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

Off-Label Communications: A Guide to Sales & Marketing Compliance, 4th Edition

September 2014

Want to ensure that your company and clients meet the complicated FDA regulations for off-label advertising and promotion of pharmaceutic...

Food and Drug Law and Regulation, 3rd Edition

December 2014

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

Pharmacy Compounding: The New Legislation and Essential Background — An FDLI Primer

July 2014

Instant Access, Purchase and Download Now by Rachael G. Pontikes and Elizabeth R. Jungman FDLI’s Pharmacy Compounding primer...

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...

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

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

August 2014

Volume 4 Issue 7 of the FDLI Policy Forum – GRAS Issue 7 of the FDLI Policy Forum focuses on the generally recognized as safe (GRAS...

E-cigarettes: A life-saving technology or a way for tobacco companies to re-normalize smoking in American Society?

July 2014

This issue of Policy Forum, written by Joel Nitzkin, focuses on e-cigarettes and recommend adding a tobacco harm reduction component to t...

Can Bayesian Extrapolation Improve FDA Regulation of Off-Label Uses of Drugs and Devices?

June 2014

In this Policy Forum, Authors Ryan Abbott and Ian Ayres explore the issue of extrapolation arising in the regulation of medicine. The aut...

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

Pharmacy Compounding: The New Legislation and Essential Background — An FDLI Primer

July 2014

Instant Access, Purchase and Download Now by Rachael G. Pontikes and Elizabeth R. Jungman FDLI’s Pharmacy Compounding primer...

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...

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...