NATO Retailers Respond to FDA Form

Published in Tobacco E-News

Fourteen submit comments electronically on FDA violation reporting form

By  Thomas A. Briant, Executive Director

Fourteen NATO retail members submitted comments electronically via the federal government's www.regulations.gov Web site, in response to the FDA's proposed Tobacco Products Violation Reporting Form.

The FDA is proposing to allow the public and other stakeholder organizations (including anti-tobacco groups) to report possible retail violations of the FDA's tobacco regulations by using a new Violation Reporting Form. The FDA is planning to allow the reports to be filed over the telephone, over the Internet, through a smart phone application or by mail.

Just like the concerns raised in NATO's two sets of comments filed in regard to the proposed Violation Reporting Form, NATO retailers cautioned the FDA about the potential for the public to file inaccurate and even false reports or to target certain retailers as the object of violation reports. Moreover, retail members questioned whether the FDA has the authority to encourage the public to file reports, since the law granting the agency the authority to regulate tobacco products only mandates that the FDA enter into contracts with state agencies to conduct compliance inspections.

The time period to submit public comments to the FDA on the proposed Violation Reporting Form expired on Oct. 21, 2011. The FDA is now reviewing the comments submitted, and must determine how to proceed. The FDA must request final approval to issue the form from the federal Office of Management and Budget (OMB). The OMB is then required to request further public comments on the Violation Reporting Form, and NATO will respond with additional comments at that time and encourage retail members to do so as well.