Teeth Whitening Product Classification

MarkL

Registered
A company I work with is looking at importing a teeth whitening product from the EU to Canada. The only information I can find on the Health Canada site says:

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In the past, most tooth whitening was performed in a dental office by a qualified oral health professional. Today, there are several products available directly to consumers in different applications such as strip, paint-on, or tray kits.
In Canada, all tooth whitening products (unless they contain fluoride) are considered cosmetics. In terms of regulatory requirements, this means that manufacturers and importers must submit a cosmetic notification form to Health Canada, preferably accompanied by safety and labelling information. Health Canada does not 'approve' notifications, but submitted information is reviewed to assess that concerns related to its ingredients and directions of use have been addressed. Ultimately, the safety of a cosmetic product is the responsibility of the manufacturer or importer.
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and basically says it is considered a cosmetic unless it contains sodium fluoride which many, but not all, whitening products do. Another reference point I saw said that if they contain fluoride then technically they fall under the Drug categorization. However, many of the most popular in office whitening systems currently sold in Canada are neither listed on the Drug database or on MDALL (unsurprisingly).

Thoughts on how best to proceed?
 
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