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.

This audio conference covers:

• Understanding FDA recall authority under the FSMA
• Record-keeping requirements under the FSMA, including who is affected and what specific information must be documented
• How these new requirements relate to recall authority and the overall scheme of the FSMA in general
• Examples of the kinds of business records that may be required in the event of a recall or near-recall situation
• How the interplay between the new record-keeping requirements and recall authority will work in practice

About the speaker:

Mitchell S. Fuerst, Esq. is a founding member of Fuerst & Ittleman, P.L. and is the firm's managing partner. He has almost 30 years of experience practicing Food and Drug Law, and has advised clients around the world on food safety, labeling and marketing compliance of food, dietary supplements, pharmaceutical, medical devices, biologics, and cosmetic products. He advises and represents clients on compliance matters before the U.S. Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA), U.S. Federal Trade Commission (FTC), and U.S. Customs and Border Protection (CBP).

Mr. Fuerst was born in New York, New York. He received his B.S.B.A. from American University in 1975, his Juris Doctor, Cum Laude, from the University of Miami School of Law in 1978 and was a Member of the University of Miami Law Review from 1977-1978. Mr. Fuerst was an adjunct professor at the University of Miami School of Law, Master in Taxation Program, from 1986 to 1990. He is admitted to the Bar in Florida, the U.S. Supreme Court, U.S. Court of Appeals for the Fifth and Eleventh Circuits, U.S. Tax Court, U.S. District Court for the Southern District of Florida, U.S. Court of Federal Claims and the United States Court of International Trade.

Who should attend?

• Attorneys
• Compliance Officers
• Quality Assurances
• Regulatory Directors
• Quality Controllers
• Regulatory Consultants