There have been wide-spread reports of shortages of personal protective equipment such as face masks in U.S. hospitals and health-care facilities as the coronavirus pandemic has worsened. In response, dozens of fashion and apparel companies have begun sharing patterns and materials and redirecting labor and manufacturing resources to quickly produce PPE replacements. These manufacturers, brands and designers across the globe have joined an army of individual citizen sewers working at their homes to help produce urgently needed equipment for our health-care workers on the front lines. We are all grateful for these efforts.
The Face Mask Shortage
The individual citizens and fashion industry employees who are creating face masks around the globe are making a heroic and heartening effort to alleviate shortages. The trouble with the homemade masks is that, if they’re made with regular fabrics available to most consumers, they’re not considered medical grade, or PPE. On March 17, 2020, the U.S. Centers for Disease Control and Prevention said the following about the use of homemade masks by health-care personnel, or HCP:
“In settings where face masks are not available, HCP might use homemade masks [e.g., bandana, scarf] for care of patients with COVID-19 as a last resort. However, homemade masks are not considered PPE, since their capability to protect HCP is unknown. Caution should be exercised when considering this option. Homemade masks should ideally be used in combination with a face shield that covers the entire front [that extends to the chin or below] and sides of the face.”
In addition, we have seen where these homemade masks are being used as a second line of defense over approved PPE masks, when health-care workers are forced to reuse one-time-only disposable masks.
In short, homemade face masks are better than nothing, but the CDC does not deem them PPE. Still, in this time of crisis, we should be thanking those who have rushed to rearrange their homes and workspaces to produce face masks and other needed equipment as quickly as possible.
The Underlying Problem
When you hear about PPE — please remember that PPE is a broad term and these products are designed and regulated differently depending on the intended market. A PPE product meant to protect a manufacturing or construction worker is potentially different than a similar product meant to protect a health-care worker. These differences are a result of designs for different hazards and governed by different regulatory agencies. These regulations help protect industrial and health-care workers from harm.
For those companies helping to alleviate the shortage by producing fabric masks and garments — and for those that may look to create consumer apparel that incorporates protective technology in the future — it’s important to know some basics about the underlying problem these products are designed to solve and the regulations and guidelines that apply to them. Designers, product developers and retailers all need to quickly familiarize themselves with the guidelines that relate to fabric technologies and how they fit in the health and wellness space. As with industrial and health-care PPE requirements, these regulations are meant to protect consumers from harm.
The problem is that some makers of antimicrobial fiber and textile technologies have already made unsupported claims globally about their products’ effectiveness against COVID-19, with one even referring to “life-saving chemistry,” which is both illegal in the U.S. and can be dangerous to people’s health.
Also, fashion and apparel companies must beware: If they buy such input products to use in finished goods, they, too, are not allowed to make any similar kinds of claims about the end products’ ability to fight COVID-19. U.S. laws prevent companies from making “public health claims” about viruses and consumer textiles.
The Very Basics About Marketing Antimicrobial Textile and Fabric Products
To distribute or use an antimicrobial product in the U.S., the antimicrobial product must be registered with the EPA. For these antimicrobials, EPA has stringent rules regarding what language can be used to state or imply the antimicrobial capabilities of a registered product. For instance, marketing claims must be limited to the protection of the “treated article” (the finished product made with the technology-enhanced fabric or materials) and cannot claim or imply antimicrobial activity beyond protection of that finished product itself.
Also, the antimicrobial claims must be limited to protection/prevention from microorganisms that are not considered “public health-related microorganisms.” That means companies cannot market products with references to specific organisms infectious to humans, like a virus, unless the antimicrobial product has been approved by the EPA to make these claims — based on EPA-approved testing. Without EPA approval, claims cannot be made that a product can “sterilize,” “sanitize” or “disinfect.” These rules covering marketing claims are applicable to packaging, advertising, written and verbal communication, web sites and other forms of messaging that state or imply antimicrobial capabilities.
What this means practically for fashion- and apparel-makers is that even though they might have created products using textiles and fabrics that claim to have the ability to fight COVID-19 or other public health-related microorganisms, they won’t be able to market their finished products the same way in the U.S. and likely elsewhere as well.
Here are the marketing guideline basics that companies making products with antimicrobial properties need to know:
• The claim must be limited to the protection or preservation of the finished.
• The claim can’t be an unqualified claim of “antimicrobial” activity; the antimicrobial protection must be linked to the finished.
• The claim can’t imply or refer to specific health-related microorganisms (e.g., SARS-CoV-2 or MRSA), as these are referred to as “public health.”
• The claim must not state or suggest general “germicidal,” “antibacterial” or “bactericidal” activity, which suggests a public-health-related microorganisms.
• The claim can’t refer to protection beyond the finished article, such as for personal protection (e.g., “for skin, wound, or respiratory protection”).
• The brand name for the product can’t include terms indicative of protection from health-related microorganisms.
• The graphics used to present the article can’t include or imply protection of public health significance and the antimicrobial claims should not take prominence over other normal product claims.
These details will also be important for fashion and apparel brands that may think about incorporating materials that offer antimicrobial benefits into their finished products sometime in the future. Brands need to know what claims they can and cannot legally make regarding end products and adhere to all laws regarding the marketing of such products in order to protect consumers, both during the coronavirus pandemic and after.
Terry Walmsley is the director of regulatory affairs and sustainability at Noble Biomaterials.
Read more from WWD:
WATCH: How Fashion’s At-Home Workforce Is Helping to Fight Coronavirus