The FDA is considering putting peanut butter in the "high risk" category. Sounds great, but what does that mean? The definition, from the FDA's Compliance Program Guidance Manual is "foods that may present hazards, which FDA believes, may present a high potential to cause harm from their consumption." That is pretty general, and I've never seen a list of formal criteria.
What foods are considered "high risk?" I've been unable to find a complete list.
For some foods considered high risk -- soft cheese, seafood, and juice -- the FDA has created detailed and specific compliance guidance. The rest of the high risk foods -- whatever they are -- are subject to heightened scrutiny but not to special regulatory rules tailored to those foods.
So, speaking as a manufacturer, I can't really say what being listed as "high risk" will mean. But I assume I'll be finding out.