Bill C-51 and Natural Health Products - The Facts

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Beverly Tate
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1 Bill C-51 and Natural Health Products - The Facts 1. How will Bill C-51 change the way natural health products are regulated? Bill C-51 will not affect the way that natural health products are regulated in Canada. The Natural Health Product Regulations, introduced in 2004, will continue to operate the same way under the proposed Bill C-51. Bill C-51 has been drafted to complement and support current policies for natural health products. The Natural Health Product Regulations already recognize that natural health products are different from drugs, and that the evidence requirements for drugs are not appropriate for natural health products. Bill C-51 does not change this. In fact, Bill C-51 supports different requirements for different types of products. Therefore, the standards that are used to assess the risks and benefits of natural health products will continue to incorporate history of use, traditional uses and cultural practices. The regulated activities for natural health products have already been identified in the Natural Health Product Regulations, and do not change. These regulated activities are: manufacturing, packaging, labelling, importation and distribution of natural health products for sale. Revisions to the list of controlled activities in Bill C-51 are only for cells, tissues and organs. For natural health products, compliance and enforcement activities will continue to be guided by the Compliance Policy for Natural Health Products and the Health Products and Food Branch Inspectorate's Policy This means that any future decision to take action will continue to be based on the same risk-based principles used today: the higher the risk to human health and safety posed by a natural health product, the more immediate the compliance and enforcement action. 2. Why is it necessary to regulate natural health products? The legislation requires vigilance to ensure that tainted products are found and recalled, that what is on the label is actually in the bottle, and that health claims are supported by evidence. Health Canada often issues warnings about mislabelled products or products that have serious adverse reactions. For example, diethylene glycol was found in fluoridated toothpaste and liver toxicity has been associated with the use of a Black cohosh product that was found to contain a species of the plant different than the one stated on the label. We have also seen cases where a natural health product makes a completely unfounded health claim- the ability to cure cancer or SARS for example. In addition, the increasing import of products and ingredients from foreign countries will require oversight to assure product safety and quality for Canadians.

2 3. Why aren t natural health products regulated and legislated as foods? The Natural Health Products Regulations were developed based on the recommendations of the Standing Committee on Health. During the development of the Regulations, the vast majority of stakeholders indicated that they did not want natural health products regulated as foods. 4. Will Bill C-51 cause the price of natural health products to rise? No. Under Bill C-51, Canadians will continue to have access to natural health products that are safe, effective and of high quality. The Bill will not limit access to natural health products nor should it increase their costs as it does not call for a change to the way in which these products are regulated. 5. Will jobs be lost or will the supply of natural health products be restricted by Bill C-51? Under Bill C-51, Canadians will continue to have access to natural health products that are safe, effective and of high quality. The Bill will not limit access to natural health products nor does it call for a change in their regulatory status (from over-the-counter to prescription). 6. Will I still be able to get my natural health product at my local health food store under Bill C-51? Yes. Canadians will continue to have access to natural health products that are safe, effective and of high quality. The Bill does not apply to retail sale of natural health products and therefore will not alter consumers ability to access products. 7. Will naturopathic doctors and other health care practitioners have continued access to the products they need to assist their clients? Yes. Bill C-51 does not target practitioners who compound products for their patients. 8. Is Bill C-51 targeting natural health products practitioners or consumers? No, the activities of natural health products practitioners falls under provincial jurisdiction. Personal use of products by consumers is also not affected by Bill C-51. The regulated activities for natural health products are already identified in the Natural Health Products Regulations, and remain unchanged. These activities are: manufacturing, packaging, labelling, importation and distribution of natural health products for sale. The new definition of sale in Bill C-51 will not affect practitioners. The relationship between practitioner and patient for compounding falls under the definition of practice of medicine and is under provincial jurisdiction. Bill C-51 respects this arrangement.

3 9. What harm/safety issues justify the Natural Health Products Regulations? The Natural Health Products Regulations are the Government of Canada s response to the Standing Committee on Health s 1997 report Natural Health Products: A New Vision. In its report, the Standing Committee recommended that a unique regulatory framework for natural health products, separate from the Food and Drug Regulations, be created. These recommendations were made following a thorough analysis of consumer use of natural health products as well as the way in which these products were being regulated at the time (as drugs under the Food and Drug Regulations). While natural health products are generally low risk, Health Canada has addressed a number of health and safety issues relating to natural health products, as was found with adulterated products such as the prescription drugs benzodiazepines in sleep aids and sildenafil in herbal products for erectile dysfunction. There have been substitution problems as was found with diethylene glycol in fluoridated toothpaste, and incorrect plants being used in a Black Cohosh product (which are for relief of the symptoms of menopause). Also, where good manufacturing practices have not been respected, there have been safety issues around bacterial contamination, and the presence of heavy metals, including arsenic and lead. Infants, children and the elderly are particularly vulnerable to these types of contamination. 10. How will Bill C-51 impact manufacturers/suppliers of, and thereby my access to, professional caliber therapeutic products? Bill C-51 will not impact the way in which natural health products are regulated in Canada. Manufacturers and importers of natural health products will continue to be subject to the same regulatory requirements they have been subject to since the implementation of the Natural Health Products Regulations in January The definition of therapeutic products in the Bill is fairly broad. Natural health products are not really mentioned, where do they fall within this broad definition and is there a way to be more distinct within it? Under Bill C-51 the term therapeutic products encompasses a range of products sold for therapeutic purposes, including drugs, medical devices, biologics, and natural health products. This does not change the classification of a natural health product nor impose additional requirements. The Government is proposing amendments to the Bill that would define Natural Health Products, and would separate NHPs from drugs under the umbrella of therapeutic product. This would ensure that the third category of NHPs is created in the legislation. Deleted: ill Deleted: will 12. Does Bill C-51 require natural health product manufacturers, importers, packagers and labellers to obtain an establishment license instead of a site license?

4 No, Bill C-51 does not change the requirements for site licensing of the natural health product industry. The requirements for a natural health product site license remain consistent with the Natural Health Products Regulations. This applies to natural health product manufacturers, importers, labellers and packagers. The term establishment license is an umbrella term that is used in Bill C-51 to support a number of different types of licenses that are required to manufacture products. Bill C- 51 will allow different types of establishment licenses to be created, including site licenses for natural health products, and site registration for other products. These existing licensing systems will not change. 13. Will a health food store require a special license to sell natural health products? No. The Natural Health Products Regulations do not impose product licence requirements on retailers. The controlled activities covered by the Regulations include: manufacturing, packaging, labelling and importation of natural health products for commercial sale and distribution in Canada 14. Does section 15.1(4) of this Bill give the power to designate therapeutic products as drugs? Could natural health products be swept into the class of 'drugs' and require prescription given this power? Under the current Food and Drugs Act, products are either classified as drugs, cosmetics foods, or medical devices. Natural health products are presently classified as a subset of drugs, but have their own unique regulatory framework (the Natural Health Products Regulations) separate from the regulatory regime for drugs (the Food and Drug Regulations) The Government is proposing an amendment to the Bill that would distinguish natural health products from drugs. This would ensure that NHPs could not be classified as drugs. 15. I am afraid that by lumping natural health products into the broad definition of "therapeutic products" used in the Bill, that the line will become blurred between natural therapeutics and drugs. As an ND, I cannot prescribe drugs. Thus, I fear that in future, I may lose my rights to prescribe vital nutrients, herbs and remedies to patients. Bill C-51 will not impact the way in which natural health products are regulated in Canada. While classified as therapeutic products under the Bill, natural health products will continue to be regulated under their own regulatory system - the Natural Health Products Regulations - which is separate from the regulatory system for drugs. There is nothing in Bill C-51 that changes the regulatory status of natural health products from over-the-counter, as they are now, to prescription. Under Bill C-51, Canadians will

5 continue to have access to natural health products that are safe, effective and of high quality. Natural health products would continue to be classed as therapeutic products because they make health claims, and because the Government does not wish NHPs to become subject to the international Codex Alimentarius. Deleted: ill 16. Since the introduction of the Natural Health Products Regulations, is there an example of a natural health product being converted to a prescription drug? No. Since the Natural Health Products Regulations came into force in 2004, there have been no amendments to convert a product from a natural health product to a prescription drug. 17. What licensing will be required under Bill C-51 to permit a mother to give her child a tablet of vitamin C? No licence whatsoever will be required. The Bill does not target the personal use of natural health products by Canadians, including mothers who give natural health products to their children. 18. Do Natural Health Products require DIN numbers? No they do not. Natural health products require a Natural Product Number (NPN) or, in the case of homeopathic medicines, a Homeopathic Medicine Number (DIN-HM) in order to be legally sold in Canada. This requirement has been in place since January 1, 2004 under the Natural Health Products Regulations. The evidence requirements under the Natural Health Products Regulations are flexible, and different from those relating to DIN drugs. The standards that are used to assess the risks and benefits of natural health products will continue to incorporate history of use, traditional uses and cultural practices. 19. Is there a way to appeal a decision made by Health Canada regarding the licensing of a natural health product? Sections 9(2) and 9(3) of the Natural Health Products Regulations provide stakeholders with the option to request that the Department, on behalf of the Minister of Health, reconsider its decision to refuse to issue or amend a product license. 20. Does Bill C-51 push natural health products under the same laws as prescription drugs? Natural health products will continue to be regulated as over-the-counter products under the Natural Health Products Regulations, which have been in force since January 1, 2004.

6 21. Will changes to the Food and Drugs Act result in a ban on natural health products? Will this change mean a prescription will be required for natural health products, like Vitamin C? No. There is nothing in Bill C-51 that changes the regulatory status of natural health products from over-the-counter, as they are now, to prescription. Under Bill C-51, Canadians will continue to have access to natural health products that are safe, effective and of high quality. Natural health products will continue to be regulated in the same way under the Natural Health Product Regulations, which have been in force since January 1, Why does Bill C-51 change the definition of sell and how will this impact small natural health product business owners? Under Bill C-51, the definition of sell is amended to provide clarity with respect to distribution and leasing activities. These clarifications would mainly apply to cells, tissues and organs and to medical devices. These changes do not impact natural health products. 23. What is the future under Bill C-51 for supplements and will there be regulated doses? Will 100mg tablets of vitamin C be available and allowed without prescription? The Bill will not limit access to natural health products nor does it call for a change in their regulatory status (from over-the-counter to prescription). Under Bill C-51, Canadians will continue to have ready access to a wide range of over the-counter natural health products, including vitamin and mineral supplements of various doses and levels. Allowable dosage levels for all natural health products will continue to be determined by the evidence provided to support their safety and efficacy. 24. What impact will Bill C-51 have on the prescribing relationship between a naturopathic doctor and their patient? No impact whatsoever. Bill C-51 does not target practitioners who compound products for their patients and respects the practitioner-patient relationship. The practice of medicine falls within provincial jurisdiction. 25. If Bill C-51 passes, will this mean that ALL or most therapeutic products will need a prescription from a doctor? No. Bill C-51 does not change the classification of a natural health product nor impose

7 additional requirements such as changing their status from over-the-counter to prescription. 26. How will Bill C-51 impact clinical trials? The requirements for conducting clinical trials involving natural health products are outlined in the Natural Health Products Regulations, which have been in force since January 1, Bill C-51 will not change the manner in which clinical trials for natural health products are reviewed and authorized by Health Canada. 27. Will the increased enforcement powers, fines and penalties in Bill C-51 lead to more compliance action against natural health product companies? Updates to the Act will not result in more compliance and enforcement action taken for regulated products, including natural health products. A modernized Act will allow Health Canada to undertake more effective compliance and enforcement activities by providing the Department with the authority to act based on a product's level of risk. The fact is that the current compliance and enforcement portions of the Food and Drugs Act are over 50 years old and need to be updated. Canada lags significantly behind other parts of the world in this area, especially the United States, Europe, and Australia. The compliance and enforcement proposals will allow us to respond to risks, regardless of the product type - they will not result in more enforcement action taken against natural health products or any other regulated product. In fact, the approach to compliance and enforcement activities for natural health products will stay the same, and will continue to be guided by the Compliance Policy for Natural Health Products and the Health Products and Food Branch Inspectorate's Policy Any decision to take action will be based on the same risk-based principles that are used today: the higher the risk posed by a product, the more immediate the compliance and enforcement action. However, further amendments are being proposed by the Government that would ensure that inspectors use their powers in a reasonable way, gauging their enforcement actions according to the degree of risk of the product. Deleted: to ensure 28. Does Bill C-51 allow inspectors to go into private homes at will? No. If an inspector needed to enter a private home, they would have to have the owner's consent or, after making a compelling case to a judge, a warrant to enter. There is nothing in Bill C-51 that changes this. Some manufacturing sites may not be situated on public roads or beside public spaces. The Bill contains a provision that would permit inspectors to cross private property to gain access to a manufacturing site. This provision does not, in any way, permit an inspector to enter a private home without consent or a warrant.

8 Section 23 of the Bill sets out very clearly the requirements for a warrant to enter a dwelling house. 29. Why is it necessary to have such a dramatic increase in fines and penalties? While fines under Bill C-51 have increased, the highest fines are intended to be applied for the most severe contraventions. A minor contravention would not be treated in the same manner as an incident that has significant impacts on the health and safety of Canadians. For instance, in dealing with cases of counterfeit, Health Canada has been limited to imposing a maximum fine of $5,000. This is in comparison with other jurisdictions where fines for similar contraventions have been in excess of $5,000,000. Canada's fines and penalties structure is over 50 years old and is significantly behind modern international regulatory authorities such as the United States, Europe, Australia and New Zealand. Canadians deserve the same protections as citizens of other countries. An increase in fines and penalties will deter companies who do not intend to comply with the Food and Drugs Act and its Regulations. The increase is meant to emphasize the importance of maintaining the integrity of the Canadian supply chain, which all Canadians rely on for safe health products. 30. Since there is a backlog in approvals for natural health products, will the natural health products that are not approved be subject to the seizure and fine powers under Bill C-51? The Natural Health Products Regulations are enforced pursuant to the Compliance Policy for Natural Health Products, which employs a risk-based approach to enforcement. Compliance and enforcement action will be taken if the natural health product has not been issued a submission number or the product has been identified as posing an unacceptable risk to the health and safety of Canadians. For more information on the Compliance Policy for Natural Health Products, please visit this website: Can Health Canada seize your bank account? No. This authority does not currently exist in the Act nor is it included in Bill C Will inspectors be able to levy fines up to five million dollars or seek two years in jail for the suspect? No. Inspectors cannot levy fines or sentence people to terms in prison. As is currently the case under the Food and Drugs Act, only those regulated parties who are prosecuted and found guilty through the judicial process are subject to the fines and penalties provisions of the Food and Drugs Act. Accordingly, such fines and imprisonment terms can only be

9 applied by the courts. 33. How many inspectors will Health Canada, Canadian Food Inspection Agency and the Canadian Border Services Agency have because of Bill C-51? Bill C-51 itself does not increase the number of inspectors for Health Canada, the Canadian Food Inspection Agency or the Canadian Border Services Agency. 34. If a natural health product is licensed to do one thing and a naturopathic doctor tells me to use it for another issue, am I or the naturopathic doctor committing a crime? No you are not committing a crime. Bill C-51 does not target the health care practitioner/patient relationship or the personal use of products by consumers. However, Health Canada always encourages consumers to use products in accordance with the label instructions or to seek the advice of a health care practitioner prior to offlabel use (i.e. using a product for a reason other than what is indicated on the label). 35. What happens if a natural health product is deemed to be dangerous and the retailer will not remove it from the shelves? A product that has been determined by way of scientific assessment to be dangerous, and which the retailer nevertheless chooses to leave on the shelves would pose a serious and imminent risk to health and safety and, as such, would warrant risk mitigation steps. Accordingly, and consistent with the Health Products and Food Branch Inspectorate s Policy-0001, Compliance and Enforcement Policy, Health Canada would seize such a product. 36. Does the Minister of Health own any shares in a pharmaceutical company? No. 37. Will Bill C-51 interfere with our Charter rights? No. 38. Why should Health Canada be able to decide what a Natural Health Product can or cannot say in regards to claims of health benefit? Health Canada s mission is to help the people of Canada maintain and improve their health. Part of this includes having appropriate checks in place to help ensure that the natural health products Canadians use are safe, effective and of high quality and also that products are labelled accordingly and truthfully (including any warnings or cautions) so that Canadians can make safe and informed choices. Having a unique set of regulations for natural health products allows for them to be

10 considered within appropriate parameters, and allows for health claims to be made based on evidence that is appropriate for these kinds of products. 39. If someone wants to take a natural health product in a way that is not approved by Health Canada, but has worked for them in the past, why can t that person make the decision that s right for them? Bill C-51 will in no way impact the way in which consumers choose to use products. However, Health Canada always encourages consumers to use products in accordance with the label instructions or to seek the advice of a health care practitioner prior to offlabel use (i.e. using a product for a reason other than what is indicated on the label). 40. Is Bill C-51 going to impact the rules surrounding growing an herb garden? No. Growing is not a regulated activity under Bill C-51 s controlled activities. 41. Will Bill C-51 impact my ability to hold a pot-luck dinner? No. If you have any questions, or comments on the proposed Action Plan and/or the proposed legislation changes, please contact us by or by calling

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