Fraudulent and unauthorized N95 respirators and temporarily authorizing the use of technical-grade ethanol in hand sanitizer

The Covid Chronicle

**** Info via Health Canada

Fraudulent and unauthorized N95 respirators may not protect consumers against COVID-19

Health Canada has received reports that fraudulent and uncertified N95 respirators that falsely claim to protect consumers against COVID-19 are being illegally sold to consumers online and in some stores.

In Canada, N95 respirators are regulated by Health Canada as Class I medical devices and are manufactured or imported by companies that hold a Medical Device Establishment Licence. They are also certified by the U.S. National Institute for Occupational Safety and Health (NIOSH).

Fraudulent or unauthorized N95 masks may not meet the same performance measures required by the NIOSH N95 standard and, as a result, may not properly protect consumers from COVID-19.

When worn properly, NIOSH-certified N95 respirators are designed to secure a close facial fit and reduce the risk of inhaling hazardous airborne particles and aerosols. The “N95” designation means that when subjected to careful testing, the respirator blocks at least 95% of very small test particles, such as pathogens.

For a depiction of the NIOSH symbol, refer to the NIOSH website.

It is illegal to sell or advertise health products that make false or misleading claims. The Department takes this issue seriously and will use all available tools to stop these activities.

Health Canada monitors websites and takes action when false claims and/or unauthorized products are identified, and is working with online retailers to ensure that these products are removed from their websites.

Health Canada is also working with other government departments and agencies―such as the Competition Bureau, the Public Health Agency of Canada, and the Canada Border Services Agency―to address the issue of false and misleading claims related to COVID-19 and will continue to take compliance and enforcement actions to protect the health and safety of Canadians.

What you should do

  • Learn about the proper use of face masks.
  • Confirm that your product has been certified by NIOSH by entering the approval number, which can be found on the respirator, in the NIOSH database.
  • Review the product package and respirator to ensure it has the appropriate markings and details, as required by NIOSH. This includes the TC (Testing and Certification) approval number (a number set by NIOSH), the name of the manufacturer, the NIOSH name or logo, the model number, and filter efficiency (N95).
  • Look at product markings, such as the name of the manufacturer, to determine whether there are any obvious signs that the product is counterfeit (e.g., incorrect spelling).
  • If your mask is fraudulent or uncertified, stop using it.
  • Report information on the potential false or misleading advertising or sale of unauthorized products to Health Canada.

More information about buying health products safely is available on Health Canada’s website. For the latest and most up-to-date information on COVID-19 visit Canada.ca/coronavirus.

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Health Canada is temporarily authorizing the use of technical-grade ethanol in hand sanitizer products: Always follow the label directions when using alcohol-based hand sanitizers

Proper hygiene and disinfection is essential during the COVID-19 outbreak to reduce the risk of infection. Washing your hands frequently with soap and water for at least 20 seconds remains the most effective way to limit the spread of COVID-19. If soap and water are not available, a hand sanitizer, with at least 60% alcohol, that has been approved by Health Canada should be used.

There are a variety of hand sanitizers that meet Health Canada’s requirements for safety, efficacy and quality and have been approved. They are listed on Health Canada’s website.

Recent data released by Statistics Canada shows that there was a sevenfold increase in sales of hand sanitizer in mid-March compared to sales during the same one-week period last year. This high demand has led to shortages of raw materials, such as ethanol, which has led to searches for substitute ingredients.

Hand sanitizers are normally made with United States Pharmacopeia (USP) or food grade ethanol. However, in light of the current shortage of hand sanitizers, Health Canada recently temporarily modified its rules to allow manufacturers to use other types of ethanol for hand sanitizer without compromising safety, efficacy and quality. Health Canada is temporarily authorizing the use of technical-grade ethanol on a short-term and case-by-case basis, under specific conditions. This authorization is based on a thorough analysis of the benefits and risks to Canadians and will end as soon as USP- or food-grade ethanol can once again be produced in sufficient quantities to meet increased demand.

Technical-grade ethanol has more impurities than USP- and food-grade ethanol. One of these impurities is acetaldehyde, which is also found in alcohol and food we consume as well as products we use on our skin, such as cosmetics. Like most health products, hand sanitizers containing acetaldehyde can pose health risks if used more frequently and for a longer period than directed.

Health Canada has assessed the risks and benefits of hand sanitizers containing technical-grade ethanol and has concluded that, when used as directed and for a short period, the public health benefit to limit the spread of COVID-19 outweighs the risks. Based on its risk assessment, Health Canada is taking action immediately to ensure the safety of these products.

Specifically, Health Canada is limiting the period during which technical-grade ethanol can be used to produce hand sanitizers and is strengthening the labelling requirements for these products as follows:

Manufacturers that use technical-grade ethanol in their hand sanitizers must provide additional information on their product labels to support the safe use of these products. This includes:

  • clearly indicating that technical-grade ethanol is included as an ingredient;
  • specific directions for use and warnings that these products are intended for adult use only, that they should not be used on broken or damaged skin, that they should not be used by women who are pregnant or breastfeeding, and that they should not be inhaled; and,
  • information on how to report any adverse reactions to Health Canada.

As with all health products, Health Canada is advising Canadians to always follow the label directions when using alcohol-based hand sanitizers.

What you should do

  • To limit the spread of COVID-19, wash your hands frequently with soap and water for at least 20 seconds. If this is not possible, use a hand sanitizer with at least 60% alcohol that has been approved by Health Canada.
  • Always follow the label directions on hand sanitizer products.
  • Check whether a product and its claims have been authorized by Health Canada by searching the List of Hand Sanitizers Authorized by Health Canada. Authorized hand sanitizers have an eight-digit Drug Identification Number (DIN) or Natural Product Number (NPN).
  • Some hand sanitizers that may not fully meet Health Canada requirements and may not have a DIN or NPN on the label are being permitted for sale as an interim measure given the shortage of supply of hand sanitizers because of the COVID-19 pandemic. Check for these products by searching the List of Products Accepted under Interim Measure.
  • Report any adverse reactions to Health Canada by calling 1-866-234-2345.

More information about buying health products safely is available on Health Canada’s website. Health Canada will be posting the list of technical-grade ethanol producers who supply manufacturers of hand sanitizers, along with contact information should you want to get specific information about their product.

For the latest and most up-to-date information on COVID-19, visit Canada.ca/coronavirus.

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