The FDA’s Center for Tobacco Products has proposed using a Tobacco Product Violation Reporting Form to allow the public and stakeholder groups (i.e., health-related agencies and anti-tobacco organizations) to report possible retail violations of the FDA tobacco regulations. A report would be submitted over the Internet, through a new smartphone application, by a telephone call to the FDA, or by mailing a form to the agency. The agency estimates 1,000 violation forms would be submitted annually for the next three years.
The federal government requires that agencies proposing to collect information from the public must publish a notice about the action and receive public comments. NATO has submitted two sets of comments about this reporting form that are highlighted below.
No Congressional Authorization
The law passed by Congress granting the FDA the power to regulate tobacco products does not authorize the FDA to issue a violation reporting form to be used by the public or other groups. To the contrary, Congress requires the FDA to contract with states to conduct compliance inspections on retailers and submit reports of potential violations.
These contracts require extensive training of state agency personnel by the FDA on how to conduct a retail store compliance inspection and how to recognize and report a potential violation. If Congress had intended to deputize the general public to police retailers and report potential regulatory violations, then that intent would have been stated in the law itself.
If this reporting form is approved, the public and stakeholder organizations might target retail stores for the purpose of filing violation reports. This could rise to the level of harassment when a retailer abides by the tobacco regulations only to have inaccurate or false reports filed against the retailer’s store. That kind of behavior would call into question the very usefulness of these violation reports.
Moreover, what corrective action would the FDA take against a person or entity that files a false or inaccurate report against a retailer? What is the retailer’s recourse in the event a false or inaccurate report is filed?
Contrary to Executive Order
NATO’s comments also pointed out that the reporting form is contrary to and likely violates Executive Order No. 13563 entitled “Improving Regulation and Regulatory Review” issued by President Barack Obama on January 18, 2011. The intent of this Executive Order is to eliminate unnecessary and wasteful government regulations.
One section of the Executive Order states, in part, that a regulation must promote predictability and reduce uncertainty. Issuing a reporting form allowing the public and other stakeholders to submit reports of possible retail violations decreases predictability and increases uncertainty. Neither the public nor other stakeholder groups will have the benefit of being educated about retail regulations or how to identify a possible violation. The result will likely be inaccurate and unverifiable reports of possible violations filed by the public and other stakeholders.
In addition, the actual wording of the proposed reporting form is very vague and invites unsubstantiated and even false reports of possible violations. For example, the form makes no mention that possible violations are limited to cigarettes, RYO tobacco and smokeless tobacco. This invites reports relating to cigars and pipe tobacco that are not currently regulated by the FDA. It appears that the FDA drafted the form to make it as simple as possible to fill out and report a possible violation. However, in doing so, the ambiguity of the form itself will guarantee ambiguous reports and degrade, not improve, the results of the regulatory action.
In Section 3 of the Executive Order, federal agencies are required to promote coordination between agencies because “[s]ome sectors and industries face a significant number of regulatory requirements, some of which may be redundant, inconsistent or overlapping.” However, the proposed reporting form is redundant because the FDA already contracts with 38 state agencies to conduct retail compliance inspections to enforce the law.
NATO’s comments submitted to the FDA request that the agency rescind the notice about the violation reporting form and not pursue any further action on this proposed regulatory matter.