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Food and Drug - General. Le-Vel Brands, LLC v. Canada (Attorney General)
In Le-Vel Brands, LLC v. Canada (Attorney General) (Fed CA, 2023) the Federal Court of Appeal considered (and dismissed) an appeal from a JR that upheld a Health Canada decision that a skin 'patch' product was properly categorized as a 'natural health product' (NHP) under the Food and Drug Act (FDA).
These quotes illustrate some administrative mechanics of the FDA categorization and approval processes:[1] Le-Vel Brands, LLC (the appellant) sells and markets in Canada the Thrive Premium Lifestyle Derma Fusion Technology Patch (the Patch), a product that is claimed to improve the appearance of a wearer’s skin. While the Patch was initially sold as a cosmetic, Health Canada advised the appellant shortly after its launch that it took issue with the Patch’s classification as a cosmetic, and that it should instead be classified as a natural health product (NHP). Over the course of more than five years, the appellant and Health Canada exchanged correspondence where the appellant made submissions and provided evidence as to why the Patch should be classified as a cosmetic, and Health Canada responded with various concerns. Health Canada eventually issued a final decision according to which the Patch was classified as an NHP, and issued a compliance letter to the appellant requiring it to cease sales of the product in Canada.
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[7] On August 25, 2015, Health Canada sent the appellant an acknowledgement letter of its cosmetic notification and assigned a cosmetic product number. It nevertheless stated that the assignment of a cosmetic product number was not the result of a product evaluation or of an approval procedure, and did not constitute Health Canada’s agreement that the product was a cosmetic pursuant to the regulatory requirements: Reasons at para. 11. Pursuant to section 2 of the Food and Drugs Act, R.S.C. 1985, c. F-27 (the Act), a cosmetic is defined as including “any substance or mixture of substances manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth […]”. Unlike NHPs, cosmetics do not require a licence for sale, nor are they subjected to the same manufacturing, labelling, packaging, distribution, or inspection requirements as NHPs.
[8] On the other hand, NHPs are a subset of “drugs” within the meaning of the Act, and were defined at subsection 1(1) of the Natural Health Products Regulations, S.O.R./2003-196 (NHP Regulations) at the time of Health Canada’s decision in the following manner:natural health product means a substance set out in Schedule 1 or a combination of substances in which all the medicinal ingredients are substances set out in Schedule 1, a homeopathic medicine or a traditional medicine, that is manufactured, sold or represented for use in
produit de santé naturel Substance mentionnée à l’annexe 1, combinaison de substances dont tous les ingrédients médicinaux sont des substances mentionnées à l’annexe 1, remède homéopathique ou remède traditionnel, qui est fabriqué, vendu ou présenté comme pouvant servir :
(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans;
(a) au diagnostic, au traitement, à l’atténuation ou à la prévention d’une maladie, d’un désordre, d’un état physique anormal, ou de leurs symptômes chez l’être humain;
(b) restoring or correcting organic functions in humans; or
(b) à la restauration ou à la correction des fonctions organiques chez l’être humain;
(c) modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.
(c) à la modification des fonctions organiques chez l’être humain telle que la modification de ces fonctions de manière à maintenir ou promouvoir la santé.
However, a natural health product does not include a substance set out in Schedule 2, any combination of substances that includes a substance set out in Schedule 2 or a homeopathic medicine or a traditional medicine that is or includes a substance set out in Schedule 2. (produit de santé naturel)
La présente définition exclut les substances mentionnées à l’annexe 2, toute combinaison de substances qui contient une substance mentionnée à l’annexe 2 et tout remède homéopathique ou remède traditionnel qui est une substance mentionnée à l’annexe 2 ou qui contient l’une de ces substances. (natural health product) [9] There is no dispute between the parties that the Patch’s medicinal ingredients are identified in Schedule 1 of the NHP Regulations, such that it meets the substance requirement. It is the functional aspect of the definition that is at issue in the present dispute. More particularly, what divides the parties is whether the Patch can be said to be “modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health”.
[10] On February 5, 2016, the Consumer Product Safety Directorate (CPSD) of Health Canada informed the appellant that the Patch could not be classified as a cosmetic because the notification form or product label referred to “fat reduction (including control, reduce and prevent cellulite, weight management)”.
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[25] On November 26, 2021, Health Canada issued the final decision that became the subject matter of the underlying judicial review (Final Decision). In its opening paragraph, the email stated: “Based on the information available at this time, Health Canada stands firm on the classification of Thrive DFT Patch as a Natural Health Product”. The Final Decision also included a compliance letter which was attached to the email dated the same day. In this letter, Health Canada demanded that the appellant cease all sales of the Patch. In its most salient part, the letter provided the following rationale for the decision:
As indicated in the classification recommendation NNHPD provided previously, NNHPD considers the “THRIVE DFT patch” to be a Natural Health Product (NHP).
The patch includes substances set out in Schedule 1 of the Natural Health Products Regulations (NHPR) and is represented as providing a whole body effect on the skin and not limited to the local application, thereby via systemic absorption and modifying organic function. Therefore, the product meets the definition of an NHP as defined in the NHPR. Furthermore, as per Section 3.3 of the Guidance Document: Classification of Products at the Cosmetic-Drug Interface, in order to be a cosmetic, the product must exhibit a lack of percutaneous absorption and should not have to be absorbed systemically to achieve the effect.
While the ingredients may be found in cosmetics and there may be no explicit therapeutic claims made on the Canadian label or website, the product is represented for therapeutic and systemic use and therefore is considered an NHP.
Given the product “Thrive DFT Patch” is confirmed to be an NHP, effective immediately, you are required to stop sale, importation and cease all licensable activities of the above-mentioned health product as well as any other unauthorized health products and remove any associated advertisement including websites and/or promotional materials.
(Emphasis in the original)
[26] The Final Decision also requested that the appellant provide certain information by December 3, 2021, including confirmation that it had ceased sales of the Patch, and reminded the appellant that failure to comply with any legislation could result in more stringent compliance and enforcement actions. In assessing the main JR argument that the administrative decision was not Vavilov 'reasonable' the court, at paras 36-65, also discusses the extended consideration of the approval issues by Health Canada.
. Canada (Attorney General) v. Catalyst Pharmaceuticals, Inc.
In Canada (Attorney General) v. Catalyst Pharmaceuticals, Inc. (Fed CA, 2023) the Federal Court of Appeal reviews touches on the 'data protection regime' under the Food and Drugs Act system:[2] The impugned decision of the Minister concerned a new drug submission (NDS) by Médunik Canada (Médunik) for its drug RUZURGI (for treating Lambert-Eaton myasthenic syndrome, or LEMS), and whether section C.08.004.1 of the Food and Drug Regulations, C.R.C., c. 870, and specifically paragraph C.08.004.1(3)(b), applied to prevent the Minister from issuing a notice of compliance (NOC) granting Médunik permission to enter the market with RUZURGI. Section C.08.004.1 of the Food and Drug Regulations creates a regime that limits the right of a drug manufacturer to obtain an NOC for a new drug based on a comparison with an innovative drug. This is known as the data protection regime. This regime differs from the patent regime in that it does not provide for exclusive use of the innovative drug. Rather, it limits the use of data submitted by the manufacturer of the innovative drug. Subsection C.08.004.1(3) of the Food and Drug Regulations reads as follows:"(3) If a manufacturer seeks a notice of compliance for a new drug on the basis of a direct or indirect comparison between the new drug and an innovative drug, "
"(3)"" Lorsque le fabricant demande la délivrance d’un avis de conformité pour une drogue nouvelle sur la base d’une comparaison directe ou indirecte entre celle-ci et la drogue innovante : "
"(a) the manufacturer may not file a new drug submission, a supplement to a new drug submission, an abbreviated new drug submission or a supplement to an abbreviated new drug submission in respect of the new drug before the end of a period of six years after the day on which the first notice of compliance was issued to the innovator in respect of the innovative drug; and "
"a)"" le fabricant ne peut déposer pour cette drogue nouvelle de présentation de drogue nouvelle, de présentation abrégée de drogue nouvelle ou de supplément à l’une de ces présentations avant l’expiration d’un délai de six ans suivant la date à laquelle le premier avis de conformité a été délivré à l’innovateur pour la drogue innovante; "
"(b) the Minister shall not approve that submission or supplement and shall not issue a notice of compliance in respect of the new drug before the end of a period of eight years after the day on which the first notice of compliance was issued to the innovator in respect of the innovative drug. "
"b)"" le ministre ne peut approuver une telle présentation ou un tel supplément et ne peut délivrer d’avis de conformité pour cette nouvelle drogue avant l’expiration d’un délai de huit ans suivant la date à laquelle le premier avis de conformité a été délivré à l’innovateur pour la drogue innovante." ....
[4] Though the decision to issue an NOC rests with the Minister, it is useful to note that different groups within Health Canada are delegated to the respective tasks of (i) assessing the safety and efficacy of the drug in question, and (ii) determining whether the data protection regime applies thereto. The former task is delegated to the Pharmaceutical Products Directorate, formerly the Therapeutic Products Directorate (TPD), whereas the latter task is delegated to the Office of Submissions and Intellectual Property (OSIP). These names are used interchangeably herein with "“Health Canada”". . Taylor v. Canada (Attorney General)
In Taylor v. Canada (Attorney General) (Ont CA, 2022) the Court of Appeal gave some insight into Food and Drug Act procedures:[3] The class action concerned certain temporomandibular joint (“TMJ”) implant devices made of a material known as Proplast manufactured by Vitek Inc. in the United States. The appellant claimed that the Canadian Government (and more particularly Health and Welfare Canada (“HWC”)) owed a duty of care to members of the class to regulate and control the entry of those devices into Canada, and to warn of any dangers posed by those devices.
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[6] The regulatory regime governing the implants in issue was set out in the Food and Drugs Act, R.S.C., 1985, c. F-27, and the Medical Devices Regulations, S.O.R./98-282.[1] The trial judge repeatedly emphasized that the scheme reflected a balance between two competing policy values: on the one hand a “desire to have those in the industry find, develop and produce devices that will assist those who are suffering and on the other to avoid causing more harm.”
[7] A manufacturer of a new device was prohibited from selling or advertising a device in Canada unless it received a Notice of Compliance (“NOC”) from HWC. To obtain a NOC, the manufacturer was required to submit evidence establishing the safety and efficacy of the new product and drafts of labels, package inserts, brochures and file cards. At para. 75, the trial judge noted that a NOC was not a statement that the product was safe, only that the work and tests necessary to justify entry had been completed; the legislation made clear that the responsibility to conduct proper studies lay with the manufacturer. Consistent with the balance underpinning the policy objectives sought to be achieved by the legislation, HWC was required to make a decision within 60 days of receipt of the materials from the applicant. . 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.
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[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:
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(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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