FDA 'should have acted sooner' on e-cigarettes, vaping: FDA chief originally appeared on abcnews.go.com
The head of the agency that regulates tobacco products said Wednesday during questioning on Capitol Hill that the federal government should have acted sooner on e-cigarettes.
Ned Sharpless, acting commissioner of the Food and Drug Administration, was pressed by members of a House Energy and Commerce subcommittee on why the agency hadn't acted sooner to regulate e-cigarettes as youth consumption has skyrocketed.
"In retrospect," he said, "the FDA should have acted sooner -- we should have begun regulating these devices sooner."
But, Sharpless said, the agency has accelerated its timeline and will be working to review applications from e-cigarette companies and which current products may require limitations.
"We're going to catch up," he added.
Dr. Anne Schuchat, principal deputy director at the Centers for Disease Control and Prevention, said the CDC has been warning that young people were attracted to e-cigarettes since 2013. A recent uptick in deaths and illnesses linked to vaping has refocused a spotlight on how many young people are using related products.
"CDC's not a regulatory agency," Schuchat said, "but we have been raising the alarm about e-cigarettes and youth since 2013, when we first saw the rise."
The Trump administration announced it would move to ban flavored tobacco products in response to concern over how many teens are using e-cigarettes to ingest nicotine. The National Youth Tobacco Survey has found e-cigarettes are becoming more popular among high school students -- more than 20% reported using e-cigarettes last year.
The FDA, which regulates tobacco, said many current e-cigarette products are on the market illegally because they haven't been approved by the agency as a product with public health benefits. That requirement was added to electronic tobacco products in 2016, but it wasn't immediately enforced.
Sharpless, in his Wednesday testimony, said the agency gave companies additional time to comply and wouldn't enforce the requirement as long as producers submitted applications before an established deadline.
After a legal challenge to some of the FDA's policies on new tobacco products, a federal court gave companies until May 2020 to submit applications for agency approval, though the decision did not block FDA from enforcing requirements before then.
The FDA and agencies like the Federal Trade Commission have been investigating e-cigarette companies like Juul and whether they have been illegally advertising their products to minors.
The FDA said it plans to prioritize enforcement of that requirement for flavored e-cigarette products that are believed to be targeting young people.
Drastic increases in the number of young people using e-cigarettes and vaping products were recorded before the CDC and FDA began investigating the recent outbreak of vaping-related lung injuries. Sharpless said the outbreak presents a different set of problems for regulators because a lot of people affected have reported using e-cigarette products with THC, which is illegal on the federal level and largely regulated by states.
"To the extent those products are being reviewed and regulated, it generally occurs at the state level," he said during his testimony.
Former FDA Chief Scott Gottlieb was vocal about his concerns about young people using e-cigarettes during his time at the agency, but also defended his former office, saying it had reasons to delay requirements that e-cigarette makers apply for approval.
"We didn't want to sweep market of e-cigs at very moment we sought to regulate nicotine in cigarettes. We had to give adult smokers who still wanted to access nicotine some alternative. Our main goal was to transition adults off nicotine, or onto medicinal nicotine products," he tweeted.
THREAD: The decision in 2017 to delay applications on e-cigs was made for two key reasons: 1. We were seeking to regulate nicotine in combustible cigarettes for the first time, and saw the e-cigs as one potentially less harmful alternative for currently addicted adult smokers.— Scott Gottlieb, MD (@ScottGottliebMD) September 25, 2019
We must remember the goal was to help currently addicted adult smokers quit. It was a package deal, with regulation of nicotine at its center. The legitimate e-cigs, while not safe, are less harmful than smoking. Estimates show nicotine regulation can reduce smoking deaths by 8M— Scott Gottlieb, MD (@ScottGottliebMD) September 25, 2019