Notice: Classification of Dental Plaque-disclosing Products
June 4, 2014
Our file number: 14-105696-421
Classification of a therapeutic product by Health Canada determines whether it is to be regulated under the Food and Drugs Act (F&DA) as a drug (that is [i.e.], pharmaceutical, biologic, or natural health product) or as a (medical) device. Detailed information on the classification of therapeutic products is available in Health Canada's Guidance Document: Factors Influencing the Classification of Products at the Device-Drug Interface. Classification recommendations from the Health Canada Therapeutic Products Classification Committee (TPCC) also help guide classification decisions.
The purpose of this Notice is to communicate to industry and health care professionals Health Canada's intention to classify and regulate dental plaque-disclosing products as drugs under the F&DA. It outlines the principles and considerations applied in classifying these products, and informs on how to comply with that governing statute and its regulations. It is also to assist Health Canada in the implementation of its mandate and objectives in a manner that is fair, consistent and effective.
Rationale for the Classification of Plaque-disclosing Products as Drugs
The main cause of dental cavities and oral disease is the accumulation of dental plaque. 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. Tartar must be removed by dental professionals with specialised instruments.
Dental plaque-disclosing products can help prevent cavities and periodontal disease by highlighting the plaque that has not been fully removed by initial brushing and flossing. These products may come in the form of disclosing liquid solutions, gels, tablets or swabs, and many of them are marketed specifically for use by children.
Any product manufactured, sold or represented for use as a dental plaque-disclosing product will be considered to fall under the F&DA definition of a drug as a substance or mixture of substances for the diagnosis of an abnormal physical state. As per this classification, a dental plaque-disclosing product is not considered a medical device or an accessory to a medical device. 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 by Health Canada to enhance the use nor the effectiveness of the toothbrush itself, but to direct the user of the toothbrush where to brush.
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 require 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). Sponsors of plaque-disclosing products without appropriate market authorization will have to determine under which of those two sets of regulations the ingredients contained in their products fall.
Consultation and Transition Period
A 75 day consultation period begins with the posting of this Notice. During this period, manufacturers and distributors of dental plaque-disclosing products may submit comments on this classification. All comments received will be reviewed and Health Canada's final decision will be posted on this website. If it is decided that dental plaque-disclosing products are to be regulated as drugs, manufacturers and distributors of products non-compliant with this classification will have six months to submit their product information to the appropriate Directorate (i.e., Therapeutic Products Directorate or Natural Health Products Directorate) in order to obtain the necessary market authorization.
Comments or questions regarding this Notice can be sent to the following address:
Therapeutic Products Classification Committee
Address Locator 3102C3
Holland Cross, Tower B
1600 Scott Street
or by facsimile at: 613-941-5035
or by email, through the Therapeutic Products Classification Committee Secretariat:
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