FDA Publishes Draft Guidance for Ingredient Listing Requirement

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Today, the U.S. Food & Drug Administration (FDA) published draft guidance on its new rules that will require manufacturers and/or importers to disclose the ingredients used in cigars.

For cigar manufacturers, the listings will not be as detailed as previously feared. The draft guidance published today says that for tobacco that is prepared using no chemical substances other than “potable” water, only four descriptions will be needed to satisfy FDA’s ingredient listing requirement:

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  • the type (e.g., burley, bright, oriental)
  • the variety
  • the cure method (e.g., flue, fire, sun, steam, air) and heat source (e.g., propane, wood)
  • a description of any recombinant DNA technology used to engineer the tobacco.

(The above is a direct quote from the draft guidance. Please note, I am not an attorney, none of what is below is intended as legal advice.)

It’s still unclear what “variety” means, but it could be a reference to the USDA tobacco types, a categorization system that assigns numbers to various types of tobacco depending on style or use.

In other words, cigar manufacturers do not appear to be required to be submit information about the seed-type, the origin (other than domestic or imported), the priming or the vintage. Manufacturers would have to submit how much—in weight—each type of tobacco is used for a single cigar. They would also need to submit data about the food safe glue that is used to place caps on cigars.

For any tobacco that is modified with any substance without water, a more detailed submission would be required that outlined the expected range in chemical compound and the intended affect.

All submissions would be due by Feb. 15, 2017 for any product that is currently be sold. The one exception is for what FDA considers small-scale manufacturers, those who do less than $5 million in revenue annually and have less than 150 employees. While this would seem like good news to many smaller cigar companies, they likely won’t take advantage of the provision as almost all of them use importers. Because submissions are related to those with Alcohol and Tobacco Tax and Trade Bureau (TTB) licenses, most cigar companies technically aren’t “manufacturers” in the eyes of FDA. For those that would qualify as a small-scale manufacturer an additional six months would be granted.

FDA has still not ruled whether cellophane is considered be a component or part that modifies tobacco or whether it is simply packaging material. The agency said it would seek public comment on this matter, though there’s no record of that taking place.

Like previous draft guidance, the new document published today is not final. The agency is seeking comment over the next 30 days regarding the new rule.

For more information about FDA’s regulation of premium cigars, visit halfwheel.com/fda.

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Charlie Minato
About the author

I am an editor and co-founder of halfwheel.com/Rueda Media, LLC. I previously co-founded and published TheCigarFeed, one of the two predecessors of halfwheel. I handle the editing of our written content, the majority of the technical aspects of the site and work with the rest of our staff on content management, business development and more. I’ve lived in most corners of the country and now entering my second stint in Dallas, Texas. I enjoy boxing, headphones, the Le Mans 24-hour, wearing sweatshirts year-round and gyros. echte liebe.

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