The FDA’s Center for Tobacco Products announced in October that it has recently awarded tobacco retail inspection contracts to the states of Idaho, Montana and South Carolina. This brings the total number of states conducting retail compliance inspections on behalf of the FDA up to 40. Under the Family Smoking Prevention and Tobacco Control Act enacted in 2009, the FDA has the authority to contract with government agencies in all 50 states to conduct retail compliance inspections.
The states under contract with the FDA to conduct retail compliance inspections are as follows:
Alabama Illinois Minnesota Pennsylvania
Arizona Indiana Mississippi Rhode Island
Arkansas Iowa Missouri South Carolina
California Kansas Montana Tennessee
Colorado Kentucky New Hampshire Texas
Connecticut Louisiana New Jersey Utah
Delaware Maine New Mexico Virginia
Georgia Maryland North Carolina Washington
Hawaii Massachusetts Ohio West Virginia
Idaho Michigan Oklahoma Wisconsin
In addition, the FDA has issued compliance check contracts to the District of Columbia and three U.S. Territories including Guam, Northern Mariana Islands, Puerto Rico.
The FDA conducts two kinds of retail inspections through the state agencies. One type of inspection involves the use of a minor under the supervision of a trained inspector who enters a retail store and attempts to purchase cigarettes, roll-your-own tobacco, or a smokeless tobacco product. The second kind of inspection may not involve a minor and is conducted to determine whether a retail establishment is complying with all of the other FDA tobacco regulations such as no self-service displays of cigarettes, RYO tobacco, or smokeless tobacco products (except in age restricted tobacco stores), customers 27 and under who are buying tobacco products are asked for photo identification, and no free gifts are given with the purchase of these regulated tobacco products.
According to the FDA’s website (<i>www.fda.gov</i>), as of September 30, 2012, some 111,856 retail stores have been inspected and 95.1 percent of the stores have successfully passed the inspections with no violations. A total of 5,515 retail stores, or 4.9 percent of all stores inspected, have not passed the compliance inspections. Some 5,128 retail stores have received warning letters for an initial violation of the FDA tobacco regulations. On a first violation, the FDA does not assess a fine to the retailer, but rather sends out a warning letter listing the alleged violation and requesting a written response from the retailer as to the corrective measures that will be taken to prevent the same kind of violation in the future.
The other 387 retailers that did not pass the compliance inspections received “Civil Money Penalty Complaints” since these stores violated the FDA tobacco regulations more than once. The FDA begins assessing fines on the second and subsequent violations that are not to exceed the following amounts:
- Second Violation in 12 Months: $250
- Third Violation in 24 Months: $500
- Fourth Violation in 24 Months: $2,000
- Fifth Violation in 36 Months: $5,000
- Sixth Violation in 48 Months: $10,000
Each time that a retailer is found to have violated a FDA tobacco regulation, the state agency conducting the compliance inspections will re-inspect the store to determine if the violation continues.
Usually, the FDA issues a Warning Letter or a Civil Money Penalty Complaint to the retailer approximately 90 days after the store inspection takes place. In September, the FDA announced that it has begun sending a notice to those stores that have been inspected and during which a minor was able to purchase cigarettes, roll-your-own tobacco, or a smokeless tobacco product. This notice will inform the retailer of the date and approximate time of the inspection, that the FDA is reviewing the state agency compliance inspection report to determine if a violation of the federal tobacco regulations actually occurred, and, if so, that either a Warning Letter or fine assessment will be sent to the retailer.