On June 5, 2020, the U.S. Department of Justice (DOJ) charged a Chinese manufacturer with exporting misbranded face masks, purported to be N95 respirators. The criminal complaint against King Year Printing and Packaging Co., Ltd. includes numerous allegations that it violated the Federal Food, Drug and Cosmetic Act (FDCA). U.S. Customs and Border Protection, together with the U.S. Food and Drug Administration (FDA), monitor imports for possible fraudulent or defective products.
Willful Violations of the Law
The DOJ filed a criminal complaint against King Year, alleging that King Year knew that the masks were noncompliant, and knowingly and willfully took various actions to cover this up. They falsely labeled the respirators, the complaint states, “with the intent to defraud U.S. consumers, including medical providers and state and local governments, into believing they were buying N95 respirators approved, cleared, or otherwise authorized” by FDA and National Institute for Occupational Safety and Health (NIOSH). Other allegations include the use of a false registration document and the use of a fictitious corporation as its U.S. agent in registration documents filed with FDA. As Attorney Jessica Rifkin observed, “This suit shows that the U.S. is going to aggressively pursue “bad actors” in this area, i.e. those who willfully violate the law.”
Reminder to Importers: Conduct Due Diligence
The allegations include several problems that we have reported on previously, such as including the NIOSH logo and having N95 embroidered on the respirators even though they were not NIOSH approved. A manufacturer must be listed on CDC’s site if a mask has N95 marking on it or its box, or it is a counterfeit product and is subject to seizure. The defendant also stamped the FDA logo on their packaging according to the complaint. Any medical device that has the FDA logo on its label is misbranded. FDA recently sent a warning letter to a seller of purported COVID-19 test kits, based in part on the seller’s use of the FDA logo on its website.
We continue to urge importers to ensure that PPE is accurately labeled to reduce the risk that an inappropriate mask, for example, is not used in a surgical setting. We remind importers and distributors that failure to conduct due diligence to ensure that the goods you are selling are not counterfeit or fraudulent could lead to civil actions such as detention, seizure, and penalties, or other governmental action.
If you are in doubt as to whether the PPE (including face masks), testing kits, and other COVID-19 related products you want to import are properly classified and not counterfeit or otherwise fraudulent, and if they need FDA approval or facility registration, ask our team of regulatory consultants and affiliated attorneys. Contact us today.
This blog is provided for informational and educational purposes only and does not constitute legal advice, and is not intended to form an attorney-client relationship. Please contact your regular FDAImports representative for additional information.
