The Food and Drug Administration’s Center for Tobacco Products has issued a “Potential Tobacco Product Violations Report” form to allow the public to report possible violations of the Family Smoking Prevention and Tobacco Control Act directly to the FDA. The reports of possible violations of the FDA’s federal tobacco regulations can be filed against retailers, manufacturers, wholesalers and importers.
The reporting form is being made available to the public by the FDA in different formats and can be completed by using a smartphone application, downloading the report form and submitting it via e-mail, or completing and mailing the form to the FDA.
The Potential Tobacco Product Violations Report form lists various possible retail violations for a member of the public to select when completing the form including the following:
· Sales to minors
· Flavored cigarette sales
· Free samples
· Vending machine/self-service display/direct access to cigarette or smokeless tobacco
· Sale of cigarettes in packs of less than 20
The form also allows a potential violation report to be filed for promotional materials and the choices to select for such potential violations include:
· Direct Mail
· In-store Advertisements
· Price Signage
On the FDA’s website, the page dedicated to this new Potential Tobacco Product Violations Report form states that “[t]he information provided on the form is reviewed by the FDA. FDA evaluates the report and determines what follow-up, if any, is appropriate. Reports submitted by the public and stakeholders may be helpful in identifying possible violations of the Tobacco Control Act and related regulations that FDA enforces.”
The FDA proposed the use of the Potential Tobacco Product Violation form in August of 2011 and requested public comments at that time about the use of the form. NATO and a number of NATO members submitted comments objecting to the use of the form as being unnecessary given the FDA’s retail compliance inspection program with trained state inspectors and problematic if members of the public targeted law-abiding retailers by submitting inaccurate or even false reports.
Under federal law, a government agency is required to request approval from the Office of Management and Budget (“OMB”) of a form to collect information from the public for the purpose of enforcing a law. When the FDA submitted the Potential Tobacco Product Violation form to the OMB for review and approval, the OMB also requested comments from the public. NATO, many NATO members, the National Association of Convenience Stores and others filed comments opposing the use of this form by the public. Of the 23 sets of comments filed with the OMB, 21 sets of comments opposed the approval and use of the form and one comment filed by the New York City Department of Health supported approval of the form.
Despite the number of comments submitted opposing the use of the violations reporting form, the OMB just recently approved the FDA’s request to use the form up through July 31, 2014 when the approval will expire. The FDA estimates that approximately 1,000 violation reporting forms will be submitted by the public each year.