NATO-FDA Continue Dialogue at the NATO Show

Published in Tobacco E-News

By  Melissa Vonder Haar, Tobacco Editor

Last week at the 2013 NATO Show, representatives from NATO and the FDA's Center for Tobacco Products participated in a panel discussion that covered numerous regulatory topics. The panel members included Mitch Zeller, the director of the FDA's Center for Tobacco Products, Ann Simoneau, the director of the agency's Office of Compliance and Enforcement, NATO board member Mary Szarmach of The Cigarette Store Corp., and NATO executive director Tom Briant.

Ongoing Dialogue

One of the recurring themes during the panel discussion was the ongoing dialogue between NATO and the FDA on retail regulatory issues. With Zeller having been the director of the Center for Tobacco Products for only seven weeks when he appeared at the NATO Show, it was important to hear his commitment to encourage industry associations and industry members to submit comments and provide feedback not only on proposed regulations, but on how current regulations are interpreted and enforced by the FDA. Over the past more than three years, this interaction with the FDA has included the submission of written comments, in-person meetings with FDA staff and attendance at FDA stakeholder meetings.

Compliance Inspections

With the FDA having conducted compliance inspections in 41 states, Szarmach suggested that the agency have state inspectors leave a card so a retailer is aware that an inspection took place. The card could include the FDA website address for the retailer to access to find out if the store passed the compliance inspection or had a violation.

Szarmach also reiterated NATO's recommendation that the FDA send a letter to each retailer that passes a compliance inspection to reinforce the importance of store clerks doing their job and preventing the sale of tobacco products to minors.

Zeller indicated that the agency is not contemplating sending out such letters because the FDA website provides the results of each compliance check and can be accessed by all retailers online.

Potential Violation Form

The panelists also discussed the FDA's "Potential Tobacco Product Violation Form," which allows a member of the public to submit to the agency via phone call, smartphone application or mail a report that a retailer may have violated one of the federal tobacco regulations.

Briant noted that NATO has filed written comments asking the FDA to consider revising the form to clarify that the public can submit reports only on cigarettes, roll-your-own tobacco, and smokeless tobacco products. Otherwise, the public may believe that the potential violation form could be used to submit a report on cigars, pipe tobacco or electronic cigarettes, which are not yet regulated by the FDA. Also, the form includes various answers listing potential violations and one of the answers is the word "unsure." NATO has asked the agency to remove the "unsure" answer since if a citizen does not know whether a violation occurred, then a report should not be submitted.

Overall, the panel discussion reaffirmed the importance of communication between the industry and the FDA, and NATO has already extended an invitation to Zeller to return to the NATO Show in 2014.