FDA Raises Maximum Fine by 10% for Tobacco Sales to Minors

Federal compliance checks top 335,000 nationwide as fine is raised to $11,000.

September 18, 2014

WASHINGTON – The monetary fine for retailers illegally selling FDA-regulated tobacco products just went up — going from $10,000 to $11,000 for a 6th violation within 48 months.  According to updated FDA guidance on “Civil Money Penalties for Tobacco Retailers Answers to Frequently Asked Questions,” (revised June 2014), the maximum civil money penalty for six or more violations within a 48-month period was increased “to reflect inflation, as required by the Federal Civil Penalties Inflation Adjustment Act.”

The FDA is presently operating under a lighter penalty schedule issuing only a Warning Letter for first time violations. After the Warning Letter however, fines quickly climb for subsequent violations from $250 all the way up to $11,000 for the 6th violation within a 48-month period.  Fines for fewer violations were not raised, only the highest level fine.

Since 2010 when FDA initiated its enforcement program to conduct random compliance checks of retailers to ensure compliance with the Tobacco Control Act and FDA regulations (such as carding customers under 27 years old and denying cigarette, cigarette tobacco, smokeless tobacco and roll-your-own tobacco sales to minors along with other requirements of retailers), FDA has conducted more than 335,000 compliance checks. Retailers should keep in mind that while a first time inspection results in a Warning Letter only, subsequent inspections can result in multiple violations within a single FDA inspection quickly ramping up the cost of non-compliance.

“Staying compliant with both state and federal requirements is a day-to-day focus for stores responsibly selling age-restricted products,” said Doug Anderson, president of the We Card Program. Increasing the awareness of FDA requirements of retailers, knowing state and local requirements and training employees how to “card” and deny sales is a priority focus for We Card during its annual Awareness Month held in September. 

Anderson continued, “right now, we’re shipping out to stores the 2015 We Card age-of-purchase calendar, and we strongly encourage retail management equip their people with training and a set of monthly mystery shops to confirm their employees are properly identifying and denying minors attempts to buy tobacco.”

Publicly available FDA enforcement data shows more than 109,000 inspections of stores were completed in FY2013 and the pace increased significantly in FY2014 with more than 113,000 store inspections completed through the end of August.

Advertisement
Advertisement
Advertisement