FDA Extends Deadlines: Are You a Small-Scale Tobacco Manufacturer?

Today, the FDA pushed back the Ingredient Listing Deadline from February 8, 2017 to August 8, 2017.  Small-scale tobacco product manufacturers now have until February 8, 2018 to submit.

This is great news for those that are considered small-scale tobacco product manufacturers.  But what exactly is a “small scale tobacco product manufacturer”? There’s a lot of misinformation going around the industry about who qualifies for this designation, so I’ll try to clear things up a bit.

The guidance document defines “small scale tobacco product manufacturer” as:

a manufacturer of any regulated tobacco product that employs 150 or fewer full-time equivalent employees and has annual total revenues of $5 million or less. FDA considers a manufacturer to include each entity that it controls, is controlled by, or is under common control with.  

One of the most annoying things about regulatory language is that a sentence is never enough to fully define something.  Instead, you have a sentence, and within that sentence you have a lot of individual words that you need to define before you can start to understand what the heck the agency is trying to say. In this case, we have to look to the FDA’s definition of “Tobacco Product Manufacturer” which means:

any person, including any repacker or relabeler, who (A) manufactures, fabricates, assembles, processes, or labels a tobacco product; or (B) imports a finished tobacco product for sale or distribution in the United States

So, importers fit the small-scale tobacco product manufacturer definition as long as they are importing a “finished tobacco product for sale or distribution in the United States.” So what is a a “finished tobacco product”? FDA says:

a tobacco product, including all components and parts, sealed in final packaging intended for consumer use

There you have it! You have to go three definitions deep, but it appears almost anyone in the industry qualifies as a small-scale tobacco product manufacturer, even if all you’re doing is importing the finished cigars into the country for consumer use.

Of course, I have to give the disclaimer here: if you’re unsure whether your operation fits the definition, contact me and I’d be happy to weigh in.  Happy new year and keep fighting the good fight!

Jacob Delaplane

In private practice, Delaplane navigates the labyrinth of government compliance for clients in the agricultural, healthcare, and land development industries. His experience and expertise handling FDA, TTB, and USDA compliance has helped his clients thrive in some of the most heavily-regulated areas of commerce.

Leave a Reply Text

Your email address will not be published. Required fields are marked *