Toothpaste Registration/Licensing in Canada - Here’s what you need to know
Toothpaste Regulations in Canada: Understanding Cosmetics, NHPs, and Non-Prescription Drugs
Did you know that toothpaste can be classified into three different product categories? Depending on its ingredients and the intended claims, toothpaste may be categorized as a cosmetic, a natural health product (NHP), or a non-prescription drug. Each category is subject to distinct regulations and pathways to market. The majority of products typically fall under either a cosmetic or an NHP category.
Toothpaste as a Cosmetic: Regulatory Guidelines for Fluoride-Free Toothpastes in Canada
In Canada, the majority of fluoride-free toothpastes are classified as cosmetic products and are exempt from the NHP requirements. Manufacturers and importers of such products are not mandated to submit a natural product licence application to Health Canada prior to product’s sale. Instead, a Cosmetic Notification must be filed, disclosing the product's ingredients and their concentrations, either prior to market entry or within 10 days of the product’s initial sale. Additionally, manufactures and importers must ensure full compliance of their products with labelling and quality requirements outlined in the cosmetic regulations.
Cosmetic-type toothpastes are permitted to make the following claims:
Cleans/Bleaches/Whitens/Brightens/Polishes teeth
Removes stains
Prevents/Reduces tartar build-up/deposit (by brushing only)
Removes/Reduces plaque (by brushing only)
Kills bacteria causing bad breath
Fights bad breath
Reduces mouth odors
If manufacturers wish to make claims beyond the listed scope, they may consider pursuing a licence under the Natural Health Product (NHP) or a Non-Prescription Drug (NPD) category, which entails different requirements and evaluation criteria.
Toothpaste as a Natural Health Product (NHP): Regulatory Guidelines for Fluoride Containing Toothpastes in Canada
Toothpastes containing fluoride and related ingredients are categorized as natural health products (NHPs) in Canada. Manufacturers and importers of such toothpastes are required to submit a product licence application to Health Canada for evaluation and pre-market approval.
After a thorough review, Health Canada will assign a Natural Product Number (NPN) to the product, which needs to be displayed on the product label during sale. NHPs must comply with specific labelling regulations, including the proposed Product Facts Panel, to provide essential product information.
In contrast to cosmetic notifications, the NHP licensing process mandates additional substantiation regarding product quality and safety. NHP-type toothpaste cannot be distributed without undergoing Health Canada's pre-market evaluation. The timeline for the NHP licensing process varies, ranging from 60 to 310 days, contingent on the toothpaste's ingredients and the nature of the application.
Toothpaste formulations containing ingredients like acidulated phosphate fluoride, sodium monofluorophosphate, potassium nitrate, sodium fluoride, and stannous fluoride require an NPN prior to market entry. Applicants can use attest to the Oral Health Product monograph to support the safety and efficacy of these ingredients in their NHP applications. Other ingredients not included in the list might also fall under the NHP classification. Seeking guidance from experts can aid in determining the best application pathway for your product.
Toothpaste as a Non-Prescription Drug (NPD): Regulatory Guidelines
Another path for entering the toothpaste product market involves licensing the product as a non-prescription drug (NPD). For instance, toothpastes that contain cetylpyridinium chloride within the range of 0.05% to 0.075% are categorized as NPDs and must obtain a drug identification number (DIN) prior to market entry.
The regulatory process for NPDs differs from that of natural health products and necessitates a thorough product evaluation. For products that meet the monographed specifications, a DIN submission attesting to this information must be prepared and submitted to Health Canada. For products that contain other drug ingredients that are not monographed or those that do not fully meet the monographed specifications, additional evidence of safety and efficacy is required. This licensing process shares similarities with that of prescription drugs, mandating stronger evidence of safety, efficacy, and quality compared to natural health product applications.
Notable differences in labelling requirements exist between NPDs and natural health products, although there are some regulatory parallels. Instead of a Product Facts Table, NPD toothpastes must present a Drug Facts Table. This table should outline essential drug information such as active ingredients, intended uses, cautions, directions of use, and other product details. Unlike natural health products, NPD applications must include a copy of the product label. The product’s label is reviewed and approved by Health Canada prior to the product’s sale.
For further insights into how drugs are evaluated in Canada, please consult Health Canada’s official resources.