Le-Vel Brands, LLC v. Canada (Attorney General)

Le-Vel Brands, LLC v. Canada (Attorney General)
Court (s) Database
Federal Court Decisions
Date
2022-04-01
Neutral citation
2022 FC 459
File numbers
T-1802-21
Decision Content
Date: 2022041
Docket: T-1802-21
Citation: 2022 FC 459
Ottawa, Ontario, April 1, 2022
PRESENT: The Honourable Madam Justice Aylen
BETWEEN:
LE-VEL BRANDS, LLC
Applicant
and
THE ATTORNEY GENERAL OF CANADA
Respondent
JUDGMENT AND REASONS
[1] The Applicant advertises and sells in Canada the “Thrive DFT Patch” [Patch] as part of a series of “premium lifestyle” products. In June of 2015, the Applicant alerted Health Canada of its intention to sell the Patch as a cosmetic and was subsequently issued a cosmetic number by Health Canada. Shortly after the launch of the Patch, Health Canada advised the Applicant that it took issue with the Patch’s classification as a cosmetic and noted that the Patch may satisfy the definition of a natural health product [NHP], for which a license was required.
[2] Between February of 2016 and November of 2021, the Applicant provided Health Canada with detailed submissions and evidence as to why the Patch should be classified as a cosmetic, rather than an NHP. Health Canada responded to these submissions and raised various concerns regarding the representations made by the Applicant regarding the Patch, which led Health Canada to conclude that the Patch was an NHP. The Applicant stated on a number of occasions that the representations viewed by Health Canada as problematic to a cosmetic classification had been made in error, would otherwise cease being made and/or were not in fact problematic to a cosmetic classification.
[3] Following receipt of a final set of submissions from the Applicant dated November 8, 2021, on November 26, 2021, the Minister of Health, through the Health Product Compliance/Regulatory Operations and Enforcement Branch of Health Canada, issued a final decision that the Patch should be classified as an NHP rather than a cosmetic and issued a compliance letter to the Applicant, requiring the Applicant to cease sales of the product in Canada and provide further information regarding the product. It is this final decision that is at issue on this application for judicial review.
[4] The Applicant asserts that the decision of Health Canada was both unreasonable and procedurally unfair. The Applicant asserts that the following items are central to the determination of this application:
The conclusions in the final decision are not sufficiently justified and supported, and therefore the “how” and “why” underlying the conclusions reached cannot be properly understood, such that the final decision must be quashed.
Health Canada breached its duty of procedural fairness in “locking-in” a prior decision and refusing to reconsider the issue, despite full knowledge that the underlying support for the previous decision no longer existed.
In light of the undisputed facts on the record, the inevitable conclusion on product classification is that the Patch is a cosmetic product, or at the very least not an NHP, such that a declaration should be issued to that effect.
If the issue must be remitted to Health Canada, the Court should provide reasonable limits to the legislative interpretation of the cosmetic and NHP definitions, so that the accepted facts can be properly applied by Health Canada in the reconsideration.
[5] For the reasons that follow, I find that the Applicant has failed to demonstrate that Health Canada’s decision was unreasonable or that the Applicant was denied procedural fairness. Accordingly, the application for judicial review shall be dismissed.
I. Background
[6] The Applicant is a self-described “premium lifestyle” company that sells a number of products in Canada, some of which are registered as NHPs, while others (like the Patch) are sold as cosmetics. The Patch is sold in Canada exclusively through the Applicant’s Canadian website (le-vel.ca) and is marketed through the Canadian website’s product page, the brochure for the Patch and the Patch’s label.
[7] The brochure for the Patch that was used at the date of the final decision depicts the product as follows:
[8] Below the photo are the following descriptive bullet points:
Cosmetic Derma Fusion Technology
Replenishes the skin’s moisture barrier
Helps improve skin elasticity
Skin appears firm/toned
Skin appears visibly younger
[9] The brochure also contains the following text:
THRIVE Premium Lifestyle DFT is a technology driven breakthrough in cosmetics. Le-Vel’s DFT (Derma Fusion Technology) delivery system is a category creator – the first of its kind – and now, with fusion 2.0 technology, DFT has reached even greater heights. DFT was designed to infuse the derma (skin) with our unique, premium grade THRIVE Lifestyle Formula. Simply put – DFT helps you achieve premium results for a premium lifestyle.
When taken as part of the THRIVE 8-Week Experience – in conjunction with the THRIVE Premium Lifestyle Capsules and the THRIVE Premium Lifestyle Shake Mix – DFT promotes clean and healthy skin and an overall healthy lifestyle. Individuals following this plan will experience ultra premium results and incredible benefits.
[10] The website’s product page for the Patch (as of the date of the final decision) includes four of the five descriptive bullet points noted above and the same text as the brochure.
[11] The Applicant notified Health Canada of its first sale of the Patch in 2015. On August 25, 2015, Health Canada sent the Applicant an acknowledgement letter of its cosmetic notification and assigned a cosmetic product number. The acknowledgement letter stated that the assignment of a cosmetic product number (a) was not a product evaluation or approval procedure; (b) did not constitute Health Canada’s agreement that the product was a cosmetic pursuant to the regulatory requirements; and (c) did not take away responsibility from the company for ensuring that the cosmetic product meets the requirements of the Food and Drugs Act, RSC 1985, c F-27 [FDA], Cosmetic Regulations, CDC, c 869 or other associated legislation.
[12] On February 5, 2016, Health Canada informed the Applicant that the Patch was not classified as a cosmetic in Canada. The letter to the Applicant stated that based on the information provided in its cosmetic notification, the product was making representations that were outside the scope of a cosmetic as defined under section 2 of the FDA, as the cosmetic notification form or label made reference to one or more of the words “fat reduction (including control, reduce and prevent cellulite, weight management)”.
[13] The Applicant sought clarification from Health Canada on the classification notice and a response was provided by Health Canada on February 9, 2016.
[14] In 2018, Health Canada received a complaint alleging the Patch was an unlicensed NHP being sold in Canada. On October 15, 2018, Health Canada sent the Applicant a compliance request letter with respect to the Patch and another one of the Applicant’s products. The Applicant provided Health Canada with a response to the compliance letter. On April 18, 2019, Health Canada confirmed that Consumer Product Safety had classified the Patch as a non-cosmetic, that the Natural and Non-prescription Health Products Directorate classified the Patch as an NHP and that the Applicant was in violation of section 4(1) of the Natural Health Products Regulations, SOR/2003-196 [NHPR] insofar as they were selling an unlicensed NHP.
[15] The Applicant provided additional submissions in response by letter dated April 26, 2019. The Applicant submitted that the FDA defines a cosmetic as “any substance or mixture of substances manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth, and includes deodorants and perfumes” and that the Patch was specifically sold and represented to replenish the skin’s moisture barrier, improve skin elasticity and promote an appearance that is firm/toned/visibly younger, all of which are cosmetic purposes. Further, the Applicant claimed that the Patch otherwise complied with the Cosmetic Regulations and was not indicated for any therapeutic purpose. The Applicant claimed its product could not reasonably be considered to fall within the scope of the definition of an NHP, nor was it marketed as an NHP. The Applicant also asked for confirmation as to whether the classification was a “final decision”.
[16] Health Canada responded to the Applicant’s April 26, 2019 letter on May 15, 2019 to state that the decision was not considered a final decision but that a formal response to their letter would be forthcoming. Health Canada’s May 21, 2019 response stated:
The classification decision completed jointly by the Consumer Product Safety Directorate’s (CPSD) Cosmetics Program and the Natural and Non-prescription Health Products Directorate (NNHPD) was based on information presented in images of the product label as well as the following website: https://le-vel.ca/Products/THRIVE/DFT (including the linked product PDF: https://cdn.le-vel.com/en-CA/Documents/THRV003.pdf).
First, the information on the product website https://le-vel.ca/Products/THRIVE/DFT (including the linked product PDF: https://cdn.le-vel.com/en-CA/Documents/THRV003.pdf) suggests that the patch dosage form delivers ingredients to be absorbed systemically. Specifically, the information indicates the “DFT delivery system was designed to infuse the derma (skin)” and “to provide greater bioavailability and absorption”. This suggests that the claims described are achieved by modifying organic function, and “natural health product” is defined, in part, as a product that “modify[ies] organic functions”. As per the Guidance Document: Classification of Products at the Cosmetic-Drug Interface, Section 3.3: “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.”
Second, the product ingredients fall within Schedule 1 of the Natural Health Products Regulations (NHPR). Section 4 of the NHPR prohibits the sale of NHPs unless a product licence has been issued in respect of the product. Further information on the requirements of the Food and Drugs Act and its associated regulations can be found in the attached Appendix as well as on the Health Canada website.
[17] The Applicant submitted further information on May 26, 2019.
[18] On July 5, 2019, Health Canada sent another letter to the Applicant clarifying the information that led to the classification of the Patch as an NHP. In particular, the letter stated:
Health Canada would like to clarify the content of our previous correspondence, specifically the information that resulted in the classification of the Thrive DFT patch as a natural health product (NHP). The reference to the two statements “DTF delivery system was designed to infuse the derma (skin)” and “to provide greater bioavailability and absorption” was not intended to imply that these are therapeutic claims. Instead, Health Canada would like to highlight that these statements suggest that the patch dosage form delivers ingredients to be absorbed systemically and thus the claims made for Thrive DFT patch such as “Appear firm/toned” and “Appear visibly younger” are achieved through a systemic mechanism of action. As such, the product would do so by modifying organic function, thereby meeting the function aspect of the definition of a NHP as set out in section 1(1) of the Natural Health Products Regulations.
A cosmetic patch should only achieve the desired effect locally at the location where the patch is applied. The claims “Appear firm/toned” and “Appear visibly younger” are not qualified with the term “skin” (i.e. “Skin appears firm/toned” and “Skin appears visibly younger”). Additionally, the photos and video included on the website https://le-vel.ca/Products/THRIVE/DFT (including the linked product PDF: https://cdn.le-vel.com/en-CA/Documents/THRV003.pdf) show individuals wearing the Thrive DFT patch on their arm or shoulder, unlikely locations to achieve younger looking skin or an improvement in skin elasticity. These representations in addition to a lack of clear directions on application site location or clarification to the consumer that the products only exert benefit where locally applied, suggest systemic therapeutic effects and support the classification of Thrive DFT patch as an NHP.
Removing either or both of the statements “DFT delivery system was designed to infuse the derma (skin)” and “to provide greater bioavailability and absorption” from the marketing material would not change the classification of this product as an NHP. Claims and ingredients are not the only factors in determining a product classification; the representations made about the product are also used to create a net impression of what the product is and does. Representations could include a sentence, a picture, a symbol, a paragraph or an implication on product labels, package inserts or advertisements. The representations of this product in its totality, including the non-exhaustive examples above, suggest systemic absorption and action of the ingredients used in this product.
[19] In a letter dated July 19, 2019, the Applicant provided lengthy additional submissions in response to Health Canada’ clarifications. This letter included the Platt Study (which researched and analyzed the cosmetic benefits of a similarly formulated and designed product), monographs of the Patch’s active ingredients, examples of cosmetics with similar ingredients and an updated draft label which changed the claims “appear firm/toned” and “appear visibly younger” to “skin appears firm/toned” and “skin appears visibly younger”. The letter also summarized evidence and legal arguments with respect to cosmetic and NHP definitions that had been provided to Health Canada to date. Specifically, the letter stated:
Your letter indicates that the removal of the statements “DFT delivery system was designed to infuse the derma (skin)” and “to provide greater bioavailability and absorption” does not itself address the classification issue. …Le-Vel is of the view that these statements should not form any part of Health Canada’s decision regarding the classification of the Product, since Le-Vel does not make such representations about the Product.
More specifically, these statements were present by error and did not at all form part of the initial enforcement correspondence from Health Canada nor our client’s Product positioning. If the above statements continue to inform Health Canada’s position, then please advise so that we can properly address both the statements, and the overall appropriateness of Health Canada’s continued reference to these statements…
Your letter goes on to indicate that Health Canada considered the totality of information, but provides no specific examples of what information Le-Vel provided that contributes to the classification of the Product as an NHP. Therefore, notwithstanding your letter, our client continues to be in a position whereby Health Canada seems to be leaning towards a particular decision without providing clear reasons….
[…]
3. Location of the patch
Your letter states that the locations of the patch on the arm or shoulder are “unlikely locations to achieve younger looking skin or an improvement in skin elasticity.” Please note that our client promotes the Product to help provide cosmetic benefits to more difficult areas, such as the arm or shoulder (amongst others). Important considerations in this regard are as follows:
i. Many cosmetics on the Canadian market are for use on the shoulders, arms, and other areas of the skin. For example, there is an entire market of body creams available to Canadian consumers.
ii. Neither the definition of a cosmetic nor an NHP consider the location of the body where there is a topical skin application. In fact, Health Canada classifies intimate lubricant for personal use as a cosmetic.
iii. As per the Platt Study, the Product “[...] helps diffuse the dermal benefits to a significant surface beyond the patch application area”.
iv. Our client sells other products specifically targeting athletic and active individuals. As such, its existing client base typically has a more significant desire to achieve the cosmetic benefits to often-exposed areas of the skin, such as one’s arms and shoulders.
We trust the above information better explains why these locations not only make sense for a cosmetic product, but how they are key to achieving the cosmetic effect in very specific areas.
4. Lack of directions
Your letter also states that the lack of clear directions regarding the application site suggests systemic therapeutic effects. We are somewhat confused by this statement as such a statement is inconsistent with the Cosmetic Regulations and NHPR. The Cosmetic Regulations only require directions of use for products that present an avoidable hazard. The NHPR, on the other hand, requires an NHP to include directions for use on its label (i.e. recommended dose, route of administration, duration of use). A lack of directions supports a cosmetic classification, as opposed to classification as an NHP where there is an intent to provide one of the enumerated functional elements of the NHP definition above.
[20] Notwithstanding the Applicant’s assertion that the Patch is promoted to provide cosmetic benefits to “more difficult areas”, the Court has not been pointed to any evidence in the certified tribunal record of any such promotional materials. Moreover, the Applicant removed any direction as to where to place the Patch in the product label in use at the time of the final decision.
[21] Health Canada prepared a responding letter dated August 5, 2021. However, due to an administrative oversight, the letter was not transmitted to the Applicant until November 3, 2021, together with a compliance letter dated November 3, 2021. The letters confirmed Health Canada’s determination that the Patch was an NHP and requested that the Applicant immediately stop selling the Patch in Canada by November 18, 2021. In the August 5, 2021 letter, Health Canada provided the following reasons for the classification of the Patch as an NHP:
When classifying a product, Health Canada considers whether the product meets the definition of a therapeutic product, natural health product or cosmetic, as outlined in the Food and Drugs Act (see Appendix A). Product representation includes labelling and any advertisements made about the product such as, but not limited to, websites, radio advertisements, infomercials, magazine advertisements, pamphlets, packaging, mass print, television, etc. While classifications are not solely based on websites, they are considered in the overall representation of the product.
When reviewing the classification of the THRIVE DFT patch, Health Canada considered the totality of information currently available including the Canadian label, Canadian website (www.le-vel.ca) as well as additional Canadian websites promoting the product. The Platt Study was also considered and may support a local (vs. systemic) effect. However, while the label provided does not include therapeutic claims, based on the www.le-vel.ca website, the product is represented for therapeutic use. The Canadian website links to the PRODUCT PDF which describes the product as being for Weight Management, Supports Appetite Management, Nutritional Support, Mental Accuity and Supports Energy & Circulation, which are considered therapeutic effects.
The Canadian website also links to a video providing the impression that the patch is part of a “premium naturopathic and synergistic formula” (0:15) and that the patch delivers “vitamins, minerals, plant extracts, digestive enzymes, probiotics, antioxidants, protein, fiber, amino acids” (0:18-0:26). From the visuals, the patch dosage form appears to be absorbed systemically and spread throughout the body. The three layers of the patch are described (0:43) as “Layer 2” being the “active ingredient/formula” and “Layer 3” is the absorption/permeation layer”. The patch is represented as providing NHP substances via systemic absorption, to modify organic function, thereby meeting the definition of an NHP as defined in the NHPR. The video ends by directing the viewer to their American website Le-Vel.com. On the American website, the Thrive DFT patch is associated with Weight Management, Mental Acuity, Supports Appetite Management, Supports Energy & Circulation.
Furthermore, the Canadian label is almost identical to the American one and a web search in Canada for “Thrive DFT” or “Thrive patch” brings up the American website and other direct product affiliated websites, promoting therapeutic uses of the product. Websites promoting therapeutic uses of this product can be misleading to the average Canadian consumer about the recommended use of the product, particularly in the context of a label that is almost identical.
The recommendation to classify this product as a health product is based on its representation for use. While the ingredients may be found in cosmetics, the product is considered a health product because the product is represented for therapeutic and systemic use (as identified in some of the examples above). As the ingredients are substances set out in Schedule 1 of the Natural Health Products Regulations (NHPR), the recommendation is to classify the product as a natural health product (vs. a prescription or non-prescription drug)…
[22] In considering the reasons given by Health Canada in its August 5, 2021 letter, it is important to note that product PDF referenced in the letter is not the same as the current brochure for the Patch. Rather, at that time, the brochure for the Patch included the same photograph but with a heading beside the photo that stated “technology meets premium nutrition” and the following entirely different bullet points:
Weight Management
Supports Appetite Management
2.0 Delivery Technology
Nutritional Support
[23] The brochure also included the following text:
THRIVE Premium Lifestyle DFT is a technology driven breakthrough in Health, Wellness, Weight Management, and Nutritional Support. Le-Vel’s DFT (Derma Fusion Technology) delivery system is a category-creator – the first of its kind – and now, with fusion 2.0 technology, DFT has reached even greater heights. Our DFT delivery system was designed to infuse the derma (skin) with our unique, premium grade THRIVE Lifestyle Formula, different than the Capsule & Shake formula, and to result in a delivery rate benefitting the individual over an extended period of time. Simply put – DFT helps you achieve premium results for a premium lifestyle. With fusion 2.0 designed to provide greater bioavailability, absorption, and nutritional support your results with DFT 2.0 should only get better.
When taken as part of the THRIVE 8-Week Experience – in conjunction with the THRIVE Premium Lifestyle Capsules and the THRIVE Premium Lifestyle Shake Mix – DFT promotes clean and healthy weight management and an overall healthy lifestyle. Individuals following this plan will experience ultra premium results, with benefits such as improved health, wellness, and fitness, as well as, weight management and nutritional support.
[24] The video referenced in the August 5, 2021 letter includes a graphic depiction of a body wearing the Patch on its shoulder/upper arm with various coloured lines spreading from the location of the Patch throughout the body’s arms, torso and legs, arguably through the circulatory system.
[25] Neither the August 5, 2021 letter nor the November 3, 2021 letter invited or committed to reviewing additional submissions. Nevertheless, the Applicant provided additional information for Health Canada’s consideration in a letter dated November 8, 2021, which stated:
…Upon our review of the August Letter, it appears that NNHPD’s most recent reclassification decision was based upon product representations, rather than the composition of the Product itself: “[t]he recommendation to classify this product as a health product is based upon its representations for use”. Our client acknowledges that due to internal oversight, it unintentionally had links to very limited content outside of its Le-vel.ca website. However, as of November 4, 2021, our client corrected the oversight, which was clearly inconsistent with the intended and longstanding promotion of the Product as a cosmetic as is overwhelmingly obvious from its Canadian website and the Product’s packaging. Our client is committed to implementing process controls to reduce the risk of this reoccurring. More importantly, the vast majority of and dominant representations with respect to the Product were and continue to be cosmetic in nature. Examples include without limitation:
● replenishes the skin’s moisture barrier;
● helps improve skin elasticity;
● skin appears firm/toned; and
● skin appears visibly younger.
[…]
With the implementation of the very limited corrective actions noted above, the issues raised by Health Canada in the Letters are now moot. The only information available to classify the Product is cosmetic in nature, and therefore by necessity the Product must remain classified as a cosmetic… NNHPD cannot reclassify the Product solely on the basis of inadvertent, and now removed, statements suggestive of a NHP to the exclusion of clear language and submitted scientific studies showing that the Product is, and is advertised as, a cosmetic…
[26] In this correspondence, the Applicant also asked Health Canada to confirm if the classification decision was a final decision.
[27] On November 10, 2021, Health Canada indicated by email that the question of whether the decision was final was being confirmed and that the stop sale request of November 18, 2021 was no longer applicable.
[28] On November 26, 2021, Health Canada provided the Applicant with its final decision. In a covering email of the same date, Health Canada 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 and regulatory requirements outlined in the Natural Health Products Regulations apply including site licensing and product licensing requirements. In light of this, please see attached the compliance letter issued to your establishment with the response deadline of December 3, 2021.
Please note classification of the Thrive DFT Patch as a Natural Health Product is based on the information presented in product images and websites as no Product Licence Application has been submitted till date…
[29] The accompanying November 26, 2021 letter stated:
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.
[30] The letter dated November 26, 2021 also requested the Applicant “stop sale, importation and cease all licensable activities” and “remove any associated advertisements and/or promotional materials”.
II. The Regulatory Framework
[31] The FDA establishes Health Canada’s authority to regulate food, drugs, cosmetics and medical devices sold in Canada. There are many regulations enacted under the FDA, including the NHRP, which define an NHP.
[32] The FDA defines “cosmetic/cosmétique” as follows:
includes any substance or mixture or substances manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth, and includes deodorants and perfumes.
Notamment les substances ou mélanges de substances fabriqués, vendus ou présentés comme pouvant servir à embellir, purifier ou modifier le teint, la peau, les cheveux ou les dents, y compris les désodorisants et les parfums.
[33] A “drug/drogue” is defined in the FDA as:
includes any substance or mixture of substances manufactured, sold or represented for use in
(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its systems, in human beings or animals,
(b) restoring, correcting or modifying organic functions in human beings or animals, or
(c) disinfection in premises in which food is manufactured, prepared or kept.
Sont compris parmi les drogues les substances ou mélanges de substances fabriqués, vendus ou présentés comme pouvant servir :
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 ou les animaux;
b) à la restauration, à la correction ou à la modification des fonctions organiques chez l’être humain ou les animaux;
c) à la désinfection des locaux où des aliments sont gardés.
[34] Under the FDA, an NHP is considered to be a subset of “drugs”. An NHP is defined in section 1(1) of the NHPR as follows:
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
(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans;
(b) restoring or correcting organic functions in humans; or
(c) modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.
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) 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) à la restauration ou à la correction des fonctions organiques chez l’être humain;
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.
[35] Pursuant to sections 4 and 5 of the NHPR, those seeking to sell an NHP in Canada must submit a product licence application to the Minister and be issued a licence before the product can be sold in Canada.
[36] In this case, there is no dispute between the parties that the Patch includes a substance or combination of substances set out in Schedule 1 of the NHPR. Rather, the dispute turns on whether the Patch is “represented for use in …modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health”.
III. Preliminary Issues
A. Correction to the Style of Cause
[37] At the commencement of the hearing, I raised with the parties the issue of amendment to the style of cause to remove the Minister of Health as a respondent. As the Minister of Health is the decision-maker at issue, pursuant to Rule 303(1)(a) of the Federal Courts Rules, the Minister of Health should not be named as a respondent. The style of cause shall accordingly be amended with immediate effect.
B. Should the disputed portions of the affidavits of Mr. Hoffman and Ms. Richardson be struck?
[38] The Federal Court of Appeal in Association of Universities and Colleges of Canada v Canadian Copyright Licensing Agency (Access Copyright), 2012 FCA 22, has provided clear guidance on the scope of proper evidence on an application for judicial review:
…as a general rule, the evidentiary record before this Court on judicial review is restricted to the evidentiary record that was before the [decision-maker]. In other words, evidence that was not before the [decision-maker] and that goes to the merits of the matter before the [decision-maker] is not admissible in an application for judicial review in this Court…
There are a few recognized exceptions to the general rule against this Court receiving evidence in an application for judicial review, and the list of exceptions may not be closed. These exceptions exist only in situations where the receipt of evidence by this Court is not inconsistent with the differing roles of the judicial review court and the administrative decision-maker…In fact, many of these exceptions tend to facilitate or advance the role of the judicial review court without offending the role of the administrative decision-maker. Three such exceptions are as follows:
(a) Sometimes this Court will receive an affidavit that provides general background in circumstances where that information might assist it in understanding the issues relevant to the judicial review…. Care must be taken to ensure that the affidavit does not go further and provide evidence relevant to the merits of the matter decided by the administrative decision-maker, invading the role of the latter as fact-finder and merits-decider…
(b) Sometimes affidavits are necessary to bring to the attention of the judicial review court procedural defects that cannot be found in the evidentiary record of the administrative decision-maker, so that the judicial review court can fulfil its role of reviewing for procedural unfairness…
(c) Sometimes an affidavit is received on judicial review in order to highlight the complete absence of evidence before the administrative decision-maker when it made a particular finding…
[39] The Respondent asserts that the following evidence should be struck or given no weight on the basis that the evidence was not before the decision-maker and does not fall within any of the recognized exceptions:
Paragraphs 6 through 38 and exhibits C through P of the affidavit of Ms. Richardson sworn February 10, 2022; and
Those portions of the affidavit of Drew Hoffman sworn February 10, 2022 that address geo-blocking.
[40] The impugned portions of the Richardson affidavit contain pictures and information about various products, including ones that describe themselves as patches, located by the affiant following visits to various retail stores in Ottawa. The affiant then conducted a search of the product packaging and Health Canada databases to determine whether any of these products are registered as drugs, NHPs or homeopathic products. The results of those searches are included in the Richardson affidavit.
[41] The Respondent asserts that the impugned portions of the Richardson affidavit are wholly irrelevant to the decision under review, as classification or enforcement of products other than the Patch has no bearing on the reasonableness of the decision or the procedural fairness afforded to the Applicant. Moreover, the Respondent notes that the impugned portions of the Richardson affidavit have no connection to any of the arguments advanced by the Applicant in its memorandum of fact and law.
[42] The Applicant asserts that the impugned portions of the Richard affidavit constitute background information intended to demonstrate that not all patches are classified by Health Canada as NHPs, which is information that was known to Health Canada at the time that it rendered its decision.
[43] I agree with the Respondent that the impugned portions of the Richardson affidavit are entirely irrelevant to the issues before the Court, and that the evidence is inadmissible as it was not before the decision-maker and does not fall within the “background information” exception. It was entirely open to the Applicant to put this evidence before Health Canada in any of the numerous rounds of submissions and evidence that the Applicant submitted to Health Canada, which it did not do. In any event, I note that the Applicant did not refer to the evidence at all in its written or oral submissions, which demonstrates the lack of relevance of the impugned evidence. Accordingly, I give no weight to the impugned portions of the Richardson affidavit.
[44] With respect to the Hoffman affidavit, the Respondent asserts that while large portions of the affidavit constitute argument, the Respondent is primarily concerned with the fact that the Hoffman affidavit attempts to put before the Court information that was never provided to Health Canada – namely, that at some unknown point in time, the Applicant implement “geo-blocking” of its American website so that internet users in Canada are automatically re-directed away from the content and representations made about the Patch on the American website and sent to the Canadian website. References to this geo-blocking implementation appear at paragraphs 10, 11, 27, 33, and 54 of the Hoffman affidavit. The Respondent asserts that this evidence is inadmissible as it was not before the decision-maker and does not fall within any of the recognized exceptions.
[45] With respect to those portions of the Hoffman affidavit that are argumentative, the Respondent asserts that the case law of this Court is clear that such evidence is to be given little to no weight.
[46] The Applicant asserts that the impugned Hoffman evidence is admissible as it was “indirectly” addressed in the Applicant’s correspondence to Health Canada. As noted above, Health Canada raised with the Applicant in its letter dated August 5, 2021 a number of concerns about the content that appeared on the Canadian website (product pdf and a video), as well as a specific concern about Canadians conducting web searches for the Patch being able to access the American website and other direct product affiliated websites that promote therapeutic uses of the Patch. In response to the concerns raised by Health Canada, the Applicant advised in its letter dated November 8, 2021:
Our client acknowledges that due to internal oversight, it unintentionally had links to very limited content outside of its Le-vel.ca website. However, as of November 4, 2021, our client corrected the oversight, which was clearly inconsistent with the intended and longstanding promotion of the Product as a cosmetic as is overwhelmingly obvious from its Canadian website and the Product’s packaging. Our client is committed to implementing process controls to reduce the risk of this reoccurring.
[Emphasis added]
[47] The Applicant asserts that the reference to “implementing process controls” and the corrective actions taken by the Applicant to address Health Canada’s concerns included geo-blocking and as such, the impugned Hoffman evidence was known to Health Canada. I reject this assertion. I find that the Applicant’s November 8, 2021 letter fails to address Health Canada’s concern regarding internet search results obtained by Canadians and the Applicant is now attempting to remedy this deficiency through the Hoffman affidavit, which is improper. I find that geo-blocking was not “indirectly” addressed in the November 8, 2021 letter and as such, the geo-blocking efforts made by the Applicant were not before the decision-maker. Accordingly, I find that Mr. Hoffman’s evidence regarding geo-blocking is inadmissible.
[48] The Applicant asserts that even if the geo-blocking evidence was not before the decision-maker, the evidence is relevant to the exer