Although FDA is actively expanding its use of artificial intelligence with agentic AI systems “designed to achieve specific goals by planning, reasoning, and executing multi-step actions,” the agency is not nearly as open to industry’s use of such systems to comply with FDA regulations. In fact, a company recently received a warning letter for its use of...

The Government Accountability Office (GAO) has frequently reported on the under-resourcing of FDA, including both staff and funding. This was most recently detailed in a February report in which GAO stated, “Over the last decade, we have reported that FDA...

If your facility is considered by FDA to be “lower risk,” you may be in line for a “one-day inspectional assessment.” In early May, FDA announced its launch of a pilot for shorter, focused screening assessments geared toward lower-risk establishments...

State leadership vs. a patchwork of regulations: a summing up of the controversy over the “FRESH Act” in a single phrase. Due to its controversial provisions on federal food regulations superseding the states, amended GRAS allowances, and chemical ingredients, the...

GRAS is continuing to be a major topic of conversation and legislation at both the state and federal levels, with bills at both likely to advance initiatives to red light self-affirmed GRAS (generally recognized as safe) substances. Of most current...

USDA FSIS consumer complaints have been on a steady increase, with the more than 2,000 consumer complaints in FY 2025 being the highest number since the 2001 establishment of the FSIS Consumer Complaint Monitoring System (CCMS). Of the 2,016 consumer...

Although the majority of persons surveyed in the US and UK follow good hygiene and food safety practices, that majority has been declining in recent years. Surveys are showing that fewer people are washing their hands at critical times, particularly...

With new draft guidance for sanitation programs in low-moisture RTE (LMRTE) food facilities issued 15 months ago, FDA is not only holding the LMRTE industry to a higher standard, but has recently increased its enforcement actions. The industry is now...

Is your facility prepared for an FDA inspection, or are there gaps in your preparation? And … how do you know? Are You Ready for an FDA Inspection? Common Gaps in Food Safety Readiness If you feel that your facility...

When a company has a mature food safety culture, each of its workers has the knowledge, skill, and empowerment to ensure they are fulfilling their specific role in assuring food safety. But this does not mean that there are never...