FDA Marks Five Years of Tobacco Control

ROCKVILLE, Md. -- Tobacco has undergone a transformation over the past five years, partly due to changing consumer preferences, but mostly due to the Food and Drug Administration's (FDA) oversight of the category.

On June 22, 2009, President Obama signed into law the Family Smoking Prevention and Tobacco Control Act. With that swipe of a pen, the FDA gained the authority to regulate tobacco products -- from manufacturing to marketing to distribution. The Tobacco Control Act also gave the federal agency the green light to form the Center for Tobacco Products (CTP) to oversee the implementation and enforcement of the law.

In a just-released Compliance and Enforcement Report, the CTP details the accomplishments and activities of its Office of Compliance and Enforcement (OCE) from that notable day in June 2009 through Sept. 30, 2013. The report looks back on the changes since that day, with a nod toward the future.

What the CTP's check found, among other things, is that the majority of retailers are in compliance with FDA regulations. According to the numbers from the FDA's State Tobacco Retail Compliance Check Inspection Program, 221,774 retail inspections have been conducted. Of that, actions by the FDA -- including issuing warning letters and levying civil money penalties -- totaled 12,039. Violations totaled 18,960.

The FDA contracts with states and territories to conduct the inspections as part of the State Tobacco Retail Compliance Check Inspection Program. In fiscal year (FY) 2010, the agency awarded one-year contracts to 15 states. The program continued to grow over the next three years to include a total of 37 states and Washington, D.C., in FY 2011; 44 states and territories in FY 2012; and 45 states and territories in FY 2013.

Broken out by violations, the report found that 9,786 were for selling tobacco products to a minor; 6,533 were for failing to verify the age of the person purchasing tobacco products by means of photo ID; and 2,291 were for impersonal modes of sale (including vending machines or self-service displays).

Other violations included adulterated flavor cigarettes; selling a pack containing less than 20 cigarettes; mismatched descriptors (light, low, mild) on labeling or advertising; and a non-tobacco item with purchase -- a provision the FDA no longer enforces.

In addition to inspections at brick-and-mortar stores, the agency issues labeling, promotional, and advertising violations identified through Internet and publication reviews. Of these, 106 violations were issued for flavored cigarettes, and 83 were issued for "low," "light" or "mild" descriptions.

Part of the high compliance rate among retailers may be due to the agency's compliance outreach programs, which include training sessions throughout the United States, webinars and presentations. Between July and September 2012, OCE hosted a series of training sessions in Boston, Atlanta, Chicago, Dallas and Los Angeles.

In 2011, the agency expanded its reach with live webinars aimed at educating the public on, and encouraging compliance with, federal tobacco laws and regulations. Each webinar addresses a specific subject: the inspection process, details on civil money penalties, smokeless tobacco warning plan requirements, substantial equivalence reports, etc.  

Retailers are not the only ones on the FDA's radar. The agency also inspects every registered establishment engaged in the manufacturing, compounding or processing of a tobacco product or tobacco products. These inspections are performed by FDA's Office of Regulatory Affairs. As of Sept. 30, the FDA completed 102 such inspections of registered tobacco product manufacturers.

"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, [the] FDA is better able to protect the health of tobacco users and non-users, and in turn, improve the lives of every American," said FDA Commissioner Margaret A. Hamburg.