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Sharpless said the agency is expected to finalize draft guidance in the coming weeks that will “dramatically impact” the market of flavored e-cigarettes, which are widely seen as fueling the popularity of vaping among young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.
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A Question :” WHY IS THE AGE OF PEJORITY 18 YRS OLD ?? ” Answer : “BECAUSE IF YOU ARE YOUNGER THAN 18 YRS., IN THE UNITED STATES, YOU NEED THE SIGNATURE AND PHYSICAL COMPANIONSHIP OF A PARENT OR A GUARDIAN DUE TO THE LEGAL AND MEDICAL REALITY THAT YOU ARE STILL PHYSICALLY AND MENTALLY A CHILD YOUNGER THAN THAT AGE. IT IS DETERMINED YOU CANNOT MAKE INFORMED DECISIONS REGARDING THINGS THAT ARE POTENTIALLY BAD FOR YOU —– CIGARETTES, GUNS, TOBACCO, ETC UNTIL YOU HAVE A “MATURE BRAIN.” Next Question: “WHY ARE E-CIGARETTES GETTING SUCH A BAD RAP FOR TEENS AND YOUNG PEOPLE ??” ANSWER: “AGAIN, BECAUSE THEIR BRAINS AND BODIES HAVE NOT MATURED INTO THAT OF 30+ YEAR OLD’S, WHICH ARE STILL DYING AND BECOMING EXTREMELY ILL. FOR PEOPLE 18 AND UNDER 18 YRS, THE ADDICTION POTENTIAL ALONG WITH THE TOXIC POTENTIAL ARE HUGE, ESPECIALLY WITH FLAVORED eCIGS, AND IN THE CASES OF THESE VICTIMS, HEALING MAY NOT BE ASSURED.
Assesing new products, and alerting Congress to their implications, as well as the need for forward thinking regulations is also what The Office of Technological Assessment use to do for Congress prior to its dismantling
With the regulations that are being proposed, the FDA will singlehandedly destroy the best innovation in harm reduction in the last 100 years.
Just maybe it might be time to sit down with some of the industry leaders arm enact some common sense regulations.
FDA in Gottlieb regime just blew it. Clean up crew is trying to put the cat in the bag. Good Luck FDA.
Why is this illness only present in the USA?
Nearly every smoker started when they were children and those things tasted awful. We know cigarettes kill half a million a year and yet they are still legal. These bans will just force people back into the arms of big tobacco, or to the black market that created this “illness” by selling contaminated THC carts.
Absolutely!…and the bans will do nothing but make the basement sellers of liquid and cartridges rich while people keep dying from the tainted THC stuff. They will accomplish exactly what they’ve been wanting to do for years…shut down the e-cig business and send people back to smoking. And we know how many people die every year from smoking!
And no one thinks it odd that e-cigarettes have been in use in this country for over 10 years and suddenly they’re deadly?…follow the liquid trail and it won’t lead to reputable sellers and manufacturers!
Absolutely disgusting grandstanding from all involved. This will solve nothing and may accelerate the deaths and illnesses. Well done