Wednesday, May 4, 2011

Record-keeping and Recall Requirements Under the New FSMA

is being presented by Mitchell S. Fuerst, Esq., Managing Partner, with Fuerst & Ittleman, P.L. and airs on Thursday, June 9th, 2011. For more details, or to register please visit our site at www.fxconferences.com

With the passage of the FDA Food Safety Modernization Act (FSMA), a lot of attention has been devoted to the new recall authority granted to the FDA. While the FDA now has the authority to issue mandatory recalls when it deems it is necessary to protect against serious adverse health consequences, this is not the only consequence of mandatory recall authority. With recall authority comes a variety of new record-keeping requirements that food growers and manufacturers must abide by under the FSMA.

Although the FSMA limits this recall authority to situations where the food producer has not voluntarily recalled its own goods, the record-keeping requirements are broader in scope and allow the FDA to request business records before a recall is ever contemplated. Where the FSMA gives authority to FDA to require food producers to turn over records before a recall has been ordered, these record-keeping requirements are a central feature of the mandatory recall scheme.

Knowledge of these record-keeping requirements is critical to understanding the entire recall scheme. This audio conference presents an in-depth look at the new record-keeping requirements in the FSMA. Beginning with an overview of the requirements and FDA recall authority in general, the speaker explores specific obligations imposed by the FSMA, and examines the record-keeping requirements within the overall recall scheme to provide an understanding of how the provisions all work together in practice.