Drugged Dietary Supplements

by Elizabeth Miller, Pharmacist at the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Compliance, Silver Spring, MD

Good Manufacturing Procedures Clarify Requirements for Dietary Supplements

by Mark A. LeDoux, Chairman and Chief Executive Officer, Natural Alternatives International, Inc., San Marcos, CA

Substantiation Still Matters: The Importance of Science Behind Functional Food Claims

by Elizabeth B. Fawell, Associate with the law firm of Hogan & Hartson, L.L.P.,
Washington, DC

and

Miguel H. Del Toro, Associate with the law firm of Hogan & Hartson, L.L.P., Washington, DC

Current Issues in Dietary Supplement Marketing
by Randal M. Shaheen, Counsel with the law firm of Arnold and Porter LLP, Washington, DC

and

Amy R. Mudge, Counsel with the law firm of Arnold and Porter LLP, Washington, DC

Introducing Dietary Supplement and Functional Food Products to the Canadian Market
by Lewis Retik, Lawyer in the law firm of Gowling Lafleur Henderson LLP, Ottawa, Canada

What Lurks in the Regulatory Crystal Ball for Dietary Supplements?
by Steve Mister, President and CEO of the Council for Responsible Nutrition, Washington, DC

Rethinking How to Respond to Government Investigations
by J.P. Hanlon, Partner with the law firm of Baker & Daniels LLP, Indianapolis, IN

and

Erin Reilly Lewis, Counsel with the law firm of Baker & Daniels LLP, Indianapolis, INC

and

Ralph F. Hall, Distinguished Visiting Practitioner and Professor, University of Minnesota Law School and Counsel with the law firm of Baker & Daniels LLP, Indianapolis, MN

Practical Advice for Managing Product Retrievals
by Christopher L. Hagenbush, Partner in the law firm of Patton Boggs LLP, Washington, DC

“The World’s Most Trusted Article on Puffery”: Non-Actionable Puffery or Misleading?
by Abhiskhe K. Gurnani, third year law Student, The John Marshal Law School and Intern at Amin Hallihan, LLC, Chicago, IL

and

Ashish R. Talati, Partner and Chair of the Food and Drug Law practice group at Amin Hallihan, LLC, Chicago, IL

Good Clinical Practice Warning Letters: Lessons Learned

by Michael Marcarelli, Director, Bioresearch Monitoring, Office of Compliance, Center for Devices and Radiological Health, the Food and Drug Administration, Rockville, MD

New Internet Promotion Options Pose Risks for Drug Manufacturers
by Maura Martin, Associate at the law firm of Sidley Austin, LLP, Washington, DC

Ontario Drug Benefit Formulary Moves Toward Tendering
by Alexander Stack, Associate at the law firm of Gilbert’s LLP, Toronto, Canada

Enforcement Corner

A Bad Fit: Qui Tam Actions and Off-Label Use Allegations

by John R. Fleder, Principal in the law firm of Hyman, Phelps & McNamara, PC,
Washington, DC

Global Corner

Requirements for the Substantiation of Dietary Supplement Claims

by Matthew R. Weinberg, Chief Executive Officer, THE WEINBERG GROUP, Washington, DC

Canadian Corner

Canada Revises Excessive Price Guidelines for Patented Pharmaceuticals
by Brian Daley, Partner in the law firm of Ogilvy Renault in Montreal, Quebec, Canada

Associates’ Corner

Drug Pedigree Rules in Effect, Yet Remain in Flux

by Joanne S. Hawana, Associate with the law firm of Arent Fox LLP, Washington, DC