2015 reporting on compliance monitoring: Testing of natural health products for vulnerable populations

We reviewed 24 natural health products (NHPs) from random brands across Canada from September to December 2015. Learn about our findings and how we conducted our review. 

On this page

• What products were reviewed?
• What did we find?
• What actions did we take to address non-compliant products?
• What products complied?
• What are the shared responsibilities for health and safety?
• How do you identify a licensed product?
• For more information

What products were reviewed?

The review focused on products meant for vulnerable people, such as children and pregnant women. We selected 4 types of NHPs commonly available to Canadians:

1. melatonin supplements
2. cough and cold syrups for children
3. liquid vitamin D drops for infants and children
4. folic acid supplements (which are often recommended for use by pregnant women)

We examined each product with the following questions in mind.

• Is the product licensed?
• Is it labelled and packaged appropriately?
• Does it contain ingredients that it should or shouldn’t contain?

Before an NHP can be sold legally in Canada, it must:

• have a product licence, which is either an 8-digit natural product number (NPN) or homeopathic medicine number (DIN-HM)
• be manufactured, labelled and packaged according to the Natural Health Products Regulations

Laboratory testing

The tests completed included the following.

• Melatonin supplements were tested for the amount of melatonin.
• Non-homeopathic cough and cold syrups were tested for microbiological contaminants.
  • A microbiological contaminant is bacteria, yeast or mould that shouldn’t be in the product.
• Liquid vitamin D drops were tested for the amount of vitamin D as well as microbiological contaminants.
• Folic acid supplements were tested for the amount of folic acid.
• All tested products underwent a general screening for certain known and common drug substances or adulterants.
  • An adulterant is an ingredient that has been added to a product but isn’t allowed to be there.

What did we find?

Of the 24 products examined:

• 23 products passed our laboratory testing
  • 1 didn’t pass because it had less melatonin than its label specified
• 22 products had proper labelling, which means:
  • the labels didn’t make any health claims that aren’t allowed to be made
  • important information was legible and presented in both French and English
    • this includes medicinal ingredients and non-medicinal ingredients, cautions and warnings
• 1 unlicensed folic acid supplement was found, which means it:
  • hadn’t been previously reviewed for safety
  • was being sold without a valid product licence

Overall, 20 of the products complied with the Natural Health Products Regulations.

The results only apply to the products actually tested using the specified test methods. They are meant to reflect the compliance of a single batch of the product. Therefore, we can’t guarantee the compliance of other batches.

What actions did we take to address non-compliant products?

Based on the conducted tests and our findings, we took action on 4 products.

What products complied?

Based on the conducted tests and our findings, the following 20 products complied with requirements.

What are the shared responsibilities for health and safety?

The health and safety of Canadians is a shared responsibility between:

• product licence holders
• companies that manufacture, package, label or import NHPs
• retailers
• the federal government

Product licence holders

Product licence holders are responsible for:

• ensuring that they’re complying with Canada’s regulatory requirements
• applying for and receiving a product licence before a product can be legally sold in Canada
• keeping their product licences up to date

Companies

Companies that manufacture, package, label or import NHPs must:

• follow the requirements for good manufacturing practices, which are described in the Natural Health Products Regulations
• ensure their products follow all other requirements set out in the regulations, including those about product quality

Retailers

Retailers are responsible for making sure the NHPs they sell have a valid product licence number (NPN or DIN-HM).

Federal government

It’s our responsibility to regulate the safety, effectiveness and quality of health products. This includes drugs, NHPs and medical devices. We use a number of ways to confirm that health products are meeting regulatory requirements, such as:

• examining products at the border
• responding to complaints
• conducting planned reviews
• monitoring international information

We take action when a company or product isn’t complying with the Food and Drugs Act or its regulations. Actions are based on the risk posed to Canadians.

Usually, we achieve compliance through a cooperative approach with the regulated party. But, if needed, we will take appropriate action to address non-compliance to reduce risk to Canadians.

How do you identify a licensed product?

You can check to see if your natural health products have a valid licence by looking them up in the Licensed Natural Health Products Database. Only buy NHPs that have an 8-digit NPN or DIN-HM number on the label.

If you have questions about a health product, speak with your health care provider. This will help you avoid taking something that may interact with medications or other products that you’re already taking.

For more information

• Drug and health products available in Canada
• Health product complaint form (FRM-0317)
• Quality of Natural Health Products Guide
• Recalls and safety alerts
• Regulation of natural health products in Canada: Myths and facts
• Risks of buying natural health products online
• Natural Health Products Compliance and Enforcement Policy (POL-0044)