CONSUMER ADVISORY FOR VISITORS FROM THE US
Notice Concerning Product Claims About Face Coverings and COVID - 19
Efficacy, cost-effectiveness and value are important aspects of general-purpose face coverings — however being safe, healthy,
and ecofriendly is of equal concern to consumers. This is why the Research Consortium has been lobbying and working with standards organizations and consumer groups across the globe to require a consumer advisory product label...like ours below.
International standards intended to regulate general-purpose face coverings do not address the use of antimicrobial or antiviral materials, finishes, or mechanisms, many of which are subject to oversight by the U.S. Environmental Protection Agency (EPA) and Food and Drug Administration (FDA) * and may warrant additional testing and regulatory oversight as to their efficacy and safety. Further, there are several aspects that relate to the material composition and design of face coverings that are not addressed by most standards but warrant attention relative to their safety, health and environmental impact of including, but not limited to potentially toxic finishes, inhalable substances from materials, and bioburden inhibitors. Understanding this, the Research Consortium believes it is important that end users familiarize themselves with the specific special claims being made for products and ask for information to verify such claims. For an expanded discussion of this topic see the New Face Covering Standards section inside.
The Stay Safer Reusable Protective Face Covering is neither a NIOSH certified respirator nor an FDA-approved surgical mask. It is technically a "medical device" per the FDA which classifies ALL face coverings that are intended to curb community spread as a medical device. Like all fabric face coverings, it is authorized for use by the general public to help slow community spread during the pandemic under an Emergency Use Authorization.
* Without specific EPA or FDA approval, claims can't be made about any antimicrobial agent’s protection against specific organisms infectious to humans or that of any fabric treated with the agent. While our product does not cause damage nor bring added risk to wearers when used as intended, it can't be stated that it can prevent or protect the wearer from any risk to a person's health or safety, illness or disease. The data provided in support of the science/technology behind our product (while truthful, accurate and complete) is for educational purposes only.
United States Federal Government Oversight
Some face covering manufacturers make false, misleading and deceptive claims about the efficacy, safety and environmental impact of their products. As such, the Food and Drug Administration (FDA) recently imposed severe limitations on claims that can be made about face coverings and antimicrobials. Likewise, the US Environmental Protection Agency (EPA) has strict rules regarding marketing claims made about antimicrobial capabilities, especially as it regards their effectiveness against COVID-19. The American Association of Textile Chemists and Colorists (AATCC), a highly regarded international standards organization, created AATCC M14-2020 Guidance and Considerations for General Purpose Textile Face Coverings, a voluntary specification intended to be a manufacturer guide. Wanting a true standard, the CDC's National Institute for Occupational Safety and Health (NIOSH) engaged the American Society for Testing and Materials (ASTM International) to create a national standard to serve as a baseline for source control devices and to provide a level playing field for demonstration of product claims and avoid the general confusion related to community barrier face covering effectiveness. It is taking the form of ASTM WK73471: New Specification for Barrier Face Coverings and due to be issued in Q1 2021.
Mr. Richard Nicholas, the founder of the Research Consortium, is a member of the workgroup that wrote the AATCC M14-2020 specification. He is also a member of the ASTM F23.65 workgroup tasked by the CDC/NIOSH with developing a national face covering standard. This standard will ensure that general purpose face coverings meet minimum requirements for both source control and to reduce the amount of particulates inhaled by the wearer.
Restrictions and Requirements
Until recently, general-purpose cloth face coverings had not been regulated when they were intended solely as source control to curb viral spread in non-medical settings. Due to their more widespread use, that changed. Now, without specific EPA or FDA approval, claims cannot be made about an antimicrobial’s protection or prevention against specific organisms infectious to humans or that of the treated fabric. Unless authorized by the EPA or FDA, any face covering's claim re: its antimicrobial’s capability must be limited to the covering itself; be specific and not unqualified; not reference health-related microbes, and; refrain from denoting personal (e.g., “for skin, wound, respiratory”) protection.
Many claims are made about an antimicrobial's "perceived" effectiveness against COVID-19. As of January 2021, no organization can justly make a claim about a product’s effectiveness against COVID-19. To be clear, there has been no approval, for any form of government-sanctioned testing performed in the US or elsewhere, to prove the effectiveness of any antimicrobial agent against COVID-19. Further, while an active antimicrobial biocide may be effective against a virus in its pure state, it may not have proven antiviral properties when it is built into fabrics and coverings.
Emergency Use Authorization (EUA)
While the Stay Safer Reusable Protective Face Covering hasn't been FDA cleared it is authorized by the FDA for use by Health Care Personnel (HCP) as Personal Protective Equipment (PPE) to help curb the spread of infection/illness in healthcare settings per an Emergency Use Authorization (EUA ) and by the general public to help slow COVID-19 spread. The Stay Safer covering is authorized only for the duration of the declaration that circum-stances exist justifying the authorization of the EUA of medical devices, including alternative products used as medical devices, during the COVID-19.
Information provided by the Research Consortium, as to the efficacy, safety and eco-impact of triboelectric air filters and certain QAC antimicrobials, beyond those described above, are not approved by the FDA. We believe the public must have access to accurate, up-to-date research and information and, for educational purposes, we are making available the Research Consortium’s 75-page study – COVID-19, Its Transmission and Face Mask Efficacy – and other research on triboelectric air filters and QAC-based chemical antimicrobials and their effectiveness, safety and environmental impact.
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