Food Supplements: German Risk Institute Takes Dim View

Categories

Health

Legislation

The German Federal Institute for Risk Evaluation, formerly the Federal Office for Consumer Health Protection, has established a risk assessment model for deducing maximum safe levels of nutrients provided in supplements and fortified foods, according to a recent report of nutraingredients.com. The report was published in two parts, one dealing with minerals, the other with vitamins, both available in PDF format - so far only in German language (Minerals here) (Vitamins here). We will have to wait some months for a translation, I am told.

Germany has long been one of the most restrictive countries on vitamin and mineral products, perhaps because of the relative strength of its pharmaceutical industry, which sees a threat to profits on pharmaceutical drugs as more and more people seem to turn away from drugs and try the "natural option".

Germany is also hosting and chairing the once-a-year meeting of a Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) of the international Codex Alimentarius. The committee recently finalized a Codex Guideline for Vitamin and Mineral Supplements, which states that "upper safe levels" are to be set for vitamin supplements. The procedure used to determine such dosage restrictions will be discussed in a workshop jointly organized by the FAO and the World Health Organization.

The recent publication by the Federal Institute affords us a glimpse of the direction this international process is taking, although formally it is "only" a proposal on how to put the dosage restrictions of the European Food Supplements Directive into effect. No doubt however, once used in Europe, Germany and the European Union will lobby for these same principles to be applied internationally, by making them part of the Codex procedure for setting "upper safe levels". The giudeline is up for approval in July this year, and the exact procedure will be determined by FAO/WHO.

The coming rules will hit what is arguably the safest product category in existence by a wide margin - natural health products. Supplements and herbal products are safer than normal, everyday foods and infinitely safer than pharmaceutical medicines. Medicines are often found to be highly toxic despite bearing the authorities' seal of approval. Modern medicine and specifically adverse drug reactions have been identified as a major cause of death in the Western world.

Coming back to Germany after this digression, here are my first impressions from reading the German proposal on vitamin dosage limits:

- - -

First, some background

The German administrative position has long been that of allowing a maximum of 3 times the RDA amount in the formulation of supplements of water soluble vitamins and correspondingly less (1 x RDA level) for vitamins with a narrower safety margin and for minerals. Any supplements with nutrients in higher dosage have been kept off the market as "illegal medicines" by a refusal to grant marketing authorization. Where such authorization was not sought, products were forced off the market.

Typically this was run as a two-pronged operation, a tried and tested approach involving both pharmaceutically inspired watchdog or "consumer protection" associations and the health authorities themselves. While the associations threatened and at times took legal action demanding removal of an "illegal product", more often than not collecting hefty legal fees, the health authorities finished the job where necessary by arranging police raids on offending companies.

Of course this created bad blood, especially with supplement producers in the UK, where vitamins are quite freely available. The English found they could not export their products to Germany, but at home they still faced stiff competition from those same pharmaceutical companies that had all but conspired with the German authorities to keep their products out. In 1998 the European Commission had received so many complaints that it warned Germany to change. A year later, the Commission took legal action against Germany, charging that the low-dose policy for supplements constituted an artificial barrier to European trade. The EU Court of Justice decided in April 2004, stating in its judgement that Germany was wrong to apply an across-the-board limit of 3 times the RDA to vitamin products. It was therefore no longer possible to consider all higher dosed products to be medicines to keep them out of the German market. Unless, that is, it could be shown that each substance had been evaluated on its own merits.

Enter the German "Risk Assessment" Proposal

The European Food Supplements Directive decrees that maximum amounts of vitamins and minerals in food supplements shall be set, taking into account safety levels derived from what is referred to as "scientific risk assessment". The directive adds "varying degrees of sensitivity of population groups" as a parameter to be considered as well as expected nutrient intake "from other dietary sources". As if by way of an afterthought, the directive also lists "reference intakes", as a point to consider. These reference intakes are what is generally known as dietary recommendations or RDAs.

This may seem like a pretty wide latitude for determining dosage limits, but it is entirely consistent with what Codex Alimentarius Nutrition Committee recently decided would be best for the international market as well.

It is against this background we must consider the recent German publication on a risk assessment strategy for vitamins and minerals. Here is its general direction:

1) Upper safe levels as set by previous committee work, such as the European Scientific Committee on Foods, the U.S. Food and Nutrition Board and the UK's Expert Consultation on Vitamins and Minerals are not directly challenged. Instead, the German institute proposes to use those previously established "upper safe levels" and to re-interpret them in the light of further data. No mention of the fact that these previous levels already have been set so low as to avoid any and all conceivable risks, and that many of them are being challenged as being too much on the cautious side.

2) Where previous committee recommendations appear too high by German standards - which seems to be the case consistently - the amount is lowered by subtracting the highest possible estimates of intake from consumption of foods and fortified foods. The levels so obtained are then subjected to further "risk assessment" to make sure no one ever, not even the most sensitive individual, will have too much of any one nutrient.

3) Where that "risk based" approach yields levels for a nutrient that are still considered too high, or where this approach does not allow to determine an upper limit because there simply isn't any conceivable risk, it is proposed we fall back on what the Germans call the "nutritional-physiological" approach, adopting an upper level for supplementation consistent with the RDA, with "nutritional need".

One Example

We can see on the Example of Vitamin B 12, where we will end up with this approach to "risk assessment".

"So far, no unwanted side effects have been described that could be connected to an excessive consumption of vitamin B 12 from foods or supplements, so no tolerable upper level could be established. Therefore, an upper level based on mainly toxicological considerations is not possible and the proposed formula is not applicable."

"For reasons of precaution and because of the incomplete knowledge base, the Risk Evaluation Institute (BfR) recommends that supplements should not contain more than a maximal dosage of 3 to 9 micrograms/day. The limitation is justified because of a physiologically limited capacity for absorption and because a significant increase of the recommended daily consumption does not bring any nutritional-physiological gains."

Scientific risk assessment is being used here to provide cover for a very different agenda. Consider that supplements on the international market of 300, 500, 1000 and more micrograms of vitamin B 12 are by no means rare, and have never caused any problems to those consuming them, indeed it is acknowledged that "no unwanted side effects have been described". Yet, quantities available in supplements are to be limited to what is absolutely necessary, if the German authorities will have their way.

The approach for other nutrients is similar. A sampling of proposed limits shows 15 milligrams for vitamin E, 4 milligrams for vitamin B1, little more than 5 milliigrams for vitamin B 6 and a whooping 225 milligrams for vitamin C!

Prescriptive approach

The whole of this German approach is extremely prescriptive. There is no latitude for consumers to decide for themselves, just like there is no space for real health outcomes to be pursued with supplements. Reducing your chance of sliding into chronic disease or treating an acute illness with nutritional means is definitely out. Every detail is accounted for by the "auth