NATO Submits Comments Regarding FDA Form

Published in Tobacco E-News

NATO opposes FDA form to report possible tobacco regulation violations

By  Thomas A. Briant, Executive Director

NATO has submitted a four-page comment letter to the U.S. Food and Drug Administration, opposing a notice published by the agency in the Federal Register on August 22, 2011, which seeks public comments on a proposed Tobacco Product Reporting Violation Form.

The FDA wants the general public and other stakeholders (which may include anti-tobacco organizations and health-related advocacy groups) to submit reports to the agency about possible violations of the FDA tobacco regulations. The FDA is planning to allow reports of possible violations from the public and stakeholder groups to be submitted over the telephone, by completing a form on the FDA's Website, by filling out and mailing in a report form to the agency and by using a smartphone application. In the official FDA notice, the agency  estimates that 1,000 reports of possible violations will be made each year for the next three years.

NATO's comments point out that the FDA’s authority to regulate tobacco products does not contain any provision allowing the FDA to request possible tobacco regulation violation reports from the public or other stakeholder groups. Moreover, the FDA has currently contracted with 35 states and the District of Columbia to conduct retail compliance inspections, and these state inspectors receive extensive training on the tobacco regulations, how to conduct a compliance inspection and how to recognize a potential tobacco regulation violation. This same training requirement is not required of the public or other stakeholder groups, and they may not be knowledgeable enough about the tobacco regulations to understand what may or may not be a violation.

Moreover, NATO points out that the use of this reporting form could also lead to members of the public and stakeholder groups targeting and harassing law-abiding retailers, by submitting inaccurate or possibly even false violation reports.