The Food and Drug Administration “should have acted sooner” to rein in the e-cigarette industry but pledged to “catch up,” acting commissioner Ned Sharpless said Wednesday during a congressional hearing that quickly became a referendum on federal regulation of e-cigarettes.
Sharpless said the agency is expected to finalize draft guidance in the coming weeks that will “dramatically impact” the market of flavored e-cigarettes, which are widely seen as fueling the popularity of vaping among young people. But Sharpless faced tough questions about why the agency hadn’t acted sooner — or done more — to grapple with the growing e-cigarette industry.
“I am disappointed it’s taken so long to get to this point,” said Rep. Frank Pallone (D-N.J.), the chairman of the Energy and Commerce Committee, which has oversight authority over the FDA.
The expected guidance will mark a pivot from the agency’s previous stance on e-cigarettes. The FDA has authority over cigarettes and smokeless tobacco under federal law. In 2016, the agency determined that e-cigarettes also fell under that umbrella and asked companies to file applications to market their products by August 2018. But in 2017, former FDA Commissioner Scott Gottlieb rolled out a new plan to curb nicotine levels in traditional cigarettes — and noted that e-cigarettes could play an important role in that plan by giving adult smokers an alternative to conventional cigarettes.
So the FDA used its “enforcement discretion” to delay those marketing application deadlines to 2022. The deadline has since been moved to May 2020, though companies can file applications sooner.
“We didn’t want to sweep market of e-cigs at very moment we sought to regulate nicotine in cigarettes,” Gottlieb said on Twitter Wednesday. He noted that the agency’s goal was to help adults who were currently addicted to smoking cigarettes to quit the habit.
The new guidance, when finalized, will mean the agency is no longer exercising that enforcement discretion, Sharpless said. The FDA will start sending warning letters with the expectation that flavored vaping products — other than those flavored like tobacco — will be removed from the market. If they aren’t pulled from shelves, the agency would follow up with more warning letters, fines, injunctions, or other actions.
“We believe this policy will have a dramatic effect on the flavored products sold on the market today,” Sharpless said. He did not confirm whether the final guidance would include mint and menthol vaping products, but said the “data support mint and menthol being significant problems.”
The hearing came on the heels of the news that Juul, the e-cigarette giant, is suspending all of its advertising and will not lobby against the federal guidance on flavored vaping products. The company also announced on Wednesday that its chief executive officer is stepping down.
Juul’s marketing practices also came under scrutiny during the hearing. Rep. Kathy Castor (D-Fla.) noted the FDA’s warning letter to Juul earlier this month over the company’s unproven safety claims, including statements made in a presentation to students during school. She also pressed the health officials on how they plan to tackle the promotion of e-cigarettes on social media platforms such as Instagram and Snapchat.
“We’re seeing the kind of tactics used with cigarettes being used again,” said Anne Schuchat, the deputy principal director of the CDC, of e-cigarette marketing broadly.
Lawmakers also grilled Sharpless and Schuchat, the deputy principal director of the CDC who was also testifying, about the ongoing outbreak of vaping-related illnesses. The outbreak has been tied to hundreds of illnesses and nine deaths. Schuchat said she expects the number of cases to increase “by hundreds” when the CDC releases new data later this week.
Both health officials said their agencies feel a strong sense of urgency about addressing both the vaping-related illnesses and the widespread use of e-cigarettes among young people.
“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,” Sharpless said.