Another day, another FDA delay.
The U.S. Food & Drug Administration (FDA) has published a revised version of its Listing of Ingredients in Tobacco Products, which follows its draft guidance that was published in October. The guide is to help better explain what information FDA is seeking from manufacturers of cigars about what goes into cigars.
For the most part, the details of the required information remain the same. Any whole leaf tobacco product that is prepared using no chemical substances other than “potable water,” will be required to submit four pieces of information:
- 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.
It’s still unclear what FDA means by “variety,” as the word only appears in the document once—and without any explanation. Manufacturers will have to specify how much of each tobacco type, by weight, is used in cigars. In addition, they will likely need to detail how much and what kind of food safe glue is used to place caps on cigars.
If a manufacturer uses anything other than water as part of its tobacco, a much more detailed submission is required explaining any chemical reactions and other properties.
The big news is that FDA has pushed the deadline for submissions by six months, meaning most manufacturers will have until Aug. 8, 2017 to submit the data. The original deadline was Feb. 15, 2017.
Any manufacturer who generates less than $5 million in revenue and has less than 150 employees will have an additional six months from the August deadline, Feb. 15, 2018.
It’s still unclear how many manufacturers will qualify as a small-scale manufacturer. Because most submissions are likely to be tied to Alcohol and Tobacco Tax and Trade Bureau (TTB) licenses, which are typically held by importers as opposed to small manufacturers, the few companies that might meet the requirements from the revenue and employee side may not be eligible because their importer exceeds the revenue requirement.
This is the second time FDA has an extended a deadline this month. Previously, FDA announced it would move the deadline for domestic factories to submit a list of products they produced from Dec. 31, 2016 to June 30, 2017.