On May 5, 2016, the Food and Drug Administration (FDA) issued a final rule deeming e-cigarettes, cigars, and pipe tobacco to be covered by the Family Smoking Prevention and Tobacco Control Act of 2009. 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” (PMTA). Since e-cigarettes were not on the market in 2007, manufacturers of this product are unable to point to a predicate product, and thus would be required to go through the expensive and long PMA process.
In February 2017, Representatives Tom Cole (R-OK) and Sanford Bishop (D-GA) introduced bipartisan legislation to amend the Tobacco Control Act to permit products subject to the FDA’s proposed rule, including e-cigarettes, to use the date the final deeming rule is issued as the “predicate date.” This would permit e-cigarette manufacturers to have their products approved as long as they are substantially equivalent to e-cigarettes marketed prior to that date.
Tobacco products are still a major driver of traffic into convenience stores. In 2015, e-cigarettes sales totaled over $603 million for the convenience store industry. If the predicate date of 2007 is not changed, e-cigarettes will be subjected to a grueling application process in order to stay on the shelves.
NACS supported retailers verifying age on e-cigarette purchases in order to most responsibly sell these products 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.
Through its leadership within We Card, NACS is working to ensure merchants are properly trained in the responsible retailing of electronic cigarette and vapor products and is awaiting final FDA deeming regulations that would set a regulatory regime for these products.
For more information on the deeming rule, NACS members should visit the Compliance Resource Center .