The Food and Drug Administration has authorized 34 e-cigarette products and devices to date, and that number is going to “continue to increase,” the FDA’s Center for Tobacco Products (CTP) Director Brian King said in a session Sept. 13 at CSP’s Tobacco Plus Forum in Schaumburg, Illinois.
Of the 34 e-cigarette products and devices, 11 of them were authorized by the FDA in the past few months, King said.
The FDA has received applications for nearly 27 million deemed products and has made determinations on more than 26 million of these applications.
“We have issued negative decisions to millions and that’s because they haven’t met the bar,” King said.
King told the packed room of tobacco category managers, suppliers and manufacturer that he is seeing the quality of the applications “increase,” and that the FDA is “continuing to engage with the [tobacco] industry.”
“I’m hopeful that as folks get clarity on what exactly is needed on their end that we’re going to see more authorizations for those products that have met the necessary public health standard,” he said.
King called out the FDA’s latest PMTA authorizations, including menthol-flavored e-cigarette products.
The FDA issued marketing granted orders to Njoy LLC for four menthol-flavored e-cigarette products: Njoy Ace Pod Menthol 2.4%, Njoy Ace Pod Menthol 5%, Njoy Daily Menthol 4.5% and Njoy Daily Extra Menthol 6%. This marks the first non-tobacco flavored e-cigarette products to be authorized by the FDA. In July, the FDA also issued marketing granted orders for seven e-cigarette products from R.J. Reynolds Vapor Co. They are the Vuse Alto Power Unit and six Vuse Alto tobacco-flavored pods, which are sealed, pre-filled and non-refillable.
Given these recent activity, King reminded the audience that “I’m not here to rubber stamp applications.”
Congress has given a “clear standard” of what needs to be done, and “we’re going to obey the law, but we’re also going to work closely with the industry to make sure we’re supplying the information to meet that bar.”
Turning to tobacco product sales, King outlined the FDA’s final rule that raises the minimum age for certain restrictions on tobacco product sales.
Beginning Sept. 30, retailers must verify with photo identification the age of anyone under the age of 30 who is trying to purchase tobacco products, including e-cigarettes. Previously, this requirement applied to anyone under the age of 27. The federal minimum age for sale of tobacco products in the United States is 21.
King offered his appreciation to those in the retailer sector for their work “to make sure we are preventing underage sales and obeying the law.”
During his presentation King also gave a recap of CTP’s new five-year strategic plan. King outlined the goals for the agency, which include ensuring timely, clear and consistent product application review and strengthening the compliance of regulated industry using all available tools and robust enforcement actions.
The CTP’s strategic plan includes a new vision statement for the organization: “To make tobacco-related death and disease part of our nation’s past by ensuring a healthier future and advancing health equity for those living in the United States.”
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