Final Notice: Classification of Dental Plaque-Disclosing Products as DrugsPublished on July 9, 2018
Author: Bhavesh Patel, C. Chem.
Last month, Health Canada posted a notice for consultation with industry and other stakeholders of its intention to regulate dental plaque-disclosing products as drugs under the Food and Drugs Act (the “Act”).
Effective immediately, no new dental plaque-disclosing product will be allowed in the marketplace without a DIN or an NPN.
As set out in Health Canada’s notice, the accumulation of dental plaque is not in itself a disease or abnormal physical state, but a 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, mineralizes, and becomes tartar which cannot be removed by brushing or flossing and requires the intervention of a dental professional with specialized instruments.
Depending on its ingredients, a dental plaque-disclosing product can be regulated as a drug under the Act 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 requires a Natural Product Number (NPN).
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 be subject to appropriate compliance and enforcement action by Health Canada.
Thank you for reading Regulated Affairs, the CAPRA Blog. CAPRA is a non-profit organization dedicated to providing professional development opportunities in Regulatory Affairs. Feel free to share our blog posts and join us on social media.
Rare Diseases and Orphan Drugs Regulatory Framework in Canada: Recent Initiatives by Government of Canada
What are Rare Diseases and How do They Affect Canadians? According to Health Canada, rare diseases are life-threatening, debilitating, or serious and chronic conditions that...
Health Canada changes filing requirements for product monographs
Did you know, effective immediately, Health Canada is changing the submission requirements for second language product monographs for human drugs? This is for only post-life...
Pragmatic Clinical Trials: Testing Treatments in the Real-World
What is a Pragmatic Clinical Trial? Clinical trials can be designed to be either pragmatic or explanatory. Explanatory trials are designed to find out whether a treatment...