FDA Issues

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 […]

The U.S. Food and Drug Administration is increasingly stopping and examining imported shipments of food attempting to enter the United States.  Often, the FDA does not allow the food to enter the United States by declaring it to be misbranded or adulterated by filth or decomposition.  Virtually always, refused food is then either destroyed or exported from the United States. There is a little known, but valuable, option called “reconditioning”.

Once reconditioned, food that was originally rejected by the FDA may legally enter the commerce of the United States.  How, when, and why to recondition food is the subject of a webinar on May 25, 2011, sponsored by the Journal of Commerce.

John Verbeten is the Director of Operations and Policy Branch, Division of Import Operations and Policy, at FDA Headquarters.  The discussion will cover detention without physical examination (DWPE), the Food Safety Modernization Act, the FDA Regulatory Procedures Manual, and the practical use of FDA Form 766.

Registration for the webinar is done on-line at the Journal of Commerce website.

Separately, a seminar for importers, customs brokers, and other persons involved in international trade is taking place in Tampa, Florida, on June 1, 2011. This will be a practical “how to” regarding the Food Safety Modernization Act of 2011, FDA’s Detention Without Physical Examination (DWPE) and Notice of Refusal procedures, FDA Import Alerts, and U.S. Customs and Border Protection issuance of Liquidated Damages for failure to redelivery FDA refused merchandise.