Final Notice: Classification of Dental Plaque-Disclosing Products as Drugs
April 18, 2018
Our file number: 18-104928-312
On June 4, 2014, Health Canada posted a notice on its website to consult industry and other stakeholders of its intention to regulate dental plaque-disclosing products as drugs under the Food and Drugs Act (F&DA). Health Canada received no comments during the 75 day consultation period that ensued.
Rationale for the Classification of Plaque-Disclosing Products as Drugs
Although the accumulation of dental plaque is not in itself a disease or abnormal physical state, it is an important root cause of dental cavities and oral disease. Controlling plaque involves the prevention of its accumulation and its removal from the teeth and adjacent gingival tissues. Unless completely removed, plaque accumulates, mineralises and becomes tartar which cannot be removed by brushing or flossing but requires the intervention of a dental professional with specialised instruments.
Dental plaque-disclosing products can help prevent tooth cavities and periodontal disease by highlighting the plaque before brushing. Many of these products are specifically marketed as a learning tool for children.
Dental plaque-disclosing products in liquid, gel or tablet form fall under the F&DA definition of a drug as substances or mixtures of substances manufactured, sold or represented for use in the prevention of a disease (which, in this case, results from the accumulation of tartar). As per this classification, a dental plaque-disclosing product is not considered a medical device nor an accessory to a medical device under the F&DA. An accessory to a medical device is one that enables or assists the function of a particular device. Dental plaque-disclosing products are not considered to enhance the use nor the effectiveness of the toothbrush itself, but to direct the user of the toothbrush where to focus the brushing action.
Depending on its ingredients, a dental plaque-disclosing product can be regulated as a drug under the F&DA either as a pharmaceutical drug subject to the Food and Drug Regulations and requires a Drug Identification Number (DIN), or as a natural health product subject to the Natural Health Products Regulations and require a Natural Product Number (NPN).
Regulation of New Dental Plaque-Disclosing Products as Drugs
Effective immediately, no new dental plaque-disclosing product will be allowed in the marketplace without a DIN or an NPN.
Transition Period for Plaque-Disclosing Products Currently Sold Without a DIN or a NPN
As per the date of this notice, sponsors currently marketing dental plaque-disclosing products without a DIN or an NPN are granted a six month period to submit the necessary information to Health Canada's Therapeutic Products Directorate or to the Natural and Non-Prescription Health Products Directorate in order to obtain market authorization for their products. As of September 3, 2019, no sale of a dental plaque-disclosing product without a DIN or an NPN will be allowed in Canada. Non-compliant plaque-disclosing products found in the marketplace will then be subject to appropriate compliance and enforcement action by Health Canada.
For more information regarding the classification of therapeutic products as either a device or as a drug, please refer to the Guidance Document: Classification of Products at the (Medical) Device-Drug Interface on the Health Canada website.
Questions regarding the content of this notice can be emailed to the Therapeutic Products Classification Committee (TPCC) Secretariat at:
Questions on how to obtain market authorization for a product that requires a DIN can be forwarded to the Therapeutic Products Directorate at the following address:
- Office of Submissions and Intellectual Property
Therapeutic Products Directorate
101 Tunney's Pasture Driveway
Address Locator 0201A1
- E-mail: OSIP-BPPI@hc-sc.gc.ca
Information on applications and submissions related to the Natural Health Products Regulations is available on the Health Canada website.
Questions on how to obtain market authorization for a product that requires a NPN can be forwarded to:
- Submission Administration Unit
Natural and Non-prescription Health Products Directorate
250 Lanark Avenue
Address Locator 2002B
K1A 0K9 (Canada Post delivery; including Xpresspost)
K1Z 1G4 (Courier service; excluding Xpresspost)
- Email: firstname.lastname@example.org
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