  No other member state has carried out such work, making the German study a powerful resource for the European Food Safety Authority in the future.

A discenting view

However, a natural healthcare association, the Alliance for Natural Health (ANH), claims the data is "meaningless for the majority of the population".  The group has previously contested the science used by the SCF to draw up upper safe levels for nutrients.  It says that the German institute has now gone beyond this to further reduce these levels by taking into account dietary intakes and susceptible population groups, and ended up with "unreasonably low maximum recommended levels for food supplements".

Dr Robert Verkerk, executive director of the ANH, told NutraIngredients.com: "We have always been concerned that this approach, [as proposed in article 5 of the food supplements directive], would end up with very low levels, and the German report shows that it does."  David Adams, chair of the UK's Health Food Manufacturers Association (HFMA), agreed that "the figures look terribly low".

"The UK trade obviously wishes to see maximum safe levels that are in line with established UK practice," he added, noting that the assocation had had "very constructive discussions" with the UK's Food Standards Agency after an expert group (known as the EVM) produced guidance levels for supplement nutrients in 2003.  These discussions resulted in a system of advisory statements, currently found on supplement labels in the UK, to warn consumers of potential risks — a welcome alternative to banning high dose supplements altogether.

The German report has clear implications for the UK industry, one of Europe's largest, which offers supplements at higher doses than many other member states.

Dr Verkerk points out a number of problems from the approach used by the BfR, particularly in their grouping together of nutrients and populations for efficiency purposes.  "If you look at iron types as a group, the data for the most toxic form is applied across the board.  So the toxic ferrous sulphate impacts data on iron bisglycinate, [considered lower risk]."

"You are also looking at the most susceptible population groups, such as in the case of beta-carotene.  Some of the main data on this nutrient comes from trials including smokers and asbestos workers, naturally at higher risk of disease."  Subjecting the whole population to the same risk assessment as more susceptible groups skews the safety data to levels that are unnecessarily low for most people, he suggests.

Dr Verkerk believes that regulators should initially focus on high risk nutrients as a priority.  "Risk management is about focusing energy on high risk problems.  We should focus specifically on the 30-40 high risk nutrient forms, such as the fat-soluble vitamins and some potentially toxic mineral forms like selenium and zinc, and develop a risk assessment system for these as the first move forward," he said.

"But to also include vitamin B12 in this is crazy.  Even the SCF could not impose a safe upper level on this nutrient."

Dutch food authorities have set a precedent for this kind of approach, added Verkerk, by allowing all supplements to be sold as food, and only imposing limits on a small number of nutrients, like certain vitamins known to present risk in high doses.