I spent years enforcing FSMA before most of the companies affected by it had finished reading the summary. So when people ask me what it actually means in practice, I try to give them a different kind of answer than they'd get from a lawyer or a trade association. The short version: FSMA changed who is responsible for food safety in the United States, and most companies still haven't fully absorbed that. The Pre-FSMA World Before 2011, FDA's posture toward food safety was mos

I spent years as an FDA Investigator drafting and issuing 483 Inspectional Observations to noncompliant firms. I read dozens of 483 responses as a Compliance Officer and noticed that companies across food, supplements, and cosmetics write bad 483 responses for the same reason: they do not know what the agency is actually looking for. The 15-day window is real When an investigator hands you a 483 at the close of an inspection, you have 15 business days to submit a written resp

In February, FDA published its Human Foods Program 2026 Priority Deliverables — roughly 25 items spanning chemical safety, nutrition, and microbiological food safety. Almost five months in, the honest answer is: some of it is moving, some of it isn't, and which is which doesn't always match the order FDA listed them in. Food Chemical Safety GRAS reform is likely the most polarizing deliverable, and it has been since its final rule was released 10 years ago. Right now, a compa