FDA and DOJ’s efforts in controlling the US market are seen as “too little, too late”. Photo credit: SmileSmith25, CC 4.0.
Democrat and Republican senators took the Food and Drug Administration (FDA) and the Department of Justice (DOJ) to task during a US Senate Judiciary Committee hearing on enforcement of e-cigarette laws, accusing both agencies of failing to prevent the sale of illegal e-cigarettes.
“You’ve completely fallen down on the job,” Sen. Dick Durbin (D-Ill.), chair of the committee and one of the Senate’s most vocal critics of FDA’s approach toward vaping, admonished Brian King, director of FDA’s Center for Tobacco Products (CTP).
Senators have been criticizing FDA for months over its lax enforcement of illegal tobacco products, arguing that the agency has been too slow in completing a court-ordered review of premarket tobacco product applications (PMTA) from manufacturers seeking federal approval to sell their devices in the US.
Lawmakers stress that the issue is particularly urgent, noting that many unauthorized vapes are targeted at children. Durbin emphasized this point by displaying images of a wall of vapes for sale in a convenience store just a short distance from FDA headquarters. The Illinois Democrat then held up a disposable e-cigarette that his staff had purchased from the same store.
“I want to assure you that the FDA is committed to taking more … escalated enforcement actions in conjunction with our federal partners, but the road to get there is complicated,” King said. “FDA has received nearly 27 million … applications for e-cigarettes, which we are required by law to review. This, combined with a rapidly evolving tobacco product landscape, presents an unprecedented time and resource challenge that no other center at FDA has ever faced.”
King was adamant that, while there was work to be done, his agency was making progress in curbing the spread of illegal vape devices, pointing out that vape use among middle and high school students has declined more than 60%.
FDA and DOJ announced just days before the hearing a multi-agency task force formed to sweep the market of illegal vapes. However, lawmakers from both parties questioned the delay in creating this group, noting that an independent panel had recommended the establishment of such a task force about a year and a half ago.
Durbin noted that it had been 33 months since the US District Court for the District of Maryland instructed FDA to finalize its PMTA reviews. He underscored that the court's September 2021 ruling found the agency in violation of federal law for permitting vape sales from unauthorized manufacturers. He also said the new interagency vaping task force came too little, too late.
Lawmakers from both sides of the aisle voiced their discontent over the surge in illegal vapes for different reasons. Democrats criticized what they viewed as the industry’s efforts to addict children, while Republicans were concerned about the illegal importation of flavored vapes.