Time: 2023-02-14
Views: 453
A new U.S. House bill would require the FDA to update its vaping product enforcement guidance to specify "how the agency will prioritize enforcement of single-use vaping products.
The bill was introduced last week by Representative Sheila Cherfilus-McCormick and has been assigned to the House Energy and Commerce Committee.
"As a mother of two and a former health care executive, I am pleased to introduce this important legislation," said Rep. Cherfilus-McCormick, a Democrat serving South Florida's 20th Congressional District. "For the sake of our young people, I call on the Biden Administration to close this harmful loophole and end this nationwide pandemic."
HR 901 is not a ban on flavors or disposable e-cigarettes
HR 901 would not ban disposable e-cigarettes or give FDA additional powers, but it would put pressure on the agency to take enforcement action against the most popular vaping products now found in convenience stores/gas stations part.
In the Republican-controlled House, Cherfilus-McCormick's bill has little chance of passing. But groups like the Campaign for Tobacco-Free Kids will use the bill as a wedge to pressure the FDA to step up its enforcement of disposables — a stepping stone to TFK’s preferred policy: an outright ban on all flavored vaping products.
The push for new FDA guidelines specifically to make disposable e-cigarettes a high enforcement priority has drawn support from tobacco control groups, congressional Democrats and even tobacco companies.
Last week, tobacco giant RJ Reynolds filed a formal FDA citizen petition asking the agency to prioritize enforcement on single-use e-cigarettes. Reynolds' tobacco and mint-flavored Vuse e-cigarettes can't compete with the more potent popular flavors of disposable e-cigarettes.
On February 6, Jason Altmaier, a former member of the Democratic House of Representatives, published a commentary in the "Capitol Hill", urging the Biden administration to close the loopholes in law enforcement.
Hill's article, the RJ Reynolds citizen petition, and the introduction of Rep. Cherfilus-McCormick's bill all happened over the course of three days.
loophole never
The so-called one-time e-cigarette loophole refers to FDA’s 2020 law enforcement guidelines, which exempt some disposable e-cigarette products from law enforcement.
As we explained at the time, the exemption for single-use products only includes other compliant products such as NJOY Daily and blu disposables. FDA specifically noted in its executive document that, like FDA's previous compliance policy for deemed new tobacco products that did not receive premarket authorization, this guidance document does not apply to any deemed products that were not on the market on August 8, 2016. In other words, products entering the market after 2016 will remain the focus of enforcement.
This popular flavored disposable started hitting the market in 2019. As the FDA explained when it ordered the Puff Bars to be taken off shelves, they were in violation of FDA regulations in the first place.
There's nothing stopping the agency from taking the same action now that it took against Puff Bar in 2020. Disposable products arriving after the original 2020 Premarket Tobacco Application (PMTA) deadline or the 2022 synthetic nicotine e-cigarette product application deadline are not protected against FDA enforcement action unless they have a PMTA still under consideration, or There are suspensions issued by the FDA or a federal court.