Warning about Face Mask Imports
Update 6/10/2020 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...
FDA Expands EUA to Include more Imported Disposable Face Masks
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...
Bringing Face Masks to Market
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...
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,...
FDA’s Notice of Intent to Inactivate Outdated Drug Listing Records: What Does This Mean?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...