C.HUMPHREY & ASSOCIATES P.A.

Our FDA Attorneys Advise Clients on Food-Related Emergencies

After the events of Sept. 11, 2001, the U.S. Congress passed and the President signed the Public Health Security and Bioterrorism Preparedness and Response Act legislation. It empowers the FDA to respond to bioterrorism and other potential food-related emergencies. As a result, all manufacturers, processors, packers and holders of food under FDA jurisdiction must register with the agency and keep records with respect to the food they receive and release. In addition, those importing food into the United States must provide the FDA with prior notice of the food’s entry.

The Bioterrorism Act expanded FDA authority in many areas: 1) registration of food facilities; 2) prior notice of imported food shipments; 3) record keeping; and 4) detention of any food that credible evidence indicates presents a threat of serious adverse health consequences or death to humans or animals; 5) Disbarment; and 6) Marking requirements for refused food.

Our FDA attorneys advise our clients on the intricacies associated with these regulations and the ever-changing guidance documents that FDA issues on a periodic basis. For the most recent FDA guidance documents, click here.

Recent Bioterrorism Guidances

Docket No. 2003D-0554, CFSAN 200485. Compliance Policy Guide Regarding Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Availability.PRE-PUB]

The Guidance PDF Version 
The Guidance Word Version

Docket No. 2003D-0562, CFSAN 200486. Revised Compliance Policy Guide Sec. 110.300--Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Availability. [PRE-PUB]

The Guidance Word Version 
The Guidance PDF Version

FDA and CBP Announce Revised Compliance Schedule for Enforcement of The Prior Notice Interim Final Rule and Contingency Plan for Prior Notice System Outages

For the full article, click here.