Checking in on Compliance

FDA Center for Tobacco Products director of compliance enforcement speaks at CSP tobacco meeting

ROSEMONT, Ill. -- There is no such thing as a "quota," when it comes to FDA tobacco compliance inspections that uncover violations. In fact, Ann Simoneau, director of compliance enforcement at the FDA's Center for Tobacco Products, told attendees at the CSP 8th Annual Tobacco Category Review Meeting, "Nothing would please me more than to have no violations. That means everyone's in compliance and they're following the law."

Violations of the tobacco compliance checks could include not asking for ID of anyone under the age of 27; selling to minors; having self-service displays [image-nocss] of cigarettes, roll-your-own tobacco or smokeless tobacco when minors are allowed in stores; selling individual cigarettes, or "loosies"; providing free samples of cigarettes or smokeless tobacco; or giving gifts in exchange for buying cigarettes or smokeless tobacco.

And while tobacco retailers are not quite at the "no violations" stage, Simoneau shared that of 16,836 of the inspections completed as of July 21st of this year, only 532 warning letters were issuedmeaning 97% of retailers were compliant.

If a retailer has a violation, they receive a warning letter. And Simoneau said she personally signs them all. "I can just tell you, because I sign and review each and every one of these, that the majority of them are for selling to minors."

She added that part of the review process prior to signing is to ensure consistency and that there is, in fact, a violation. "We designed this so that before my name goes on any warning letter, I ensure that this is the violation and that it is sufficient evidence and that it supports it."

The list of violations in a warning letter might not be exhaustive, however, according to Simoneau. "We go in and check, but there are things we could miss," she said. "So everybody is under responsibility to review their practices and review what they're doing to ensure they're in compliance."

The FDA eventually plans to do follow-up inspections of retailers who had violations the first time around. Subsequent violations could mean a civil money penalty, which could range from $250 to $10,000, depending on the number of violations. "I don't expect that we're going to get many repeat violations, because just on the response to the warning letters, people want to comply," Simoneau said, adding that retailers have been very responsive in saying they're retraining their staff and taking measures to ensure they are in compliance going forward.

The FDA currently has contracts with 21 states and the District of Columbia to conduct the compliance checks, and plans to have contracts in all states, tribes and territories by the end of fiscal 2012.

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