• As our readership is well aware, FDA regularly issues guidance documents that provide the Agency’s current thinking on how best to comply with laws and regulations governing food, feed and other FDA-regulated products.  In addition, associations or organizations associated with a specific industry also draft guidance documents to help industry understand best practices when producing food, feed and other regulated products.
  • On Tuesday, January 31, 2017, FDA released tips for industry on crafting industry guidance called “5 Steps Toward Working with FDA on Human and Animal Food Guidance Documents”.  In general, FDA encourages industry to consult with the Agency when drafting guidance documents.  In this way, FDA can potentially: (1) provide technical advice as needed in the development of the guidance document, (2) link to the final document for informational purposes, and (3) incorporate industry guidelines into its own guidance.
  • Keller and Heckman attorneys are well-versed in the laws governing FDA regulated products and stand ready to assist interested parties in developing industry guidance.