New sampling regulations for low-risk OTCs and natural health products

On March 13, 2020, CUSMA received Royal Assent and included regulatory commitments

to the Food and Drug Regulations (FDR) and the Natural Health Products Regulations (NHPR), which came into force on July 1, 2020. These amendments allow for:

• The distribution of specific low risk non-prescription drugs and natural health products as samples directly to consumers; and
• The release of certain non-prescription drugs to the Canadian market without quarantine and additional testing upon importation and direct shipment of such products to retailers and wholesalers.

As part of the CUSMA implementation, Health Canada established guidance on the distribution of drugs as samples, as well as lists of the specific non-prescription drugs and natural health products that can be distributed as samples directly to consumers.

Further to this, Health Canada will be expanding the current list of products indicated in the tables below (Appendix A&B).

In the meantime, while Health Canada works towards implementing the expanded lists, all products listed in Appendices A (NHPs) and B (OTCs) will be exempt from the sampling prohibitions in light of the impending changes, and enforcement actions will be de-prioritized.

The Retail Council of Canada will soon be hosting a webinar with Consumer Health Products Canada and Health Canada to update members on these new regulations, as well as offer members an opportunity to ask Health Canada any questions they might have.

APPENDIX A: Proposed Updates to the List of Certain Natural Health Products for Distribution as Samples

Column 1	Column 2	Column 3	Column 4	Column 5	Column 6
Class of Natural Health Products	Medicinal Ingredient (s)	Quantity of Medicinal Ingredient(s)	Qualifier (s)	Route(s) of Administration	Permissible Use(s) or Purpose(s)
Toothpastes	All approved ingredients	All approved quantities	For human use	Oral Cavity	All approved uses or purposes
Mouthwashes	All approved ingredients	All approved quantities	For human use	Oral Cavity	All approved uses or purposes
Antiseptic Skin Cleansers	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes
Sunscreens	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes
Anti-Dandruff Products	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes
Diaper Rash Products	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes
Medicated Skin Care Products	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes except antifungals, antivirals, antibiotics, corticosteroids, counterirritants, and analgesics
Acne Therapy Products	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes
Throat Lozenges	All approved ingredients	All approved quantities	For human use	Oral cavity	All approved uses or purposes
Athlete’s Foot Treatments	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes
Antiperspirants	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes

APPENDIX B: Proposed Updates to the List of Certain Non-prescription Drugs for Distribution as Samples, and the List of Non-prescription Drugs for which identity and
confirmatory testing are not required upon importation

Column 1	Column 2	Column 3	Column 4	Column 5	Column 6
Class of Non-prescription Drugs	Active[1] Ingredient (s)	Quantity of Active Ingredient(s)	Qualifier (s)	Route(s) of Administration	Permissible Use(s) or Purpose(s)
Toothpastes	All approved ingredients	All approved quantities	For human use	Oral cavity	All approved uses or purposes
Mouthwashes	All approved ingredients	All approved quantities	For human use	Oral Cavity	All approved uses or purposes
Antiseptic Skin Cleansers	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes
Sunscreens	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes
Anti-Dandruff Products	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes
Diaper Rash Products	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes
Medicated Skin Care Products	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes except antifungals, antivirals, antibiotics, corticosteroids, counterirritants, and analgesics
Acne Therapy Products	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes
Throat Lozenges	All approved ingredients	All approved quantities	For human use	Oral cavity	All approved uses or purposes
Athlete’s Foot Treatments	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes
Antiperspirants	All approved ingredients	All approved quantities	For human use	Topical	All approved uses or purposes

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[1] Column 2 in List D will be maintained as “Medicinal Ingredient(s)”.