I have been in communication with the FDA regarding the implications of the new regulation affecting the premium cigar industry.

What I can tell you is that as of August 8th, 2016 the new law is going into effect. Whether the predicate date will change or not, there is a very low likelihood that it will change by the time it becomes enforceable.

Therefore, the quicker we as an industry prepare for compliance; the easier the transition will be into this new era of regulation.

This doesn’t mean we stop lobbying and working to modify the law, it just means the sooner we accept the new realities of the changes, the sooner we can adapt and continue commerce.

Ashley Schelske is a Policy Analyst at the FDA’s Center for Tobacco Products. Ashley has provided a few links for manufacturers that will help navigate the steps that need to be taken to make products legal for sale.

Here are a few of them that should help you jump to the most important sections:

User Fees
Guidance for Submission
Exemptions from Substantial Equivalence
Demonstrating Substantial Equivalence (.pdf)
Application for Premarket Review

Here is a full transcript of her response:

Dear Waqas,

Thank you for contacting the Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) regarding premium cigars.  On May 5, 2016, FDA finalized a rule extending its authority to all tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others.  The links below provide information for cigar importers, manufacturers, and retailers.

Please note the final rule goes into effect on August 8, 2016.  Tobacco product applications submitted prior to this date will not be accepted.

Sincerely,

Ashley Schelske

Center for Tobacco Products

Leave a Reply

Your email address will not be published.