Biolane^® Product Safety Information

Biolane^® has been safely sold and consumed in New Zealand since 1974, and in Europe since 1977. Important factors to consider when looking at its safety include:

• Biolane^®’s long, safe history of speaks for itself. The extract has had no safety incidents in the 30+ years that it has been on the market.
• Biolane® has been subjected to both toxicity and teratogenic studies to confirm its safety.
• Biolane® is derived from selected parts of the NZ green lipped mussel, a shellfish, which is extensively consumed as food in New Zealand and around the world.

Historical safety

Since 1974, many millions of capsules containing Biolane^® have been consumed with no incidence of toxic reactions. A significant amount of this volume has been consumed by human subjects under strict clinical supervision during clinical studies carried out in New Zealand, Australia, United Kingdom, and France.

Raw material safety

The mussels used to produce Biolane^® Extract must come from cultivated marine farms, which must be licensed by the New Zealand Government. The NZ green lipped mussel industry is world-renowned for its quality and safety guidelines, and has also been positively recognised by environmental organisations.

Mussel growing waters are monitored, the mussels themselves are monitored, and harvested mussels are monitored. This constant monitoring helps to ensure the safety and purity of the Biolane® raw material mussels.

Manufacturing process safety

The fresh live mussels are delivered to the Biolane^® manufacturing facility within hours of being taken out of the ocean.

This manufacturing facility is a registered meat and seafood processor, with an approved Risk Management Programme that includes internationally-recognised HACCP plans (Hazard Analysis and Critical Control Point).

The programme has been approved by the NZ Regulatory Authority (NZ Food Safety Authority), and is audited by the NZFSA, US FDA and EU representatives on a regular basis. The Biolane^® manufacturing facility complies with EU, USA and other market regulations for the manufacture of natural biological materials into nutritional ingredients.

After the raw material monitoring and testing; processing controls, checks, certificates and licensing; Biolane^® also tests the final product before releasing it for sale. The results of this testing are provided in a Certificate of Analysis that is available for every batch of Biolane®.

Clinically researched safety

The Department of Medicine at the University of Auckland has put Biolane^® through a range of pharmacological toxicity and teratogenicity (i.e. the potential to interfere with foetal development) studies. Although Biolane^® is a food, these studies were conducted using the standard protocol for new drug products.

The tests showed that Biolane^® is non-toxic and not teratogenic. Please note however, that although research shows that Biolane^® is not dangerous to take when pregnant, we still recommend that pregnant or breastfeeding consumers consult a healthcare professional for medical advice before using it.

Researched side effects

Biolane^® is a natural product, and most people experience no side effects from taking it. Occasionally, some people may experience indigestion, but this can be minimised by taking Biolane^® just before a meal.

Additionally, a small number (perhaps 1-2%) of people initially react with a temporary increase in joint pain. Interestingly, these people are often the ones who get the most benefit from Biolane^®, so they should continue to take the product. Most often, after a couple of days, they find the pain dissipates and they then begin to notice beneficial results.

Contra-Indications

Some people should avoid using Biolane^® Extract. These include:

• People with gout
• People with seafood allergies
• People on a total salt-free diet (Biolane^® contains natural marine minerals)
• Children

People taking prescription medications, or who are pregnant or breastfeeding should consult their healthcare practitioner.

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