FSMA Facility, Recall Reinspection Fees Remain On Ice As FDA Heats Up Making Program ‘Feasible’

As it has every year since FSMA was passed in 2011, FDA doesn’t plan to impose reinspection fees until it publishes guidance for small businesses to request reductions. FY2025 budget proposal includes plan “to re-structure the fee programs to make it more administratively feasible to operate.”

The US Food and Drug Administration has published its latest rates for user fees it won’t collect for re-inspections of dietary supplement manufacturers, but, more than a decade since the fee program’s authorization, the agency plans “to make it more administratively feasible to operate.”

The fiscal year 2025 hourly rates for re-inspections on food and supplement manufacturing facilities and on recall non-compliance when domestic...