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...
Imports
FDA Removes Taiwan from Country-Wide Import Alert for Color Additive Violations in Cosmetics
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...
GAO Study on FDA’s Seafood Import Alerts Released
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...
New Year, New Compliance for the Nutrition Facts Panel
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...
New US Tariffs on EU-Origin Products Announced
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,...
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...
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...
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...