FDA Enforcement Penalty Calculator

Select your violation type and prior violation count to see the estimated FDA penalty. Penalties escalate rapidly — a fifth violation within 36 months results in a No-Tobacco-Sale Order banning ALL tobacco sales from your store.

Violation Type

Prior Violations (last 36 months)

Warning Letter

$0

First violation — written warning from FDA

FDA Penalty Escalation Path

1stWarning Letter$0

2ndCivil Money Penalty$279

3rdCivil Money Penalty$559

4thCivil Money Penalty$2,236

5thCivil Money Penalty$11,182

6th+No-Tobacco-Sale OrderStore ban

Recent Enforcement Activity

In FY2025, FDA issued over 9,000 import refusals for unauthorized tobacco products and filed penalty actions against 100+ retailers. The maximum civil penalty per violation is $21,903 (adjusted annually for inflation).