Not Happy. Sent Rennie’s letter and this is their(unacceptable) response:
Thank you for contacting Health
Health Canada has advised Canadians of concerns about the inhalation of graphene particles from face masks containing graphene. Please see the public advisory published on April 2, 2021, for more information.
The Department has since received many inquires about these masks, and answers to many of the common questions are provided below:
How can a graphene mask be identified?
Many of these masks are being sold online and through various retailers. At this time, based on available information, graphene-containing masks cannot be identified by colour or design alone. To date, Health Canada has identified that model numbers SNN200462, SNN70370B, SNN70369B and SMDP20605 manufactured by Shandong Shenquan New Materials Co. Inc. may contain graphene. However, this is not an exhaustive list, as the Department continues to receive and review information.
Health Canada advises Canadians to check product labels for ‘graphene’ or ‘biomass graphene.’ Alternatively, if you are uncertain whether a mask contains graphene, you should contact the manufacturer identified on the label to inquire about the mask’s components.
Additionally, all medical devices sold in Canada must be labelled in either English or French as a minimum. If the devices you have received do not have English or French labelling, you should notify Health Canada by submitting an online complaint form.
What are the impacts on my health if I wore a graphene mask daily for 1 month? 3 months? 6 months?
Is there a minimum length of time before developing negative health effects from graphene inhalation? Are the health effects of graphene inhalation permanent?
Is age a factor in how graphene inhalation may impact my health? Does it affect more young or old people?
It is not clear whether graphene-containing masks have any impact on human health, as the potential for people to inhale graphene particles from face masks and the related human health risks are not yet known, and may vary considerably based on mask design. Health Canada is currently evaluating the potential exposure and risks. The recall was precautionary, as the manufacturer did not provide evidence of safety and effectiveness as requested and as required under the Food and Drugs Act and the Medical Devices Regulations.
Consult your health care provider if you have used graphene face masks and have health concerns or symptoms, such as new or unexplained shortness of breath, discomfort or difficulty breathing.
What symptoms should I look for to determine if I am developing side effects from inhaled graphene?
Are the negative health effects from graphene inhalation immediate?
Could I experience symptoms even after I stop wearing graphene masks?
Can I get tested for inhaled graphene toxicity?
It is not clear whether wearing graphene-containing masks is associated with any negative human health effects. The potential for the inhalation of graphene particles from face masks and the related health risks may vary considerably based on mask design. Health Canada is currently reviewing all available information to assess potential risks.
Consult your health care provider if you have used graphene face masks and have health concerns, such as new or unexplained shortness of breath, discomfort or difficulty breathing.
Are these masks regulated by Health Canada?
Graphene face masks, like all face masks which make therapeutic claims, are regulated by Health Canada as Class I medical devices under the Medical Devices Regulations. Class I medical devices do not require a Medical Device Licence from Health Canada and do not require pre-market review by the Department; however, manufacturers of Class I medical devices are required to have a Medical Device Establishment Licence prior to manufacturing or importing medical devices.
While there is no pre-market review for Class I medical devices, manufacturers of medical devices are responsible for ensuring that the devices they sell are safe and effective for the medical conditions, purposes and uses for which they are manufactured, sold or represented. In addition, importers and distributors are required to have procedures in place to manage post-market risks in order to fulfil regulatory requirements, including record keeping, complaint handling, mandatory problem reporting, maintaining distribution records and conducting recalls. In addition, companies are required to promptly provide Health Canada with any information requested. As is the case with all health products, when the Department becomes aware of a potential health risk, we assess the risk and take appropriate action as necessary.
Should you have any additional questions, please contact the Medical Devices Compliance Program by e-mail at hc.mdcu-ucim.sc@canada.ca
Again, thank you for writing
Yours sincerely,
Medical Devices Compliance Program
Regional Operations and Enforcement Branch
Health Canada
hc.mdcu-ucim.sc@canada.ca |
