Compliance with the Tobacco Control Act: A Key Part of Reaching the Law’s Potential

By: Margaret A. Hamburg, M.D.

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) gave FDA the authority to regulate tobacco products, marking a groundbreaking advancement in protecting public health. One vital way in which FDA works to realize the potential of this important law is by making sure it’s followed. This is where a rigorous compliance and enforcement program comes into play.

Margaret Hamburg, M.D.FDA’s tobacco compliance and enforcement efforts run the gamut – from training and education, to monitoring compliance with the law, to initiating advisory and enforcement actions. And some key highlights and accomplishments are contained in FDA’s new comprehensive Compliance and Enforcement Report, which covers activities from June 22, 2009 through September 30, 2013.

While it’s clear that we’ve made progress in reducing the burden of tobacco use on the nation, it’s imperative that we end youth access to tobacco products. Each day in the U.S. more than 3,200 youth under age 18 smoke their first cigarette, and more than 700 become daily cigarette smokers. In order to combat this reality, FDA inspects tobacco retailers to ensure, among other things, that retailers are checking IDs and not selling regulated tobacco products to anyone under the age of 18.

Most tobacco retail establishments FDA inspects are in compliance with the law. In fact, as of May 1, 2014, more than 289,000 inspections show that retailers in 51 states and territories are keeping regulated tobacco products away from kids. However, when violations are found during an inspection, FDA is ready to take action. In a significant milestone this past summer, FDA issued its 10,000th Warning Letter for observed violations of federal laws found during tobacco retailer inspections. In addition, FDA has brought over 1430 civil money-penalty actions against tobacco retailers for violations found during follow-up inspections.

Notably, through its monitoring and surveillance efforts, as of May 1, 2014, FDA has issued over 150 Warning Letters for violations of Tobacco Control Act requirements related to tobacco product promotion, advertising and labeling found online or in print publications.

FDA also regularly inspects registered establishments involved in the manufacture or processing of a tobacco product to determine compliance with existing laws and regulations. Additionally, FDA performs investigations at sites that distribute free samples of smokeless tobacco to monitor for compliance with relevant restrictions, including age verification by photo ID.

These achievements signify the impact of our compliance and enforcement program and its contribution towards assisting FDA in meeting its goal of protecting Americans, especially young people, from the dangers of tobacco use.

FDA understands that it is important to educate the regulated tobacco industry about their obligations under the law, and how they can best comply. As part of a broad compliance and training initiative, FDA recently developed the Sales to Minors: Age and ID Requirements for Sales of Regulated Tobacco video as a new tool to assist industry and retailers in protecting America’s youth. FDA also provides additional education and training opportunities, including guidance for industry publications and online webinars that aim to provide easily accessible educational opportunities.

The laws around tobacco control form the cornerstone of our efforts. And we are dedicated to providing compliance training and education to regulated industry; monitoring regulated industry’s compliance with the law through surveillance, inspections, and investigations; and initiating advisory and enforcement actions against non-compliant industry as appropriate. This way, FDA is better able to protect the health of tobacco users and non-users, and in turn, improve the lives of every American.

Margaret A. Hamburg, M.D., is Commissioner of the U.S. Food and Drug Administration

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