news May 12, 2020

COVID-19, Face Masks, and FDA – What you need to know.

A day in the city during flu epidemic : Stock Photo

Wearing and seeing people wear face masks when out in public has become a “new norm” in our society that will likely be around for some time to come. The COVID-19 pandemic in combination with CDC recommendations to prevent the spread of the virus has created a huge demand for these products that many companies are struggling to meet.

However, these companies may also be selling these products without fully understanding if their activities are regulated by the Food and Drug Administration (FDA), if they have incurred any FDA regulatory obligations, or if they are at risk of being the target of an FDA enforcement action for failure to meet one or more of those obligations. Moreover, as FDA adjusts to what it describes as a “very fluid situation,” these requirements are prone to being changed. Below, we provide a summary of the most recent state of affairs for face masks.

What is a face mask?

It is important to distinguish face masks from other similar devices like N95 respirators. An N95 respirator is a disposable half-mask filtering facepiece respirator (FFR) regulated as a medical device by FDA that covers the user’s nose and mouth and has been tested and proven to filter out 95% of the particulate materials to which the wearer is exposed in addition to providing fluid barrier protection.  Some of these are regulated by FDA as Class II medical devices and there are many FDA requirements associated with these products and their distribution, many of which have recently been relaxed by FDA (look for upcoming articles on these details).

Face masks, on the other hand, offer only a limited amount of protection. These are the type of masks that merely cover the user’s nose and mouth and may or may not meet fluid barrier or filtration efficiency levels. They can generally be broken into two broad categories: 1) those that are not intended for a medical purpose; and 2) those that are intended for a medical purpose.

What is a “non-medical” face mask?

A non-medical face mask is marketed to the general public for general, non-medical purposes, such as use in construction and other industrial applications (e.g., anti-pollution). These products are not regulated by FDA. Because their labeling and advertising do not include any statements to suggest that they are intended for use in the cure, mitigation, treatment, or prevention of disease, they fall outside of FDA’s jurisdiction and are not regulated by the agency.

Accordingly, because they are not FDA-regulated products, a FDA device marketing authorization is not required to distribute these products and all of the other FDA-requirements for medical devices do not apply to firms that manufacture, import, or distribute them.

However, if these items are labeled or sold in a way that suggests they are intended to be used for a purpose related to the prevention of disease, among other “medical” purposes, FDA can assert jurisdiction over these products. Therefore, it is prudent to review your labeling and promotional materials for these products to ensure that these materials do not contain any words, images, or other information that could potentially trigger FDA regulation.

What is a “medical face mask?”

A face mask (as described above) becomes an FDA-regulated “medical face mask” when it is intended for a medical purpose. Use of face masks by the public to cover their mouths and noses to prevent the spread of the COVID-19 virus is viewed by FDA as a type of activity that constitutes a medical purpose that brings these products within its regulatory authority. Thus, labeling or promoting an otherwise non-medical face mask for such use makes it a regulated medical face mask from FDA’s point of view.

In response to concerns relating to insufficient supply and availability of face masks, FDA issued an Emergency Use Authorization (EUA) authorizing the use of face masks by members of the general public, including health care personnel in healthcare settings, as personal protective equipment (PPE), to cover their noses and mouths, in accordance with Centers for Disease Control and Prevention (CDC) recommendations, to prevent the spread of the COVID-19 virus.

This EUA opened the door to a myriad of companies seeking to fill the demand for these product and permits manufacturers and distributors to label, promote, and distribute face masks for this purpose. It exempts these parties from the need to comply with many (but not all) of FDA’s regulatory requirements that would normally apply.

However, the EUA imposes certain requirements that must be met in order for these face masks to be lawfully distributed. These include, among others:

  • Limitations on the types of statements that can appear on the labeling and advertising materials for these products;
  • Specifying certain statements that must appear on the labeling and advertising materials;
  • Requirements for providing labeling to each end user, or end user facility;
  • Record keeping requirements related to the distribution of these face masks; and
  • Requirements for submitting adverse event reports related to the use of the face masks.

Failure to meet the EUA’s requirements can make the responsible party vulnerable to an FDA enforcement action. This is the case even if the responsible party was unaware their actions violated the law. It is, therefore, important that companies that are presently or plan to distribute these “medical face masks” be fully aware of the applicable regulatory obligations and conduct a detailed review of the planned advertising and promotional materials before bringing their face masks to market.