The U.S. baby food industry has seen its fair share of advocacy and regulatory headlines in recent years. Most recently, FDA released its Draft Guidance for Industry: Action Levels for Lead in Food Intended for Babies and Young Children. Is this regulatory focus on heavy metals a one-off, or an overview of things to come for the collective industry? This article will discuss the consumer and regulatory drivers of recent years, and also explore the congressional investigation and FDA's subsequent Closer to Zero effort. It will also discuss the latest developments and what moves can be expected next from FDA.