Natural health products (“PSN“) are substances which include homeopathic medicines, traditional medicines and other substances of natural origin, in particular minerals, certain vitamins, essential fatty acids, amino acids, probiotics, plants and their extracts. These substances are regulated under the Natural Health Products Regulations (the “RegulationsWhich fall under the Food and Drugs Act. The Regulations also set out the requirements applicable to manufacturers, distributors, importers, packagers and labellers of NHPs.
In Canada, no one can sell an NHP unless a product license (a “PSN license”) Has been issued in respect of this NHP. Under the Regulations, an applicant begins the process of obtaining an NHP license by submitting an application to the Minister of Health (the “Minister“). Such a request (a “APL“) shall include the information set out in section 5 of the Regulations, including, as indicated in paragraph 5 (g),” information that demonstrates the safety and effectiveness of the natural health product when used in accordance with the recommended conditions to use “. If all of the conditions set out in section 7 of the Regulations are met, the Minister will issue an NHP license to the applicable NHP applicant. These conditions include:
- as set out in paragraph 7 (a), determine whether the request is submitted to the Minister in accordance with section 5 of the Regulations; and
- as set out in paragraph 7 (d), a determination of whether the issuance of the NHP license is not likely to result in damage to the health of a purchaser or consumer.
Despite the seemingly simple nature of Sections 5 and 7 of the Regulations, applicants who submit PLAs to the Minister may still wonder what information is actually required to meet the requirements of those sections. The recent decision of the Federal Court of Appeal in Canada RNA Biochemical Inc. v. Canada (Health) (the “C-RNA Decision”) Provides guidance on this issue.
In the C-RNA decision, Canada RNA Biochemical Inc. (“RNA-C”) Sought to overturn the Federal Court’s decision to uphold the Minister’s decision to deny an NHP license to C-RNA under the Regulations. The Minister concluded that the information submitted by C-RNA as part of its PLA was insufficient to support the safety of the NHP in question. At the Federal Court level, C-RNA argued that Sections 5 (g) and 7 (a) of the Regulations do not create a substantive standard but only an administrative requirement to file safety and efficacy information. . C-RNA also argued that the substantive safety requirement is found in subsection 7 (d), which requires that the approval of the PSN is “not likely to result in damage to the health of a buyer or consumer ”. The Federal Court disagreed.
On appeal, the Federal Court of Appeal upheld the conclusion of the Federal Court on this point, noting that paragraph 7 (a) (with reference to Article 5 and in particular paragraph 5 (g)) and paragraph 7 (d) of the Regulations create two distinct requirements for the issuance of an NHP license:
 … As the Federal Court observed, safety and efficacy considerations are brought together in paragraph 5 (g) as part of the risk-benefit analysis, while paragraph 7 (d) confirms that although this risk-benefit analysis favors licensing, a product license not be granted if it is likely to cause harm. In summary, an applicant must not only demonstrate that their product is not likely to cause harm to health (paragraph 7 (d)), but also that it is safe when used under the recommended conditions of use. (paragraphs 5 (g) and 7 (a)).
The C-RNA decision also provides the following takeaways that are important for all applicants for NHP licenses to keep in mind during the PLA process:
- the onus is on the applicant to demonstrate to the satisfaction of the Minister that the product for which an NHP license is sought is both safe and effective, and that such product would be so under the circumstances or under the conditions under which it would be used or manufactured available;
- the applicant must provide proof that demonstrates to the satisfaction of the Minister that the product is safe and effective. That is, the Minister must be satisfied that the applicant has not only filed safety and efficacy information, but that the evidence supports that the product is safe and effective when used. in accordance with its recommended conditions of use;
- in addition to satisfying the risk-benefit analysis contemplated in paragraph 5 (g) of the Regulations, the applicant must also demonstrate that the product is not likely to harm the health of a purchaser or consumer – which whether the product produced is effective; and
- there is no burden on the Minister to prove that a product for which an NHP license is requested is not safe or effective. However, any grounds for refusal must be rationally justified by scientific analysis, regulatory criteria and relevant policies.
With such a regulatory framework, Canadian consumers can continue to be reassured that the NHPs to which they have access are safe and effective and regulated in a manner commensurate with the level of risk these NHPs may pose to those consumers.