Consulting Consumers on Self-Care Product Labelling: A Report on What We Heard

Prepared by Delaney and Associates

Table of Contents

Executive Summary

Through its Self-Care Framework (SCF) initiative, Health Canada is looking to update its approach to regulating self-care products, which include cosmetics, natural health products and non-prescription drugs. The objective of the SCF is to modernize the regulatory approach to self-care products, while continuing to allow for a wide range of products to be available for Canadian consumers, and better supporting consumers’ ability to make informed choices.

Through Phase I of the SCF initiative, Health Canada will introduce, for consultation, proposed amendments to the Natural Health Products Regulations to improve the labelling of natural health products (NHPs), including: a facts table and requirements for risk information, which will be clearly displayed and expressed in plain language. The use of plain language ensures that information on labels can be easily read and understood by Canadians and that the format or presentation of labels does not impede comprehension. These changes are intended to better support consumers in selecting and safely using a product and include the following considerations:

Labels are an important tool to assist Canadians in making informed decisions when using health products such as self-care products. The label is generally the first point of interaction between the consumer and the self-care product, and conveys key information, including: medicinal ingredients, warnings, directions for use, non-medicinal ingredients and who to contact in the event that something goes wrong. It is important that this information is legible, discernable and in plain language to support informed product choice and use, including supporting comparative choices between products.

To support the development of Health Canada's Phase I regulatory proposal to improve NHP labelling, Health Canada undertook various consultations across all stakeholder groups, including consumers. The focus of Health Canada's consumer engagement was to seek feedback on:

Consumer consultations were conducted as four two-hour engagement sessions hosted across the country with a cross-section of the Canadian public.

This Report on What We Heard describes the consumer consultations and the following key findings:

Introduction

Background

Currently, three different sets of regulations apply to self-care products, each with different requirements and oversight. This inconsistent approach makes it difficult for consumers to make informed choices. For example, a consumer looking to purchase a sunscreen would find various options on the store shelf that look very similar, are used for the same purpose, and are conveniently located beside each other. However, depending on the use, ingredients, and the claims made, a sunscreen can be regulated as a natural health product (NHP), a non-prescription medication [commonly referred to as an over-the-counter (OTC) drug], or a cosmetic. As a result, label information is presented in various formats which makes it difficult for consumers, patients, and health professionals to locate, read and compare important safety information.

Health Canada is in the process of updating its approach to regulating self-care products. The intention is for updates to be done in phases:

Phase I - Introduce targeted amendments to the Natural Health Products Regulations to improve the labelling of natural health products. This would include a facts table, requirements for risk information, which will be clearly displayed and expressed in plain language. These changes would be intended to better support consumers in selecting and safely using a product.

Phase II - Introduce targeted amendments to the Food and Drug Regulations to introduce a risk-based approach to the regulatory oversight of non-prescription drugs. This would include expedited pathways for lower-risk products. These would be intended to align the oversight for non-prescription drugs with other self-care products of comparable level of risk.

Phase III - Introduce regulatory amendments to address evidence standards for similar health claims, extend risk-based regulatory oversight to NHPs and cosmetics and seek additional powers for Health Canada, such as the ability to require a recall or label change for all self-care products.

Prior to formal consultation through Canada Gazette, Part I, Health Canada engages stakeholders on the development of proposed regulatory changes. The feedback described in this Report provides Health Canada with important information about consumer perspectives and behaviours in selecting and using NHPs, which helps inform the proposed regulatory changes for NHP labelling in Phase I. All of the proposed amendments would be subject to the usual regulatory process requirements, including Governor-in-Council approval.

Objectives

The objective of the Phase I initiative is to require the display of NHP labelling information in a standardized, easy-to-read format in order to enhance their safe and effective use. The proposed labelling changes are intended to help consumers make better informed decisions about their health and the health of their families.

Understanding consumer perspectives and behaviours on the use of labels informs the development of proposed regulatory changes.

Overview of the Consultation Strategy

Background and Overall Objective

This consultation supports the development of Phase I of the Self-Care Framework. It is intended that the findings of these consumer sessions will inform Phase I policy development, as well as other aspects of the Framework's implementation, including operational, transitional, and educational elements.

The overall objective of the sessions was for Health Canada to ensure that the Department's proposed approach to improving the labelling of NHPs is consumer-focused.

Method and Participants

Four consumer engagement sessions were held in July 2018 across Canada. In total, 39 consumers participated, as follows:

City: Halifax, Nova Scotia

Date: July 10, 2018

Number of participants: 10

City: Toronto, Ontario

Date: July 12, 2018

Number of participants: 11

City: Vancouver, British Columbia

Date: July 17, 2018

Number of participants: 10

City: Montreal, Quebec

Date: July 19, 2018

Number of participants: 8

Health Canada engaged the support of a third-party, Delaney and Associates, to ensure that these sessions were methodologically sound and neutral. All sessions were two-hours in length and started at 6:00PM. Participants received an honorarium for their time. Sessions were audio-recorded with the consent of the respondents and a note-taker was present.

The sessions were held in a focus-group format with round-tables led by a neutral facilitator who followed a pre-established interview guide regarding exploring the consumer perceptions of NHP labelling. Only the facilitator and an assistant were present in the room during the session. The note taker(s) were behind a two-way mirror to assure anonymity and reduce any interference.

The participants were all eighteen years of age and older. Each group included ethnic diversity, age, gender, household income and education level.

Following the pre-established guide, participants were asked general questions about their use of labels, and comparative feedback on a variety of pre-established samples of products that were standardized (based on the Self-Care Framework) and others that were not. No reference to Health Canada's proposal was mentioned until the end of the session, and only for the purpose of seeing whether or not they had heard about the initiative.

What We Heard

Below is a summary of what was heard during the engagement sessions. Each session was broken down into five topics, which are outlined below in separate sections. Each section includes the specific objectives, as well as a brief description of the activity and material used.

Section I: Using Product Labels

Objective: To better understand how much, how often, why and when consumers use labels to inform decisions when selecting and using a self-care product and what information they look for.

  • Output: Participants will identify how much, how often, why and when self-care product labels are used in product selection.

Key Highlights:

Why, What and When

Participants were shown a number of examples of self-care products that are commonly used. A whole-group discussion was held about why and when they may read the labels of these products, and what information they look for.

Participants listed a number of reasons why they read product labels:

1. To compare two or more products:

2. To find out what is in the product:

3. To find out whether it will be effective for their symptoms or intended use/result:

4. To learn about product use:

5. To find out about side effects or adverse reactions:

6. To find out other information of importance about a product, for example:

7. When a particular product is brought to their attention, for example:

These last set of reasons, (item 7 above) were also mentioned when asked what would make them more likely to read a label that they would perhaps otherwise not read. A few participants also mentioned that they took a course at a grocery store about reading labels in general, which prompted them to read labels on self-care products more often or more closely.

Participants said that they are more likely to read labels when looking for a product they have never used before, compared to when buying or using a familiar product. However, there are some triggers or instances that participants said would make them likely to read the label on a product they have used in the past. For example:

Some participants indicated that they read labels at every purchase for certain products even if they are familiar with them. This is most commonly done because they feel that ingredients tend to change over time or because new products enter the market that they would like to compare with their usual product.

Moreover, participants indicated that the category or type of product also dictates whether a label is read. For example:

Besides reading labels, participants also indicated that pharmacists are an important source of information for OTC medications as this gave a sense of security or certainty that the correct product is being bought.

Unprompted, some participants mentioned issues they have with reading labels due to small fonts, lack of colour contrast, or other readability or clarity issues, such as the wording not being in plain language, causing them not to understand the ingredients or terminology. Some indicated that addressing these elements would make them more likely to read a label and less likely to ask a pharmacist for information.

A few participants mentioned that the English and French content is not always the same, with French translation not always being clear or accurate.

Also unprompted, some participants discussed that they looked online for product information. This is done more often for products that are not used in acute situations, but for which there is more time to decide, such as supplements or cosmetics. Some also look online for ingredients and do more research on those that could potentially be harmful.

How Often and To What Extent

After a general discussion, participants were asked to use the "first of five" approach to show to what extent they look at or read a label. A show of 0 fingers meant they usually don't look at the label at all, 1 meant they quickly glance at it, and 5 fingers meant they usually read the entire or complete labels carefully. Answers were discussed.

The "first of five" exercises revealed that before purchasing a product, many participants ranked their label-reading habits on the moderate to higher end of the scale, most often showing three, four or five fingers.

Participants said the reasons for high rankings included:

Participants who gave more moderate to low rankings gave a number of reasons for this, including:

Participants again indicated that they are more likely to review the information for OTC medications and somewhat less so for other products such as cosmetics or cosmetic-like NHPs that are every-day products, such as lipstick or toothpaste.

A second "first of five" exercise showed that for future uses of a product, label-reading is generally more limited, with most participants showing zero, one or two fingers.

Participants said this was because:

As was seen with the initial-use (or "before they use a product" section) comments, participants indicated that for products used infrequently and in particular for OTCs (e.g. anti-nausea or allergy medication), labels are more likely to be read again, and more in-depth, even when they are familiar to them. There was also some unprompted discussion about what would happen if the product had changed, with some participants admitting they would likely not notice it, unless the package had changed, prompting them to be more likely to look again.

Section II: Reading Product Labels

A. Importance of Label Information

Objective: To better understand how consumers use labels to inform decisions when selecting and using a self-care product.

  • Output: Stakeholders will prioritize a list of the information they use when selecting and using a self-care product.

Key Highlight:

Participants were given handouts with a mock-up of information typically found on an NHP label. They were also given three sticky notes and asked to individually think about what information they may look for when selecting a self-care product and to write down their top three (ranked in order) information elements. After this individual exercise, all sticky notes were combined on a wall, sorted and themed by participants to reveal which information elements the group had identified as most important.

Findings revealed that participants look at labelling information somewhat differently. While this exercise did not show one clear priority, some top information elements were brought forward by participants:

B. Label Design

Objective: To engage consumers on specific attributes of a facts table on a product label

  • Output: Stakeholders will provide feedback on the usability and the legibility of current product labels
  • Output: Stakeholders will provide feedback on the use of various font types and sizes on self-care product labels
  • Output: Stakeholders will provide feedback on comparability of proposed NHP labelling to OTC labelling.

Key Highlights:

Participants were given handouts with two sets of label designs with facts tables. In the first set, example A had 6-point regular (100%) font and example B had 6-point 85% condensed font. In the second set, example C was a marketed product label with white, 3-point font on a red background with no facts table and all capital letters for headings, and example D was a label with black, 6-point font on a white background in a facts table format. Participants were asked to fill out a short questionnaire on overall readability, font, layout and suggested changes.

Overall Readability

Most participants indicated that the label with the regular 100% (non-condensed) 6-point font (Label A) was generally easier to read than the label with the 85% condensed font (Label B).

Some also indicated that the standardization and size of the font (6 point with 85% compression) were seen as an improvement when compared to a product they would find on the shelves today, though Label B was seen as less optimal than Label A. At the same time, there was some sense, particularly among older participants, that both options were not easy to read and would be more legible with a larger font.

There was general support that the label with the black font on a white background (Label D) was easier to read than the label with a smaller white font on a red background (Label C).

Readability was almost always related to font and contrast.

Font

Most participants indicated that the label with the regular 100% (non-condensed) 6-point font (Label A) was preferred over the label with the 85% condensed font (Label B). The font size and type on label A were mostly seen as "just right" while those on Label B were more likely to be seen as "too crowded" or "too small." Some felt that both labels were smaller than desired, while others felt that they were both ok and represented improvements from the currently marketed products.

The Label C, which had smaller and white font on a red background, was widely viewed as too small, too crowded, and not having enough contrast to read clearly. A few participants commented favourably on the all caps used in the headings on Label C.

Unprompted, there was some discussion about making fonts bigger, and how much or how much less information would fit on a label. Participants understood that this was a trade-off. Also discussed unprompted was what Health Canada would mandate to be on labels, and that would dictate the amount of information required, along with the font size (in order to fit all information on a label).

6-point font, black and white contrast and a standardized format were preferred by participants.

Layout

Participants preferred the standardized table layout used in Labels A, B and D over the layout in Label C. They said that all of the information on those labels was laid out in a manner that was easily found and read under the various headings.

There was some debate about whether it would be better to display the English and French text next to each other (with "/" in between) or whether it was best in two separate tables. Participants were split on this.

Overall Preference (Readability, Font, Layout)

Participants clearly preferred Labels A and D over Labels B and C for a multitude of reasons such as readability, font size, and layout.

Suggested Changes

Participants made a number of suggestions that they felt would make labels easier to read, and therefore more likely to be read. These included:

A few participants felt that in general, labels were "boring" or "formal", and that the proposed standardization would make them even more so. This would generally not entice those few participants to read labels, and they felt that they could be "spruced up" a bit by for example using some colour or "more interesting" design elements. However, it was also quickly said that this should not come at the cost of legibility or clarity, and because of this, others countered a standardized, plain approach would be more beneficial overall.

Participants were then shown mock-ups of two similar products, one of which was an OTC and the other an NHP. The OTC product displayed its current label, using new Health Canada guidelines for plain language labelling, while the NHP label was mocked-up using the same table style and layout, with the same 6-point black font on a white background. Comparability of the two products was discussed with the group.

Most participants said that at first glance, the layouts increased their ability to compare the two products.

However, upon closer reading, it was noticed and mentioned that since the headings were not the same for the two products, comparability was not as optimal as they might have expected. Once it was explained that one product was an OTC and the other an NHP, and that this was the reason for the difference, participants were generally clearer on why the labels could not have the same content. However, participants felt that to be truly comparable, having the same format but not the same information on both was still not optimal. Some cautioned that consumers might try to compare "apples and oranges" (i.e., an OTC and an NHP) without knowing this, since the labels looked the same. Others felt that other indicators on the packaging would make this clear. In particular, this related to the use of the title ("drug facts table" versus the use of "product facts table") and the ingredient information ("active/inactive ingredients" versus "medicinal/non-medicinal ingredients").

C. Label Ingredient Information

Objective: To engage consumers on specific attributes of a facts table on a product label.

Key Highlights:

Attention was given to the same mock-up of information typically found on NHP labels that were used for the Reading Product Labels exercise. Participants were asked to look specifically at the section that showed "other ingredients" and a whole group discussion was held about these elements of the label.

Non-medicinal Ingredients

Participants said that that non-medicinal ingredients, or the information in the section labeled as "also contains" was very useful:

There was some general discussion about moving information off the label to make more room and to allow for a larger font. While some initially supported this, the non-medicinal ingredients were not seen as the best fit for this. Participants generally did not feel that moving this information off the label was a good idea. Reasons for this opinion included:

Allergens

Participants said that allergens are not always easily recognized on current labels. Given the importance of this information, some suggested that they should be emphasized by clearly indicating which ingredients could be potential allergens:

Information on allergens was seen as being a key element on labels and has been gaining importance due to the higher levels of awareness about allergic reactions and sensitivities in recent years. The larger discussion on the non-medicinal ingredients listed showed that there was not much support for moving this information off the label.

Section III: Selecting and Using Products

Objective: To engage consumers on the preferred location of information.

  • Output: Stakeholders will provide feedback on what information is needed to select a self-care product at the point of purchase and what information is needed to use the self-care product safely.

Objective: To consult consumers on information needs when selecting and safely using a self-care product.

  • Output: Stakeholders will provide feedback on what types of information should be made available via URL.

Key Highlights:

A. Essential Labelling Information

Ingredient information on the label is essential.

Using the same mock-up of information typically found on an NHP product label, participants used dot stickers in three different colours to identify the information needed to purchase a product, and whether some information could be moved off the label:

  • Green = essential to have on the label
  • Yellow = nice-to-haves
  • Red = can be moved elsewhere

This colour-coding exercise revealed that for the most part, participants want the current information to remain on the label:

B. Online Product Information

A general discussion was held on reading product information online. Following that, a mocked-up webpage or URL with a Canadian Drug Facts Table and image of the product were shown to participants for comments. The webpage included a Health Canada reference.

Online Resources

Most participants had looked up information about a self-care product online in the past before making a purchase decision, while very few had done so after purchasing a product. Again, this is particularly true for unfamiliar products. While some participants had done so only occasionally, others had done so more regularly.

Reasons for consulting online resources are similar to the reasons why participants read labels in a store. For example:

However, participants also mentioned additional reasons for going online:

Those who have never or only very rarely looked up information online tended to say they generally have no time for nor interest in doing so, and say that it is not a necessity since they find the information they need on the package or label. There was also a general comment that participants look for information (only) at the point of sale.

While online resources may be used, participants were uncertain about the proposal to move key information off the package to online. Online information was expected to duplicate what was on the label, and provide additional information over and above what was currently on the label.

Online Mock-up

Participants said that the URL of the Canadian Drug Facts Table as mocked up was useful. The main reasons for this included:

However, most participants assumed that online information about all products would be on a central (Health Canada) website, which would facilitate comparison, and would give them confidence that the information was unbiased. When it was explained that these URLs would be on manufacturers' sites, it was generally still seen as useful, although not as universally accepted.

Participants said that the Health Canada attribution is very important, and is seen as a consumer protection measure as it indicates that the information has been reviewed, is neutral, and can be trusted. Some went as far as to call it "fundamental" or "essential." This is especially true if this information is on the manufacturer's website.

Section IV: Regulating Self-Care Products in Canada - Awareness

Objective: To inform stakeholders of the proposed approach to regulating self-care products in Canada

  • Outcome: Stakeholders will have a baseline understanding of self-care products, how they are regulated and what changes Health Canada is proposing.
  • Outcome: Health Canada will be able to assess consumer awareness of the updated approach to regulating self-care products in Canada.

Key Highlights:

As a closing item, participants discussed recent Health Canada initiatives they may have heard of, including those related to self-care product labelling. A short presentation about the proposed self-care framework was given. Participants also had the opportunity to ask questions for clarification.

Very few participants had some awareness of Health Canada initiatives. Product recalls were mentioned, as was an unspecified policy related to homeopathic products. Participants were not aware of any proposed changes to health product labelling, including for OTCs and NHPs.

After a short presentation on this topic, participants confirmed that there was minimal awareness of ongoing Health Canada initiatives. Participants indicated after the presentation, as well as in the session evaluation that they appreciated the information provided as it was informative and gave them a good general understanding of the topic. Moreover, as a result of the discussion and the presentation, they would be more likely to pay attention to labelling of their self-care products in the future.

Conclusion

Session participants made it clear that self-care product labels are important to them and are being read when making purchasing decisions and when using these products. While frequency of reading, thoroughness of reading and the reasons why they are read vary from individual to individual, from product to product, and from circumstance to circumstance, the information contained on labels is important to ensuring that the right decisions are being made when choosing self-care products.

While a certain hierarchy was revealed in terms of importance of certain information, with Warnings, Ingredients and Dosage information in particular often cited as most important, there was a clear sense among participants that the information currently on labels is appropriate. There was support for online product information to be used as a supplement to the on-label information, rather than as a replacement. Health Canada endorsement of online information would go a long way in ensuring that the information is viewed as accurate and unbiased.

Legibility, in terms of font size, font colour and label layout, was determined to be important, and while the proposed 6-point font (black, on a white background) was generally well-received, there were still those who found it too small. The idea of streamlining the label layout and design into a table was also supported.

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