FDA Pursues, NATO Opposes Retail Violation Reporting Form

The FDA continues to pursue approval of a "Potential Tobacco Product Violations Reporting Form" that would allow the public and stakeholders (i.e., anti-tobacco advocates) to report potential retail violations of the federal tobacco regulations by calling the FDA's Tobacco Call Center, using a smartphone application, completing a form on the FDA's website, or by mailing in a completed form to the agency. Whether the use of this potential violations reporting form is allowed is now up to the federal Office of Management & Budget (OMB).

Since last fall, NATO and NATO members have submitted comments objecting to the FDA's proposed use of a retail violation reporting form. On March 8, 2012, the FDA responded by dismissing each of these substantive comments by stating, "FDA disagrees with this comment" and proceeding to request that the OMB grant clearance to begin using this form. Prior to granting such clearance, the OMB asked for additional public comments on the reporting form and NATO and its members have responded to the OMB comment request.

NATO and some of its key members have submitted comments to the OMB that seriously question the FDA's dismissal of the association's objections to the retail reporting form and specifically highlight the FDA's failure to respond to many of the challenges to the reporting form raised by NATO and its members.

For the benefit of the OMB staff, additional comments submitted this month by NATO and its members clearly point out that (1) Congress required the FDA to contract with states to conduct compliance checks on tobacco retailers and did not authorize the FDA to create a violation reporting form and to rely on the untrained general public to call in or submit via the Internet possible retail violations; (2) President Obama's Executive Order 13563 titled "Improving Regulation and Regulatory Review" designed to eliminate unnecessary and wasteful government regulations should prevent the FDA from issuing the retail violation reporting form; (3) the FDA's own estimate that it would take a citizen 15 minutes to stand in a retail store and watch for potential violations and then complete and submit the violation form is seriously miscalculated; and (4) the FDA's claim that its intent in creating the violation reporting form is not to target retailers fails to provide any assurance that retailers will not be targeted with false or inaccurate violation reports.

The OMB will now review the additional comments submitted in response to the FDA's request that clearance be granted to begin using the violations reporting form. A final decision by the OMB should be issued in the next 90 days.

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