IADSA briefs

United States
Ginseng tops list for adverse events
Following concerns about the adequacy of dietary botanical supplement surveillance in the United States, a recent study set out to characterise adverse event reports submitted to FDA.

Data from 1999 to 2003 submitted to the Centre for Food Safety and Applied Nutrition's Adverse Event Reporting System (CAERS).involving adverse events associated with the six most frequently used DBS: Echinacea, Ginseng, Garlic, Ginkgo biloba, St. John's Wort and peppermint was analysed. It was found that reports involving ginseng were the most frequent, and St John's wort the least frequent.? Most reports involved multiple ingredient DBS, with gastrointestinal and neurological problems the most common clinical outcomes among single-ingredient DBS.

The report concluded that the CAERS surveillance system is potentially effective, but that reported incidents may under-represent DBS adverse events.

Source: AHPA American Herbal Products Association; [email protected]

New dietary supplements law proposed in Japan
The fundamental principles of the New Dietary / Food Supplements Law has recently been agreed by NNFA Japan. The following guidelines were released to the media by NNFA Japan's Legal Task Force Team:

  • Name and Definition
  • Health Claims
  • Responsibilities of the Business Operator
  • Scientific Substantiation of Functional Ingredients regarding both Efficacy and Safety
  • Scientific Substantiation of Dietary / Foods Supplements regarding both efficacy and Safety
  • Assurance of Quality
  • Education/communication to consumers
  • Post Launch Monitoring and Reporting of Adverse Events

The object is to facilitate discussions among all relevant groups such as members of the Japanese Parliament, the supplement industry and other stakeholders, so as to be able to propose the new law to Japan's Ministry of Health, Labour and Welfare.

Source: NNFA Japan; [email protected]

EU update on colours, sweeteners, additives
The lead Environment Committee (ENVI) in the European Parliament has now adopted its amendments to the proposed legislation package for food additives/enzymes and flavourings.

Points of particular interest include:

  • ADDITIVES — AZO colours:? The Committee added a clause that if there is evidence that a specific additive may cause undesirable side-effects (AZO dyes were quoted as an example), the Commission, in consultation with Member States, should take immediate action to ban such a substance. ?An amendment requiring that the labelling of food additives containing AZO dyes should carry a warning label was re-introduced despite rejection at first reading by the Commission because such labeling is outside the scope of this Regulation.
  • ENZYMES: The Council of Ministers had already excluded enzymes for nutritional purposes from the scope of the regulation; the European Parliament Committee also excluded 'enzymes for digestive purposes.'
  • FLAVOURS: The Committee's view was that the adoption of the Community list of flavours should be postponed from 31 December 2008 to 31 December 2010 and should only be adopted after the completion of the evaluation program.
  • Use of the term 'Natural': The Committee's view was that 100% of the source material should be obtained from natural sources, thus removing several specific requirements relating to the percentage of source material to be derived from natural sources.
  • Herbs and Spices:? The Committee excluded herbs and spices from the scope of the regulation. It also reversed the proposed system on maximum levels: no maximum level is to be defined unless the European Food Safety Authority assesses the harmfulness of certain naturally occurring undesirable substances.

In relation to children, the overall view of the Committee is that sweeteners and colours should not be allowed in foods aimed at children, and that additives should only be used if they provide an advantage to the consumer.

The European Parliament is expected to vote in Plenary on this issue in July.

Source: EHPM European Federation of Associations of Health Product Manufacturers; [email protected]

Novel foods regulation
The European Commission is currently consulting to update the approvals process and clarify the definitions for novel foods, including the latest developments in the area such as cloning and nanotechnology.

The key proposals are to:

  • speed up the approvals process by centralising the authorisation procedure
  • develop a simplified safety assessment system for traditional food from non-European Union countries
  • clarify the definition of novel food to take account of new technology, such as cloning and nanotechnology
  • update the scope of the regulation in relation to parallel legislation on specific categories of foods, such as sources of vitamins and minerals
  • provide some data protection for innovative products

Source: EHPM European Federation of Associations of Health Product Manufacturers; [email protected]

New Zealand
NZFSA warns against herbal tea
The New Zealand Food Safety Authority (NZFSA) is warning people not to consume seeds that may be found in a Chinese herbal tea made from the plant Abrus Cantoniensis and sold in retail packs under various brand names.

Also known as Canton Love Pea or Herba Abri, NZFSA is advising anyone who has the product not to consume it and to return it to the place of purchase.? The plant is not permitted to be sold as a food or food ingredient under the Australia New Zealand Food Standards Code as the seeds and possibly the seed pods are believed to be toxic.

Source: NPNZ (Natural Products New Zealand Inc.; [email protected]

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