Forward Regulatory Plan 2019-2021: Self-Care Framework

Title of Regulatory Initiative

Self-Care Framework

Enabling Act

Food and Drugs Act

Description

Health Canada will update its approach to regulating self-care products based on extensive consultations over recent years. The Self-Care Framework will roll out in phases over the coming years:

Phase I – Targeting spring 2020: Introduce, for consultation, targeted amendments to the Natural Health Products Regulations to improve labelling of natural health products (NHPs). This proposal will require essential risk information to be presented in a standardized format, with minimum font size and black-on-white contrast, making it easier to read, understand and compare with that for other similar self-care products, such as non-prescription drugs, on store shelves. The use of plain language will also ensure that information on labels can be easily understood by Canadians.
Phase II – Targeting spring 2020: Introduce, for consultation, targeted amendments to the Food and Drug Regulations to introduce a risk-based approach to regulatory oversight for non-prescription drugs. These include: expedited pathways for lower-risk products. These changes are intended to align the oversight for non-prescription drugs with other self-care products of comparable level of risk.
Phase III – Targeting 2021: Introduce, for consultation, regulatory amendments to address: evidence standards for similar health claims, extending risk-based regulatory oversight, seeking additional powers for Health Canada, such as the ability to require a recall or label change for all self-care products.

This regulatory initiative was identified by Health Canada in its Health and Biosciences Sectoral Regulatory Review Roadmap which addresses stakeholder comments suggesting a disparity between the regulation of cosmetics, NHPs and non-prescription drugs.

This regulatory initiative is associated with Health Canada’s stock review plan.

Regulatory cooperation efforts (domestic and international)

International Context:

Phase I – The proposed regulatory changes align with similar steps taken in Australia, Europe and the United States to improve labelling of consumer health products.

Phase II & III – The proposed regulatory changes to introduce a proportional risk-based approach for all self-care products (Phase II – non-prescription drugs; Phase III – NHPs and cosmetics) align with international best practices in Australia, Europe and the United States.

Domestic Context:

The Self-Care Framework proposals are already integrated and in line with other major Health Canada priorities underway (i.e. Regulatory Review).

Potential impacts on Canadians, including businesses

These proposed regulatory changes are anticipated to:

Help Canadians make more informed choices and support the safe use of self-care products by improving labelling on NHPs, building on the approach in place for non-prescription drugs.
Establish proportional risk-based rules for all self-care products, which would result in significant reductions in regulatory costs to industry.

These proposals also have anticipated impacts on international trade.

Consultations

Since the fall of 2016 Health Canada has held a series of public consultations seeking input on modernizing the Department's approach to regulating self-care products. Summaries of the consultations are available online.

Canadians will have the opportunity to provide comments on both Phase I and Phase II of the Self-Care Framework during the Canada Gazette, Part I public comment period, which is expected to take place in spring 2020 and last 70 days.

Further information

For latest developments and updates to the proposal, please visit the Self-Care Products web page.

Additional information can be requested from the Departmental contact.

Departmental contact information

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada

Telephone: 613-946-6586
Email: hc.lrm-mlr.sc@canada.ca

Date the regulatory initiative was first included in the Forward Regulatory Plan

April 1, 2015

Consult Health Canada's acts and regulations web page for:

a list of acts and regulations administered by Health Canada
further information on Health Canada's implementation of government-wide regulatory management initiatives

Consult the following for links to the Cabinet Directive on Regulation and supporting policies and guidance, and for information on government-wide regulatory initiatives implemented by departments and agencies across the Government of Canada:

To learn about upcoming or ongoing consultations on proposed federal regulations, visit:

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