The U.S. Food and Drug Administration (FDA) has not only set a number of compliance deadlines that the cigar industry must comply with, but we face further complications by changes to those dates. Sometimes the changes are occasioned by benevolent action by the regulators; occasionally they are the result of court action initiated by the various industry attorneys working on these matters.
The purpose of this article is to update you on some of the various deadlines and requirements that impact cigar-related businesses. These are by no means all of the deadlines, so for compliance requirements that your company must address we urge you to consult with counsel familiar with your specific situation.
By the time this article goes to print, the period for submitting comments to the FDA’s Advance Notice of Proposed Rulemaking (ANPRM) on the three subjects below will have passed. I hope you, or the industry organizations you are affiliated with, have taken the opportunity to submit comments to these dockets. It is critical for industry participants to understand that failure to submit relevant and persuasive comments can be construed under the law as “failing to make one’s case.”
In other words, an industry has something of an obligation to point out the error in a federal agency’s proposed action if that industry expects to seek relief from it. Fortunately, even if valid points were not raised at this initial stage for comments, there will be another comment opportunity at the proposed rule stage (assuming the FDA issues a proposed rule). If you are not closely aligned with advocates on your behalf, whether they are trade organizations, attorneys, etc., I urge you to find a partner.