I authored "Recent Developments in Food and Drug Law, 2012 Edition" which was just published by Thomas Reuters. It is part of a series called "Inside the Minds" written by attorney thought-leaders in food and drug law from the top law firms across the United States. It analyzes the latest food and drug laws, regulations and policies that affect food and drug companies. It also focuses on violations by persons and companies, and how to successfully defend any investigation by the U.S. Food and Drug Administration (FDA) without having to go to court.
The full title of the 408 page publication is "Recent Developments in Food and Drug Law, 2012 Ed.: Leading Lawyers on Dealing with Increased Enforcement, Keeping Up-To-Date with FDA Requirements, and Developing Compliance Practices". The book is written for C-level executives to learn the very latest trends about food and drug law enforcement and compliance requirements by the FDA. According to the press release
This Aspatore legal title provides an authoritative, insider’s perspective on complying with FDA regulations and staying up-to-date on the latest trends in food and drug law.
The Food Safety Modernization Act (FSMA) gave the FDA recall authority, so companies must know how and when to do a voluntary recall and when a product is safe and effective or, alternatively, defective. The book will precisely explain the labeling requirements acceptable to the FDA and when the statements about the use of a product may be false and misleading so that the product is considered to be "mislabeled" by the FDA. Readers should understand when is a violation handled administratively by the FDA’ Office of Regulatory Affairs (ORA), and when a suspected violation is investigated by the FDA’s Office of Criminal Investigations (OCI). Knowing the difference, and how to handle each of these types of inquiries, audits, or investigations may make the difference in avoiding a fine or being arrested.
The book is available for only $90. Click here for a complete description or to purchase.