There are four different ways a company could receive approval to sell or continue to sell a product. Most cigar companies will opt for either substantial equivalence, an exemption from substantial equivalence or a grandfathering provision if the product was commercially marketed as of Feb. 15, 2007.
The fourth and final way is a Premarket Tobacco Product Application (PMTA). This process could cost upwards of $1 million, however, FDA has repeatedly stated it expects no cigars to apply under this standard.
It should be noted, none of these are applications provided by FDA, rather, these are reports created by applicants. FDA provides guidelines, but, there is no set standard. Furthermore, there is no application fee for submitting these documents, rather, the costs are associated with producing the reports, some involving lawyers, engineers and lab testing.
THERE ARE THREE MAIN PATHS TO PRODUCT APPROVAL FOR CIGARS
The easiest path to submission will be grandfathering. Any product that was marketed on or before Feb. 15, 2007 and has been commercially available since is likely to qualify under the grandfather provision. The Tobacco Control Act sets the date of Feb. 15, 2007—the date the legislative process began—as the grandfather date.
FDA believes that 60 percent of cigars will be grandfathered. (Final Regulatory Impact Analysis, 36)
Products must be commercially marketed, other than exclusively in "test markets," as of Feb. 15, 2007 in order to be eligible for the grandfather provision. In addition, a manufacturer will need to prove the product has remained on the market since 2007.
FDA suggests including the following information in order to prove the product was marketed as of Feb. 15, 2007.
- dated copies of advertisements
- dated catalog pages
- dated promotional material
- dated trade publications
- dated bills of lading
- dated freight bills
- dated waybills
- dated invoices
- dated purchase orders
- dated customer receipts
- dated manufacturing documents
- dated distributor or retailer inventory lists
- any other document you believe demonstrates that the tobacco product was commercially
(Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007, 5)
Manufacturers will need to be able to show the product has been in the market since Feb. 15, 2007 as well, though the standard for scrutiny seems less strict.
- SUBSTANTIAL EQUIVELANCE
- SUBSTANTIAL EQUIVELANCE EXEMPTION
FDA has indicated that it will not consider a product to be new if the blend was changed due to "the natural variation of tobacco (e.g., tobacco blending changes due to variation in growing conditions) in order to maintain a consistent product." (Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act…, 84)
However, the agency states that if a manufacturer attempts to change the characteristics of a cigar other than for consistency, it would require the manufacturer to submit a new approval report. It does not indicate how it will determine a manufacturer's intent.
FDA does consider packaging to be a vital part of determining whether or not a product is new. Cigars that come in multiple packaging options or have had packaging changes might lose their grandfather status. (See below)
Manufacturers will be able to introduce new products up until Aug. 8, 2016. After that any new product will require authorization through substantial equivalence. There's no evidence that FDA intends to use the same sort of scrutiny to prove a product was on the market prior to Aug. 8, 2016 as it is using for the Feb. 15, 2007 grandfather date. Furthermore, there's no evidence that products in "test markets" would not qualify for the Aug. 8, 2016 inclusion.
As such, it's widely expected that many manufacturers will introduce large amounts of new product prior to the Aug. 8 deadline. The advantage to introducing the product prior to Aug. 8, 2016 is that it will able to be on the market for roughly two years before a manufacturer would need to remove the product from the market. However, any manufacturer that intends on keeping the product on the market beyond Aug. 8, 2018 will need to apply for substantial equivalence (Aug. 8, 2017) or a substantial equivalence exemption (March 10, 2018).
Manufacturers will continue to be able to sell products introduced prior to Aug. 8, 2016 while FDA reviews their application so long as the application has been received by FDA prior to the aforementioned dates.
- When can substantial equivalence applications be filed?
- If a cigar is packaged in multiple formats, do I have to submit separate applications?
- If I had a product that would meet the Feb. 15, 2007 date but the packaging changed, do I need to apply under substantial equivalence?
- Is information submitted confidential?