Welcome to the first monthly update on FDA’s enforcement over regulated tobacco products. This update will examine trends in Warning Letters, and cover some unique Warning Letters and enforcement actions that have occurred in the previous month. As the first post regarding tobacco products, we begin with an alert regarding FDA’s issuance of civil money penalty complaints. The update also provides a summary of tobacco related Warning Letters issued by the FDA to date.[1]
The most significant enforcement event over the last month is the issuance of twenty (20) civil money penalty complaints to retailers by the FDA. The Family Smoking Prevention and Tobacco Control Act provides for civil money penalties for violations of FDA’s tobacco regulations at 21 C.F.R. part 1140. This is a significant concern, particularly as some of these complaints allege five (5) violations, which is the minimum necessary for FDA to bring a "No Tobacco Sale Order" against a retailer. The following tables list the violations identified in the complaints, the values of the civil money penalties assessed, and the states where the retailers are located.
Overall, there have been 1,370 Warning Letters issued by the Center for Tobacco Products since the Family Smoking Prevention and Tobacco Control Act was passed in 2009. The majority of Warning Letters were issued as the result of state contract inspections of retailers. The remaining 45 Warning Letters were issued directly by the Center for Tobacco Products to Internet retailers and manufacturers.
Tobacco Warning Letters Issued to Date
Tobacco Warning Letters Issued in 2011
The most common violation among brick-and-mortar retailers is the sale of a tobacco product to a minor, which is prohibited by 21 C.F.R. § 1140.14(a). This violation is often combined with a violation for the failure to check for identification, which is a requirement of 21 C.F.R. § 1140.14(b)(1). These violations arise out of the undercover purchases made by minors who are accompanied by state contract inspectors. FDA has also given considerable attention to the use of self-service displays and vending machines, which are prohibited in establishments that permit anyone under the age of 18 to enter. Inspections of facilities that do not permit anyone under the age of 18 to enter are generally conducted only by the state contract inspector, and do not include a minor. The following table provides totals for violations found among all state contract inspections.
In addition, four (4) Warning Letters cited brick-and-mortar retailers for selling cigarettes that contained a characterizing flavor, and forty-four (44) brick-and-mortar retailers were notified regarding the use of modified risk language in labeling.
Warning Letters issued directly by the Center for Tobacco Products, and not as the result of a state contract inspection, were primarily sent to Internet retailers. These Warning Letters generally concerned the sale of cigarettes with a characterizing flavor (39 of 45 Warning Letters), and the use of modified risk language in advertising and labeling (19 of 45 Warning Letters). Two manufacturers were cited for sponsoring an event, and one was cited for offering a free gift or item for the sale of a tobacco product.
The FDA has taken a hard line against cigarettes containing a characterizing flavor, and it is not surprising to see the agency continuing to monitor the Internet for such products. Use of modified risk language, even if explaining a change in product name, has also been a focus of the FDA with regards to Internet retailers and manufacturers.
Warning Letters regarding the offer of a free gift or item generally involved a free item, most commonly a lighter. One Warning Letter, however, involved a rewards program, which offered a check to customers in exchange for providing proof of purchase of specially marked tobacco products.[2] This is the first public Warning Letter to address the issue of a rewards program (as opposed to a free item), and it remains to be seen what attention the FDA will give to more general rewards programs.
Based on this data, retailers should review their training policies and procedures, and be on the lookout for state contract inspections with an undercover minor. There are a number of programs available, and counsel may be retained to assist with implementing such programs. Further, given the large penalties possible under the Tobacco Control Act, any company that receives a Warning Letter or complaint should retain counsel to represent its interests before the FDA.
Next month will include an examination of trends seen between different states.
[1] This includes all Warning Letters posted by the FDA as of January 13, 2012