Imports | Bioterrorism Act Compliance

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act, or BTA) was signed into law as a direct response to the terrorist attacks of September 11, 2001. The BTA amended the Food Drug and Cosmetic Act (FDCA) and was intended to provide FDA with new inspection and enforcement tools to help the agency prevent and respond to a bioterrorism event. The Bioterrorism Act focused primarily, although not exclusively, upon foods.

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The BTA expanded FDA's authority with respect to foods through several specific areas of new FDA regulatory and administrative power:

1. Registration of food facilities with FDA (foreign and domestic) is required under the BTA;
2. Prior notice of virtually all imported food shipments under FDA authority is required under the BTA;
3. Record keeping requirements for food facilities (to include transporters of food in the U.S. and international carriers bringing food into the U.S.) were established under the BTA;
4. Authority was granted for FDA administrative detention (not import detention) of food if FDA has credible evidence that such food presents a threat of serious adverse health consequences or death;
5. Authority for FDA to institute debarment of food importers for various violations related to food importation; and
6. Creation of a clear way to re-import previously refused foods if certain criteria are met.

FDA has implemented four of the major BTA authorities by promulgating bioterrorism regulations related to FDA Food Facility Establishment Registration, FDA Prior Notice of Imported Foods, FDA Administrative Detention, and FDA Record Keeping requirements related to foods.

FDAImports.com, LLC's consultants and affiliated attorneys regularly provide guidance and representation with respect to all aspects of the BTA, FDA's implementing of bioterrorism regulations, the agency's bioterrorism security guidance for food, cosmetic, drugs, and biological products establishments and their respective products.

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At FDAImports.com, LLC we make certain our importing clients understand the importation process and assist our clients in identifying appropriate actions and responses should Customs demand redelivery of a conditionally released product, or should that agency issue a demand for payment of liquidated damages pursuant to the importation bond. It is important for your company to know and follow the laws, regulations, and procedures when importing products into the United States. Get Started.