Information: Regulating natural health products in Canada

February 2013

News Release: Harper Government announces Canadians will have greater access to natural health products - New streamlined approach improves access and safety

What is a natural health product (NHP)?

Natural health products refer to a group of health products that include:

• vitamin and mineral supplements
• herbal and other plant-based health products
• traditional medicines, such as traditional Chinese medicine
• homeopathic medicines
• probiotics and enzymes
• some personal care products like toothpastes and sunscreens that contain natural ingredients

NHP Regulations

The Natural Health Products Regulations, which came into effect in 2004, were created after many consultations with Canadian consumers, academics, health care practitioners and industry stakeholders.

These Regulations help give Canadians access to a wide range of natural health products that are safe, effective and of high quality.

Under the regulations, to be legally sold in Canada, all NHPs must have a product licence, and the Canadian sites that manufacture, package, label and import these products must have site licences.

New Approach to NHPs

The Government has introduced a new approach to NHPs that provides a stable, predictable regulatory environment for the efficient processing of applications.

The new approach introduces new policies and process improvements to speed up application review and focus evaluation efforts on complex applications. These changes are complemented by newly revised guidance on the requirements and pathways for licensing NHPs. The Department is also developing a new approach to site licensing focused on greater quality assurance for products.

From now on, product licensing decisions will be made in 180 days or less. Decisions on certain types of products will be made within 30 days.

Consumer Safety

Safety remains the top priority. The policies under the new approach do not change the measures in place to protect consumer safety. The level of evidence required to demonstrate safety remains the same, and products will continue to be labelled with required cautionary statements.

Companies are still required to submit reports of serious adverse reactions (ARs). This will not change. Health Canada will continue to collect, monitor, and analyze ARs to NHPs through the Canada Vigilance Program. The Department is also developing new tools for monitoring NHP ARs in the Canada Vigilance database.

Temporary Natural Health Products (Unprocessed Product Licence Applications) Regulations

When the Natural Health Product Regulations came into effect, they captured a large number of products that were already on the market and needed to be licensed. This created an immediate large number of unprocessed applications.

To address this, the Government introduced a temporary set of regulations in August 2010 called the Natural Health Products (Unprocessed Product Licence Applications) Regulations (NHP-UPLAR).

NHP-UPLAR provided a short-term way for products to be legally sold when Health Canada had not completed its licensing decision within 180 days.

NHP-UPLAR, which ends February 4, 2013, will no longer be needed because the Government has introduced a new approach to the regulation of NHPs.

The repeal of NHP-UPLAR does not change Canadians' access to NHPs. Companies wishing to sell NHPs will continue to apply for licences under the Natural Health Products Regulations. In fact, Health Canada will provide a transition period - developed using key input from stakeholders - that provides time for companies to make necessary adjustments to business practices and/or to phase out products that are not in compliance.