Liability Considerations for Manufacturers of Face Masks Intended for Source Control in the Age of COVID-19
In April, the Centers for Disease Control and Prevention (“CDC”) began recommending that the public wear face masks as “source control” to limit the spread of COVID-19. [1] In response to this recommendation, the Food and Drug Administration (“FDA”) extended its prior Emergency Use Authorization (“EUA”) to cover face masks intended for use as source control. In May 2020, FDA again updated its guidance documents and defined face masks used for source control as medical devices subject to FDA regulation and requirements. To aid in increasing the availability of products intended to help curb the spread of COVID-19, the Department of Health and Human Services (“HHS”) issued a declaration that provides potential manufacturers of countermeasures with immunity from liability in certain cases. Now that FDA has defined face masks used for source control as medical devices covered by its EUA, face mask manufacturers may be able to claim protection under these immunity provisions. FDA regulation and potential civil products liability still pose legal risks, and would-be manufacturers should understand the regulatory requirements, immunities, and protections surrounding face mask manufacturing before wading into this highly regulated industry.
Manufacturing Guidance from FDA
In response to the CDC’s recommendations that members of the public use face masks to cover their noses and mouths, FDA issued a Letter of Authorization for the use of face masks (hereafter “Authorization Letter”). [2] Under FDA’s most recent guidance, all face masks intended for use as “source control” are considered medical devices. [3] In this context, source control “refers to the use of a face mask or cloth face covering over the mouth and nose to contain that individual’s respiratory secretions to help prevent transmission from infected individuals who may or may not have symptoms of COVID-19.” [4] Simply put: manufacturers producing even simple cloth face coverings are now producing medical devices regulated by FDA and must therefore comply with certain regulatory requirements. [5]
Although this may sound daunting, FDA’s Authorization Letter makes compliance very straightforward. First, manufacturers acting under the Authorization Letter may only produce masks intended for source control. [6] In other words, the Authorization Letter does not permit a manufacturer to produce a face mask intended for another medical purpose, like a surgical mask or respirator. Second, they must comply with the following labeling requirements:
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The product is labeled accurately to describe the product as a face mask and includes a list of the body contacting materials (which does not include any drugs or biologics);
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The product is labeled accurately so that it does not claim to be intended for use as a surgical mask or to provide liquid barrier protection;
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The product labeling includes recommendations against use in a clinical setting where the infection risk level through inhalation exposure is high;
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The product is not labeled in such a manner that would misrepresent the product's intended use; 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;
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The product is not labeled as a respiratory protective device, and therefore should not be used for particulate filtration; and
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The product is not labeled for use in high risk aerosol generating procedures. [7]
Finally, they must comply with the Conditions of Authorization as detailed in the Authorization Letter. [8] The Conditions of Authorization reiterate the labeling requirements while also requiring the manufacturer to (1) take steps to ensure that the labeling information is available to the end user; (2) include instructions regarding the recommended cleaning of the materials; (3) implement a process to report adverse events; (4) maintain records related to the Emergency Use Authorization; (4) maintain records related to the production and distribution of the masks; and (5) comply with certain requirements for advertising and promoting the masks. [9] If a manufacturer complies with these requirements, they “do not need to take any action . . . to be authorized under th[e] [Emergency Use Authorization].” [10]
Health and Human Services Liability Immunity
A byproduct of FDA’s designation of face masks as medical devices covered by FDA’s Letter of Authorization is that face mask manufacturers now may qualify for liability immunity under a declaration by HHS. [11] Under this declaration, manufacturers of “Covered Countermeasures” are immune from liability for all claims “under Federal and State law . . . for loss caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a covered countermeasure.” [12] The only exception to this immunity is for “death or serious physical injury proximately caused by willful misconduct” on the part of the entity otherwise entitled to immunity. [13]
The term “Covered Countermeasure” includes, among other things,
a drug (as such term is defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)), biological product (as such term is defined by section 262(i) of this title), or device (as such term is defined by section 201(h) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321(h)) that is authorized for emergency use in accordance with section 564, 564A, or 564B of the Federal Food, Drug, and Cosmetic Act . . . . [14]
In this context, face masks for source control may qualify as “Covered Countermeasures” because FDA views face masks intended for this purpose as “devices” [15] and “authorized [them] for emergency use” in its Authorization Letter. Accordingly, face mask manufacturers may be able to take advantage of the broad liability immunity established by HHS’s declaration.
Closing Thoughts
Despite FDA’s efforts to simplify regulatory compliance for face mask manufacturers, liability and regulatory risks remain. Those interested in producing face masks should seek guidance from an attorney experienced in FDA and regulatory compliance to ensure full compliance with FDA’s requirements, as well as an attorney experienced in issues surrounding products liability to ensure that the immunity protections provided by HHS will apply to the manufacturer’s actions in producing face masks.
[1] See CDC’s recommendations here: Masks and Respirators (cdc.gov).
[2]See U.S. FOOD & DRUG ADMIN., FACE MASK LETTER OF AUTHORIZATION (April 24, 2020) (hereafter “AUTHORIZATION LETTER”).
[3] MASK GUIDANCE, at 5 (“FDA pronounced that “[f]ace masks . . . are devices when they are intended for a medical purpose, such as prevention of infectious disease transmission (including uses related to COVID-19).”
[4]Id. at 4.
[5] Face masks not intended for a medical purpose are not considered medical devices. See MASK GUIDANCE, at 3-4. Accordingly, a manufacturer producing, for example, dust masks or masks intended for use in industrial applications, are not regulated by FDA’s new face mask guidance. See id.
[6] AUTHORIZATION LETTER, at 3.
[7]Id. at 3-4.
[8]Id. at 5.
[9]Id. at 5-7.
[10]Id. at 4.
[11]See Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85 Fed. Reg. 15198 (March 17, 2020) (hereafter “Declaration”).
[12] 42 U.S.C. §247d-6d(a)(1).
[13]Id. at § 247d-6d(d)(1).
[14]Id. at § 247d-6d(i)(1)(C) (footnote omitted).
[15] The term “device” is defined by the Food, Drug & Cosmetic Act as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is . . . (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals . . . .” 21 U.S.C. § 321(h)(2). As discussed above, FDA’s Mask Guidance clearly states that face masks intended for source control are included in this definition. See, MASK GUIDANCE, at 5.