Ned Sharpless, MD
Earlier this week, Acting Commissioner of the U.S. Food and Drug Administration (FDA) Ned Sharpless, MD, testified before the U.S. House Energy and Commerce Subcommittee on the FDA’s planned regulation of electronic nicotine delivery systems and investigation of vaping illnesses. His remarks are reproduced below.
Thank you for the opportunity to be here today to discuss the regulation of electronic nicotine delivery systems, or ENDS, and the Agency’s role in the ongoing investigation into lung injuries experienced by individuals who use vaping products.
As you know, prior to coming to FDA, I was Director of the National Cancer Institute, and I’m a long-time cancer doctor. My experience treating patients has informed all of my work at the agency, including the issues before the committee today.
We are here to discuss two top priority issues: first, the ongoing investigation into the cause of lung injury associated with the use of vaping products. Second, [the] FDA’s ongoing efforts to address an epidemic of youth use of ENDS products; including the Administration’s recent announcement about our intention to issue a policy that would address ongoing marketing of flavored ENDS products.
Let me start by discussing the vaping illness outbreak.
Working with state partners, the FDA and the Centers for Disease Control & Prevention (CDC) have been investigating an outbreak of severe lung injury associated with the use of vaping products. Most cases have reported recent use of vaping products containing tetrahydrocannabinol (THC), the psychoactive ingredient in marijuana. Although these cases seem similar, it is not clear if they have a common cause or if they have differing pathogenesis with similar presentation. The investigation has not identified any specific substance or product that is linked to all cases.
Let me outline the main components of our investigation. The FDA’s Office of Emergency Operations has activated an Incident Management Group to coordinate across the agency and work alongside CDC’s Incident Management System.
FDA’s regulatory field force is playing a critical role in fact-gathering and analysis. With State health departments, we are collecting samples for analysis at our Forensic Chemistry Center (FCC). The FCC is using state-of-the-art methods to assess the presence of a broad range of chemicals including nicotine; THC and other cannabinoids; opioids; cutting agents and other additives; pesticides; and toxins. Additionally, we are working with Customs and Border Protection to identify illicit vaping products at the International Mail Facilities.
FDA’s Office of Criminal Investigations is focused on identifying the products that are making people ill and following the supply chain to the source. FDA is not pursuing any actions associated with personal use of any vaping products—our interest is in the suppliers. But to be clear, if we determine that someone is manufacturing or distributing illicit, adulterated vaping products that caused illness and death for personal profit, we would consider that to be a criminal act. Because many of the products associated with cases contain THC oils, we have engaged the Drug Enforcement Administration to help with our investigation.
Now let me turn to FDA’s efforts to address the disturbing rate of ENDS use by kids.
This summer, working with the CDC, the Agency received preliminary data from the 2019 National Youth Tobacco Survey (NYTS). Despite strong compliance and education strategies, the 2019 data indicate another alarming increase in youth use of ENDS products.
FDA’s response to the 2018 NYTS data was aggressive and multipronged. We stepped up compliance and enforcement efforts by issuing warning letters and civil monetary penalties to retailers for sales of ENDS to minors. We collaborated with the Federal Trade Commission to remove kid-appealing products from the market, and pursued ENDS manufacturers employing unlawful online posts by social media influencers.
Most recently, we issued a warning letter to JUUL Labs Inc. for marketing unauthorized modified risk tobacco products, including in a presentation to children given at a school.
We also expanded our efforts to educate youth about the dangers of e-cigarette use. Our Youth E-Cigarette Prevention Campaign, the Real Cost, is a comprehensive effort targeting nearly 10.7 million youth aged 12–17 years old.
Despite these significant efforts, the 2019 NYTS preliminary data, as well as another study supported by NIDA, demonstrate a continued rise in the disturbing rates of youth e-cigarette use especially through the use of nontobacco flavors. In particular, these data show that more than a quarter of high-school students were current e-cigarette users in 2019, and youth e-cigarette users cited fruit and menthol/mint flavors as being the most popular.
In short: the data indicate that FDA must do more.
That’s why the President announced his support for the FDA’s intention to soon finalize a compliance policy related to flavored ENDS. This policy would prioritize the FDA’s enforcement of premarket authorization requirements for nontobacco flavors. The FDA is not banning flavors, as has been described in some news reports. Rather, the FDA intends to enforce existing law that limits the marketing of such products.
This policy would not mean that flavored e-cigarettes could never be marketed. If a company can show through an application to the FDA that a specific product meets the standard set forth by Congress, then the FDA would authorize that ENDS product for sale.
The FDA intends to prioritize enforcement action such that flavored e-cigarette products will be expected to exit the market unless and until manufacturers of these products provide scientific evidence demonstrating that marketing their products is appropriate for the protection of the public health.
I want to assure the subcommittee that I am firmly committed to employing all of the tools at FDA’s disposal to tackle these problems. We will not rest until we have answers to the questions in the investigation, and until we have dramatically reduced the access and appeal of e-cigarettes to kids.
