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? 

Access our FDLI Writing Opportunities Guide,  review author guidelines, or email us for more information at  publications@fdli.org.

 



Books & Primers

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

June 2015

In the last decade, importation of food into the United States has almost doubled, accounting for about 50 percent of all FDA-regulated i...

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

June 2015

This primer is designed to be an introduction to food law and regulation. Food law is an ever-growing and ever-changing area of law and r...

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 and Drug Law and Regulation, 3rd Edition

March 2015

Written by the most experienced food and drug attorneys in the United States and edited by four of the most distinguished authorities in ...

Food & Drug Policy Forum

Reply to Professor Sugarman

June 2015

This special edition of the Food and Drug Law Institute’s Food and Drug Policy Forum features a response to an earlier article...

Finding the Right Benefit-Risk Balance in U.S. Sunscreen Regulation

June 2015

FDLI’s Food and Drug Policy Forum May 2015 issue, “Finding the Right Benefit-Risk Balance in U.S. Sunscreen Regulat...

Should Food Businesses Be Able to Use the First Amendment to Resist Providing Consumers with Government-Mandated Public Health Messages?

April 2015

Should government-mandated food labeling ever be considered unconstitutional as impermissible “compelled speech”?  Steph...

Food & Drug Law Journal

Embracing 21st Century Information Sharing:Defining a New Paradigm for the Food and Drug Administration’s Regulation of Biopharmaceutical Company Communications with Healthcare Professionals, 70 Food and Drug Law Journal 143–160 (2015)

January 2015

The Food and Drug Administration (FDA) plays a unique role in protecting the public health and minimizing the risk of the distribution of...

Drugs, Devices & Discovery: Using Fee-Shifting to Resolve the Twombly/Iqbal Problem for Parallel Claims Under the FDCA, 70 Food and Drug Law Journal 187–207 (2015)

January 2015

The Supreme Court’s decisions in Twombly and Iqbal ushered in a new federal pleading standard, requiring plaintiffs to state a &ldq...

The End of “Patent Medicines”? Thoughts on the Rise of Regulatory Exclusivities, 70 Food and Drug Law Journal 39–54 (2015)

January 2015

Georgetown University Law Center: Reflections on Current Food and Drug Law Issues For this inaugural issue of the FDLI–Georgetown...

Update Magazine

Members Only ContentUpdate Magazine May/June 2015

July 2015

Table of Contents  (Coming soon)

Members Only ContentUpdate Magazine March/April 2015

March 2015

Featured Food Labeling Consultations and Modernization in Canada By Martha A. Healey  HIPAA and MOBILE HEALTH APPS: What develop...

Members Only ContentUpdate Magazine January / February 2015

January 2015

Table of Contents Featured Risky Business – On the Trial of Tainted Dietary Supplements by Jason Humbert  Between Two Ev...

Primers

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

June 2015

In the last decade, importation of food into the United States has almost doubled, accounting for about 50 percent of all FDA-regulated i...

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

June 2015

This primer is designed to be an introduction to food law and regulation. Food law is an ever-growing and ever-changing area of law and r...

The Regulation of Medical Devices in Canada

January 2015

Sara Zborovski, Partner, Davis LLP Andy Radhakant, Partner, Davis LLP Andrew Lord, Associate, Davis LLP Canada’s reg...

FDLI Announcements

GRAS Exemption and GRAS Notification: Is There a Need for Significant Changes to Current Policy?

August 2014

GRAS, or generally recognized as safe, is an exemption that allows ingredients that are considered to be GRAS for their intended use to b...

E-cigarettes: A Life-Saving Technology or a Way for Tobacco Companies to Re-Normalize Smoking in American Society?

July 2014

E-cigarettes are an increasingly hot topic in the tobacco world, especially after the release of FDA’s proposed deeming regulations...

FDLI Names New President and Chief Executive Officer

May 2014

FDLI Names New President and Chief Executive Officer Amy Comstock Rick to lead organization effective August 25th The Food and Drug Law ...

Over the Counter Status of Oral Contraceptives is Focus of New FDLI Food and Drug Law Policy Forum

March 2014

“Should Oral Contraceptives Be Available Over the Counter?” is the timely topic addressed by Britt Whalin, AM (Director of De...