NATO Submits Comments Asking FDA to Clarify Violation Form

Thomas A. Briant, NATO Executive Director

On Feb. 22, 2013, NATO filed with the FDA's Center for Tobacco Products a supplemental set of comments asking the agency to review the recently approved Potential Tobacco Product Violation Report form and to consider making several changes to the form.

Please recall that the FDA received approval from the Office of Management and Budget to begin using a "Potential Tobacco Product Violation Report" form that allows a member of the public to report a possible violation of the federal tobacco regulations by calling the FDA, submitting a report over the Internet, or by using a smartphone application to complete and file the report form.

In its comments, NATO is asking the FDA's Center for Tobacco Products to consider three changes to the report form.

First, the directions state that the form is to be used to report "tobacco-related violations" of the federal regulations. Since the FDA only regulates cigarettes, roll-your-own tobacco and smokeless tobacco products at the present time, NATO suggests clarifying the form so that the public does not think that a potential violation report can be filed regarding cigars, pipe tobacco or electronic products.

Second, NATO recommends that an answer on the form be clarified so that the public does not file a report against a tobacco store that has self-service displays since those retail stores that do not allow minors to be present or permitted to enter the store have access are allowed to have open displays of cigarettes, RYO and smokeless tobacco products.

Third, the form includes the word "unsure" in a list of possible answers to questions. If a member of the public is not certain whether a potential violation has occurred, then how can the FDA act upon the report? NATO has asked that the answer "unsure" be removed from the report form.