FDA Stepping Up Compliance Efforts

Organization striving for contracts in most states by year's end.

Linda Abu-Shalback Zid, Senior Editor

The U.S. Food and Drug Administration (FDA) plans to beef up its efforts in tobacco compliance-check activities by the end of fiscal 2011.

By then, the organization's Center for Tobacco Products (CTP) hopes to have contracts in place with 75 percent of the country's states to assist in such efforts, according to Ann Simoneau, director of the office of compliance and enforcement at CTP, during a webinar last week.

States contract with CTP to "assist in inspecting retail establishments that sell cigarettes and/or smokeless tobacco products," according to the agency's request for [image-nocss] proposals, issued at the end of December.

Currently, 15 states have contracts: Alabama, Arkansas, Arizona, Colorado, Idaho, Kansas, Maine, Maryland, Massachusetts, Mississippi, Missouri, Illinois, Pennsylvania, Tennessee and Washington. And ultimately, the FDA's goal is to have all states, territories and tribal communities under contract.

Once a state is awarded a contract, they provide a list of retailers who sell tobacco to CTP. They also provide a list of state employees who would conduct compliance-check inspections. "Those individuals have to go through a rigorous background check and investigation before they are commissioned as FDA-commissioned officials," Simoneau said.

The officials then undergo extensive training with the FDA to conduct compliance-check inspections to ensure consistent inspection throughout all 50 states, the tribal lands and territories.

Officials then go with minors under the age of 18 to retailers in the state, to attempt undercover purchases. The minors then document any violations and forward the information to CTP. CTP reviews inspections and brings enforcement actions where appropriate.

Enforcement can come by way of warning letters, civil money penalties or no tobacco sales orders.

First-time violations receive the warning letter. Simoneau said, "It requests that retailers submit a corrective action plan to the agency to identify what it is they plan to do to fix the violations, because failure to fix any potential problem at their retail establishment may result in further enforcement action by the center."

She said follow-up inspections at the retail establishments are then conducted, with continued violations resulting in the civil money penalties. She added, "'No tobacco sales orders' is another enforcement tool that we could pursue if there's been repeated violations over a period of time at the same retail establishment."