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 monthly Food and Drug Policy Forum addressing policy issues; and numerous new books each year.

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Interested in writing for us? Please email publications@fdli.org.

 



Books & Primers

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...

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 ...

The Basics of Biostatistics in FDA Regulation – An FDLI Primer

November 2014

Instant Access, Purchase and Download Now By Coleen Klasmeier, Partner, Sidley Austin LLP; Ryan Kaat, Associate, Sidley Austin LLP Biosta...

FDA Regulation of Tobacco: A Comprehensive Guide - An FDLI Primer

October 2014

Instant Access, Purchase and Download Now By Azim Chowdhury, Keller and Heckman LLP; J. Ben Haas, Latham & Watkins LLP; Natalie N. Sa...

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

Medical Device Color Additives: What’s All the Ruckus About?

January 2015

Volume 5 Issue 1 of the FDLI Policy Forum – Medical Device Color Additives Brenda Seidman, M.S., Ph.D., RAC, Principal, Seidman R...

Federal Marijuana Regulation: Why is Flexibility Critical in the Dawn of Legalization?

December 2014

Federal Marijuana Regulation: Why is Flexibility Critical in the Dawn of Legalization? Andrew Ittleman, Esq., Partner, Fuerst Ittleman Da...

Should FDA Assume Sole Enforcement Responsibility for Alleged Violations of the FDCA? Lessons from Recent Medical Device Enforcement and Qui Tam Cases

November 2014

Volume 4 Issue 11 of the FDLI Policy Forum – Medical Device Enforcement Actions  Issue 11 of the FDLI Food and Drug Policy For...

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 Medical Devices in Canada

January 2015

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

The Basics of Biostatistics in FDA Regulation – An FDLI Primer

November 2014

Instant Access, Purchase and Download Now By Coleen Klasmeier, Partner, Sidley Austin LLP; Ryan Kaat, Associate, Sidley Austin LLP Biosta...

FDA Regulation of Tobacco: A Comprehensive Guide - An FDLI Primer

October 2014

Instant Access, Purchase and Download Now By Azim Chowdhury, Keller and Heckman LLP; J. Ben Haas, Latham & Watkins LLP; Natalie N. Sa...

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...