NATO will be filing comments with several significant concerns about the FDA’s recent notification that the agency plans to accept consumer and other stakeholder reports of potential violations of the FDA tobacco regulations.
This FDA notification states that the agency plans to seek approval from the U.S. Office of Management and Budget (OMB) of a new reporting form to allow members of the public to report potential tobacco regulation violations by calling the Center for Tobacco Products toll-free number, using an Internet form on the FDA website, using the FDA’s smart phone application (for iPhones, Android phones and similar smart phones) or by mailing a letter to the Center for Tobacco Products. For a copy of the official FDA notice, please click here.
In this notice, the FDA states that a similar violation reporting form for banned flavored cigarettes resulted in several complaints filed by either an Internet form or by email. However, the FDA estimates that 1,000 citizens will file reports of tobacco regulation violations each year for the next three years. Consumers will be asked for the following kinds of information:
- The date of the potential violation
- A description of the potential violation
- The type of potential violation
- The type of tobacco product (cigarettes, roll-your-own or smokeless tobacco)
- The tobacco product brand name
- The type of promotional materials
- The name, address, phone number and email address of the person who potentially violated a tobacco regulation
- The website address of the potential violator
In response to this notice, the FDA is asking for comments on whether collecting this kind of information is necessary for properly administering the tobacco regulations, ways to enhance the quality and utility of the information to be collected, and options to minimize the burden on the person reporting the potential violation. As indicated in the accompanying notice published by the FDA, comments need to be submitted by October 21, 2011.
As soon as NATO’s comments to this notification are completed, a copy of the comments will be provided to Tobacco E-News recipients.
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