Subject: Face Masks and Face Coverings
Attention: All Walmart and Sam's Club (including Walmart.com and Samsclub.com) Hardlines, General Merchandise, and Consumables Merchandising Teams
This is an advisory about Walmart Inc.’s protocol regarding the procurement and distribution of non-medical face masks and face coverings. In addition to complying with all applicable quality and regulatory requirements, face masks and face coverings sold or marketed for disease source control or for preventing the transmission of COVID-19 to another person must also comply with the applicable FDA packaging and labeling guidance provided under the Emergency Use Authorization (EUA). In order to gain PREP Immunity, we must ensure that all products covered under the FDA EUA meet the FDA standards.
This protocol covers cloth face coverings and non-medical sterile and non-sterile clinical masks. Face covering are defined as simple facial coverings serving much the same purpose as tying a kerchief around ones' nose and mouth. Fashion masks are an example of a cloth face covering. These face coverings are typically made of cloth but can be made of other materials. Clinical masks are a type of medical face mask which covers the nose and mouth and provides a barrier to minimize the direct transmission of infective agents. These masks are not rigid and are usually made of several layers of material.
This protocol does not apply to face masks or other items that can be used as face coverings that are not intended for source control and are clearly marked or marketed for purposes other than disease source control. Examples include costume masks, bandanas, or masks sold in the hardware department that are clearly marked for use in sanding, painting or other home improvements or construction.
Key FDA requirements, as of June 6, 2020, are noted below. This list is not all inclusive, and the requirements are subject to change. Refer to the FDA Regulatory Guidance webpage (see Resources section) for the most current list of requirements.
FDA Labeling Requirements
Face masks and face coverings must meet the following labeling requirements:
• Must be labeled accurately to:
o describe the product as a face mask; and
o include a list of the body contacting materials (which does not include any drugs or biologics).
• Label must include recommendations against use in a clinical setting where the infection risk level through inhalation exposure is high.
• Label must not claim that product is intended for use as a surgical mask or to provide liquid barrier protection.
• Label must not misrepresent the product’s intended use.
o For example, the labeling must not state or imply that the product is intended for antimicrobial or antiviral protection or related uses or is for use such as infection prevention or reduction.
• Product must not be labeled as a respiratory protective device or for particulate filtration use.
• Product must not be labeled for use in high risk aerosol generating procedures.
FDA Conditions of Authorization- Manufacturers and Distributors
• Instructions for Cleaning: Manufacturers and Distributors will include instructions for recommended cleaning and/or disinfection materials and processes, if applicable, for their authorized product(s).
• Adverse Event Reporting: Manufacturers will have a process in place for reporting adverse events of which they become aware to FDA under 21 CFR Part 803. Adverse events of which the manufacturer becomes aware will be reported to FDA.
FDA Conditions Related to Advertising and Promotion
• All advertising and promotional descriptive printed matter relating to the use of the product shall clearly and conspicuously state that:
o The product has not been FDA cleared or approved.
o The product has been authorized by FDA under an EUA for use as source control by the general public as well as by HCP in healthcare settings as to help prevent the spread of infection or illness during the COVID-19 pandemic.
o This product is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices, including alternative products used as medical devices during the COVID-19 outbreak, under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.
• Please forward this message to all relevant Associates within your organization.
• Please communicate this document to all potentially impacted suppliers and remind your suppliers of their ongoing obligation to comply with all laws and regulations pursuant to their respective supplier agreements.
• Please review your current and future assortments to determine whether all items are appropriately packaged and labeled consistent with the above guidance.
• FDA Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised) Webpage: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-face-masks-and-respirators-during-coronavirus-disease-covid-19-public-health
• U.S. Product Quality and Compliance Manual: Retail Link > Apps > Product Quality and Compliance Library > US Product Quality and Compliance Manual
• Questions pertaining to product safety, regulatory compliance, or testing requirements should be sent to: