MINNEAPOLIS -- This week, I attended a Food, Drug and Law Institute conference on FDA tobacco regulations. As a part of his presentation at the conference, U.S. Food and Drug Administration (FDA) Center for Tobacco Products director Mitch Zeller updated attendees on the agency’s retail compliance inspection program. The aggregate record of retail compliance with the federal tobacco regulations continues to be very high, demonstrating that retailers are doing their part to keep tobacco out of the hands of underage youth.
Since the compliance check program began in 2010, some 335,000 inspections of retail stores have been completed in all 50 states. The FDA contracts with either state agencies or private companies to conduct the retail compliance checks. Over the past four years that the state retail compliance check program has been in place, the FDA has issued contracts with the states and private companies that total an aggregate of $118 million dollars.
There are two kinds of retail inspections conducted. One kind of compliance check involves using a minor decoy to attempt to purchase cigarettes, roll-your-own tobacco or smokeless tobacco products. The second kind of inspection focuses on retailer compliance with other federal tobacco regulations such as the ban on self-service displays of cigarettes, RYO tobacco or smokeless tobacco in stores that allow minors to enter, the ban on the sale of single cigarettes, and the prohibition on free samples of these tobacco products.
According to Director Zeller, the FDA has issued 18,600 warning letters and 1,800 civil money complaints since the retail inspection program began. Warning letters are issued to retailers the first time that a FDA inspector detects a violation under either of the two different kinds of inspections. There is no fine assessed with a warning letter, but the retailer is required to respond to the FDA in writing and state what actions will be taken to avoid the same kind of violation in the future. A civil money complaint is issued for a second or subsequent violation at the same retail store and seeks a fine based on the number of violations cited by the inspector.
The schedule of fines for retailers that violate the federal tobacco regulations is as follows:
First Violation: Warning Letter, No Fine
Second Violation within 12-month period: $250
Third Violation within a 24-month period: $500
Fourth Violation within a 24-month period: $2,000
Fifth Violation with a 36-month period: $5,000
Sixth or More Violations in a 48-month period: $10,000
Nationwide, retailers have successfully passed FDA compliance checks 94.5% of the time based on the issuance of 18,600 warning letters out of a total of 335,000 compliance inspections. Since the FDA inspectors conduct a follow up compliance inspection on each store that receives a warning letter, the low rate of warning letter issuance also demonstrates that the majority of the retailers that have a first violation do not have a similar violation when the subsequent compliance inspection is conducted. Moreover, with only 1,800 civil money fines assessed out of 335,000 inspections, this means that 99.5% of retailers inspected have not received a civil fine.
Overall, the high retail compliance rates show that retailers are complying with the law and this compliance rate is based on good training practices and responsible employees.
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