Wendy Hulton03.01.02
In late December of last year the long awaited and eagerly anticipated draft of Natural Health Products Regulations was published in Canada Gazette Part I.
In announcing the new regulations, Health Canada acknowledged the large scope of this industry by indicating that Canadian sales are estimated to exceed $1.5 billion. Further, it noted that recent surveys show more than half of Canadians regularly consume natural health products (NHPs).
Once these new regulations are enacted, Canada's Federal Department of Health will transfer the responsibility for an estimated 25,000–30,000 products to the regulatory authority of the Natural Health Products Directorate (NHPD) of Health Canada. This will include products that are currently regulated as drugs (such as vitamin and mineral supplements) as well as many products that are currently unregistered.
Historically in Canada, NHPs have been regulated as either food or drugs. This has led to significant confusion in the marketplace as consumers have been offered products labeled as foods (without health claims) alongside of almost identical products labeled as drugs (with health claims and directions for use). This situation has pushed Canadian consumers to demand regulation of these products in order to obtain assurances of both the safety and quality of NHPs.
The proposed regulations contain requirements governing the manufacture, packaging, labeling, storage, importation, distribution and sale of NHPs. Under the new regulations, NHPs will be considered a subset of drugs under the Canada Food and Drugs Act.
The proposed definition of a natural health product has a function and a substance component. NHPs will be products that are manufactured, sold or represented for use in:
• the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans;
• restoring or correcting organic functions in humans or
• maintaining or promoting health or otherwise modifying organic functions in humans.
NHPs will also include homeopathic preparations and traditional medicines.
The substance component of the definition is ingredient driven and is comprised of an inclusion list, which outlines the medicinal ingredients that can be contained within an NHP as well as an exclusion list, setting out the substances, which are not permitted in an NHP (Table 1).
Note that the proposed NHP definition allows for a full range of health claims including structure/function, risk-reduction and therapeutic or treatment claims.
The proposed regulatory framework for NHPs includes product licensing, adverse reaction reporting requirements, site licensing, Good Manufacturing Practices (GMPs), clinical trials and labeling/packaging.
Product Licensing. NHPs will be required to obtain a product license prior to sale in Canada. The applicant must provide information on the medicinal ingredient(s), recommended conditions of use, information that supports the safety and efficacy of the NHP, a copy of the specifications to which the NHP complies and an attestation that the NHP was manufactured, packaged, labeled, imported, distributed and stored in compliance with the NHP GMPs regulations. For domestic products, GMP compliance information will be derived from the site license number and in the case of imported products, the applicant will be required to submit other evidence of GMP compliance. This evidence may include a report from a Health Canada inspector or a compliance audit conducted by a person having the requisite technical expertise. Upon successful completion of pre-market review, the NHP will be issued a product license, which will include the product license number. License applications for NHPs that comply with a monograph found in the Compendium of Monographs published by Health Canada will be subject to a 60-day disposition clause. A list of monographs currently being developed by NHPD is shown in Table 2.
Adverse Reaction Reporting. Product license holders are responsible for providing Health Canada with a case report for each serious adverse reaction to their products within 15 days of becoming aware of the reaction.
Site Licensing. A site license will be required for importers, distributors, manufacturers, packagers and labelers of NHPs. A site refers to any building in which a NHP is imported, distributed, manufactured, packaged, labeled or stored prior to sale. The site license will specify which activities are permitted at the site for which it is issued.
Good Manufacturing Practices. Part three of the regulations laid out the proposed GMP regulations for NHPs. These provisions outlined the requirements for product specifications (identity, purity, potency), premises, equipment, personnel, sanitation program, operations, quality assurance, stability, records, sterility, lot or batch samples and recall reporting.
Clinical Trials. The regulations contain detailed information in connection with the sale or importation of NHPs for clinical trials.
Labeling and packaging are very important issues and all NHP labels will be required to include several items. A list of these specific requirements can be found on Table 3.
Schedule A Claims. Industry stakeholders are concerned that NHPs will be unable to make certain label claims, even if there is scientific evidence to justify them, due to the restrictions of Section 3 and Schedule A of the Food and Drugs Act. The NHPD is currently working with other Directorates within Health Canada to resolve this issue.
Standards of Evidence for Safety and Claims. A significant component of the new regulatory framework, namely, the standards of evidence for the evaluation of safety and claims for NHPs also remains undetermined at this time. A discussion document that sets out a proposal based on traditional and non-traditional uses of NHPs was tabled by the NHPD during a stakeholder consultation meeting in late October 2001.
In comparing the Canadian Natural Health Products Regulations to the Dietary Supplement Health and Education Act (DSHEA) of 1994, it has been noted that Canadian NHPs have the potential to legally make a wider array of claims than their U.S. counterparts. The flip side is the requirement for product and site licensure for NHPs sold in Canada.
Incidentally, only days after the introduction of the draft NHPs regulations Health Canada put out two advisories in connection with two products traditionally regarded as natural health products, ephedra and kava. On January 8, 2002, Health Canada requested the recall of all those ephedra products in the Canadian marketplace that did not carry a drug identification number (DIN). On January 16, 2002, Health Canada issued another advisory requesting that consumers not use kava products with or without a DIN.
Not surprisingly, members of the NHP industry in Canada have voiced concern over the potential cost of compliance with the new regulations and many stakeholders approach the new regulations with mixed feelings. It is widely acknowledged that it is realistic to anticipate that there will be fees associated with the licensing of both products and sites in the foreseeable future.
With the publication of the draft regulations on December 22, 2001, a 90-day comment period commenced during which industry stakeholders could offer comments on the proposed regulations. And the new regulations will not become law until they are published in Part II of Canada Gazette. Following enactment of the regulations, there will be a period of time for NHP manufacturers and importers to bring their products and sites into compliance with the new regulations. In the meantime, most NHPs are treated by the Canadian regulatory authorities as "Products Subject to Special Measures" and accordingly, are subject to Health Canada's Interim DIN Enforcement Directive.NW
About the author:
Wendy Hulton is a partner with the law firmMiller Thomson LLP, Toronto, Ontario, Canada. She advises food, drug, cosmetic and natural health product companies on a variety of regulatory matters. She can be reached at 416-595-8608; E-mail whulton@millerthomson.ca.
In announcing the new regulations, Health Canada acknowledged the large scope of this industry by indicating that Canadian sales are estimated to exceed $1.5 billion. Further, it noted that recent surveys show more than half of Canadians regularly consume natural health products (NHPs).
Once these new regulations are enacted, Canada's Federal Department of Health will transfer the responsibility for an estimated 25,000–30,000 products to the regulatory authority of the Natural Health Products Directorate (NHPD) of Health Canada. This will include products that are currently regulated as drugs (such as vitamin and mineral supplements) as well as many products that are currently unregistered.
Historically in Canada, NHPs have been regulated as either food or drugs. This has led to significant confusion in the marketplace as consumers have been offered products labeled as foods (without health claims) alongside of almost identical products labeled as drugs (with health claims and directions for use). This situation has pushed Canadian consumers to demand regulation of these products in order to obtain assurances of both the safety and quality of NHPs.
The proposed regulations contain requirements governing the manufacture, packaging, labeling, storage, importation, distribution and sale of NHPs. Under the new regulations, NHPs will be considered a subset of drugs under the Canada Food and Drugs Act.
Proposed Definition of a Natural Health Product
The proposed definition of a natural health product has a function and a substance component. NHPs will be products that are manufactured, sold or represented for use in:
• the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans;
• restoring or correcting organic functions in humans or
• maintaining or promoting health or otherwise modifying organic functions in humans.
NHPs will also include homeopathic preparations and traditional medicines.
The substance component of the definition is ingredient driven and is comprised of an inclusion list, which outlines the medicinal ingredients that can be contained within an NHP as well as an exclusion list, setting out the substances, which are not permitted in an NHP (Table 1).
Note that the proposed NHP definition allows for a full range of health claims including structure/function, risk-reduction and therapeutic or treatment claims.
The Proposed Regulatory Framework
The proposed regulatory framework for NHPs includes product licensing, adverse reaction reporting requirements, site licensing, Good Manufacturing Practices (GMPs), clinical trials and labeling/packaging.
Product Licensing. NHPs will be required to obtain a product license prior to sale in Canada. The applicant must provide information on the medicinal ingredient(s), recommended conditions of use, information that supports the safety and efficacy of the NHP, a copy of the specifications to which the NHP complies and an attestation that the NHP was manufactured, packaged, labeled, imported, distributed and stored in compliance with the NHP GMPs regulations. For domestic products, GMP compliance information will be derived from the site license number and in the case of imported products, the applicant will be required to submit other evidence of GMP compliance. This evidence may include a report from a Health Canada inspector or a compliance audit conducted by a person having the requisite technical expertise. Upon successful completion of pre-market review, the NHP will be issued a product license, which will include the product license number. License applications for NHPs that comply with a monograph found in the Compendium of Monographs published by Health Canada will be subject to a 60-day disposition clause. A list of monographs currently being developed by NHPD is shown in Table 2.
Adverse Reaction Reporting. Product license holders are responsible for providing Health Canada with a case report for each serious adverse reaction to their products within 15 days of becoming aware of the reaction.
Site Licensing. A site license will be required for importers, distributors, manufacturers, packagers and labelers of NHPs. A site refers to any building in which a NHP is imported, distributed, manufactured, packaged, labeled or stored prior to sale. The site license will specify which activities are permitted at the site for which it is issued.
Good Manufacturing Practices. Part three of the regulations laid out the proposed GMP regulations for NHPs. These provisions outlined the requirements for product specifications (identity, purity, potency), premises, equipment, personnel, sanitation program, operations, quality assurance, stability, records, sterility, lot or batch samples and recall reporting.
Clinical Trials. The regulations contain detailed information in connection with the sale or importation of NHPs for clinical trials.
Labeling and Packaging
Labeling and packaging are very important issues and all NHP labels will be required to include several items. A list of these specific requirements can be found on Table 3.
Schedule A Claims. Industry stakeholders are concerned that NHPs will be unable to make certain label claims, even if there is scientific evidence to justify them, due to the restrictions of Section 3 and Schedule A of the Food and Drugs Act. The NHPD is currently working with other Directorates within Health Canada to resolve this issue.
Standards of Evidence for Safety and Claims. A significant component of the new regulatory framework, namely, the standards of evidence for the evaluation of safety and claims for NHPs also remains undetermined at this time. A discussion document that sets out a proposal based on traditional and non-traditional uses of NHPs was tabled by the NHPD during a stakeholder consultation meeting in late October 2001.
Conclusion
In comparing the Canadian Natural Health Products Regulations to the Dietary Supplement Health and Education Act (DSHEA) of 1994, it has been noted that Canadian NHPs have the potential to legally make a wider array of claims than their U.S. counterparts. The flip side is the requirement for product and site licensure for NHPs sold in Canada.
Incidentally, only days after the introduction of the draft NHPs regulations Health Canada put out two advisories in connection with two products traditionally regarded as natural health products, ephedra and kava. On January 8, 2002, Health Canada requested the recall of all those ephedra products in the Canadian marketplace that did not carry a drug identification number (DIN). On January 16, 2002, Health Canada issued another advisory requesting that consumers not use kava products with or without a DIN.
Not surprisingly, members of the NHP industry in Canada have voiced concern over the potential cost of compliance with the new regulations and many stakeholders approach the new regulations with mixed feelings. It is widely acknowledged that it is realistic to anticipate that there will be fees associated with the licensing of both products and sites in the foreseeable future.
With the publication of the draft regulations on December 22, 2001, a 90-day comment period commenced during which industry stakeholders could offer comments on the proposed regulations. And the new regulations will not become law until they are published in Part II of Canada Gazette. Following enactment of the regulations, there will be a period of time for NHP manufacturers and importers to bring their products and sites into compliance with the new regulations. In the meantime, most NHPs are treated by the Canadian regulatory authorities as "Products Subject to Special Measures" and accordingly, are subject to Health Canada's Interim DIN Enforcement Directive.NW
About the author:
Wendy Hulton is a partner with the law firmMiller Thomson LLP, Toronto, Ontario, Canada. She advises food, drug, cosmetic and natural health product companies on a variety of regulatory matters. She can be reached at 416-595-8608; E-mail whulton@millerthomson.ca.
