Shortages of PPE, Cloth Face Coverings, Disinfectants and Sanitation Supplies: New Recommendations by FDA and USDA
On May 22, 2020 the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) announced their recommendations to deal with shortages during the COVID-19 pandemic for cloth face coverings, sanitation supplies, disinfectants and personal...
Understanding the Difference Between FDA Enforcement Discretion and EUAs
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...
New EUA Requirements for Serology Tests
On May 5th, the FDA added a very significant new requirement for commercial manufacturers of COVID-19 serology tests that are currently on FDA’s so-called “section IV.D list”: Submit a complete Emergency Use Authorization (EUA) Request to FDA before Monday, May 18,...
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,...