WASHINGTON, D.C. – Oregon’s Senator Jeff Merkley, joined by Senators Lisa Murkowski (R-AK), Dick Durbin (D-IL), Richard Blumenthal (D-CT), and Jeanne Shaheen (D-NH), today introduced new legislation to set safety standards in the design of e-cigarette and vaping devices.
The Senators’ legislation—the E-Cigarette Device Standards Act of 2019—follows a spate of hundreds of illnesses and eight deaths linked to vaping across the United States. In some of the most serious cases, victims reportedly may have fallen ill because of adulterated THC oil that they were able to insert into vaping devices.
“It doesn’t take a rocket scientist to realize that the ability to put a random substance into a vaping device is a recipe for disaster, especially when teenagers are experimenting with these devices,” said Merkley. “We can’t stand by as this epidemic grows. It’s time for clear safety standards in the design of vaping devices.”
“The reality is, kids are not only figuring out ways to buy these products but also to alter them, such as putting THC oil in the cartridges. That should alarm us all,” said Murkowski. “As we work to address the epidemic of youth vaping, it is equally important that we work to prevent consumers from adding harmful substances to these products. This bill takes important steps to stop these devices from being tampered with and used for purposes not intended by the manufacturer. Health and safety should always be a top priority.”
“None of the e-cigarettes currently on the market—including kid-popular cartridge-based e-cigarettes, like JUUL—have been approved for sale by the Food and Drug Administration. Lacking regulation and tamper-proof technologies, children have easily found ways to use these devices to vape substances other than, or in addition to, nicotine—substances that carry their own health risks and are sickening young people at alarming rates,” said Durbin. “Until cartridge based e-cigarette companies can prove their products are safe, actually help smokers quit, and cannot be tampered with, it’s time for the FDA to get them off the shelves and internet.”
“FDA has failed to act in the face of countless deceptive and dangerous vaping products that may be responsible for serious illnesses and numerous deaths,” said Blumenthal. “No vaping product is safe—especially those with cartridges that can be modified or altered. FDA needs to ensure that all vaping devices are tamper-proof, do not contain concoctions of addictive and deadly chemicals, and are strictly regulated.”
“The vaping crisis is a developing public health emergency. As we continue to see people get sick, and in some cases die, it’s imperative that Congress take action by implementing federal standards and demanding accountability from e-cigarette companies to help keep Americans safe,” said Shaheen. “The Food and Drug Administration has a role to play here to ensure that vaping companies cannot continue to sell e-cigarette products that can be refilled with THC or other harmful substances that are making e-cigarette use even more dangerous, and even deadly. This bipartisan legislation would empower the agency with the authority to do just that. With the vaping crisis worsening—and American middle and high schoolers being among the most vulnerable—Congress cannot afford to wait. It’s time to act.”
The E-Cigarette Device Standards Act of 2019 would require the Food and Drug Administration (FDA) to establish standards regarding the design of e-cigarettes and vaping devices that, at a minimum, prevent consumers from modifying or adding any substances to electronic nicotine delivery systems in a way that is not intended by the manufacturer. Under the bill, the Secretary of Health and Human services will issue proposed regulations to carry out the standards within 180 days after the enactment of the bill, and issue final regulations no later than one year after the date of enactment.
The bill comes as youth e-cigarette addiction is rapidly growing in the United States, and young Americans have disproportionately been impacted by the impact of vaping-related lung illness. According to the Centers for Disease Control and Prevention, 16% of the known cases involve patients under 18 years old, and more than half involve patients under 25 years old.
Preliminary data from the 2019 National Youth Tobacco Survey (NYTS) show that five million children—including one in four high school students—are now vaping. This is a 135 percent increase over the past two years.
Cartridge- or pod-based e-cigarette products, such as JUUL, are especially popular among children in part because of their sleek design and appeal. JUUL’s cartridge-and pod-based products currently have more than a 70 percent share of e-cigarette market in the United States. In March 2019, then-FDA Commissioner Dr. Scott Gottlieb stated that if youth e-cigarette use spiked again in 2019—which preliminary data shows it has—the FDA should revisit the marketability of pod based e-cigarettes because kids mostly abuse cartridge based systems and “closed [e-cigarette] system may have no redeeming public health value.”
Given the continued surge in children using e-cigarettes and the ongoing outbreak of severe pulmonary disease—which has affected 530 Americans, including individuals in their low teens—there is now compelling evidence that the FDA should issue standards and consider device design through a pre-market review process.
The full bill text of the E-Cigarette Device Standards Act of 2019 can be found here.