The Federal Food Safety Modernization Act (FMSA): Its Impact on Your Clients (Online Seminar)

MCLE Credits: 2.0
Ethics Credits Included: 0

MCLE Credit:  2.0 (Ethics: 0)
Live-Interactive Credit: 0.0
Price: $135 (Includes a downloadable audio version.)
Viewable Through: 9/30/2017


A pre-recorded streaming AUDIO replay of the entire September 2014 live seminar, The Federal Food Safety Modernization Act (FMSA): Its Impact on Your Clients.

Topics covered include:

  • The intricacies of this important law
  • How the FDA is expanding its regulatory reach—and may touch your clients
  • How your clients can avoid inadvertent missteps

Course Purposes:

  • Persuade jurors to draw reasonable inferences in your favor
  • Persuade the court to admit your evidence so the jury can consider it
  • Persuade the jury that it is you they should listen to and that your client should prevail

Signed into law in early 2011, the Food Safety Modernization Act (FSMA) was intended to ensure food safety by creating significant additional regulatory requirements for companies that: 1) Manufacture, 2) Process, 3) Pack, 4) Hold, 5) Import, or 6) Transport foods for human or animal consumption in the United States.

The new law, and the approved and proposed regulations, will give the U.S. Food and Drug Administration broad new authority and additional enforcement powers, including:

  • More detailed registration requirements
  • Company-conducted safety analyses and documentation of the same
  • Increased mandatory recordkeeping
  • Increased inspection authority
  • Verification of the safety of imported foods
  • Increased product-tracing requirements to allow for more effective recalls

If you represent food companies, or companies with business associations with food companies, you should know FSMA and its potential to impact, and possible disrupt, your clients’ businesses.

The FDA has new power to punish non-compliance—help your clients to comply!


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New Virginia Lawyer? (less than three years) Receive a 25% discount on this and most seminars and publications.



Ricardo Carvajal, Hyman Phelps & McNamara, P.C. / Washington, DC

Ricardo Carvajal provides FDA and FTC regulatory counseling and litigation support to manufacturers and marketers of foods (including dietary supplements and medical foods), cosmetics, and OTC drugs. He has substantial experience with all food and dietary supplement issues, including recalls, Reportable Food Registry issues, and GMP and HACCP compliance issues. He also has substantial experience with labeling and advertising issues, including those that arise from the use of health, nutrient content, structure/function, and disease claims. He has particular expertise in the regulation of products derived through biotechnology and nanotechnology. From 2002 to 2007, Mr. Carvajal served as Associate Chief Counsel in FDA’s Office of Chief Counsel, where his work was recognized with several individual and team awards. He currently serves on the Editorial Advisory Board for the Food and Drug Law Institute Monographs, and served as Chair of the Public Policy Outreach and Implementation Task Force of the Institute of Food Technologists.

Brian J. Donato, Hyman Phelps & McNamara, P.C. Washington, DC

Before joining Hyman, Phelps & McNamara in 1991, Brian Donato practiced law in firms he founded in Virginia and in Florida. In the period from 1976 to 1980, he served as General District Court Judge for Albemarle County, Virginia. He was Chief Judge for all of the General District Courts in the Sixteenth Judicial District of Virginia for the years 1978 and 1979. He was appointed to the position of Lecturer at the University of Virginia Law School for 1978 through 1988, and since 1982 has been a faculty member at the University’s annual National Trial Advocacy College. He is the recipient of an FDA Commissioner’s Special Citation for his work in helping FDA communicate with members of the regulated industries. He is also the recipient of awards from FDLI, RAPS and The Orange County Regulatory Affairs Discussion Group. In January of 2001, he received The William J. Brennan, Jr. Award from The National Trial Advocacy College for his efforts in teaching trial tactics and techniques.

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