August 10, 2016
On Monday, August 8th, the FDA issued a final rule outlining its refuse to accept policy for tobacco product submissions that do not meet the minimum threshold for acceptability for FDA review. According to the FDA, a ‘tobacco product’ is “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product.” Among other products, this includes cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, e-cigarettes (also called electronic cigarettes or electronic nicotine delivery systems (ENDS)), cigars, hookah, pipe tobacco, nicotine gels, and dissolvables.
“Under the rule, FDA will refuse to accept a premarket submission that:
If a submission is not accepted by the FDA, the Agency will notify the contact person (if available); if FDA does accept the submission for further review, an acknowledgement letter will be sent.
In its Federal Register notice, FDA notes that “by refusing to accept submissions that have the deficiencies identified in the rule, FDA will be able to focus our review resources on submissions that meet a threshold of acceptability and encourage quality submissions.”
FDA is asking interested parties to submit either electronic or written comments by October 24, 2016. Given the specific deficiencies that will result in FDA refusing to accept a submission, the Agency does not believe that there will be any significant oppositions to the rule. As such, FDA states that “is issuing this action directly as a final rule,” which will take effect on December 21, 2016.
If any significant adverse comments are received, FDA states that it will publish a document withdrawing the direct final rule before its effective date.
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