Thursday, August 26, 2010

What is an NPN and what does it mean?

In Canada, natural health products (NHPs) are regulated by a government agency called the Natural Health Products Directorate (NHPD). For a company to legally sell or distribute a product that is classified as an NHP in Canada, it must apply to the NHPD for a product license, also called an NPN.

First, what is the Canadian definition of an NHP?

From the regulations:
"natural health product" means a substance set out in Schedule 1 or a combination of substances in which all the medicinal ingredients are substances set out in Schedule 1, a homeopathic medicine or a traditional medicine, that is manufactured, sold or represented for use in
(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans;
(b) restoring or correcting organic functions in humans; or
(c) modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.

Schedule 1 is a listing which sets out what products/ ingredients qualify as NHPs.

So there is a very well defined set of regulations and definitions which allow the general public and manufacturers to understand what qualifies as an NHP. Also whether a product is a food or an NHP is defined on the basis of how it is to be used. NHPs are typically sold in a format that allows them to be consumed in measured or controlled amounts (doses). If a product is sold in a particular food format (for example, a beverage) that lends itself to dosing (for example if it is sold in single dosage units or it is sold with a measure that indicates it to be consumed in controlled amounts) this is one indication that the product is an NHP. Also the product must make some form of claim as how it would affect the person’s well being as stated above.

Once a company determines the product is an NHP and what it is that they want to claim the product can do, they are now ready to start the license process. There are 3 options (assuming this discussion is limited to typical NHPs and excludes homeopathic medicines):
1. Follow a monograph as set out by NHPD. Monographs are technical documents that define what the ingredient(s) are, what they can be claimed to do, the permitted dosages, and any cautions etc that should be on the label. These are formulated based upon an expert advisory committee and always contain a bibliography of the research used to come to their conclusions. Monographed products will be licensed rapidly by NHPD and must comply 100% with the monograph.
2. Another is termed precleared information. In this situation one may be combining ingredients which are all monographed but they are in a new or novel combination. Assuming the dosages etc meet the requirements set out in the evaluation guidance, then these as well should be licensed in a short time period of less than 60 days.
3. Finally are products where all medicinal ingredients are not found in the compendium of monographs and the safety and efficacy (effectiveness) are supported by research submitted by the company. In this case, the product will be evaluated by experts within NHPD and this may take a significant amount of time to be licensed depending upon how well the company has formulated its argument and the information provided to support the argument. The time to receive a license may be up to a year or possibly more.

So as you can see in Canada NHPs are well governed by regulation and if all products are assessed in this manner then you the public should be able to have confidence that the products that you take should produce outcomes as expected and advertised.

As of August 27, 2010 the NHPD has entered the final stage of the development of the licensing program. This final stage will be expected to clear all back logged products and to start the actual enforcement of licensing. There is a 6 month transition period, meaning that after February 2011 the NHPD will be in a position to start to put pressure on manufacturers and distributors to remove products from the market that do not have a license number.

Also as an interim measure, the NHPD will allow companies to market products that have been submitted for a license but are still in the assessment phase. To get this permission a product application must have been in the assessment process for 180 days, it must also only be marketed to an adult population. If it meets these basic properties it will be given what is called an exemption number. All exempt products will be listed on the NHPD website. So if you are uncertain if a product that does not contain an NPN is legal for sale you can check this listing. If it is not on this list, it is not a product that is permitted for sale in Canada. We would expect this list to start in February 2011.

This evaluation and licensing regime is one that many other countries in the world are looking at closely and is the first of its kind. Based upon this process, it does mean that product innovation may be somewhat hindered but at the same time you the consumer can feel assured that any product that has an NPN license has met the basic quality requirements, has been produced in a licensed GMP facility, is backed by credible research findings, should be effective and is safe to use.

Monday, August 16, 2010

How much chondroitin is really in your joint supplement?

In many joint supplements, there is a combination of three ingredients: MSM, Glucosamine and Chondroitin Sulfate. MSM and Glucosamine are very easy to test and the test results are generally not in dispute. However this is not the same for chondroitin sulfate.

Why? Chondroitin sulfate (chondroitin) is a naturally occurring polymer found in most animals. A polymer is a chain of repeating molecules. These can be one molecule repeated over and over again, such as starch, which is the sugar glucose attached in a long branched chain. In chondroitin, there are 2 molecules that are attached to each other that then repeat over and over again in a long straight (unbranched) chain. The repeating unit in chondroitin is one where one molecule is always glucose plus a molecule that is glucose with 2 other groups attached. The placement of these other groups leads to the differences in the main unit. In general there are 3 different types of these 2 unit molecules and this is where things get a bit more complicated. Certain animals put these 3 unit into the chondroitin chains in a unique way. This can be detected in some test methods to indicate if the product is from a certain animal, ie shark, bovine, porcine, avian. The length of the chain can be as many as 100 of these units on average. It is because of this variety that testing for chondroitin is so difficult.

There are in general 2 ways to test for chondroitin. One of these methods cannot tell the difference between the animal type (species) of chondroitin while the other can. Because the animals make the chondroitin chain with slightly different lengths, it is another complicating factor in the analysis.

All this is to say that no method of testing the quantity of chondroitin is absolutely correct. It is done in comparison to a standard chondroitin, but again the quantity of chondroitin in this standard must be agreed upon since it depends upon which of these test methods is used in how the testing methods might see this chondroitin.

The current USP (United States Pharmacopeia) uses a method which detects the reaction of a certain chemical with one of the molecules attached to the glucose back bone. This method is often used to confirm the level of chondroitin in a product, but there are certain situations where this method does not work well and provides low results if the quality of the chondroitin is not high enough.

The other method uses a fairly complicated and uses a High Performance Liquid Chromatograph (HPLC). First the chondroitin is treated with enzymes that can break down the chondroitin to its simple 2 molecule components. This takes some very careful work to ensure that the enzymes work to completion. Then the unknown material is compared again to an agreed standard of chondroitin to determine the quantity. In this case it is complicated in that your standard must be from the same species as the test product. If the test product is a combination of more than one species, then this test does not work well or gives inaccurate results.

The bottom line is that no matter which method is used, the outcome is based upon a general agreement as to what it is measuring. So as a user of chondroitin, it is difficult to know if first the product you are using was even tested for chondroitin. If it was tested, it is difficult to know how well the test was performed or which testing procedure was followed.

As a manufacturer, we are committed to producing high quality products. For this reason, we have standardized one test method (the generally accepted USP method) and we test all finished products containing chondroitin to ensure that we are delivering what our labels indicate that we deliver. We use only the highest quality chondroitin. Another reason to trust iWinDirect.

Friday, August 6, 2010

Buyer Beware: The importance of an NHPD Site License

The US Food and Drug Administration has alerted the public in regards to spiking of nutritional supplements with pharmaceuticals and the like.

or the Health Canada site for warnings:

So it is buyer beware. You need to take caution with what you are taking in terms of nutritional supplements and natural products. There are many products in both Canada and the United States which have been recalled for just these reasons.

So how do you protect yourself?

First and foremost is to purchase from a reputable supplier. The next is to look for the natural product license number on the label. This tells you that the Natural Health Products Directorate (NHPD) in Canada has assessed the product and the company has been granted a license to sell this product based upon the NHPD reviewing and agreeing to the safety and the effectiveness of the product for the claims being made on the product. A company is required to be able to provide the NHPD with proof that they are testing the product according to the requirements set out in their license. Therefore, you should feel confident that products with an NPN are doing what they say and contain no harmful contaminants. Manufactures of NPN products must also have a site license which is issued to them by the NHPD after a though review of documentation to provide evidence that the company follows strict Good Manufacturing Practices as set out by the NHPD.

As part of its commitment to the safety of its products tests, Direct NutriSciences tests every single lot of product produced to ensure that it passes the requirements for microbiological safety at a bare minimum. The cause of many food and other product safety recalls is the presence of harmful bacteria or microbiological contaminants.

At Direct NutriSciences, we recently renewed our site license and again met – or exceeded - all requirements. Though food products (such as protein powders) do not require an NPN, many of our supplements have met the requirements and received an NPN. We are committed to have more in future. If there is interest, I will write a future post to give more details on what is the process around getting a product license.