Publications

The Food and Drug Law Institute provides a marketplace for discussing food and drug law issues through conferences, publications and member interaction. FDLI’s scope includes food, drugs, animal drugs, biologics, cosmetics, diagnostics, dietary supplements, medical devices and tobacco.

FDLI publishes the quarterly, peer-reviewed Food and Drug Law Journal presenting in-depth scholarly analysis of food and drug law developments; Update magazine providing members with concise analytical articles on cutting edge food and drug law issues; Primers offering practical, how-to guidance on contemporary food and drug law topics; the biweekly Food and Drug Policy Forum addressing policy issues; and numerous new books each year.


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Books & Primers

A Practical Guide to FDA’s Food and Drug Law and Regulation -5th Edition

April 2014

A Practical Guide to Food and Drug Law and Regulation provides a basic introduction to the laws and regulations that govern the developme...

Top 20 Food and Drug Cases, 2013 & Cases to Watch 2014

January 2014

Published for the fifth consecutive year, the Top 20 Cases book, featuring analysis and discussion of the most important food and drug ca...

Food and Consumer Health Product Claims Substantiation: A Comprehensive Guide

December 2013

If you’re a food advertising stakeholder, how many times have you heard the questions: “Can we say that?” or “Can...

FDCA Statutory Supplement, 2013

December 2013

FDCA Statutory Supplement, 2013 Edited by Joy Liu, Esq Why spend countless hours trying to piece together recent amendments to the Feder...

Update Magazine

Members Only ContentSelf-Enforcement of Regulatory Compliance through a Culture of Credibility

November 2013

At the 2013 Food and Drug Law Institute’s Advertising and Promotion Conference in September, 2013, Mary Riordan from the Office of ...

Members Only ContentAttack on Multiple Fronts in Nutraceutical Marketing: The threat of FTC, FDA and Consumer Class Actions

November 2013

Nutraceutical products recently have been the subject of a multitude of class-action lawsuits questioning their marketing, efficacy, and ...

Members Only ContentMonitoring the Safety of Dietary Supplements and Novel Foods: Looking Beyond the Recent GAO Report

September 2013

Consumers worldwide are increasingly turning to dietary supplements, and the food industry is responding with an expanding diversity of p...

Food & Drug Policy Forum

Rethinking the FDA’s Food/Supplement Framework

April 2014

FDLI Policy Forum Volume 4, Issue 4 was published on April 2, 2014. This issue focuses on the FDA guidance for industry titled, “Di...

Should Oral Contraceptives Be Available Over the Counter?

March 2014

Policy Forum – Oral Contraceptives to Over-the-Counter Status This issue of Policy Forum (Volume 4, Number 3, March 12, 2014) &ndas...

Do We ‘Like’ FDA’s ‘First Social Media Guidance’ or is it Nothing to ‘Tweet’ About?

February 2014

This issue of Policy Forum (Volume 4, Number 2, February 26, 2014) – Do We ‘Like’ FDA’s ‘First Social Media...

Food & Drug Law Journal

Beyond Cheeseburgers: The Impact of Commonsense Consumption Acts on Future Obesity-Related Lawsuits, 68 Food and Drug Law Journal, 229-239 (2013).

August 2013

Since 2004, 25 states have passed Commonsense Consumption Acts (CCAs) to shield the food industry from civil liability for claims arising...

A Comparative Legal Analysis of Social Media Advertising of Drugs in Germany and the United States, 68 Food and Drug Law Journal, 259-279 (2013)

August 2013

Pharmaceutical companies use social media such as Facebook and Twitter more and more to advertise their products. Advertising of medicina...

Meet Your Meat: The Argument for Increasing Education and Public Outreach Regarding the Regulation and Safety of Animal Biotechnology, 68 Food and Drug Law Journal, 281-307 (2013)

August 2013

Biotechnology has evolved beyond the realm of child’s guess-and-check to a precise science, and now promises to help solve some of ...

Primers

The Regulation of Follow-on Biologics: FDA Authority and Implementation

December 2013

Instant Access, Purchase and Download Now by Carolyne Hathaway, John Manthei, Elizabeth Richards and Eitan Bernstein In 2010, the Bio...

FDA’s Regulation of Veterinary Drug Products

September 2013

Instant Access, Purchase and Download Now by Hughes-Coons and Nobert FDA Regulation of Animal Drug Products is a primer for stakeholder...

How to Comply with cGMPs

April 2013

Instant Access, Purchase and Download Now by Cathy Burgess; Appendix by Neil Di Spirito All pharmaceutical and biologics stakehold...

FDLI Announcements

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...

Winckler to Step Down as FDLI President and CEO; Recruitment Underway

March 2014

The Food and Drug Law Institute, the premier educational organization in the field of food and drug law, announced today that President a...

FDA’s Social Media Draft Guidance Is Focus of New FDLI Food and Drug Law Policy Forum

February 2014

“Do We ‘Like’ FDA’s ‘First Social Media Guidance’ or is it Nothing to ‘Tweet’ About?&rdqu...

“Natural” Claims on Food and Consumer Healthcare Products Is Focus of New FDLI Food and Drug Law Policy Forum

January 2014

“Ravioli Trees and Tortellini Bushes: What Should Courts Expect from the Reasonable Consumer When it Comes to ‘Natural’...