FDA1

On August 8th, 2016, the first day the U.S. Food and Drug Administration (FDA) Deeming Regulations for premium cigars went into effect came word of several cigar companies having import shipments held up at U.S. Customs by FDA Inspectors. It turns out this is a part of a process that comes with being a regulated product – namely filing of proper paperwork to prove your product is in compliance.

This process for imports is being done in conjunction with the U.S. Customs and Border Patrol (CBP). It pretty much adds an extra step to now have the paperwork signed off by the FDA before s shipment can be released at U.S. customs. The paperwork process is new to cigar importers, but it is not a new process. It is standard operating procedure for all regulated products. In other words, this is not a unique thing for cigars or tobacco.

As for the timetable for turning around this process, when looking at how this works for other regulated products, the process is described as relatively quick – unless the paperwork is incomplete or filled out incorrectly.

There were erroneous reports floating around about this paperwork being a “surprise” requirement that was put forward by the FDA, but it was something spelled out in the Deeming Regulations. The compliance requirements for the paperwork are documented on the FDA web-site. These compliance requirements apply to all regulated products and are not specific to tobacco.

If there was a shipment significantly delayed, nobody we have talked to has come forward publicly and made a statement. In fact several were aware of the new requirements and have said they have been in compliance providing the proper paperwork.