Publications

The Food and Drug Law Institute publishes a broad spectrum of resources for practitioners, scholars, students, policy makers, and others interested in diverse areas of food and drug law and policy. Our periodicals, books, and primers offer timely coverage of emerging issues, policy debates, scholarly research, and practice guidance. 

Now in its 70th edition, the premier scholarly quarterly Food and Drug Law Journal is co-published with the Georgetown University Law Center. Update magazine, available free to members in both print and electronic editions, provides concise articles on cutting-edge food and drug law issues. The monthly Food and Drug Policy Forum, complimentary to FDLI members, promotes research, dialogue, and recommendations on complex policy issues. 

Primers offer practical, how-to guidance on current food and drug law topics, and FDLI’s book publishing program ensures comprehensive desk reference material is available for use in the office and the classroom.


To purchase a publication

Contact service@fdli.org or download our Publication Order Form


Interested in writing for us? 

Review author guidelines, or email us for more information at publications@fdli.org.

 



Books & Primers

Tobacco and Nicotine Delivery: Regulation and Compliance, 2nd Edition

July 2016

Tobacco and Nicotine: Regulation and Compliance provides a comprehensive guide to the regulatory landscape that is actively shaping the t...

Guide to U.S. Import Requirements for Cosmetics and Other Personal Care Products - An FDLI Primer

June 2015

Edited by Kathleen W. Cannon and Sarah Roller, Kelley Drye & Warren LLP Cosmetics and other personal care products that are destine...

Food Law and Regulation, Inspection and Enforcement – an FDLI Primer

June 2015

By Marc C. Sanchez, Contract In-House Counsel and Consultants, LLC This resource offers an overview of the regulation of food from the p...

Bringing Your Pharmaceutical Drug to Market

April 2015

Written by the most experienced drug attorneys in the United States and edited by three distinguished authorities in the field, Bringing ...

Food & Drug Policy Forum

How Will FDA Regulate Off-Label Communications in the Post-Facteau World?

September 2016

Child-Resistant Packaging for Liquid Nicotine: Are Current State and Federal Policy Responses Adequate?

March 2016

Stakeholders in the tobacco space are carefully tracking the progress of FDA’s deeming regulations for nicotine products.  Thi...

Pure Powdered Caffeine: Stakeholders Take Measure of FDA’s Warning Letters

February 2016

FDLI’s first Food and Drug Policy Forum for 2016, guest-edited by Brenda Seidman, offers multistakeholder perspectives on...

Food & Drug Law Journal

FDA's Flexibility in Subpart H Approvals: Assessing Quantum of Effectiveness Evidence

August 2016

Food and Drug Law Journal Volume 70, Issue 4 2015

February 2016

To purchase articles, go to https://shop.heinonline.org/.   Table of Contents i Rep...

Comprehensive Legislative Reform to Protect the Integrity of the 340B Drug Discount Program

January 2016

The 340B Drug Discount Program (340B Program) is a federally facilitated program that requires drug manufacturers to provide steep discou...

Update Magazine

Update Magazine March / April 2016

March 2016

Contents Letter Letter from the President & CEO Features Managing the Risks Embedded in Embedded Marketing: Five Things Every Manuf...

Members Only ContentInterview With Mark McClellan

March 2016

Members Only ContentUpdate Magazine January/February 2016

February 2016

Contents Letter Letter from the Chair   Features Separating Drugs from Supplements by Jessica P. O’Connell and Miriam Gug...

Primers

Guide to U.S. Import Requirements for Cosmetics and Other Personal Care Products - An FDLI Primer

June 2015

Edited by Kathleen W. Cannon and Sarah Roller, Kelley Drye & Warren LLP Cosmetics and other personal care products that are destine...

Food Law and Regulation, Inspection and Enforcement – an FDLI Primer

June 2015

By Marc C. Sanchez, Contract In-House Counsel and Consultants, LLC This resource offers an overview of the regulation of food from the p...

The Regulation of Medical Devices in Canada

January 2015

Edited by Sara Zboroski, Andy Radhakant, and Andrew Lord, Davis LLP Canada’s regulatory regime for medical devices is rooted in the Medi...

FDLI Announcements

FDA in Action – Recent Changes to Food Regulation

June 2016

Over the past month, FDA has released numerous final and draft guidance documents and new rules to further the safety and regulation of o...

Food and Drug Law Journal Symposium’s Call for Abstracts, Deadline July 11

June 2016

Call for Abstracts DEADLINE: JULY 11 Food and Drug Law Journal Symposium Law and Food Systems: Institutional Pathways toward a New Paradi...

Members Only Content2016 Annual Conference: Top Food and Drug Cases, 2015 & Cases to Watch, 2016

June 2016

As in years past, one of the most popular sessions at FDLI’s Annual Conference brought law professors and practitioners together to...

A First Look at the Deeming Regulations

June 2016

The long-awaited deeming rule, released May 5 and set to take effect in early August, grants FDA broad authority to regulate e-cigarettes...