FDA E-Cigarette “Deeming Rule”
Last Updated: January 23, 2019
In May 2016, the Food and Drug Administration (FDA) issued a final rule, effective August 8, 2016, deeming e-cigarettes, cigars, and pipe tobacco to be covered by the Family Smoking Prevention and Tobacco Control Act of 2009 just like cigarettes. This included a requirement than any new tobacco product must be approved by the FDA as either being “substantially equivalent” to a predicate product which had been on the market in 2007, or approved by the FDA through a “premarket tobacco application” (PMA). Since e-cigarettes were not on the market in 2007, manufacturers of this product are unable to point to a predicate product, and thus will be required to go through the expensive and long PMA process. While e-cigarettes could remain on the market during the PMTA process, it’s an extremely expensive route with an uncertain outcome. The FDA previously indicated that it did not have the authority to change the predicate date, and that it could only be done by congressional action.
FDA has, however, provided extensions on the pre-market approval requirements of the deeming rule. So, while the newly deemed tobacco products are subject to FDA’s rules restricting the age of purchasers and requiring age verification by checking photo identification, pre-market approvals are not yet required. Pre-market applications for newly-regulated combustible products, such as cigars, pipe tobacco and hookah tobacco, do not need to be submitted until Aug. 8, 2021, and applications for non-combustible products such as electronic nicotine delivery systems (ENDS such as e-cigarettes) do not need to be submitted until Aug. 8, 2022. Additionally, the FDA will allow manufacturers to continue to market products while it reviews product applications.
Tobacco products are still a major driver of traffic into convenience stores. In 2017, e-cigarette sales totaled over $1.1 billion for the convenience store industry. In order to stay on shelves, manufacturers of e-cigarettes will have to undergo a grueling application process beginning in 2022 if the current predicate date remains intact.
For the newly deemed products, the rule prohibits the underage sales of the products to customers under 18 years old, requires age verification, and requires warning labels on products and advertisements. As of August 2018, retailers may not offer, sell, distribute, or import deemed products with non-compliant packaging, nor display ads that do not contain a proper warning.
If found in violation of the new deeming rule, the FDA may issue a warning letter, a civil penalty, or, in some circumstances, a no sale order.
NACS supported retailers voluntarily verifying age on e-cigarette purchases long before FDA proposed its deeming rule. NACS supports its members’ ability to sell these products responsibly and supports changing the “predicate date” for certain tobaccos products, including e-cigarettes, from 2007 to the date of FDA’s final tobacco deeming rule.