The U.S. Food and Drug Administration (FDA) announced recently that it is disclosing more information about inspections and court actions, and now has a web portal on its enforcement activities as part of Phase II of the agency’s Transparency Initiative. Now, FDA’s enforcement and compliance-related activities will be more accessible, downloadable, and searchable online.

According to FDA’s press release:

fda-logo.jpgThe information includes a summary of the most common Inspectional Observations of objectionable conditions or practices made during inspections and a searchable Inspections Database that includes the names and addresses of inspected facilities, inspection dates, type of FDA-regulated products involved, and final inspectional classification. By the end of 2011, FDA will also begin to disclose additional information about FDA evaluations of filers, expand disclosure of Untitled Letters, and in appropriate situations, support industry efforts during a food recall to inform consumers of products that are not subject to the recall.

Access to this information about FDA’s enforcement and compliance activities will provide the following to the public and regulated industry:

  • More information about company practices that may jeopardize public health, as well as about companies that have had satisfactory FDA inspections
  • Information about recall and enforcement activities that will help consumers make decisions about products
  • Information about inspection results, which can be expected to create a greater incentive to bring practices into compliance with the law
  • Information about food products that are not subject to a particular recall, which can help reduce consumer confusion.

The Transparency Initiative was first launched in June 2009. These most recent actions by FDA represent some of the first of the original proposals to be implemented.

Print:
Email this postTweet this postLike this postShare this post on LinkedIn
Photo of Claire Mitchell Claire Mitchell

Claire received her J.D. degree from Hofstra University School of Law with a concentration in Energy and the Environment in May 2010. She received her B.A., majoring in English, from Villanova University, magna cum laude. During law school, Claire served as Articles Editor…

Claire received her J.D. degree from Hofstra University School of Law with a concentration in Energy and the Environment in May 2010. She received her B.A., majoring in English, from Villanova University, magna cum laude. During law school, Claire served as Articles Editor for the Hofstra Labor & Employment Law Journal, was elected President of the Legal Emergency Aid Project and elected Treasurer of Hofstra Law Women. She is currently pursuing an LL.M. degree in Food and Agricultural Law at the University of Arkansas School of Law. In August 2010, Claire was selected as the recipient of the Marler Clark Graduate Assistantship, part of a new public/private partnership that will allow the University of Arkansas School of Law to partner with leaders in the food and agricultural legal communities. Although she began the LL.M. Program in Fayetteville, Arkansas, Claire is now living in Seattle in order to devote more time to her work at Marler Clark and is completing her LL.M. degree through distance learning. In addition to her academic and professional commitments, Claire blogs on Food Poison Journal and has been published in the Food and Drug Law Institute’s Update and the American Agricultural Law Association’s Update.