Samples of Certain Natural Health Products

Summary#

These are the final Regulations Amending the Natural Health Products Regulations (Distribution of Natural Health Products as Samples). They set out when and how certain natural health products can be given out as samples to health practitioners, pharmacists, or directly to adults. The item was published in the Canada Gazette on April 29, 2020 (registered April 7, 2020).

What it does#

• Adds a new list, List A (the document titled "List of Certain Natural Health Products for Distribution as Samples", dated March 2020), and allows products that meet that list’s conditions to be distributed as samples.
• Lets someone distribute a natural health product as a sample to a practitioner or pharmacist when that practitioner or pharmacist has given a signed order that names the product and quantity. An order can be set to repeat for up to six months.
• Allows distribution to a practitioner or pharmacist without a signed order if:
  • the product has a localized effect and is for use in the oral cavity or on the skin, or is a throat lozenge;
  • the product matches the ingredient and description rules in List A; and
  • the expiry date is at least 30 days after distribution (or falls in a later month if the label only gives month and year).
• Allows direct distribution of those same kinds of sample products to consumers who are 18 years of age or older, if the product meets the same List A, expiry and regulatory requirements.
• Requires the distributor who fills an order to keep records showing who received the sample, the product brand, quantity and dosage form, and the date of distribution. Those records and the orders must be kept for at least two years.
• The regulations come into force on the day section 57 of the Canada–United States–Mexico Implementation Act comes into force; if the regulations were registered after that day, they come into force on the registration day.

Who's affected#

• Practitioners and pharmacists who accept or order samples.
• Companies and people who make, market, distribute or supply natural health products.
• Consumers aged 18 years or older who might receive free samples of topical or oral-local natural health products.
• Regulators and compliance staff who must keep records and check that sampled products meet List A and expiry rules.

If it’s unclear whether a specific product is covered, check whether it appears on List A and meets the ingredient and expiry conditions.

Why it matters#

• It clarifies and expands when samples of some natural health products can be distributed.
• It may make it easier for manufacturers and sellers to give samples to health professionals and directly to adults for certain topical or oral-local products.
• Consumers could see more availability of trial-sized or free samples for things like throat lozenges or skin/oral cavity products.
• There are set safety checks: only products that match List A, meet expiry rules, and comply with the Regulations may be distributed, and distributors must keep records for two years.