Date: April 6, 2020
From: Russ Mogell, CEO, Seven Sourcing
To: Our Valued Clients
Subject: COVID-19; KN95 Respirators & Other Medical Supplies from China
Over the past several months, the world has witnessed the onset and spread of the COVID-19 virus. Hundreds of thousands of health care practitioners relentlessly continue their daily battle to heal and comfort those infected with the COVID-19 virus. These nonstop efforts have strained both health care practitioners and their supply of reusable items (e.g., ventilators) and one-time use personal protection equipment (e.g. respirators, masks & gowns) that satisfy current federal safety regulations.
In an effort to alleviate this burden, the U.S. Food and Drug Administration (“FDA”) issued several Emergency Use Authorizations (EUA) exempting certain unapproved filtering facepiece respirators (FFR) from many FDA requirements, including pre-market notification, registration and listing, quality system regulation, and product identification. Specifically, in March 2020 the FDA issued two EUAs permitting the emergency use and distribution of certain general-use, NIOSH (National Institute for Occupational Safety and Health)-certified and non-NIOSH-certified FFR (e.g., Model N-95) to health care practitioners provided they met identified performance standards and product classifications. These EUAs conspicuously omitted various FFRs (e.g., Model KN-95) from China. However, on April 3, 2020, the FDA issued a separate EUA permitting the emergency use and distribution of FFR that are manufactured in China and not NIOSH-approved, provided they satisfied specific criteria and received pre-importation approval from the FDA.
As several customers have inquired about the importation of Chinese-manufactured KN-95 FFR & other supplies including gowns gloves & other masks, we have carefully reviewed the relevant FDA EUAs and our available supply options. Due to a lack of reliable information about Chinese-manufactured KN95 & compliance with the EUA requirements, our currently diminished ability to detect the presence of counterfeit merchandise, and the potential liability of our customers and Seven Sourcing resulting from the distribution of such products, Seven Sourcing will not import nor distribute Chinese-manufactured KN95 respirators & other medical supplies (including but not limited to surgical & non-surgical masks, gloves & gowns) at this time since we cannot guarantee that our customers will receive safe, effective, and FDA/CDC approved Chinese-manufactured products.
While we understand that our decision may disappoint some of our customers, Seven Sourcing’s first concern is safety. We will continue to actively monitor the situation, examine all available options, and advise you immediately if viable supply options develop. We value your business and thank you for your continued support during these trying times. Should you require any further information regarding this matter, please do not hesitate to contact firstname.lastname@example.org .