After the closure of public consultation in July, several refinements have been suggested for the proposed regulatory framework. Firstly, a third product class will be added to create a three-tiered risk based system:
Class I – Registration system for products with non-therapeutic claims (some minor therapeutic claims could be allowed)
Class II – Registration system for products with therapeutic claims supported by scientific or historical use evidence (Claim examples within this class include “cough”)
Class III – Review and approval process for products with therapeutic claims supported by scientific evidence (Claim examples within this class include “cold and flu”)
Stakeholders have indicated that splitting cough and cold/flu indications over two separate regulatory classes with very different requirements is confusing. The reason that Health Canada is currently classifying these claims this way is due to the risk posed by treatment failure. Secondly, Health Canada intends to apply the Plain Language Labelling (PPL) principles to all self care products, but wants to acknowledge the commitment and funds that the OTC industry has already put towards developing a specific approach to labelling. Ideally, the proposed Framework should build on this investment and try to avoid the need for additional repackaging. It is hoped that OTCs would be appropriately transitioned under the Framework through “grandfathering” existing labelled products. Labels would be updated through the labelling revision cycle after the Framework is implemented.
There is also uncertainty regarding the placement and layout of the product facts table. The current proposal is for Class I products (mostly cosmetics) to include a URL link to product information in the format of a facts table, while all other products would be required to include a facts table on the outer package. Health Canada is also considering options that would incorporate products currently regulated as Natural Health Products (NHPs) into these requirements without imposing more restrictions or going back on the formatting and flexibilities negotiated in the Good Label and Package Practices (GLPP) Guide.
Health Canada had also proposed two voluntary statements that could be added to product labels to differentiate science based products:
- “This product is based on scientific evidence”
- “This product is not based on scientific evidence”
It has not been determined where these statements would be located, and stakeholders are skeptical that their voluntary use would be effective in informing consumers.
The Natural and Non-prescription Health Products Directorate (NNHPD) has begun testing the regulatory model by determining which category various products will fall into. They will also host technical sessions with industry professionals and health care practitioners in early 2018. Consumer focus group testing may also be done to test specific labelling policies on label statements.
If you need assistance determining how the proposed regulatory framework may affect your consumer products, please do not hesitate to contact Focal Point Research Inc. We are leading Canadian regulatory consultants for Natural Health Products, OTC Drugs, Cosmetics, and other personal care products.