Food & Drug Bulletin

Dear Reader:

We usually devote this column to a key topic of importance to all FDA regulated companies. With this issue, however, we are taking the liberty of talking about ourselves. Specifically, we are pleased to announce that effective June 1, 2000, Michael A. Swit, Of Counsel, who rejoined McKenna & Cuneo, L.L.P. in March 1999, will relocate his FDA practice to our San Diego office, having passed the July 1999 California Bar exam.

This move will allow us to better serve our West Coast clients not only in San Diego County, but throughout California and the entire West Coast. From that perspective, Michael also will frequently work out of our Los Angeles, San Francisco and soon-to-open Palo Alto, California offices.

With this initiative, we are responding to many of you who have told us that having an FDA regulatory lawyer on the West Coast would benefit them in several key ways, such as:

expanded direct access to FDA legal and regulatory guidance;

faster and less expensive availability of on-site counseling - e.g., during an FDA inspection - and crisis management;

heightened ability to handle - in a single firm - FDA-related litigation filed in West Coast courts;

increased availability of regulatory counsel with greater familiarity with local business conditions; and

FDA expertise that you can call with the comfort that you don't need to adjust your timing for East Coast time.

These are among the factors that had prompted McKenna & Cuneo, L.L.P. to establish offices in the three major California cities to serve our high tech, government contracts, litigation, environmental, international, and other business clients. For our West Coast clients, having McKenna attorneys available locally has proven to be more efficient, less costly, and allowed a much more direct and personal level of service. We are pleased to extend these benefits to our FDA practice group clients and friends.

As part of our West Coast initiative, later this year we will conduct a series of seminars at each of our California offices on key issues facing the FDA-regulated community during the new century. We hope that you will be able to join us and look forward to seeing you.

As with any matter raised in our newsletter, if you have any questions or concerns on how this West Coast initiative can benefit you, please feel free to contact me or any other member of our FDA practice group.

Sincerely,

Donald R. Stone

Articles In This Issue

FDA Issues Final Rule on Structure/Function Statements Made for Dietary Supplements

FDA Issues Guidances on Review of Reprocessing of Single Use Devices

EU Issues Opinions on Cosmetics Ingredients

Clinton Signs Executive Order Prohibiting Genetic Discrimination

Canada Proposes Amendments to Clinical Trial Regulations

FDA Issues Dietary Supplement Strategy

EC Issues GMO Directives

FDA and Customs Coordinate to Ensure Safe Imported Food

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