IADSA Briefs

Warnings on black cohosh and isoflavone safety
Following the actions taken in the UK and Canada, Japan's Ministry of Health, Labour and Welfare (MHLW) has now put out a warning message to Japanese users of black cohosh to the effect that, while there are no actual examples of the herb causing health problems in Japan, care should be exercised regarding its intake.

The MHLW also issued advice about soybean isoflavone. Previously, MHLW had advised consumers that the upper limit of soybean isoflavone should not be more than 30mg/day if taken in the form of soybean isoflavone aglycone. It also warned people who wanted to avoid taking too much isoflavone in supplements or other concentrated or fortified foods that they should not consume such products.

However, MHLW's advice has caused confusion with users, who pointed out that a single serving of tofu contained more than 30 mg isoflavone. As a result, MHLW has now issued further advice to the Japanese people. The notice promotes both soybeans and soybean-derived foods as important nutrition sources for their protein and calcium content, but it also advises that they should be consumed as part of a properly balanced diet.

CoQ10: Upper level set
The Ministry of Health, Labor and Welfare has sent out a notice concerning the upper intake limit of Coenzyme Q 10 (CoQ10). Taking into account the Food Safety Commission's conclusive assessment report, which stated that it is difficult to set the upper limit, the Ministry has decided that any product that exceeds the pharmaceutical upper limit of 30 mg must have its safety guaranteed by the manufacturer/marketer.

The Ministry has recommended the industry to implement the following:

  • Verification of safety for long-term use
  • Providing consumers with intake warnings
  • Accumulation of information on consumer health hazards

The Japan Health Food & Nutrition Food Association (JHNFA) has already begun communicating the above to the industry by setting a guideline for No. 1 and No. 2. Concerning consumer health hazards, the association plans to provide a questionnaire on its website. It will also hold meetings in Tokyo and Osaka where the safety of CoQ10 will be discussed.

Conference on maximum levels
The European Federation of Associations of Health Product Manufacturers (EHPM) and the European Responsible Nutrition Alliance (ERNA) will hold a high-level conference in Brussels, Belgium, on November 24 on setting maximum and minimum amounts for vitamins and minerals in foods.

Entitled Setting Maximum Amounts for Vitamins and Minerals, the conference will be introduced by Mr Robert Madelin, Director General of DG SANCO of the European Commission, and will bring together key stakeholders, regulators scientists and opinion-formers in a discussion forum aimed at facilitating progress toward a common understanding of how such levels should be set.

More information: Valérie Talamini at [email protected]

Association appeals government order on maximum levels
The French dietary supplement association, SDCA, has recently lodged an appeal against its government's order, announced earlier this year, which fixed (low) national maximum levels for vitamins and minerals in dietary supplements.

In summary, the grounds for SDCA's appeal are as follows:

  • the procedure of the Food Supplements Directive are poorly transposed into French law
  • the directive does not allow a member state to create new rules, as has been done in France
  • the general principles of food law are not adequately taken into account
  • the principle that maximum levels should be set on safety grounds is not adequately taken into account
  • consideration of the principle of free movement of goods is lacking
  • the order has an insecure legal basis caused by the absence of transitional measures.

United Kingdom
Kava kava ban upheld
The sale and import of foods and herbal medicines containing kava kava was originally banned in the UK on the grounds that in rare cases the use of products containing the herb could lead to liver damage. At the time, it was agreed that the evidence leading to the ban and any new data that became available would be reviewed after two years.

Now, both the UK Food Standards Agency (FSA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) have carried out the promised reviews, but both bodies have concluded that the ban should be upheld. In the view of FSA, "The new data were not sufficient to demonstrate the safety of food products containing kava kava …" and MHRA considered that the prohibition order continued to be "… justified and proportionate."

Kava kava is also withdrawn from sale to varying degrees in France, Germany, Portugal and Ireland. The USA and New Zealand are carrying out safety assessments while products remain on sale, while Canada and Australia are also conducting safety assessments but are advising consumers not to use kava kava while this process takes place.

New Zealand
Warning for vitamin K-enriched milk
The New Zealand Food Safety Authority (NZFSA) is requiring that two new bone-health products — a milk and a yoghurt enriched with vitamin K — carry warnings that vitamin K can interfere with the blood anticoagulant drug warfarin, commonly taken by people with heart disease.

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