WASHINGTON - On Tuesday the Food and Drug Administration (FDA) held a webinar for retailers to discuss the various enforcement options the agency has at its disposal regarding tobacco violations.

Although President Obama signed the Tobacco Control Act almost two years ago, the FDA has only recently begun inspecting retail outlets to ensure compliance. Tobacco retailers must understand that their outlets may be inspected at any time. FDA will not announce inspections ahead of time. In fact, retailers will not know if their store has been inspected until after the inspection occurs and FDA staff has a chance to review the inspector??s report. Further, inspections are likely to include undercover youths posing as tobacco purchasers to test retailer??s compliance with age and identification requirements.

As detailed during the webinar, the FDA has a variety of enforcement options that they may utilize against retailers.

The most lenient penalty is a Warning Letter, which will be issued the first time FDA conducts an inspection and finds a violation. These letters will request a retailer submit a corrective action plan to FDA, and the agency will then determine ?" generally through a re-inspection of the facility ?" whether the retailer has taken appropriate corrective action. Retailers will have 15 days to respond to a warning letter; FDA expects a response to include: (a) a plan for preventing future violations, and (b) a timeline for implementing that plan. All warning letters will be posted on the FDA??s website.

FDA also indicated on Tuesday that it will post notices of store inspections that yield no violation, but will not be sending retailers individual letters to this effect.

Other possible penalties include civil fines for multiple violations at the same retail location, and no-tobacco-sale orders against retailers who repeatedly (at least five violations over a 36-month period at a particular retail outlet) violate the Tobacco Control Act??s requirements. Note that retailers are subject to less extensive fines if they have an adequate "retailer training program" in place. Complete details pertaining to retailer training programs can be found here.

NACS members are encouraged to utilize the We Card training system, which encompasses approximately 90 percent of FDA??s recommended training program components. NACS has urged FDA to utilize We Card??s expertise and stipulate that full compliance with the We Card program is an effective training program warranting the lower schedule of penalties.

Other possible penalties include civil fines for multiple violations at the same retail location, and no-tobacco-sale orders against retailers who repeatedly (at least five violations over a 36 month period at a particular retail outlet) violate the Tobacco Control Act??s requirements.

The civil fine process involves FDA filing and serving an administrative complaint on the retailer, at which point the retailer will have 30 days to respond or else pay the fine demanded in the complaint. Once the retailer responds, it may engage in settlement negotiations with the FDA and offer evidence for a reduction of the fine proposed by FDA. Cases that are not settled will be decided by an Administrative Law Judge.

FDA has recently finalized a guidance document detailing its current policies with respect to these enforcement options.