Next steps on the self-care products initiative
Self-care products fall into three broad categories:
- natural health products
- non-prescription drugs
Different sets of rules apply to the regulation of self-care products, each with different requirements and oversight. Some of these rules – specifically, the regulations for non-prescription drugs – are over 50 years old. In comparison, newer regulations for natural health products were established in 2004.
Health Canada is in the process of updating its approach to regulating self-care products. Our updates are based on extensive consultations. As the scope of the regulatory proposals is significant, work will continue in phases over the coming years.
Health Canada has amended the Natural Health Products Regulations (NHPR) to ensure that the information on labels of natural health products (NHPs) are clear, consistent and legible for Canadians to support them in safely selecting and using these products. As well, that NHPs are labelled in a comparable manner to similar self-care products, such as non-prescription drugs.
The amendments respond to recommendations made by the Commissioner of the Environment and Sustainable Development as part of its 2021 audit. Noting that NHP labels were not easy to read without magnification, the audit recommended that Health Canada ensure that product labels are readable.
In its response to the audit, Health Canada committed to improving the labelling of NHPs through these amendments.
Health Canada is intending to propose for consultation amendments to the Food and Drug Regulations to introduce a risk-based approach to regulatory oversight for all self-care products. This would introduce expedited pathways for lower-risk non-prescription drugs and would align the oversight for non-prescription drugs with other self-care products of comparable level of risk.
Health Canada is also working to propose for consultation, regulatory amendments to support continuous improvement of the NHP regulatory framework:
- strengthening the oversight of quality of NHPs
- extending risk-based regulatory oversight
- seeking additional powers for Health Canada, such as the ability to require a recall or label change for all self-care products
We will continue to engage stakeholders as the regulatory proposals are developed.
- What's new: Natural and non-prescription health products
- Calendar of engagement on the self-care framework priorities
- Self-care products
- Regulations of non-prescription drugs
- Regulations of cosmetics products
- Regulations of natural health products
- Self-care products consultations – 2017
- What we heard report – 2016
- Self-care products consultation – 2016
- Forward Regulatory Plan 2022-2024: Self-Care Framework
- Non-prescription Drug Action Plan
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