Around the world, fashion companies have rushed to reallocate resources in order to address shortages in essential products amid the current global health pandemic. Paris-based giant LVMH Moët Hennessy Louis Vuitton has pivoted its manufacturing to produce hand sanitizers, while Milan-based Prada has produced thousands of hospital gowns and face masks.
Right here in Canada, fashion companies big and small have done their part to contribute to bettering the circumstances surrounding the pandemic. Canada Goose has used its facilities in Toronto and Winnipeg to produce medical gear and patient gowns. Meanwhile, Toronto designers NARCES and Hilary MacMillan began creating non-medical grade masks in response to the pandemic. In the midst of what has proven to be an exceptionally challenging time for many communities globally, the fashion industry has stepped up to provide resources where possible.
However, as homemade and factory-made masks have become a growing means of supporting the public and healthcare workers in times when resources may be scarce, health authorities have cautioned that there are foundational requirements that must be met in order for any mask to be as effective as N95 respirators, surgical masks, or other personal protection equipment (PPE).
America’s Center for Disease Control (the CDC) and the Food and Drug Administration (the FDA) have released notices informing the public that there is a significant difference between “surgical” and “non-surgical masks”, and accordingly, the labeling of these products must reflect this difference. The regulation of surgical masks by the FDA generally includes standards relating to the use of specific medical-grade textiles and coating technologies that aid in filtration to ensure that the masks block minuscule airborne particles. Other regulatory guidelines also include the manufacturing and storage of the masks in an environment that meets the legally defined “quality system requirements”. Similarly, in Canada, various PPE, such as masks and respirators, are regulated as medical devices by Health Canada. However, meeting the regulatory standards within Canada, the United States, or other regulatory bodies around the world can prove to be difficult for small and independent fashion designers.
Given the rapid progression of COVID-19, Health Canada has worked towards streamlining the approval process for medical devices. On March 18, 2020, the Minister of Health, pursuant to subsection 30.1(1) of the Food and Drugs Act, made an Interim Order setting out that device licensing provisions of the Medical Devices Regulations do not apply to necessary devices if certain procedures are followed. Similarly, as indicated in a March 2020 release, the FDA stated that given the circumstances surrounding the COVID-19 Public Health Emergency, it will “not object to the marketing and distribution of” certain face masks without the “usually-required prior-clearance”. These temporary regulatory changes and relaxed standards may better assist American and Canadian fashion brands in producing PPE. Regardless, fashion companies must properly assess and consider whether the products they are producing meet their government’s current regulatory measures. Though brands such as New York’s Christian Siriano have noted that they intend to make masks that meet FDA standards as soon as they can acquire approved materials, meeting these standards may not be a feasible option for some designers. In these cases, proper product labeling as outlined by regulatory bodies must be followed.
The FDA has stated that companies may produce non-surgical masks if the product labeling respects the following requirements: it may be used when FDA cleared masks are unavailable; it recommends against use in a surgical setting or where significant exposure to liquid bodily or other hazardous fluids may be expected; it makes no claims of antimicrobial or antiviral protection; it makes no claims of infection prevention or reduction; it makes no claims regarding flammability; the labeling contains a list of the body contacting materials; and the mask is not labeled as a “surgical mask”; rather it may be labeled as a “face mask”.
Health Canada has also advised the public and healthcare professionals on various important considerations for the use of homemade masks to protect against the transmission of COVID-19. Specifically, Health Canada has noted: “Homemade masks are not medical devices, and consequently, are not regulated like medical masks and respirators. Their use poses a number of limitations, [including] they have not been tested to recognized standards, they may not provide complete protection against virus-sized particles, the edges are not designed to form a seal around the nose and mouth, the fabrics are not the same as used in surgical masks or respirators, [and] they can be difficult to breathe through and can prevent you from getting the required amount of oxygen needed by your body”.
As fashion companies continue to reallocate resources in order to make essential products throughout the current global health pandemic, it remains crucial that independent designers and global fashion companies alike understand the various regulatory considerations and distinctions between surgical and non-surgical masks.
Written by Alessia Monastero, IPilogue editor and articling student at Deeth Williams Wall LLP.