Are you a manufacturer, processor, packer or holder of food products? If you are, or know someone who is, you need to keep up with the latest and greatest updates regarding compliance with the FDA's Food Safety Modernization Act (FSMA). This post includes a background on FSMA, an update from FDA with 2 new guidance documents, FDA's extension to file biennial registrations, and an update on FDA using its enforcement power to suspend a facilities registration - meaning they can NOT import into the U.S.
The Food Safety Modernization Act of 2011 (FSMA) has for the first time, specifically put the onus on importers to have a program in place to verify that the food products they are bringing into this country are safe. The idea behind FSMA is to change FDA regulatory enforcement and focus to more of a preventative approach, instead of reactionary. These new requirements include risk-based controls, foreign supplier verification program, certification, and audits. Among the requirements are new rules for Bioterrorism Act registrations. Read on to make sure your registration isn't cancelled unnecessarily.
On December 12, 2003, the U.S. Food and Drug Administration (FDA) implemented the Bioterrorism Act of 2002. That Act basically required that companies shipping food to the United States must first be registered with the FDA, and that importers of food must provide "prior notice" to the FDA of any particular shipment before it physically arrives in the United States. Over the past 7 years, has the Bioterrorism Act lived up to its expectations to protect the American consumer from eating dangeously contaminated food?
The United States Congress is considering legislation to make the food we eat, especially imported food, "safe and secure". In my opinion, even if our food needs protecting, the proposed legislation only adds to the current Federal bureaucracy. The U.S. Food and Drug Administration already has a comprehensive regulatory procedure to stop, examine, and refuse imported food which it considers adulterated or misbranded, or otherwise not fit for human consumption. The current FDA system is working very well, and the only achievement of the proposed legislation will be to increase the price of food.