Tobacco

Tobacco Regulation and Compliance Book – Order Online

Books & Primers

Top 20 Food and Drug Cases, 2012 & Cases to Watch 2013

April 2013

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

A Practical Guide to FDA's Food and Drug Law and Regulation, 4th Edition

April 2012

The Fourth Edition of A Practical Guide to FDA's Food and Drug Law and Regulation updates and expands the widely-used Third Edition, incl...

Tobacco Regulation and Compliance: An Essential Resource

March 2012

Released December 2011 FDLI’s first publication focused exclusively on tobacco, this book serves as an essential resource to stak...

Articles

Substantial Equivalence Under the Family Smoking Prevention and Tobacco Control Act of 2009: How Can FDA Create a More Effective and Efficient Regulatory Scheme?

April 2013

(A Response to Mark E. Greenwold’s ‘What Standards Should FDA Apply in Ruling on Applications for Substantial Equivalence for...

What Standards Should FDA Apply in Ruling on Applications for Substantial Equivalence for Tobacco Products Under the Family Smoking Prevention and Tobacco Control Act of 2009?

September 2012

by Mark Greenwold In this issue of the Policy Forum (Volume 2, Number 18, September 26, 2012) Mark Greenwold, Senior Consultant for the C...

“Substantial Equivalence” Standard for Tobacco Products Is Focus of New FDLI Food and Drug Law Policy Forum

September 2012

Food & Drug Law Journal

Your Business in Court and at Federal Agencies: 2011-2012, 68 Food and Drug Law Journal, 1‑52 (2013).

March 2013

FDA transparency effort continued, including the Secretary’s adopting eight measures to improve access to Agency information and ac...

Toward a Comprehensive Policy on Nicotine Delivery Products and Harm Reduction, 67 Food and Drug Law Journal, 393 404 (2012).

December 2012

Implementation of the Family Smoking Prevention and Tobacco Control Act is resulting in FDA establishing a comprehensive tobacco policy, ...

Your Business in Court and at Federal Agencies: 2010-2011, 67 Food and Drug Law Journal, 243-292 (2012).

June 2012

This year the government aggressively pursued Manufacturers under the enhanced provisions of the False Claims Act (FCA), as well as un...