FDA Adjusts Tobacco Violation Penalties in Accordance with Federal Legislation
The U.S. Food & Drug Administration (FDA) has introduced revised penalties for violations of federal laws governing tobacco products in the country, marking an adjustment in accordance with the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. This legislative provision mandates that penalties keep pace with inflation, affecting both tobacco companies and retailers found in contravention of FDA regulations concerning tobacco.
Under the updated penalty framework, these are the new fines:
- First Violation: $0 (Accompanied by a Warning Letter)
- 2 Violations within a 12-month period: $345 (Up from $320)
- 3 Violations within a 24-month period: $687 (Up from $638)
- 4 Violations within a 24-month period: $2,757 (Up from $2,559)
- 5 Violations within a 36-month period: $6,892 (Up from $6,397)
- 6 Violations within a 48-month period: $13,785 (Up from $12,794)
These penalties are applicable to tobacco companies and retailers found to breach FDA rules, spanning issues such as the absence of proper warning labels on e-cigarettes to retailers selling cigars without verifying the identification of undercover buyers.
Notably, due to the successful outcome in the legal case Cigar Association of America et al. v. United States Food and Drug Administration et al., companies exclusively dealing in premium cigars are less likely to face these penalties. Premium cigar entities are subject to fewer regulations that could lead to such penalties. However, it’s important to emphasize that cigar retailers in the U.S. remain susceptible to FDA enforcement actions, including undercover operations to verify compliance with age verification protocols.
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