Importing FDA-Regulated Foods in Today’s Security-Focused Environment
by Robert E. Brackett, Ph.D., Director, Center for Food Safety and Applied Nutrition, FDA, College Park, MD

Xtra-Strength Gates at the Border: FDA and Customs
by Deane A. Johnson, Of Counsel with the law firm of Sandler, Travis & Rosenberg, P.A., Washington, D.C.

Importing FDA-Regulated Merchandise: Liquidated Damages
by J. Steven Jarreau, Attorney in the Office of Regulations and Rulings, U.S. Customs and Border Protection, Washington, D.C.

A Coordinated Response to Stop Bioterrorism at the Border
by Leslie Alan Glick, Partner at the law firm of Porter, Wright, Morris & Arthur, Washington, D.C.

When Is Food Inherently Dangerous?
by John B. Mullahy, Attorney in the law firm of Kaufman, Borgeest & Ryan LLP, Ridgewood, NJ

The Clinical Aspects of Claim Substantiation
by Ioana G. Carabin, M.D., President and Medical Director of Women’s Health Sciences Institute (a nonprofit (501(c)(3)) organization), Vero Beach, FL

FDA Issues Draft Guidances on Promotion and Advertising
by Edward M. Basile, Senior Partner at King & Spalding LLP, Washington, D.C., where he leads the firm’s FDA practice group.
and Kate A. Williams, Associate in the FDA practice group at King & Spalding LLP, Washington, D.C.

AdvaMed Code Education―The Two-Pronged Approach
by Greg S. Radinsky, Market Development Manager with Medtronic, Minneapolis, MN

The Continuing Evolution of Patient Privacy: California Legislation Impacts Drug Marketing
by David J. Bloch, Partner in the Health Care Group at Reed Smith, LLP, Washington, D.C.
and Daniel A. Cody, Associate in the Health Care Group at Reed Smith, LLP, San Francisco, CA

Making History
“THEY’RE BAAACK” … Lydia Pinkham, Sloan’s Liniment, and Master Violet Ray Generator et al.
by Suzanne White Junod, Ph.D., Historian with the Food and Drug Administration, Rockville, MD

Enforcement Corner
The Risk of Public Comment: FDA’s Coordination With the SEC
by Steven M. Kowal, Partner in the law firm of Bell, Boyd & Lloyd LLC, Chicago, IL

Global Corner
The Salmon Debate:
Food Safety, Assessing Risk, Policymaking, and the Impact on International Food Trade
by Matthew R. Weinberg, Chief Executive Officer, THE WEINBERG GROUP, Washington, D.C.

Associates’ Corner
Re-Exporting Seized Drugs: A User’s Guide to 21 U.S.C. § 334(d)(1)
by Frederick R. Ball, Associate in the law firm of Duane Morris LLP, Chicago, IL

Note: All author affiliations are current as of the date of publication of the issue.