FDA Withdraws Final Rule Regarding Procedures for Refusing to Accept Premarket Tobacco Products Submissions

According to the Cigar Rights of America, the FDA has withdrawn its Final Rule regarding the procedures for refusing to accept premarket tobacco products submissions.

In a letter to its stakeholders the CRA states:

In our continuing effort to keep you informed of actions and communications from or about  the U.S. Food & Drug Administration – Center for Tobacco Products, please see the announcement below.

Today, the FDA posted in their advanced Federal Register notice that they are withdrawing their final rule regarding procedures for refusing to accept premarket tobacco product submissions  that was published on August 8, 2016.

FDA is withdrawing the rule because of significant adverse comments objecting to the rule. The core objections criticized the lack of time frame for the determination to be made on the refusal of acceptance as well as that the statute did not give FDA the authority to promulgate such a process.

Please click here to read the announcement regarding the rule.

A request to Glynn Loope for an explanation of this, has not yet been returned.

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