OMB Approves FDA's Potential Tobacco Product Violations Reporting Form

Thomas A. Briant, NATO Executive Director

The Federal Office of Management and Budget (OMB) has approved the Food and Drug Administration's request to begin using 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. A report of a possible violations of the FDA's federal tobacco regulations can be made by using a smartphone application, a downloadable report form that can be completed and submitted via e-mail (see attached copy of "Potential Tobacco Product Violations Report"), or a form that is completed and mailed to the FDA.

The Potential Tobacco Product Violations Report form lists various possible violations for a member of the public to select when completing the form including the following:

  • Sales to minors
  • Flavored cigarette sales
  • Advertising/promotion/marketing
  • Free samples
  • Vending machine/self-service display/direct access to cigarette or smokeless tobacco
  • Sales of cigarettes in packs of less than 20
  • Unsure

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."

In addition, this website page indicates that "Reports can be submitted anonymously; however, reports accompanied by name and contact information are helpful in cases when FDA needs to follow up for more information. All reports to FDA remain private to the extent allowed by law, as explained in FDA's Privacy Policy." A link to the FDA's webpage relating to the Potential Tobacco Product Violations Report accompanies this bulletin below.

When the FDA requested that the OMB approve the use of this violations reporting form, 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.