FDA’s Notice of Intent to Inactivate Outdated Drug Listing Records: What Does This Mean?
On September 12, 2019, the U.S. Food and Drug Administration (FDA) will begin removinginactive drug listings from its drug listing database. In other words, inactive drug listings will no longer be “listed” with FDA, as required by law. A removed drug listing can be...
FDAImports.com and Mesh Intelligence – Providing Threat Intelligence for FDA-regulated industries
FDAImports.com has entered into a new type of Strategic Partnership with Mesh Intelligence that will bring together FDAImports.com’s deep technical, advisory and consulting expertise in FDA, USDA and Customs compliance and regulation, with Mesh Intelligence’s...
Annual Renewals for FDA-Registered Facilities
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...
Possible Resolution of Antidumping Duties on Mexican Tomatoes
Earlier this week the U.S. Commerce Department announced there is a new draft suspension agreement, which will avoid the need for antidumping duties (ADD). Their press release indicated that after a 30-day notice period, a final agreement could be signed on September...
Latest Information on List 4 Tariffs
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 Issues First Warning Letter for Failure to Comply with FSVP
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...
Coming Soon: FSVP Enforcement?
Last week the Food and Drug Administration (FDA) took a critical step towards enforcement of FSVP by creating Import Alert 99-41, "Detention Without Physical Examination of Human and Animal Foods Imported from Foreign Suppliers by Importers Who Are Not in Compliance...
The Trade War with China is Back On: List 4 Tariffs to be Imposed September 1st
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...
Possible EU Tariff Product List Expanded
The Trump administration’s trade war with the European Union may be escalating. The U.S. Trade Representative (USTR) announced earlier this week that it is considering adding $4 billion worth of products to an existing list of $21 billion of goods that could be...
China – U.S. Trade Update: List 4 to be Delayed; FAQs for List 3 Exclusion
President Trump announced on Saturday that proposed new tariffs on Chinese imports (aka List 4 goods) will be delayed as trade talks resume. Proposed goods on List 4 were to include most products not already covered by previous tariffs. The U.S. Trade Representative...