U.S. Senate Majority Whip Dick Durbin (D-IL), Chair of the Senate Judiciary Committee, called on the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) Director, Dr. Brian King, and U.S. Department of Justice (DOJ) Principal Deputy Assistant Attorney General, Brian Boynton, to testify at a Senate Judiciary Committee hearing on the sale of unauthorized e-cigarettes, which has resulted in millions of children using tobacco products.
The hearing was held on Wednesday, June 12, in the Dirksen Senate Office Building.
NACS wrote a letter to Chairman Durbin and Ranking Member Lindsey Graham, expressing its gratitude for holding this hearing and specifying its aim to work with Congress in cleaning up and enforcing the e-cigarette market.
In the letter, NACS wrote:
Our industry has significant concerns about illegal e-cigarettes that have flooded the U.S. The current market is characterized by a large number of illicit products and a number of actors, from manufacturers to retailers, acting irresponsibly to make and sell products that should not be sold in the United States. In fact, many of these illicit products are coming in from China.
An important aspect of the current situation is that there is widespread regulatory confusion in this market. Businesses have tremendous difficulty deciphering the regulatory status of ENDS products. The result is that even good actors who expend significant resources attempting to comply with the legal limits on sales of ENDS products may inadvertently sell products that should not be sold.
NACS emphasized the lack of clarity within current guidance, noting that retailers need complete and clear information from the CTP.
During the hearing, Sen. Durbin questioned Arun Rao, Deputy Assistant Attorney General of the Consumer Protection Branch in the Civil Division of the Department of Justice (DOJ), about the delayed PMTA reviews, despite a deadline of September 9, 2021 ordered by the U.S. District Court for the District of Maryland for FDA to complete PMTA reviews.
“Thirty-three months. Thirty-three months since the Maryland court said you are required through FDA to get your job done and nothing has happened. You call this an urgent need. What is urgent about waiting almost three years and doing nothing?” Durbin asked.
On a second panel, David Spross, the executive director of the National Association of Tobacco Outlets, testified. In his testimony, he emphasized that illicit markets pose a threat to the responsible retail community operating within the legal system. He stated that more aggressive enforcement actions are needed to restore order to the marketplace. An effective regulatory system requires a framework that clearly communicates FDA enforcement priorities, specifying which products should be immediately removed and which can remain on the market.