FDA1

Premium Cigars are still very much subject to regulation by the U.S. Food and Drug Administration (FDA). However there was a minor tweak to a proposed companion rule.

Back when the Deeming Regulations were published, there was a companion rule proposed called. “Refuse To Accept Procedures for Premarket Tobacco Product Submissions“. This deals with the application process. Basically the FDA could automatically reject an application being submitted for approval of a product if it didn’t meet minimum thresholds. For example, the application might have been missing on piece of information. When the Deeming Regulations were published on August 8th, this proposed companion rule was opened to public comment. After numerous comments, the companion rule was withdrawn. It was only this proposed companion rule that was withdrawn and not the encompassing Deeming Regulations.

The change in the rule means the submitter will be given an opportunity to correct the application as a part of the process instead of being automatically rejected.

The withdrawal of the proposed companion rule is not very newsworthy, however, this particular announcement set off a lot of activity on social media. This is because many looked at the word “withdrawal” and thought it was a withdrawal of all of the regulations. This is not the case, nor can this withdrawal be looked upon as an indicator of further things to come.