Extensive studies on toxicity have been carried out on Seatone GLME and no toxic effects were observable in the test subjects at 120 times the standard dose.

These studies are similar in design to those conducted by pharmaceutical companies to show that a drug is safe to use in people. Not only was Seatone GLME safe at very high dosages, but it also had no teratogenic effects (i.e. no harmful effects on developing fetuses when administered to pregnant animals).

Healtheries Green Lipped Mussel Extract (GLME) Powder was first introduced to the New Zealand market in April 1974. Since that time the demand for this product has spread to over 30 countries worldwide with the greatest demand currently coming from the European Union countries, the United States and Japan. Although the product is derived from a shellfish, which is extensively consumed as food, it has been subjected to both toxicity and teratogenic trials to ensure that the derived material is as safe to consume as the original food source.

Since 1974 many millions of capsules of the GLME have been consumed with no incidence of toxic reactions. It is pertinent to comment that a significant amount of this product has been consumed by human subjects under the strict supervision of clinicians during clinical studies carried out in New Zealand, Australia, United Kingdom, and France.

There are, of course, inherent safety concerns with any marine based product and which have little or nothing to do with the properties of the food itself. These are addressed individually in the following text.

Source of Raw Material - Green Lipped Mussels

Shellfish used to produce Healtheries Green Lipped Mussel Extract must come from cultivated sources (marine farms) and the farms must be licensed by the New Zealand Government. The fact that the farms are licensed ensures that they are located in suitable (unpolluted) areas of the coastal waters and also that shellfish may only be harvested from them when conditions are appropriate. For example, rainfall in the region adjacent to marine farming areas is monitored and, if the rainfall exceeds a certain level, harvesting of shellfish from farms in the affected area is not permitted. Enforcement of this regulation is effective in that processing plants, which in order to be licensed to process shellfish are subject to stringent regulations monitored by the Ministry of Agriculture and Forestry (MAF) cannot receive or process shellfish not suitably certified.

Biotoxins

The potential exists for filter feeding marine shellfish to become contaminated with species of algae containing natural biotoxins, which have adverse effects on human health. Whilst the adverse effects and their mode of action vary with the species, this is not relevant so far as the safety measures taken to preclude biotoxins poisoning incidents resulting from the consumption of Green Lipped Mussel Extract powder is concerned.

To this end the Government established a Biotoxins Management Committee which has the responsibility for monitoring all areas of the coastal waters where marine farming of shellfish takes place. Regular sampling and analysis of the phytoplankton present in these waters ensures that algal species known to contain biotoxins are not present in numbers, which could cause toxicity problems in shellfish. In addition, periodic samples of mussels being used to prepare the extract are submitted to the authorized laboratories for biotoxins testing to be carried out.

There is an additional safety factor involved with the absence of biotoxins contamination in Green Lipped Mussel Extract. It is due to the fact that there is a significant time delay between the harvesting of the shellfish and the availability of the final product in powder or capsule form. This time delay ensures that in the unlikely event of a retrospective finding of algal contaminants in mussels, the final product would not have been released to the market prior to the manufacturer becoming aware of the situation.

Microbiological Contaminants

Because marine farming is essentially a coastal water operation, it is subject to the influence of land drainage and other discharges, which have the potential to cause microbiological contamination of the waters. Mussels are filter-feeding animals and thus are able to concentrate contaminants as well as foods from their surrounding waters. Although the licensing criteria for marine farms require that they be situated away from areas directly influenced by sewage and other such discharges there is always the possibility of microbiological contaminants from sea birds, run off waters from grazing pastures etc being present in the waters of the farm area.

To prevent any risk of microbiological contaminants being present in cultivated mussels, or the extract processed from them, routine monitoring of the waters is carried out and, in addition, every batch of mussels received for processing is subjected to microbiological assays at the factory on arrival. Further, the factory quality control programme requires that the processing of the mussels, through the several stages from shellfish to powder or capsules, be monitored by sampling and analysis for microbial levels by the in house laboratory.

As a final safeguard, the end product in powder or capsule form is subjected to microbiological assay and certification by an independent, Government approved laboratory.

Heavy Metal Contaminants

Most countries to which the mussel extract product is exported have mandatory maximum levels for the content of heavy metal contaminants in food products they will accept. New Zealand is not a heavily industrialized nation and therefore there is no problem with heavy metals in industrial effluents (which are more damaging than, their natural, elemental forms). There are, however, natural background levels of metals present in the seas around New Zealand but not of a magnitude to cause problems in marine derived products.

However, the maximum specified levels for heavy metal content apply to the mussel extract and therefore to ensure that the levels in the product are less than these maxima, samples of the final product are subjected to analysis and certification by government approved laboratories.

Pesticides and Herbicides

Inevitably pesticidal and herbicidal sprays will drift into the sea from crop spraying activities. In addition rain and subsequent land drainage causes residual spray to be washed into streams and rivers, which eventually finish up in the sea. For this reason pesticide and herbicide residue testing is carried out on mussels and also on random batches of the final mussel extract product. There have been no problems associated with either of these contaminants during the past 24 years of producing mussel extract powder.

Safety Aspects During Manufacture

The manufacturing process for Healtheries Green Lipped Mussel Extract is carried out to a Hazard Analysis Critical Control Point (HACCP) programme as required by the USFDA for products acceptable to the USA. The programme has been approved by the Regulatory Authority (MAF) appointed by the USFDA for local administration under a Memorandum of Understanding between the two countries. The Company has an HACCP Coordinator on staff and the requirements of the programme ensure that reception of shellfish and subsequent manufacture is all carried out to the approved standards. These are monitored randomly each week by MAF officers.

In addition the Company has its own laboratory and quality assurance and control programme which monitors the reception of raw materials and their progress through the processing stages.

Pharmacological Safety of the Product

As has been mentioned above, the Green Lipped Mussel Extract has been subjected to both toxicity and teratogenic studies by the Department of Medicine at the University of Auckland. Although the Green Lipped Mussel Extract is a food these studies were conducted to the standard protocol as used for new drug products since they apply equally to food or drugs. The product has been shown to be non toxic and not teratogenic. There is of course the possibility of a person experiencing an allergic reaction to the product but this is something, which can happen with any food, drug or contact material.

Conclusion

Healtheries Green Lipped Mussel Extract processed in the manner and to the standards described above is a safe product for consumption on a continuous and regular basis.