2015 reporting on compliance monitoring: natural health products

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. 

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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.

Actions taken
Product type Product name NPN Product licence holder Where it was bought Observations Actions
Melatonin tablets
Nu-Life Melatonin 80024675 Lifeagen Biosciences of Florida, Inc. dba Nu-Life North America Supplement King (Nova Scotia) The level of melatonin found in the product was 84% of what the label claimed We confirmed that the manufacturer has discontinued the sale of this product
Cough and cold products for children Herbion Cough Syrup for Children

80042293 Herbion Canada Pharmasave (British Columbia) The name of the product licence holder was not the same as the name on the label We confirmed that the company has taken appropriate action to meet labelling requirements
Folic acid tablets Good ’N Natural Folic Acid 800 mg
Unlicensed Not applicable Bulldog Nutrition (Ontario) This product does not have a valid product licence and cannot be legally sold in Canada We confirmed that both the retailer and manufacturer have stopped selling the product
Folic acid tablets Natural Factors Folic Acid 1 mg
80000192 Natural Factors Nutritional Products Limited Optimum Health Vitamins (Alberta) A caution statement on the product licence was not on the product label We confirmed that the company has taken appropriate action to meet labelling requirements

What products complied?

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

Melatonin supplements
Product name NPN Product licence holder Where it was bought
Diem Melatonin 5 mg
80008343 WN Pharmaceuticals Ltd. Medicine Shoppe (British Columbia)
GNC Melatonin
80000813 General Nutrition Centres (GNC) Company GNC (Nova Scotia)
Nature’s Harmony Melatonin
80006449 Purity Life Health Products, LP Pete’s Frootique (Nova Scotia)
Swiss Natural Melatonin Dissolvezzz 5 mg Sublingual Tablets
80028803 Valeant Canada LP / Valenat Canada S.E.C. Shoppers Drug Mart (Alberta)
Trophic Melatonin
80002056 Trophic Canada Healthy Selection (Nova Scotia)
Webber Naturals Melatonin Extra Strength 5 mg
80008343 WN Pharmaceuticals Ltd. London Drugs (Alberta)
Cough and cold syrups for children
Product name NPN Product licence holder Where it was bought
Cold Guard for Kids

80022451 Flora Manufacturing & Distributing Ltd. Healthtree (Quebec)
Helixia Cough
80024461 PendoPharm, Division of Pharmascience Inc. Pharmaprix (Quebec)
Adorable Sirop contre la Toux
02204959 Supplements Aromatik Inc. Walmart (Quebec)
Souris Verte Sirop aux herbes
80042686 Souris Verte / Greenie Mouse Inc. Avril Supermarché Santé (Quebec)
Liquid vitamin D drops for infants and children
Product name NPN Product licence holder Where it was bought
Disney Liquid Vitamin D3 400 IU/UI
80027024 Vita Health Products Inc. Walmart (British Columbia)
Enfamil D-Vi-Sol Liquid Vitamin D Supplement
00762881 Mead Johnson Nutrition Co. Walmart (Manitoba)
Life Brand Vitamin D3 Drops for Infants
80004595 Euro-Pharm International Canada Inc. Shoppers Drug Mart (Manitoba)
Rexall Vitamin D Drops for Infants
02243870 Pharmetics (2011) Inc. Rexall Pharma Plus (Manitoba)
Treehouse Liquid Vitamin D3
80020666 WN Pharmaceuticals Ltd. Real Canadian Superstore (Manitoba)
Folic acid supplements
Product name NPN Product licence holder Where it was bought
Compliments Folic Acid Tablets USP 1 mg
02048841 Pharmetics (2011) Inc. Safeway (British Columbia)
Health First Folic Acid 1 mg Tablets
02244539 Accurex Health Care Manufacturing Inc. Peaches & Green (Ontario)
Jamieson Folic Acid 1,000 mcg / 1 mg
00318973 Jamieson Laboratories Ltd. Rexall Pharma Plus (Alberta)
Nature’s Harmony Folic Acid 1 mg Tablets
80002353 Purity Life Health Products, LP Healthy Planet (Ontario)
Trophic Folic Acid
00685828 Trophic Canada Healthy Planet (Ontario)

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.

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