Second in a Series: FDA's Proposed Retail Violation Reporting Form

FDA in process of reviewing comments about form

Thomas A. Briant, NATO Executive Director

In June of 2009, Congress passed and President Barack Obama signed into law the Family Smoking Prevention and Tobacco Control Act, which authorized the U.S. Food and Drug Administration to regulate cigarettes, roll-your-own tobacco and smokeless-tobacco products. While the FDA has implemented various tobacco-related regulations since the law took effect, there are several significant regulatory matters that either remain under consideration and review or are subject to litigation. This is the second in a series of weekly articles, providing an update on the status of various FDA regulations.

In August of 2011, the FDA published a notice seeking public comments on a proposal to allow consumers and other stakeholders (such as anti-tobacco organizations) to submit reports to the agency about potential retailer violations of the agency's tobacco regulations. This proposal would allow the public to file these violation reports by telephone, over the Internet, through a smart phone application or by mail. The FDA estimates that 1,000 citizens will file reports of retail tobacco regulation violations each year for the next three years.

The Tobacco Control Act does not contain any requirement that the FDA request or accept notification of possible tobacco regulation violations from the public or other stakeholders. In fact, under Section 103 of the Tobacco Control Act, the FDA was granted the authority to contract with states to conduct compliance inspections on retailers and submit reports of potential violations -- not to seek out reports of possible retail violations by members of the public.

The contracts entered into between the FDA and states to conduct compliance inspections on retail stores requires extensive FDA training of state agency personnel, on how to conduct a retail store compliance inspection and how to recognize and report a potential violation of a tobacco regulation. The general public has no such training on what constitutes a potential violation, and this may lead to inaccurate and false reports or even result in specific retailers being targeted for potential violation reports.

Rather than enlisting the public to submit reports, the most fair and reasonable means to report potential violations of the tobacco regulations is through an FDA-sponsored state-compliance inspection program that must be conducted according to a set of rules, and utilizes knowledgeable inspection officers that employ uniform inspection techniques.

More than 20 sets of comments were submitted in response to this proposed violation reporting form, including two sets of comments by NATO. Only a few of the comments supported the use of this form. The comments opposing the use of the form noted that the FDA law did not direct the agency to issue such a violation reporting form, the FDA is already contracting with state government agencies to conduct retail compliance inspections, the public may not have the necessary knowledge to determine what is and is not a violation and various organizations may file inaccurate or even false reports to target a specific retailer.

Moreover, NATO's second set of comments pointed out that the proposed violation reporting form is contrary to and may likely violate Executive Order No. 13563, "Improving Regulation and Regulatory Review," which was issued by President Obama on January 18, 2011. The intent of this executive order is to eliminate unnecessary and wasteful government regulations. As NATO pointed out in the association's supplementary comments, the violation reporting form is vague and unnecessary, since the FDA is already contracting with states to conduct retail compliance inspections.

The FDA is in the process of reviewing the comments submitted about the violation reporting form. Once the FDA finalizes its review of the comments, the Office of Management and Budget will also seek public comments on this proposed form, since taxpayer time is involved in completing the form and submitting the report to the FDA.