USDA to Strengthen Organic Regulations
Recently U. S. Department of Agriculture (USDA)’s Agricultural Marketing Service (AMS) released a proposal to modify organic regulations. The proposed rule is intended to increase oversight of industry and institute more procedures for certifiers and industry members...
DOJ Charges Manufacturer for Exporting Misbranded Masks
On June 5, 2020, the U.S. Department of Justice (DOJ) charged a Chinese manufacturer with exporting misbranded face masks, purported to be N95 respirators. The criminal complaint against King Year Printing and Packaging Co., Ltd. includes numerous allegations that it...
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...