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Food and Drug Act (Canada)

. Canada RNA Biochemical Inc. v. Canada (Health)

In Canada RNA Biochemical Inc. v. Canada (Health) (Fed CA, 2021) the Federal Court of Appeal reviewed aspects of the federal Food and Drug Act, here dealing with Natural Health Products (NHPs):
[9] The NHP Regulations fall under the Food and Drugs Act, R.S.C., 1985, c. F-27 (FDA). The purpose of the NHP regulatory framework is to provide Canadians with access to safe, effective and high quality NHPs, and to regulate these products in a manner commensurate with their level of risk.

[10] There is an inter-relationship between the NHP Regulations and the Food and Drug Regulations, C.R.C., c. 870 (Food and Drug Regulations). The definition of "“natural health product”" under the NHP Regulations explicitly excludes drugs described in Schedules C and D of the FDA, and subsection 2(2) of the NHP Regulations prevents substances from being considered NHPs if they are required to be sold by prescription (FC reasons at para. 17). Similarly, if a drug is included on the Prescription Drug List, it presumptively falls outside the scope of the NHP Regulations (FC reasons at para. 18; Food and Drug Regulations, s. C.01.040.3).

[11] Apart from these legislative demarcations or distinctions, the regulatory evaluation and analysis conducted under each scheme are "“legally and operationally discrete”" from one another (Canada (Health) v. The Winning Combination Inc., 2017 FCA 101, 413 D.L.R. (4th) 362 at para. 8 (Winning Combination)).

[12] An NHP is defined to include naturally-occurring substances (or synthetic duplicates) identified in Schedule 1 of the NHP Regulations which are manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease or disorder (NHP Regulations, s. 1). Schedule 1 includes animal products or products that are derived from animals. NHPs are intended for self-directed over the counter use by consumers, with no or limited practitioner oversight and monitoring. NHPs are thus necessarily sold without a prescription; as noted, any substance requiring a prescription is regulated pursuant to the Food and Drug Regulations.


[15] The NHP Regulations place the onus on a licence applicant to satisfy the Minister that the proposed product is safe and efficacious and that it would be so in the circumstances or conditions under which it would be used or made available, in this case, over the counter. The existence of some evidence demonstrating the safety and efficacy of the product does not require the grant of a licence; there must be evidence which demonstrates, to the satisfaction of the Minister, that the product is safe and efficacious. Even in the face of contradictory or competing evidence as to safety and efficacy, there is no obligation on the Minister to decide in favour of an applicant. This is subject to the important caveat that the reasons for the refusal are rationally supported by the scientific analysis, regulatory criteria and relevant policies (compare Winning Combination).

[16] The operation of the scheme, its purposes and objectives, the stages of the decision process and the reconsideration mechanism provided by the NHP Regulations were described in detail by this Court in Winning Combination and set forth by the Federal Court.

[17] Section 5 of the NHP Regulations prescribes the mandatory content of an application for a product licence. At the time of C-RNA’s application for a product license, subsection 5(g) required that information be submitted that "“supports”" the safety and efficacy of the product.

[18] It was subsequently amended to align with the French version of the NHP Regulations (Regulations Amending Certain Department of Health Regulations (Miscellaneous Program), S.O.R./2018-69, Canada Gazette Part II, Vol. 152, No. 8, p. 775 at 779). The French version consistently uses the word "“montrer”" in subsections 5(g), 11(2)(c), 17(1)(b) and 17(2)(a). Prior to 2018, subsection 5(g) was the only one of these subsections to use the word "“supports”", whereas the three other subsections used the word "“demonstrates”". This change thus created congruity across both versions of the NHP Regulations.

[19] As outlined in subsection 5(g), this includes information that demonstrates the safety and efficacy of the product:
"Licence Application "

"5 An application for a product licence shall be submitted to the Minister and shall contain the following information and documents:


(g) information that demonstrates the safety and efficacy of the natural health product when it is used in accordance with the recommended conditions of use.
[20] Section 7 of the NHP Regulations outlines when the Minister is required to issue a product licence:
"Issuance and Amendment "

7 The Minister shall issue or amend a product licence if

(a) the applicant submits an application to the Minister that is in accordance with section 5 or subsection 11(2), as the case may be; "

(b) the applicant submits to the Minister all additional information or samples requested under section 15; "

(c) the applicant does not make a false or misleading statement in the application; and "

(d) the issuance or amendment of the licence, as the case may be, is not likely to result in injury to the health of a purchaser or consumer.
[21] Subsection 7(a) requires an application be made "“in accordance with section 5”" for a product license to be issued. Thus, to satisfy subsection 7(a), the applicant must also comply with section 5 – namely, the Minister must be satisfied that the applicant has not just filed information on safety and efficacy, but that the evidence supports that the product is safe and effective when used in accordance with its recommended conditions of use.

[22] I do not read the word "“supports”" to authorize the grant of an NHP licence on a lesser standard than required by the word "“demonstrates”". While the word is suggestive of a different standard, neither the context nor the purpose supports the conclusion that the Governor in Council intended to authorize licencing of natural products intended for human consumption on a lesser standard of safety. Such a conclusion would offend both the context and the purpose of the regulatory scheme.

[23] Further, statutes are to be read harmoniously, such that like meaning is given to like terms in like circumstances unless a different intention is indicated (Canada Trust Mortgage Co. v. Canada, 2005 SCC 54, [2005] 2 S.C.R. 601 at para. 10). The subsequent amendment of the word to align with the other provisions in the NHP Regulations confirms this interpretation.

[24] The interaction between subsections 7(a) and 7(d) is similarly relevant for new product licensees in that the product must not only be effective, but it must also not be likely to cause injury to health. As the Federal Court observed, safety and efficacy considerations are joined in subsection 5(g) as part of the risk-benefit analysis, whereas subsection 7(d) confirms that even if this risk-benefit analysis favours licensing, a product license will not be granted if it is likely to cause injury. In sum, an applicant must not only show that their product is not likely to cause injury to health (subsection 7(d)), but also that it is safe when used under the recommended conditions of use (subsections 5(g) and 7(a)).

[25] As the scheme indicates, the decision whether to issue a product licence is contingent on the Minister being satisfied that the product is safe and efficacious when used in accordance with its intended conditions of use. Here, with respect to the appellant’s product, the Minister was not satisfied that that was the case. That decision was grounded in an ample evidentiary record and the appellant has not identified any aspect of the regulatory review process that could be considered unreasonable.


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