FDA issued interim final regulations implementing sections 305 and 307 of the Public Health Security and Bioterrorism Preparedness Act which are effective on December 12, 2003. This regulation pertains solely to domestic and foreign facilities that manufacture/process, pack, and hold food, food/feed additives or food/feed ingredients for human/animal consumption in the U.S. These sections cover the mandatory registration of food facilities and the mandatory prior notice requirements for all imported food shipments. The Dietary supplement industry is covered by these regulations.
Sabinsa Corporation is proud to announce that it has fully registered with the FDA and has received its FDA registration number. In addition, all our overseas manufacturing and distribution operations have registered and received their FDA registration numbers too.
We are following the developments on the new regulations closely, and will work with our factory and custom brokers to ensure that proper notification is made on our entries. We are confident about our compliance. Additionally, we have maintained ample inventories to supply our customers, and will continue to follow the same planning.
Please feel free to contact Mark C. Sysler, Sr. Executive Vice President if you have any questions or concerns.