The FDA recently reissued an Emergency Use Authorization (“EUA”) for the sale and import of certain non-NIOSH-approved respirators manufactured in China and used by healthcare personnel in the United States but, critically, has limited the authorization of respirators to those expressly included in Appendix A to the EUA. Specifically, under a June 6, 2020 EUA, the FDA had authorized use of non-NIOSH-approved respirators manufactured in China if the respirators were included in a list of respirators authorized in Appendix A to EUA, or if the respirators met three criteria included in the EUA intended to ensure authenticity and adequate particulate filtration in a healthcare setting. As such, the June 6 EUA permitted Chinese manufacturers to apply for authorization by submitting proof that their respirators met the three criteria outlined in the EUA.
The October 15 EUA, however, states that authorization for the sale, import, and use of respirators manufactured in China that are included in Appendix A to the EUA will continue, but removes the three criteria necessary for which non-NIOSH approved, non-authorized Chinese manufacturers can apply for authorization under the EUA. As such, manufacturers who are not included in Appendix A can no longer apply for authorization under the October 15 EUA. The October 15 EUA continues to emphasize that it is tailored to use of the non-NIOSH-approved respirators as personal protective equipment (“PPE”) in a healthcare setting, but is expressly addressed both to healthcare facilities and to importers and commercial wholesalers. Thus, the October 15 EUA places a broad class of entities involved in the chain of supply of these respirators on notice of the changes to the EUA.
Manufacturers, importers, retailers and others in the chain of supply seeking to market non-NIOSH-approved Chinese respirators that are not included in Appendix A to the October 15, 2020 EUA may nevertheless avail themselves of additional marketing avenues. Given that the October 15 EUA is directly applicable to PPE for healthcare personnel, those in the chain of supply can continue to sell non-NIOSH-approved, non-authorized respirators as face masks (rather than PPE) to the governmental entities, businesses, and the general public. In fact, face masks and coverings are subject to a separate EUA from April 24, 2020, which we have previously summarized here.
Finally, of significance, the PREP Act enacted during the initial stages of the COVID-19 pandemic in the United States granted liability immunity to claims of bodily injury to those in the chain of supply of a product authorized for emergency use during the period of time the EUA remains in effect. Such immunity expressly extends to distribution of a product in connection with a federal contract or agreement, or “in accordance with the public health and medical response” of the relevant governmental authority (which could include, for example, distribution of these products government entities for their essential workers). As such, those in the chain of distribution of non-NIOSH-approved Chinese respirators that are authorized under the October 15 EUA may enjoy liability immunity for respirators distributed in accordance with a public agreement or contract. On the other hand, those in the chain of supply of non-NIOSH, non-authorized Chinese respirators distributed in accordance with a public agreement or contract may still avail themselves of immunity to liability if they meet the standards set forth in the April 24 face mask EUA.
This alert does not purport to be a substitute for advice of counsel on specific matters.
Harris Beach has offices throughout New York State, including Albany, Buffalo, Ithaca, Long Island, New York City, Rochester, Saratoga Springs, Syracuse and White Plains, as well as New Haven, Connecticut and Newark, New Jersey.