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FDA Revises Guidelines for Civil Penalties

12/21/2016

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The Food and Drug Administration (FDA) published revised guidelines this month for civil penalties for tobacco retailers. The updates reflect the final deeming rule from the Federal Civil Penalties Inflation Adjustment Act Improvement of 2015 (Public Law 114-74).

As of August 8, 2016, the following rules apply to all covered tobacco products:

• Check photo ID of everyone under age 27 who attempts to purchase any tobacco product.
• Only sell tobacco products to customers age 18 or older.
• Do NOT sell tobacco products in a vending machine or self-service display unless in an adult-only facility.
• Do NOT give away free samples of newly-regulated tobacco products, including any of their components or parts.

A retailer, with an approved training program who violates the regulations issued for the first time, is issued a warning letter. 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). 

Penalties for violating other Food Drug and Cosmetic Act (FD&C) requirements relating to tobacco products may not exceed $15,000 for each violation or $1 million for all violations adjudicated in a single proceeding. Violations of certain provisions may be subject to enhanced penalties.

The Tobacco Control Act allows the FDA to impose a no tobacco sale order against a person found to have committed repeated violations, which is defined as at least five violations over a 36-month period. The duration of the no tobacco sale order will undergo the same considerations as the civil money penalties, and also determine whether employers have taken certain steps to promote compliance with the FD&C Act.

PFMA recommends all retailers have their associates ask if the purchaser is 18. Have a policy in place to card all tobacco sales and use age verification equipment. Also, be sure to document your training program.

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