Retailer View: Tobacco Part 2

Q&A Part II: Cumberland Farms’ Flint shares her take on FDA, CTP and the regulatory outlook

[EDITOR'S NOTE: In the second part of Convenience Store Products' two-part interview with Anne Flint of Cumberland Farms,  we discuss the FDA’s relationship with the tobacco retail community, and the potential impact of pending regulations on OTP.]

The exclusive “invite-only,” day-long meeting was 18 months ago. But Anne Flint, senior category manager of tobacco and other tobacco products (OTP) for Framingham, Mass.-based Cumberland Farms Gulf Oil, hopes Food and Drug Administration (FDA) officials have long memories about the dynamics that drive retail tobacco marketing.
In August 2011, Flint was one of 20 executives invited to a day-long roundtable summit with Dr. Lawrence R. Deyton, director of the Center for Tobacco Products (CTP), and a dozen FDA agency staff members. (Last week, Deyton announced he is stepping down from the post, and will be replaced by Mitchell Zeller.) In additional to Flint, the private contingent included other retailers, distributors/wholesalers and importers.
Flint hopes the feedback the CTP staff received that summer day about tobacco retailing struck a chord as the CTP prepares to issue regulations in April governing electronic cigarettes, which have proven to be surprisingly strong sellers at Cumberland Farms, as well as cigars, pipe tobacco and other tobacco products. The Family Smoking Prevention and Tobacco Control Act created a regulatory framework for cigarettes and smokeless tobacco, but did not establish provisions for OTP. FDA intends to fill this gap.

The regulations could have a major impact on shaping the new product pipeline for tobacco products this year and beyond, says Flint, whose chain has 600 stores in 11 East Coast states.
For example, most e-cig brands were introduced after 2007. If FDA requires that e-cigs introduced into the market after 2007 (so essentially all of them) apply for a substantial equivalence determination, it could create a merchandising disaster. If FDA simply adds e-cigarettes under the existing regulatory framework, hundreds of brands could be taken off the market, and makers must re-apply for that determination before hitting the shelves again.

With this as a backdrop, Convenience Store Productscontinued its conversation with Flint about her interaction with and impressions of the FDA—then and now—during a recent interview.

What are your impressions working with FDA on the tobacco regulations?

They have been good to work with. They have listened well. Admittedly, they did not know our business and wanted to learn more about the retail tobacco business. I think they realize the hardship that’s been placed on us, and they have tried to work with us.

What is your main takeaway of the meeting last August with the CTP?

The meeting was planned to review the implementation of the Tobacco Control Act and establish productive working relationships and channels for communication with diverse stakeholders.One of the takeaways of the meetings was that FDA needed to be clearer and more precise in the materials provided to retailers and the public, as some were confusing to us. They have accomplished this in many ways including a state-of-the-art website that can answer just about any question.

Do you think that Dr. Deyton’s departure from CTP will have any impact—positive or negative—on the final OTP rule-making, or no impact at all?
We have appreciated Dr. Deyton’s professionalism in his role as Director of the Center for Tobacco Products and his willingness to listen to retailers and their perspectives on tobacco-related regulations. We look forward to continuing our working relationship with the Center for Tobacco Products as Mitch Zeller takes on the role as the Center’s director.

With FDA regulations pending on OTP, what are some of your hopes and concerns?

Until the new regulations are announced, we are not sure which other products will be covered by regulations and what kind of regulations will be proposed. We plan to take the opportunity to submit public comments on the proposed regulations and dialogue with the FDA to ensure that the new regulations are reasonable and workable from a retailer’s perspective.

How helpful are the new pre-warning letter notices, which the FDA sends to retailers before an official warning letter is issued after an alleged violation?

I applaud the FDA in deciding to send to retailers a new notice before an official warning letter to sent, if a compliance inspection finds that a store clerk is allegedly selling a tobacco product to a minor. At Cumberland Farms, we take the responsibility of not selling tobacco to underage youth very seriously, and this new early notice will help retailers identify which clerk may be responsible and take corrective action to prevent a similar occurrence in the future.

There is some controversy on the FDA’s Potential Violation Reporting Form; what is your own take?

We do have some concern with the new reporting form, which would allow anyone in the public to submit a report to the FDA if they thought they witnessed a potential violation of a tobacco regulation while in a retail store. My concern is that members of the public are not knowledgeable about the numerous FDA retail regulations that retailers must comply with and may not know whether a particular action is a violation or not.

Is there a clear solution to rectify this?

That role should be left to the state inspectors who are trained by the FDA to conduct compliance checks and ensure that retailers are following the law.