FDAImports.com, LLC, consultants and affiliated attorneys have been thinking about and praying for all of our friends, colleagues and clients affected by the massive earthquake and tsunami which struck Japan on March 11th. We wanted to provide an update on the affect of these events upon those importing FDA-regulated products to the United States from Japan. Certainly the earthquake in Japan will exact personal, social, and economic consequences that will be with us for many years. More particularly, this will have long-term … READ MORE

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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 assumption. Food is food in FDA’s mind. And at the border FDA tends to think of imported articles in ways to enhance agency power, not to restrict it. So even though the FSMA was passed with a view to increasing food safety, there are areas of concern Pharma companies should watch out for or find themselves … READ MORE

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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 series of reviews of this new law and some opinion as to what will work, what will not, and what it will mean to foreign food manufacturers and exporters and U.S. food companies of all kinds.

FIRST: What has changed that matters today; right now?  Not much. Almost nothing in the new amendments will go into effect … READ MORE

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