Today, on April 11, 2019, FDA issued a final regulation which changes the ingredients permissible for use as active pharmaceutical ingredients (APIs) in hand sanitizers. Effective April 13, 2020, this final rule applies to a variety of consumer antiseptic products,...
An FDA import alert listing can destroy a supply-chain, and even result in an import ban. To issue an alert, FDA only needs to convince itself that one is necessary. Their impact and ease of issuance make import alerts FDA’s primary import enforcement tool, making it...
It’s been eight years since the Food Safety Modernization Act (FSMA) was signed into law. With that, the U.S. Food and Drug Administration (FDA) started issuing new regulations designed to strengthen the food safety system. At the same time, they took the “educate...
Update 01/13/2019:Commissioner Scott Gottlieb announced that they have increased surveillance sampling of imported high-risk products. Additionally, the FDA has expanded other activities that they have deemed "excepted, unpaid work because they're necessary to...
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...
Export lists can be a useful tool for foreign food safety authorities to verify that commodities exported from the United States originate from a trusted source. These lists serve as an unofficial “certification” that the included establishments comply with U.S. food...
Sometimes things take longer than planned and new due dates impact other commitments. That happened to the FDA, but they prevented a regulation from disappearing with just five days to spare. Current Good Manufacturing Practice (cGMP) regulations for food go back to...
The California Safe Drinking Water and Toxic Enforcement Act of 1986, commonly referred to as “Proposition 65” or “Prop 65” has new regulations that take effect on August 30, 2018. The amended regulations do not change the list of almost 900 chemicals identified by...
Between October 1 and December 31, 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...
The FDA has added a new resource to their website: the Data Dashboard, which is aimed to help importers, manufacturers, and processors comply with three separate regulations from the Food Safety Modernization Act (FSMA): the Foreign Supplier Verification Program...
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