Verifying compliance of health products on the market: April 1, 2015 to March 31, 2016

In Canada, health products are regulated under the Food and Drugs Act and its Regulations. Read about how Health Canada protected the health and safety of Canadians by verifying the compliance of health products found on the Canadian market.

Note that the information below spans April 1, 2015 to March 31, 2016 and complements other information that the Department also publishes, such as pre-market reviews, facility inspections for Good Manufacturing Practices as well as monitoring of adverse events.

Health products include:

  • Drug products such as over-the-counter drugs, prescription drugs and veterinary drugs.
  • Natural health products such as vitamins, supplements, homeopathic medicines and traditional medicines.
  • Medical devices such as bandages, toothbrushes, pacemakers, pregnancy kits and hospital beds.

Actively preventing unsafe health products from entering Canada

A large volume of health products come into Canada from other countries. These can include products purchased online by individuals or company supply chains that start outside of Canada. Not everything arriving at the border meets Canadian law.

Health Canada works with the Canada Border Services Agency (CBSA) to prevent unauthorized health products from entering Canada.

  • Nearly 46,000 shipments containing health products destined for Canada were reviewed by Health Canada.
  • Approximately 75% of these shipments were seized or refused entry into Canada because they did not meet Canadian law.
  • The percentage of shipments seized or refused has been relatively consistent over the last four years.

Health Canada participates in the annual Operation Pangea which is an international week of action coordinated by INTERPOL that combats the sale of illegal medicines online. The focus for 2015 was on unauthorized and unregulated internet sites that sell illegal drugs and medical devices. The products on these sites may be cheaper and easily purchased but riskier because they may be counterfeit (i.e. "fake"), contain the wrong level of an active ingredient, or contain toxic substances. During the week, the CBSA referred suspected non-compliant shipments of drugs and medical devices to Health Canada for inspection. Where warranted, Health Canada referred shipments to the Royal Canadian Mounted Police for investigation of intellectual property right infringements.

Following up on complaints

Health Canada hears from consumers when they have a complaint about a health product that they use.

  • We received almost 700 complaints on medical devices.
  • We received almost 890 complaints on drugs and natural health products. 40% of complaints were on natural health products.

Companies are also required to report any recalls of health products to Health Canada which they undertake. Health Canada monitors the effectiveness of a company's recall and any necessary steps they take to correct the issue and prevent it from happening again.

  • Companies reported over 800 recalls for medical devices.
  • We received over 140 reports of recalls for drugs or natural health products that companies had voluntarily initiated in Canada.

The Food and Drugs Act contains a provision on recalls.

For drugs, a recall is any action taken by a company to remove product from further sale or use, or correction of a product.

Under the Medical Devices Regulations, the definition is broader and includes notifying users of a defective or potentially defective device.

Finding problems early

Health Canada is also interested in identifying problems before it hears about them from another source. Health Canada carries out proactive surveys (planned reviews) of health products on the market as a way to verify that industry and health products are following Canadian laws. Starting in 2016, Canadians are able to read about these planned reviews for the first time.

Health Canada laboratories proactively review the quality of authorized human drugs through its Drug Quality Surveillance Program. They also test health products that inspectors identify through their daily work.

  • 518 samples were tested at the Health Canada Laboratories
  • Almost 40% of these samples were non-compliant
  • Top 3 reasons why health products were non-compliant
    • 71% were unauthorized products that contained a drug or medicinal ingredient not listed on the product label (adulterated). Using health products that contain hidden ingredients can be unsafe.
    • 6% of the lab methods used by companies were found to be deficient for testing the safety, quality and effectiveness of products. This can jeopardize the quality and effectiveness of health products.
    • 4% of products had microbial contamination. This can be risky particularly if you have a compromised immune system.

Verifying compliance

When Health Canada finds a product that does not meet the Food and Drugs Act, the department takes appropriate action to minimize the risk to Canadians and to correct non-compliance by industry. Consumers, patients and industry can learn more about unsafe products through our recall notices and public advisories.

  • Common reasons why drugs and natural health products might be recalled
    • Quality issue, including contamination or test results being outside of product specifications
    • No market authorization (unauthorized)
    • Label issue, including missing warnings and errors in expiry dates
  • Common reasons why medical devices are recalled
    • Device malfunction, including the lack of accuracy and precision
    • Label issue, including incorrect manufacturer or device name
    • Manufacturing issue, including design deficiency

Unauthorized health products are risky

Every year, we come across many unauthorized health products at the Canadian border and in the marketplace. Unauthorized products have not been reviewed for safety, quality or efficacy by Health Canada and can include counterfeit products. These can be dangerous to your health because they may contain hidden ingredients not listed on the label, dangerous additives or contaminated ingredients.

  • Of the health product shipments assessed by Health Canada this year, many were seized at the border because they contained unauthorized health products.
  • 90% of shipments that Health Canada examined at the border during Operation Pangea contained unauthorized health products. Read more about the 2015 operation.
  • 12% of complaints we received on medical devices were about unauthorized products.
  • 20% of complaints we received on drugs and natural health products were about unauthorized products.
  • 71% of health products that were found to be non-compliant by Health Canada Laboratories were adulterated unauthorized products. For example, an herbal product containing the erectile dysfunction prescription drug sildenafil not listed on the product label.

Examples of more common counterfeit or adulterated products that we saw include sexual enhancement products and weight management products (including workout supplements and fat burning pills).

Play an active role in staying safe

Everyone plays a part in the safety of health products.

Be informed and careful about where your health products come from.

  • Check that drugs have an 8-digit Drug Identification Number (DIN) on their label. This means that the product has been authorized by Health Canada.
  • Check that natural health products have an 8-digit Natural Product Number (NPN or DIN-HM) on their label. This means that the product has been authorized by Health Canada.
  • Ask your health care professional how they make sure products that they give you are safe.
  • Ask companies that you buy health products from how they make sure their products are licensed and not counterfeit.
  • Be cyber safe - Understand the dangers of buying drugs, natural health products and medical devices online.
  • Be savvy about health product advertisements. Find out more about advertising complaints received by Health Canada.

Check that health products you use are authorized in Canada:

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