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NEW
Health Canada Approves Health Claim For Immunocal
Press Release: Released on 2007-Nov-13 12:19
Immunotec Inc. (TSX-V IMM) announces that it has received regulatory approval from Health Canada to market IMMUNOCAL with the following health claim: “a natural source of the glutathione precursor cysteine for the maintenance of a strong immune system.”
The Natural Health Products Directorate (NHPD) is Health Canada’s division responsible for the evaluation of the safety, efficacy and quality of natural health products. It has issued a Natural Product Number (NPN) for IMMUNOCAL based on the credibility, strength and quality of evidence provided to support the claim.
Immunotec strongly supports the implementation of the Natural Health Products Regulation. President and Chief Executive Officer Jim Northrop notes: “The imposition of high standards to ensure the quality, safety and efficacy of natural products supports Immunotec’s commitment to excellence in product development and manufacturing. The issuance of this NPN reinforces to consumers and Distributors alike that superb scientific evidence is the foundation for IMMUNOCAL. This fact, along with the important associated health claim could have a significant impact on Immunotec’s business growth.”
Senior Vice-President, Research & Development, Dr. Wulf Dröge, is extremely pleased about this regulatory approval. “What consumers have known for quite some time has now been formally recognized by the NHPD: the health benefits of Immunotec’s lead product IMMUNOCAL for the immune system are based on solid science.”
Natural Health Products must be manufactured, packaged, and labelled in Health Canada-approved facilities according to current Good Manufacturing Practices to ensure optimal quality of the finished goods. The evaluation of the efficacy of a specific product allows consumers to make an informed choice when including natural health products in their wellness regimes.
About Immunotec
Immunotec operates out of 37,000 square foot facility located in Vaudreuil-Dorion, Quebec, Canada as well as a distribution center located in Swanton, Vermont, USA. Immunotec is engaged primarily in the development and marketing of natural products, dietary supplements, food, vitamins and personal care products, many of which are manufactured on its behalf by third parties. Immunotec's products are distributed and sold in Canada and the USA through a network marketing system and in countries under exclusive distributorship agreements.
Luc deRepentigny
Independent Distributor
613 240-7196
www.immunotec.com/cdn
www.UniqueBodyDetox.com
Sales@UniqueBodyDetox.com
Natural Product Number Issuance by Health Canada of Immunocal
Subject: NPN Issuance by Health Canada of Immunocal
Date: Fri, 23 Nov 2007 05:57:37
We are sure that many of you heard that we finally received our Natural Product Number (NPN) from Health Canada last week for our Immunocal.
What does the issuance of the NPN mean?
Basically it validates the efficacy, safety, and quality of the product by Health Canada and reassures the consumer about making an informed choice on the selection of the appropriate Natural Health Product.
Just to give you a bit of a background, on January 1, 2004, Health Canada instituted the Natural Health Products Regulations, which was created to regulate the compliance, sale, and advertising of NHPs.
The purpose of this regulation is to impose high standards and ensure that the Natural Health Products must be manufactured, packaged, and labelled in cGMP (current Good Manufacturing Practices) facilities.
How does this regulation affect manufacturers of NHPs?
All products that fall under the NHP category must submit a complete application to Health Canada, substantiating claims with the appropriate level of evidence and be manufactured in an accredited cGMP facility, otherwise Health Canada may reject the issuing of the NPN.
How does the Canadian consumer benefit from the issuance of this NPN and how can we leverage it?
It provides to consumers assurance that these products are safe since their safety has been assessed by a Health Canada evaluator and they are manufactured, packaged, and labeled in an environment meeting high standard (Site Licence). It gives credibility to the product since Health Canada has reviewed and approved the quality, safety, and efficacy that the product is safe to sell in Canada.
How does Health Canada define Natural Health Products (NHPs)?
They are classified as "vitamins & minerals, herbal remedies, homeopathic medicines, traditional medicines (such as Traditional Chinese Medicines), probiotics, as well as other products like amino acids".
Since the enactment of the Natural Health Products Regulation in 2004, Health Canada has received over 24,000 applications, of which only 4,000 NPNs have been issued. There is currently an important backlog at Health Canada with the processing of the Product License Applications. Just to give you a better idea of the timeline, we submitted the Immunocal
application in September 2004 and just received it last week; an impediment of 3 years! Product License Applications have been filed for all of our NHP products.
Health Canada is also backlogged with regards to uploading Product Licenses onto their Web site, as they only have licenses up to September 3, 2007. Therefore if you go on their Web site, you will not find the Immunocal product license on the site. We anticipate that the product license will be uploaded within the next few months and will forward you the link once Health Canada updates their site.
It's method of manufacture are unlike any other product out there.
Many illnesses BUT ONE common factor found, LOW Glutathione levels in the body.
These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease.
Information in this site is provided for informational purposes only. It is not mean to substitute for any medical advice provided by your physician or other medical professional. You should not use the information contained herein for diagnosing or treating a health problem or disease, or prescribing any medication. You should read carefully all product packaging and labels. If you have or suspect that you have a medical problem, promptly contact your physician.
