Recently Published FDA Import Refusal Report May Cause Complications for Foreign Manufacturers
FDA recently made its Import Refusal Report available again on its website. The FDA Refusal Report lists products FDA refused admission into the United States because the product appeared to violate the Federal Food, Drug, and Cosmetic Act (FDCA), and FDA believes...
FDA Food Facility Registration Requirements Change: Due to the Food Safety Modernization Act
On January 4, 2011, the Food Safety Modernization Act (FSMA) was signed into law and the U.S. Food and Drug Administration (FDA) gained significant new authorities. Among other things, the FSMA made a number of changes to FDA Food Facility Registration authority....
Analyzing the Food Safety Modernization Act
Rick D. Quinn (FDAImports) (Columbia, MD) President Barack Obama signed into law the FDA Food Safety Modernization Act ("FSMA") on January 4, 2011. FSMA is the greatest expansion of FDA's food regulatory authority since the enactment in 1938 of the Federal Food Drug...
The Administrative State and Cost Benefit Analysis: Who Really Benefits?
In an executive order signed last week, President Obama ordered all government agencies to conduct a cost-benefit analysis before issuing a new regulation and to develop any future regulations in the least-burdensome manner possible and with specific performance...
Pharma Companies Get a Surprise: Food Safety Modernization Act
Pharmaceutical companies in the U.S. might have thought that because the recently enacted Food Safety Modernization Act (FSMA) enhances food authorities at FDA, that Pharmaceutical manufacturers or importers have escaped unscathed. But this is an unsafe and incorrect...
The Food Safety Modernization Act Becomes Law: What Now?
On January 4, 2011, President Barak Obama signed the Food Safety Modernization Act (FSMA) into law amending the Federal Food, Drug, and Cosmetic Act (FDCA). The FSMA is an attempt to increase food safety in the U.S.A.; specifically imported food safety. This begins a...