Puresource has had an active Natural Health Product (NHP) product and site license registration program since Health Canada passed the regulations on January 1, 2004. We have filed 336 applications to-date for the NOW, Herbal Select and other private label customer brands. We have received 16 Natural Product Numbers (NPN's) to-date. We currently have four full time staff members (Bernd Licht, Kati Anton, Ana Cabral, Barbara Bak) who are involved with preparing applications. We should be completing all product licensing submissions by the end of 2007 (currently 642). Puresource and NOW Canada had received NHP Site License approval in May 2006. Puresource (Guelph, ON & Calgary, AB) has been registered as an importer of NHP's and NOW Canada (Guelph, ON) has been registered as an importer, packager, manufacturer and labeler of NHP's. NOW Canada has been manufacturing, packaging and labelling NOW, Herbal Select and private label brands since October 2005. The NOW Canada facility currently has five production/warehouse employees (Flora Randel, Brenda Emery, Lindsay MacDonald, Lisa Jackson, Bruce Anderson), our Production Manager (Jamie Williams) and quality control for all Puresource/NOW Canada facilities by the NHP product licensing team.

 

 

Ever since my brother, Lou, and I founded the NNFA Standards Committee in 1972, our firm has been at the forefront of new quality initiatives.  As far as I know, our firm is the only health industry supplement firm to use oxygen scavengers to protect our products. Our oxygen scavengers remove the oxygen in the container and avoids the destruction of nutrients that react with oxygen.  Many firms use desiccant packets to remove moisture, as we also do, but these do not remove oxygen.

 

 

Having a state-of-the-art laboratory is a major factor in managing quality.  Firms that depend on outside labs are not likely to run as many tests, and outside labs are not inspected as part of GMP certification.  Our firm is one of the fourteen supplement suppliers that have been GMP-certified by NNFA.  Other certifying organizations exist, but we believe the NNFA program is the best.

 

Better Methods of Analysis. 

 

Since we have an excellent lab, we have been able to develop better methods of analysis.  We subject these for acceptance by the American Organization of Analytical Chemists.  Joseph Zhou, Ph.D., of our firm, is in charge of the AOAC program for testing new methods.  Joseph's group includes three Ph.D.'s and has developed about 10 original methods, and improved about 100 existing methods.

 

 

To show the importance of having good methods, compare our method for vitamin C.  Vitamin C oxidizes at the rate of about 5% per year at room temperature, and faster if the temperature is higher.  It is converted into an oxidized form which cannot be distinguished from its original form by the standard USP test based on measuring only the acidity.  Our method uses HPLC to differentiate between the oxidized and original form.  Since the consumer buys vitamin C as an antioxidant, the oxidized form is considerably less valuable to him. The oxygen scavengers protect the vitamin C from oxidation.

 

One recent trend used by firms testing nutritional supplements is to set fixed levels below which products are not considered effective.  A problem with this is that individual needs differ greatly.  For example, 100 IU Vitamin E per day might be adequate for a youngster, but a senior citizen likely needs well over 400 IU per day.

 

Benefits of In-House Manufacturing and Packaging

 

Being able to manufacture and package products in-house also helps assure good quality.  We can add oxygen scavengers because we do our own packaging, and our ability to manufacture tablets, hard shell gelatin capsules, and cosmetic items means fresher products and less out-of-stocks.  We are concerned about nanotechnology and are able control our ingredients better than a firm that uses contract manufacturing.

 

 

Nanotechnology is using very small particles which can be absorbed through the skin or in digestion, when normal sized particles of the same material would not be absorbed.  This creates getting items into our bloodstreams that would not normally be there or in much greater amounts.  The particles have one dimension in the range between one and 100 nanometers and have unique oproperties because of their small size.  Nanoparticles are often called "engineered".  Excerpts from a Washington Post article by Rick Weiss on 5-17-06 follow:

 

"..a coalition of consumer and envurionmental groups petitioned the FDA yesterday to beef up its regulation of nanoparticle containing sunscreens and cosmetics..."

 

"..products being sold are sunscreens containing titanium dioxide or zinc oxide nanoparticles..."

 

"A number of namila studies have shown... some nanoparticles...cause biochemical damage."

 

Two years ago, Britain's Royal Society recommended that nanoproducts not be sold until they have undergone independent safety assessments

 

 

But even with outstanding quality elements in place, many stores that I visit are not fully convinced that it is possible to have good quality and reasonable prices.  I remind them to check page 30 of our current catalogue, where we list 58 trademarked products sold by our firm.  These products are analyzed by our own GMP facility, by the NPA Tru Label Program, Consumerlabs, and also the trademark holders that you may call to verify this.