The U.S. Food and Drug Administration (FDA) recently updated the existing guidance “Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers.” The guidance describes the agency’s policies towards civil money penalties (CMPs) and no-tobacco-sales orders (NTSOs) for retailers who violate the FDA’s tobacco sale and distribution regulations.
The guidance now clarifies that a violation of the FD&C Act involving the manufacture, sale and/or distribution of a new tobacco product that lacks the required marketing authorization could be subject to a penalty.
The guidance document states “The maximum civil money penalty amounts for such retailers range from $250 (for a second violation in a 12-month period) to $10,000 (for a sixth or each subsequent violation at the same retail location within a 48-month period).”
The FDA states that it “continues to monitor the marketplace, and to take actions to remove illegal tobacco products from the market, particularly those that appeal to youth.”
In February 2023, the FDA announced that it had filed CMP complaints against four tobacco product manufacturers for manufacturing and selling e-liquids without marketing authorization.
Manufacturers must submit a marketing application to the FDA and receive authorization to legally sell a new tobacco product in the United States. The FDA encourages manufacturers to learn more about the three pathways to submit an application for new tobacco products.