Health Canada on Hand Sanitizer and Disinfectants amid COVID-19

There has been a recent increase in licenses granted by Health Canada for “hand sanitizer products” amid the COVID-19 pandemic. In order to qualify as a hand sanitizer, Health Canada has specified that the product must contain at least 60% ethanol alcohol. Furthermore, in order to use the terms “hand sanitizer” or “disinfectant”, evidence that the products meet these standards needs to be included in an application to Health Canada. 

There has been some speculation and rumors in the media that Health Canada is becoming more lenient with their licensing rules surrounding products such as hand sanitizer, considering the increased demand for these products amid the COVID-19 pandemic. These speculations do not appear to be true. Recently, CBC reported that Health Canada cracked down on a business owner, Sheila Tan, from Winnipeg who began selling hand cleansing products online using the term “hand sanitizer” and hashtag #covid19prevention. Although her product contained 60% alcohol, she did not apply for a license through Health Canada. Products that have been approved by Health Canada will be issued a National Product Number (NPN) or Drug Identification Number (DIN). After being warned by Health Canada to cease using unsubstantiated hashtags and selling the product under the term “sanitizer”, Sheila Tan applied for a license to sell her product as a sanitizer.

Health Canada has established an expedited process in order to apply for products such as sanitizers and disinfectants due to COVID-19. For a list of these products, please see Health Canada’s guidance here. To learn more about the expedited procedures, please see Health Canada’s guidance here.

Health Canada and the Natural and Non-prescription Health Products Directorate have also clarified that domestic importers of disinfectants and hand sanitizers are now required to display bilingual labels on their products effective immediately. Canadian manufacturers of hand sanitizers are required to adopt the use of bilingual labelling as of June 8, 2020.

Additionally, Health Canada has stated that selling or advertising health products that make false or misleading claims is illegal, and the Department will work with the Competition Bureau to address any of these claims relating to COVID-19.  The Competition Bureau recently released a similar statement, which can be found here.

Summary By: Juliette Sakran