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ARTICLES A New Era in Natural Health Product Regulation On March 26, 1999, three years of a grueling lobbying effort finally paid off. The federal Minister of Health, Allan Rock, announced that he was accepting all 53 of the recommendations of the Standing Committee on Health included in their report "Natural Health Products: A New Vision." Quite expectedly, many consumers want to know how this will effect natural health product (NHP) regulation in Canada. To complicate matters, a few individuals and organizations have been conducting a public misinformation campaign aimed at confusing Canadians and stirring up opposition to the proposals of the Standing Committee. The following information will hopefully clear up some of the confusion. Background: Under current regulations, all vitamins, minerals and homeopathic remedies and some herbs and food supplements are regulated as drugs. These products are expected to conform to standards that were developed for the regulation of pharmaceutical products. They are regulated by "experts" whose training and philosophical orientation are strictly pharmaceutical in nature. Most herbs and nutritional supplements, however, are currently regulated as foods. These products are not required to meet quality standards. The labels of these products are not allowed to include any pertinent information on the use of the product such as accurate dosages, contraindications or claims (i.e. what the product is used for). Until recently, an increasing number of NHPs in the food category were being declared unacceptable for sale as foods by the Foods Directorate of Health Canada. It was left up to the Therapeutic Products Programme (TPP, formerly the Drugs Directorate) to decide whether these products met their narrowly defined criteria that would allow them to be sold and regulated as drugs. Very few did. As a result, an increasing number of NHPs were being classified as "New Drugs." These substances can not be sold as foods and are not allowed for sale as drugs until their is enough scientific research available to satisfy the criteria established by the TPP for inclusion in the drug category. These products were essentially regulated out of existence and many NHPs were disappearing from the marketplace. In addition, due to the current budget slashing trend, Health Canada had been instructed to create a "cost recovery" system that would allow them to collect fees for their services that could generate enough funds to cover most of their budget. A study that they conducted on the impact of this initiative projected very clearly that the majority of small to medium size companies would not be able to survive the implementation of these fees. Since the majority of NHP manufacturers fall into this category, this would have had a tremendous negative impact on the industry. The Current Situation: After a lengthy lobbying effort that was spearheaded by the Canadian Coalition for Health Freedom in the fall of 1996, before the last federal election, the political and regulatory climate has changed drastically. I have been informed by several reliable sources that federal MP's received more letters, faxes and phone calls on this issue than they have on any other issue for a very long time, possibly more than any other issue in Canadian history. In the last two years we have seen the creation of and final report of the Advisory Panel on Natural Health Products and a lengthy public inquiry by the federal government's Standing Committee on Health. During this inquiry, hundreds of consumers, practitioners, businesses and organizations expressed their views. Others made written submissions. In November of 1998, the Standing Committee released its final report, "Natural Health Products: A New Vision." This report included 53 recommendations. The following is a summary of these recommendations: On March 26, 1999, in an unprecedented move, Allan Rock, the federal Minister of Health, announced that he is accepting all 53 of the Standing Committee's recommendations. In accordance with these recommendations, he is immediately creating a Transition Team that will be made up of a wide cross-section of "stakeholders" (consumers, practitioners and industry members) from within the field to oversee the creation of the new Office of Natural Health Products. The Transition Team will be responsible for helping to select the Executive Director of the ONHP and an Expert Advisory Committee that will also contribute to the creation and implementation of the new regulations as outlined in the recommendations of the Standing Committee. As recently as two years ago, no-one expected that the results of our campaign would be this successful. Although there is still a lot to be accomplished, if we continue in the direction that we are going, Canada will have the best NHP regulations in the world, by a long shot. Sadly, in spite of the gains that have been made, there are still a handful of individuals and organizations that are trying to undermine this process. For the most part, the opposition has come from three sectors: (1) The bureaucrats at Health Canada who want to maintain control over these products and uphold the current regulatory regime. (2) Prescription drug manufacturers and some medical associations. (3) A small group of over-zealous extremists, the majority of whom haven't read the recommendations and are unaware of their actual content, and a few individuals who have a personal hidden agenda. We expected opposition from the first two groups. It is the existence of the third group that is most unfortunate because these individuals are traditional supporters of NHPs. Rather than working together for the good of the whole, they are continuing to disseminate false information to consumers in an attempt to create opposition to the initiatives of the Health Minister. The following are some of the "facts" that they have been propagating: Claim 1: The new regulations will hand over control of NHPs to huge multinational pharmaceutical companies. Reality: Industry involvement in the lobbying efforts to bring about the creation of these recommendations largely resulted from the initiative of small to medium sized manufacturers, distributors and retailers of NHPs. During the campaign, the huge pharmaceutical manufacturers opposed the direction of the Advisory Panel and Standing Committee. They want NHPs to remain under the jurisdiction of the TPP. Among the traditional NHP manufacturers, the largest companies (who are tiny compared to the pharmaceutical giants) were the last to support our position. There is another lobbying effort involving nutraceuticals and functional foods that is primarily being driven by the large food manufacturers. It would be in their best interest if many NHPs are regulated as foods. This is the position that they support. Claim 2: The new regulations will result in the disappearance of many NHPs. Reality: This has been very much the case under the current regulations. Most of the products that were removed from the marketplace resulted from the actions of the Foods Directorate of Health Canada. Almost all of these products were removed for inappropriate reasons. Until recently, Health Canada was using an elusive document that they called their "Status Manual" as the basis for policy regarding the sale of NHPs. Consumers and industry members were never able to obtain a copy of this manual because, according to the Health Canada bureaucrats, "it is always changing." And so it was. In 1997, the number of NHPs being regulated into the "New Drug" category and therefore out of existence was increasing almost on a weekly basis. However, everything has changed. At the end of 1997 when it became apparent that the Advisory Panel on Natural Health Products was going to call for radical regulatory change, Health Canada had to finally scrap their precious Status Manual. As a result, even though the new regulations have not yet come into effect, many formerly banned products are already back on the market. Examples include: ginkgo, black cohosh, kava kava, goldenseal, barberry, taheebo and many others. Many consumers were not aware that these products were banned because retail stores were still selling them. At that time, the Foods Directorate had been preparing a list of more that a dozen additional NHPs that they believed were "not suitable for sale as foods." This list contained many popular herbs including St. Johnswort. This initiative was also terminated. One of the first jobs that will be assigned to the new Expert Advisory Committee will be to revue the status of the few NHP's that are still banned or only available by prescription such as L-tryptophan and melatonin. "Although we feel that the government has a responsibility to protect public health and safety, this should not be applied in a way that unreasonably denies consumers access to products that they perceive to be necessary for their well-bing." ("Natural Health Products: A New Vision," page 69) Claim 3: Under the new regulations NHPs will be of an inferior quality. Reality: There have been many studies that have demonstrated the unfortunate practices of unscrupulous companies selling inferior quality products. This is largely made possible by the fact that many NHPs are still regulated as foods. The quality control standards for foods are very weak and they are not mandatory. The best way to ensure that the pharmaceutical industry will take over the NHP sector will be to allow NHPs to continue to be marketed as foods without appropriate regulation. As consumers become more aware that they are often being ripped-off, they will be discouraged from using NHPs. "The Committee agrees that NHPs sold on the Canadian market must meet high standards of safety and quality. Furthermore, the Committee acknowledges that GMP (Good Manufacturing Practice) guidelines relevant to NHPs must be developed … Appropriate GMP guidelines will guard against packaged products that do not contain what they claim to contain." ("Natural Health Products: A New Vision," page 29) Claim 4: The new regulations will raise the cost of NHP's to consumers and bankrupt small businesses. Reality: The cost recovery policies of Health Canada would definitely have had this result. However, when it became apparent to the government that a review of NHP regulation was necessary, the Health Minister exempted NHPs from the cost recovery fees until a more appropriate and reasonable regulatory and fee structure can be developed. The Standing Committee was also very aware of the potential impact of the regulations on the cost of manufacturing and the cost to consumers: "…the Committee considers that any cost recovery program for NHPs should be fair and reasonable and not result in unnecessary restriction of access to NHPs." ("Natural Health Products: A New Vision," p. 54). The Health Minister has committed $7 million dollars for the creation and operation of the ONHP over the next three years. He has also committed an additional $3 million for research on NHPs. This money comes from the funds that were committed to health care in the last federal budget. Some individuals are concerned that the operation of the ONHP will place an additional tax burden on Canadians. With the exception of the start-up costs that came from money that was already assigned to health care (maybe our friends would rather see this money spent on some pharmaceutical initiative), additional funding will be trimmed from the existing budgets of the Foods Directorate and the Therapeutic Products Programme since a significant part of their former expenditures resulted from the regulation of NHPs. Therefore expenditures need only be reallocated, not increased. Fortunately for Canadians, it is becoming increasingly more apparent that those who oppose the recommendations of the Standing Committee will not succeed in their efforts. If the position of the bureaucrats and pharmaceutical companies were put into effect, regulation would have continued as before. The majority of medicinal herbs and nutritional supplements would eventually disappear and all remaining NHPs would be regulated as drugs at a higher cost to the consumer. If the extremists had their way, NHPs would be essentially deregulated. Consumers would then be forced to buy products in ignorance, with no relevant information on their labels. Nor would consumers have any guarantee of the quality of these products. They could never be certain that a particular product actually contains what it says it contains and in the quantity indicated. Canadians have spoken loud and clear on this issue. They want NHPs to be readily available and freedom of access to health care products of their choice. They also want appropriate information to allow them to make educated choices, and assurances that the products they consume meet appropriate quality standards. The Standing Committee on Health and the Health Minister have obviously listened with open minds. They have made the best choices possible on a very complex issue. It is important that we support their initiatives. However, we must be vigilant. The bureaucrats at Health Canada have attempted to undermine this process at every stage. They have attempted to manipulate the Advisory Panel, the Standing Committee and the Health Minister. They will undoubtedly attempt to manipulate the Transition Team and the Expert Advisory Committee as well. Nevertheless, we have come further than anyone expected and I am very optimistic (for the first time in years) about the direction in which the Standing Committee and the Health Minister have chosen to proceed. They deserve our applause and support. This article was originally published in Vitality Magazine, May 1999. Back to List of Articles |
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