Summary: June consultation sessions – 2017

The first round of public consultation sessions to discuss the modernization of self-care product regulation was held during April and May of 2017.

The second round was held in:

  • Edmonton, Alberta on June 13, 2017
  • Vancouver, British Columbia on June 14, 2017
  • Toronto, Ontario on June 21, 2017
  • Montreal, Quebec on June 27, 2017
  • and by webinar on June 9 and June 29, 2017

On this page

Consultation summaries

To modernize self-care product regulation in Canada, we asked for feedback on the policy proposal from consumers and other stakeholders.

We thank everyone who participated in these sessions. The feedback you provided will help to shape the modernization of self-care product regulation in Canada.

Participants

The numbers of participants who attended the consultation sessions were:

  • 27 in Edmonton
  • 56 in Vancouver
  • 115 in Toronto
  • 96 in Montreal
  • 169 on June 9 by webinar
  • 202 on June 29 by webinar

Participants who attended the consultation included:

  • consumers
  • academics
  • health professionals
  • industry representatives

To protect the privacy of consultation participants, their contact information is not provided.

Key issues discussed

During the consultation, we delivered a presentation on the policy proposal, including these topics:

  • Self-care products would come to market:
    • classified using a two-category system of risk based on
      • the safety of the product
      • its harm of not doing what it is meant to do
    • with therapeutic claims or non-therapeutic claims for lower risk products registered before coming to market
    • with therapeutic claims for higher risk products verified by an authorization process, before coming to market
    • using the acceptable claims within each of the two categories
    • with similar levels of claims requiring similar levels of evidence
    • with Health Canada only conducting reviews on higher risk products
  • The information that would be made available to consumers would include:
    • Products labelled to help consumers with:
      • product identification
      • choice and use of the product (labels with statements and/or symbols and using a link to a web site for more information on the product)
    • Labels would include a:
      • table with information about products claiming a therapeutic use
      • website address for consumers to get additional information on the safety, efficacy and quality of the product
  • What the manufacturing and post-market requirements for self-care products would be, including:
    • a baseline quality standard for all products
    • an increased standard for products with therapeutic claims
    • site licensing for products with therapeutic claims and for activities identified as needing a licence
    • site licences renewed each year
    • risk based approach to proactive verification of compliance and product vigilance
  • User fees for self-care products would:
    • apply to all self-care products
    • be supported by Health Canada’s current work on user fees, called the Health Products Cost Recovery Renewal Initiative
    • be the result of consultations with stakeholders

Feedback: what we heard

Participants provided comments on the consultation process and the policy.

Consultation and engagement

Participants said they:

  • found that a lot was accomplished from the previous round of consultations
  • appreciated hearing comments from Health Canada and other participants
  • liked and wanted more time for small group discussions (some participants)
  • wanted more discussions as a larger group (some participants)

Participants want Health Canada to:

  • hold small group discussions with consumers
  • ask for more feedback from health professionals
  • advertise these public consultation sessions to interested parties much sooner
  • give participants the presentation material before the session happens
  • hold sessions in the evening (instead of during regular work hours) so that health professionals can attend
  • make sure that participants receive updates as the modernization work moves forward and keep consumers and other stakeholders involved along the way
  • let all stakeholders know when upcoming changes are expected and give more information about a future framework for self-care products

Policy Proposal

Participants said the policy proposal on how self-care products come to market should explain:

  • how the harm from failed efficacy would be defined
  • which products, claims, factors and conditions are acceptable for each risk category
  • how past product classification decisions would be reviewed, if asked by a sponsor
  • about the type of evidence acceptable for each category of self-care product
  • how the safety information currently held by Health Canada on self-care products (for example, monographs and guidance) would be updated for use in the proposed risk categories
  • how the term “historical use” would be defined when describing the evidence needed to support a therapeutic claim for some self-care products

Participants also said the policy proposal on how self-care products come to market should consider that:

  • clinical evidence may not be available for some natural health products
  • natural health products should not be grouped with non-prescription drugs or cosmetics
  • there is a need to assess the long-term use effects of ingredients (including ingredients in cosmetic products)
  • the present proposal may make it difficult to get and give evidence for therapeutic claims for traditional and homeopathic products

Participants recommended making changes to make more information available to the consumer by:

  • conducting focus groups to better understand the information needs of consumers
  • listing all of the ingredients currently explained by a single term such as “fragrance” on product labels
  • considering the title “Product Facts” rather than “Health Facts” for the table of information on product labels
  • ensuring that critical information is on the label at the point of purchase
  • limiting the use of the website address on the label for additional non-promotional information about the product
  • ensuring that the website address is accurate and shows on the product package (outer label) and on the container (inner label)
  • ensuring that there are other ways to get this information, such as practitioner handouts, for consumers who do not have Internet access
  • adding the manufacturing location on the product label (that is, the country of origin)
  • explaining why a unique identifier is needed for natural health products and non-prescription drugs even though the current regulatory system already provides a natural product number (NPN) or a drug identification number (DIN) on the label
  • keeping the present product numbering system (NPN, DIN) to identify products for consumers, the supply chain and international jurisdictions

Participants also recommended changes to manufacturing requirements to:

  • make improving the quality of products a priority in this modernization work
  • increase random testing of all self-care products by Health Canada
  • consider inspecting all sites that are conducting activities for all self-care products
  • provide more details about the baseline manufacturing standard for quality and how it will increase with the risk of the product
  • consider if it is necessary to renew site licences, in particular for companies that are compliant, to reduce time and costs
  • include testing as a licensable activity
  • consider a system that allows importers to use and easily add foreign sites to their licence
  • consider, in the compliance and enforcement strategy, giving consumers information on the impacts and risks of purchasing unapproved or illegal products online
  • consider, when planning changes to the way self-care products are regulated,:
    • the administrative burden of changes
    • the cost of labels and packaging
    • new user fees
    • the use of product numbers (NPN, DIN) (for example, for health insurance and reimbursement purposes) in an industry with many small to medium sized businesses
    • educating consumers on product categorization and labeling
  • consider that any additional rules might:
    • reduce the availability of self-care products
    • reduce the number of companies that continue to operate in this sector in Canada
    • increase the cost of self-care products in Canada

For more information

Health Canada – Health Products and Food Branch
Natural and Non-Prescription Health Products Directorate
250 Lanark Avenue, A.L. 2003C
Ottawa, Ontario
K1A 0K9

Email: selfcareproducts-produitsautosoins@hc-sc.gc.ca

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