The action plan will use "tobacco marketing surveillance" on a routine basis to monitor and evaluate promotional and advertising [image-nocss] materials in print media and retail point-of-sale (POS) displays. It will also conduct compliance checks with an underage minor to attempt to purchase cigarettes or smokeless tobacco products.
A state agency under contract with the FDA will conduct the compliance checks either in addition to other state mandated retail compliance checks or in place of the state checks.
The Family Smoking Prevention & Tobacco Control Act enacted on June 22, 2009, gave the FDA authority to regulate tobacco products in order to protect the public health generally, and to prevent and reduce tobacco use by minors. It said that advertising, marketing and promotion of tobacco products have been "especially directed to attract young persons to use tobacco products, and these efforts have resulted in increased use of such products by youth."
The FDA final regulations, entitled "Regulations Restricting the Sale & Distribution of Cigarettes & Smokeless Tobacco to Protect Children & Adolescents," which also became effective on June 22, 2009, restrict access to cigarettes and smokeless tobacco by persons under the age of 18 and reduce the appeal of such products to persons under the age of 18, through restrictions on marketing, labeling and advertising.
The tobacco marketing surveillance component of the plan is intended to promptly identify tobacco products and promotion and advertising activities of manufacturers, distributors and retailers that potentially violate the regulations.
The FDA plans to work with states to ensure that inspections of retailers are conducted to identify violations and that violations are promptly reported. In addition, the FDA plans to conduct inspections of manufacturers and distributors to assess compliance and identify violations. It also plans to conduct inspections through agency personnel and through the state tobacco retailer compliance check inspection program for identified promotion and advertising violations by manufacturers, distributors or retailers and for tobacco products that violate the regulations.
If violations are identified, the FDA plans to use appropriate enforcement tools in order to address these violations and to facilitate compliance with the promotion and advertising restrictions. These tools include warning letters, civil money penalties, no-tobacco-sale orders, seizures, injunctions and criminal prosecution.
Also, the plan includes an education component to increase the tobacco industry's awareness of the new laws and regulations and to encourage voluntary compliance with the restrictions on promotion and advertising of menthol and other cigarettes to youth, including youth in minority communities.
The agency said that it plans to monitor the progress and effectiveness of the enforcement action plan to ensure that the components of the plan meet FDA's goals and to determine if other restrictions or tools are needed to effectively limit access to cigarettes and smokeless tobacco by persons under the age of 18 and to reduce the appeal of such products to persons under the age of 18, including youth in minority communities.
The FDA plans to conduct routine surveillance of tobacco marketing activities. This surveillance would include monitoring and evaluating promotional and advertising materials, including materials that promote menthol and other cigarettes. Examples of where tobacco product promotion and advertising may be found include: newspapers, magazines, periodicals, posters, placards, nonpoint-of-sale promotional material (including direct mail) and point-of-sale promotional material (including POS materials in audio or video formats).
The FDA plans to address POS advertising in the State Tobacco Retailer Compliance Check Inspection Program. Additionally, if FDA receives a complaint regarding alleged violations involving POS materials, it plans to evaluate the information and determine whether an inspection is warranted.
The act authorizes the FDA to contract with states to carry out inspections of retailers in connection with the enforcement of the laws regarding tobacco products. On February 17, 2010, FDA announced its intent to award contracts to state agencies to assist it in inspecting retail establishments that sell cigarettes or smokeless tobacco products.
As part of each award, the contractor is required to provide a detailed plan for ensuring that inspections are conducted at a variety of different locations, such as rural, urban and suburban areas and minority communities and outlet types throughout the state.
These retail inspections will cover the age and identification (youth access) requirements, as well as requirements relating to tobacco product promotion and advertising. Items relating to tobacco product promotion and advertising requirements covered by the surveillance inspections will include, among others: rebates or coupon redemptions, free samples of tobacco products, nontobacco gifts or other items offered with the purchase of tobacco products, coupons, credits or proofs of purchase of tobacco products honored for nontobacco items and evidence of any tobacco brand name sponsorship of an entertainment or sporting event or team.
And the FDA said that it plans to work closely with the states to ensure that retailer inspections include inspections in racial and ethnic minority communities and plans to determine whether additional inspections are needed in those areas. It intends to evaluate noncompliance rates in these areas with respect to the items covered by the surveillance inspections and may redirect inspectional resources to those areas with high noncompliance rates.
When identifying which retailers to inspect in each state, the agency plans to consider several factors, including areas considered at higher risk for regulatory violations. For example, the FDA may request that inspections be conducted in geographic areas with high rates of youth cigarette smokers (e.g., higher than the national average of 19.5%), areas where youth report easy access to cigarettes, areas located in close proximity to middle and high schools or regions with socioeconomic populations historically associated with market targeting.
FDA may direct an inspection of a particular retailer if it receives a complaint or report, including unlicensed establishments and nontraditional vendors.
The act authorizes the FDA to impose penalties. In general, any person, including a manufacturer, distributor or retailer who violates regulations for tobacco products is liable for a civil money penalty in an amount not to exceed $15,000 for each violation or $1 million for all violations adjudicated in a single proceeding.
The FDA also has authority to issue no-tobacco-sale orders. These orders, which are issued to retailers, prohibit the sale of tobacco products indefinitely or for a specified period of time at a particular retail outlet. A no-tobacco-sale order may be imposed against a retailer who is found to have committed repeated violations of restrictions.
Click hereto view the full document, which provides background on the Family Smoking Prevention & Tobacco Control Act, an overview of its promotion and advertising restrictions and a strategy for implementation of the enforcement action plan.
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