Table 1

Current escalating fines, that is, civil monetary penalties (CMPs), from the FDA, March 2020

ViolationCMP
1 (warning letter only)
2nd in 12 months$297
3rd in 24 months$594
4th in 24 months$2381
5th in 36 months$5952
6th or subsequent in 48 months$11 904 (case-by-case basis)
  • These amounts are updated regularly per the statute.22

  • FDA, Food and Drug Administration.