Safety of herbs and natural products in Canada

Are herbal supplements safe ?

Herbal product regulations in Canada 

In 2004, the Natural Health Products Regulations came into effect in Canada.  NHP (Natural health products) are defined by Canada Health as: vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines such as traditional Chinese medicines, probiotics and other products like amino acids, facial products, shampoos, antiperspirants, mouthwashes and essential fatty acids. These products to not need a prescription and those that do would fall under Food and Drug Regulations. At this time, Health care practitioners do not have to be licensed under Health Canada to compound products on individual basis for their patients or to retailers of such products. The license requirements only applies to person or company that manufactures, packages, labels and/or imports NHPs for commercial sale in Canada.

In Canada, natural health products that have been licensed have a eight-digit Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM) on their label. npn numberIn theory, they can’t be sold in Canada unless they have the proper product license. To get such a license, there is an application process they applicants have to go through and a series of detailed information must be provided like: medicinal ingredients, source, dose, potency, non-medicinal ingredients and recommended use(s). Now, like anything, there is always exceptions or exemptions. If a product has not yet been approved by Health Canada, it may be provided an exemption number that will be on the label as : EN-XXXXXX. The products with the EN and number have gone through some initial assessment in order to make sure safety, quality and efficacy has been met but have not fully received certification yet. It seems Canada Health has done this in order to allow continuing access to these products for the general public, kind of like if it was a probably period pending approval.  As a consumer, I was not even aware that there where regulations in regards to these products.

Health Canada also requires that claims on products be backed up by proper evidence. What is proper evidence is where some herbalists, traditional doctors and conventional doctors disagree. Health Canada considers as evidence: clinical trials, published studies, journals, and traditional resources. Depending on the claim of the products, more or less evidence is needed to support the health claim and its safety. But, because as we know, it is often hard to establish double blinded studies, clinical trials when it comes to herbals, there lies the difficulty in its regulations. To be licensed in Canada, a NHP label must include a list of things. Health Canada also requires licensing for sites where natural health products like herbs are manufactured, packed, labeled or imported. Health Canada require that these companies promote good manufacturing practices and it requires adverse reaction reporting. Health Canada also regulates the human clinical trials. Practionners have on-line access to up-to-date information on licensed NHPs by using the  Licensed Natural Health Product Database (LNHPD). Also, practionner have access to safety issues through the The MedEffectDatabase. You can also visit the Canadian Homeopathic Pharmaceutical Association for more information.

 

In 2012, I called the Health Canada department to inquire about animal products. They told me that they didn’t regulate products that are for us in animals, so they had me called the CFIA (Canadian Food Inspection Agency). I talked to a veterinarian working for the CFIA. As far as he knows, he says they have regulations for veterinary drugs and veterinary biologics.  But, by definition veterinary herbals and natural supplements do not fall under those designations. According to him, natural health products labeled for use in animals (herbals, food supplements like omega 3, etc) don’t seem to be controlled directly by Canada Health nor the CFIA. After making other calls to different suppliers, the conclusion is that there are no agency regulating veterinary herbal products or natural products designed for use in animals in Canada. Animal health natural products and supplements fall into a grey zone and are currently not regulated. Only voluntary adherence by some companies guarantee their products sold to animals. I have looked into different herbal and nutraceuticals suppliers in Canada, and only a few have actual quality control protocols in effect.

In April 2014, I found out that in Januray 2012, Health Canada, the Canadian Animal Health Institute and North American Compendiums had joined to develop a notification program for low risk veterinary health products (LRVHPs) used in cats, dogs and horses that are not intended for food.  These products include botanicals, vitamins, minerals and homeopathic preparations. This is a voluntary program which means that animal supplement companies are not required by law to follow any safety or GMP (good manufacturing practices) guidelines. Natural Health Veterinary Products approved by this Program will use the initial NN instead of NPN which is reserved for human products. This type of program will help consumer know that when they buy a product with the NN number, that these companies have good Manufacturing practices and quality control systems in place. Furthermore, these products will have procedures in place in case of recalls and also will control what kind of claim can be put on their labels. Veterinary supplement companies wanting to apply for this program can visit this website http://www.lrvhp.ca

A study done by the University of Guelph published in October 2013 showed that a lot of over-the-counter human herbal products contained fillers or omitted ingredients on their labels or had the wrong ingredients listed. Something like over 60% of the products tested contained herbs not listed on the labels, 32% had product substitution and 20% contained fillers like rice, soybeans and wheat. Here is a link to the article for more in dept information about what the researchers found.

The moral of the story is: check your suppliers and check your own human products. Are you buying products that have NPN (for people) or NN numbers (for pets) ? Are you sure that the vitamins you are giving to your family are safe and quality controlled? I have found an improvement in the amount of NPN/NN products now available in the pharmacies but more work needs to be done. In regards to animal vitamins and over-the-counter products, I have yet to see much improvement in that department. I only buy products  from suppliers that I have researched, trust and that have established quality and security controls in place (GMP measures). In the event of a recall, I am contacted directly by my suppliers and I can contact my clients directly to prevent issues.

Written by Dr Cindy Lizotte, DVM, MBA, CVFT (CHI institute), CVA (IVAS), Grad Dip Vet Western Herb Med (CIVT) Cert CVHM (IVAS)

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