With the beginning of the new year, CA President Darren Praznik has already had two meetings with the Health Minister’s Policy Advisor assigned to our industry’s issues.
Justine Frame, with a background in health policy and regulation, as well as private sector experience, appears to bring a greater appreciation and understanding of our issues than we have experienced under previous Ministers for some time. She also has the direction of a Prime Minister and Minister who are committed to improved efficiency, reducing re-tape, improving competitiveness, and facilitating trade in consumer and consumer health products regulated by Health Canada. The sense of urgency and purpose to improve Canada’s domestic economy and trade potential appears to be finally reaching Health Canada with a new Minister and policy advisors.
This very welcome change comes as Cosmetics Alliance is actively pursuing it’s “carve-out” strategy to have low-risk cosmetic-like drugs and NHP’s moved out of the regulatory frameworks for drugs and NHP’s and into what would be an enhanced cosmetic regulation that would more appropriately regulate these products in an essentially post-market regime. The specific products included in the “carve-out” are those already defined as in Appendix 1 of the Cosmetics Annex of the Canada-United States-Mexico Agreement (CUSMA) that was approved by Parliament for a more appropriate level of regulation. This definition can be found HERE.
CA, based on Health Canada data and information gathered from several member companies, estimates that ~6.5% of natural health products and ~35% of D.I.N. applications fall within this CUSMA definition of low-risk cosmetic-like drugs or NHP’s. As to their safety record, over the past five years there have only been six (6) adverse reaction reports out of some 404,500,000 units of these products shipped. As to product re-calls, over the 15-year period from 2010 to 2025, these “CUSMA defined” products accounted for some 5.5% (92) of re-calls compared to 94.5% (1,580) recalls for non-CUSMA defined drugs and NHP’s.
Clearly these products are low risk in nature and challenges any arguments Health Canada staff at NNHPD may make that they need to be regulated under a pre-market approval regime to “protect the health and safety of Canadians”.
Under the current pre-market approval regime for NHP’s, the average days for approval with pre-cleared information (monographs) is 35 days while it is 210 days for non-precleared applications (non-monographs). All of this at a time when NNHPD was so behind in processing applications that they had to put in place a “pause” on processing for two weeks in December to help in catching up. This is exactly the kind of inefficiencies and wasted resources that the Prime Minister is trying to address.
However, NNHPD’s formal response to the Prime Minister’s red-tape reduction initiative was a rather weak proposal which was reminiscent of their response to the need for modernization over a decade ago. Their current proposal offers little to no benefit to our low-risk products.
Consequently, CA is continuing to pursue the “carve-out” at higher levels of the Department and it’s been a prime focus in our meetings with the Minister’s policy advisor.
In addition to the “carve-out” proposal, CA has also been actively engaging the Minister’s Policy Advisor with two other important trade related issues. One is our long outstanding request for a Health Canada GMP Certificate to facilitate cosmetic exports to China (without animal testing) to which the recent resolution of several trade issues with China may provide a new impetus for approval.
The other is the utilization of the proposed new authorities for the Health Minister to accept approvals for various “active” ingredients from trusted jurisdictions such as the European Union for use in Canada. CA has brought this issue to the attention of Canadian trade officials and, through our colleagues at Cosmetics Europe, it has been raised with the European Commission who recently included it in the agenda of Canada-EU regulatory meeting under the Canada-EU Trade Agreement (CETA). We understand that Canadian officials have made some commitments to pursue the issue with Health Canada.
For our industry, this specifically includes a variety of E.U. sunscreen and other product actives that are safely used in Europe that are not available In Canada due to the current requirements that they go through Canada’s new drug approval process. This process was designed and intended for medications and much higher risk products and so is both to lengthy and costly to support seeking approval for innovative new active ingredients. Again, this is another area for Health Canada to act on the new Carney government agenda.
Following our first meetings with the Minister’s Policy Advisor, we will be continuing to meet with her to advance these issues and we very much appreciate the refreshing approach which both the new Minister and her Policy Advisor brings to our files.
