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The Natural Health Products Directorate (NHPD) published their most recent draft of the proposed regulations for natural health products (NHPs) in Canada Gazette, Part I on December 22, 2001, on pages 4912-4971. By the time you read this, the 90-day consultation period will be over. Hopefully some of you took the opportunity to read the regulations and comment on them. The regulations will be updated and published in Canada Gazette, Part II. This will hopefully occur by the summer. This second publication will be followed by the last opportunity to comment on the regulations before they become law. The December 22 publication of the Canada Gazette can be accessed at: http://canada.gc.ca/gazette/hompar1-2_e.html, at Vol. 135, no.1.
Although some people have commented negatively about the regulations, I do not personally have any major concerns. One issue that has raised some concern is that NHPs are being classified as a subcategory of drugs. This, unfortunately, is unavoidable at present. All products for human consumption are regulated under the Food and Drugs Act and must therefore be classified as either a food or a drug. Since the new regulations will allow therapeutic claims for NHPs, they must be classified as a subcategory of drugs because under the current Food and Drugs Act, foods can not have therapeutic claims. As I mentioned in the last issue of the CJH, all of the health protection legislation and regulations are currently being reviewed. When this process is complete, the outdated Food and Drugs Act will be replaced by a new act. At that time NHPs will be defined as a distinct category of products.
Under the current regulatory regime, what really matters is that NHPs will have their own set of regulations with their own Directorate to implement them. The fact that they need to be classified as a subcategory of drugs is really more of a philosophical issue that will have no effect on the regulatory outcome if we have a good set of regulations.
Where the regulations do still have the potential to go astray is in the policies through which they will be implemented. These are not found in the proposals because policies don’t have to be legislated. The NHPD is continuing to organize ongoing consultation workshops with consumers, practitioners and industry members to help them create these policies. The’ve demonstrated a willingness to listen to our advice, but there are still one or two problems with some of the proposed policies, especially with respect to Good Manufacturing Practices (GMPs). I am optimistic that these will be ironed out in the coming months with continued consultation.
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On March 25 I attended the first workshop on the regulation of bulk herbs. Bulk herbs have been left out of the proposed regulations so far because they are very difficult to regulate due to the fact that most bulk herbs are sold for culinary purposes. Those of us who participated in the workshop identified some potential areas of concern. The members of the NHPD appreciated our input and promised that a follow-up meeting will be held in the late spring after they have had the opportunity to digest the results of the first meeting.
In March the coordinating committee on the proposed sector study on complementary and alternative medicine (CAM) presented our proposal to Human Resources Development Canada. If funding for this project is approved, it will go ahead as planned. We are optimistic that this will occur because the current government is very interested in CAM.
In January I attended a meeting with on the Regulated Health Professions Act of Ontario and presented our concerns about access to ‘restricted’ NHPs. I discovered at that time another area of concern. The Health Professions Regulatory Advisory Council (HPRAC) is also proposing that only regulated health professions will be able to use the designations ‘registered’ or ‘certified.’ We are very concerned about this because it means that it will be difficult for the public to identify those herbalists that meet the standards established by the OHA. This is another issue that you can write to the provincial Minister of Health about (see the Political Update in the last issue of the CJH). It is very important that all of our members send in their letters of concern. These issues have the potential to seriously interfere with the practice of herbalism in Ontario. Unfortunately, at the time that I am writing this, it is not clear if our new Premier is going to pick a different Minister of Health. If this occurs, it will be necessary to address your letters to the new minister. You can find the contact information for any MPP at the government of Ontario website at http://www.gov.on.ca.
As you can see, these are important times for herbalists and herbalism in Ontario and the country as a whole. The OHA will continue our commitment to the cause, but we must all speak out about what we believe in or we may lose our freedom of choice.
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