FDA Increases Civil Monetary Penalties for Retailers

Written by

Timothy Donahue

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The U.S. Food & Drug Administration (FDA) announced that it has increased the penalties that nicotine companies and retailers pay if found in violation of the various federal laws regarding nicotine products.

The changes are part of the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, which requires the penalties to adjust with inflation.

The updated penalties are:

  • First Violation — $0 (Warning Letter)
  • 2 within a 12-month period — $345 (Previously $320)
  • 3 within a 24-month period — $687 (Previously $638)
  • 4 within a 24-month period — $2,757 (Previously $2,559)
  • 5 within a 36-month period — $6,892 (Previously $6,397)
  • 6 within a 48-month period — $13,785 (Previously $12,794)

The civil monetary penalties are handed out to vaping and other tobacco companies or retailers that are found to violate FDA’s rules regarding vaping and other tobacco products.

Examples could range from an e-cigarette company failing to use a proper warning label to a retailer caught selling any nicotine product without checking the I.D. of an undercover buyer.

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