Forward Regulatory Plan 2021-2023: Regulations amending the Natural Health Product Regulations - Expand List A: List of Certain Natural Health Products for Distribution as Samples

Title of Regulatory Initiative

Regulations amending the Natural Health Product Regulations - Expand List A: List of Certain Natural Health Products for Distribution as Samples

Enabling Act

Food and Drugs Act


On March 13, 2020, Bill C-4 entitled the Canada–United States–Mexico Agreement Implementation Act received Royal Assent. In order to implement the Canada-United States-Mexico Agreement (CUSMA), regulatory amendments to the Natural Health Products Regulations (NHPR) were necessary for Canada to meet its commitments.

As part of the implementation, Health Canada established a guidance document on the distribution of drugs as samples, as well as a list of the specific natural health products that can be distributed as samples directly to consumers: List A: List of Certain Natural Health Products for Distribution as Samples.

Health Canada intends to amend the list for natural health products (NHPs) to include all currently authorized products in the product categories set out in the CUSMA and that meet the identified criteria (i.e., for topical use, localized and non-systemic effect, and meets the definition of a cosmetic). Currently, only a subset of those products are included in the NHPR.

Regulatory cooperation efforts (domestic and international)

This initiative delivers on a CUSMA commitment.

Health Canada considered the regimes of relevant international counterparts when developing the regulatory proposal.

Potential impacts on Canadians, including businesses

These proposed regulatory changes would allow companies to, under certain conditions, distribute samples of a wider range of low-risk NHPs than is currently permitted through the regulations.


Since developing the lists for CUSMA, further analysis and stakeholder consultation has been completed on the categorization of low-risk NHPs, as part of the work on the Self-Care Framework, which supports a broadening of the lists.

A 60 day period public consultation was launched on August 11, 2020. This public comment period was intended to gather feedback from:

In addition, Canadians will have an opportunity to provide comments on the regulatory proposal during the Canada Gazette, Part I, public comment period, which is expected to take place in fall 2021.

Further information

Related information can be found on the departmental website:

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

Date the regulatory initiative was first included in the Forward Regulatory

February 2021

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

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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