The Emergency Use Authorization (EUA), together with the Food and Drug Administration’s (FDA’s) guidance on COVID-19-related enforcement discretion, were put in place so medical product manufacturers, importers, and distributors can bring certain devices and OTC drugs...
Update 06/10/2020 On June 6, 2020, the FDA made several changes to EUAs for certain N95 respirators and Non-NIOSH-Approved Disposable Filtering Facepiece Respirators. FDA issued EUAs for products used to decontaminate certain N95 respirators for multiple-user reuse by...
A few months ago, FDA removed a country-wide import alert against cosmetic products from Taiwan for illegal color additives. Notably, the import alert disappeared with little fanfare. FDA originally issued Import Alert 53-06 in 1985, following the detection of illegal...
U.S. Government Accountability Office (GAO) recently issued a report that reviewed the steps FDA takes when removing seafood products from import alert. Although FDA intends to conduct a certain amount of sampling or inspections as part of their decision to remove a...
The Food and Drug Administration (FDA) started 2020 off strong; on January 1, 2020, FDA required compliance with new food and dietary supplement labeling regulations for manufacturers with ten million dollars in annual sales. Manufacturers with less than ten million...
UPDATE 10/07/2019 The USTR gave notice that there will be no exclusions for importers of the EU goods subject to the retaliatory tariffs. The effective date of October 18, 2019, is based on the date of entry and not the date of export. So, to avoid the EU tariffs,...
Between October 1 and December 31, certain Food and Drug Administration (FDA)-registered facilities must renew their registrations. Here are some things you need to know to ensure your renewal is completed on time. Medical device establishments: The process of paying...
Update 08/15/19The USTR has confirmed, as we expected, that the additional 10% will be applied based on entry date for both List 4A and 4B. Original Post 08/14/19On Tuesday, August 13th the United States Trade Representative (USTR) announced additional details...
FDA issued their first Warning Letter to an importer for not complying with the Foreign Supplier Verification Program (FSVP) that was introduced 8 years ago with the Food Safety Modernization Act (FSMA). For this first Warning Letter, FDA selected a food importer that...
On Thursday, August 1st President Trump announced that on September 1, 2019, he will impose a 10% import tariff on $300 billion worth of Chinese goods (which may potentially rise to 25% in the future). These goods, known commonly as List 4, will include most products...
Get up-to-date industry and regulatory news from the experts delivered straight to your inbox.