A new House bill will require the FDA to update its electronic cigarette product enforcement guidelines to clarify how the agency will prioritize enforcement of disposable e-cigarette 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 children and a former healthcare executive, I am pleased to introduce this critical legislation," said Representative Cherfilus-McCormick, a Democratic representative serving Florida's 20th congressional district in southern Florida. "I urge the Biden administration to close this harmful loophole for our young people and put an end to this nationwide epidemic.
HR 901 is not a ban on flavors or disposable e-cigarettes.
The HR 901 bill will not ban disposable electronic cigarettes nor will it grant the FDA any additional powers, but it will put pressure on the agency to enforce regulations on such products. Disposable electronic cigarettes are currently the most popular products in the convenience store/gas station market in the e-cigarette industry, hence the need for enforcement action.
Cherfilus-McCormick's bill has little chance of advancing in the Republican-controlled House of Representatives. However, groups like "The Campaign for Tobacco-Free Kids" will use the bill as leverage to pressure the FDA to increase enforcement of disposable e-cigarette products - a stepping stone towards the organization's preferred policy of a complete ban on all flavored e-cigarette products.
The effort to push the FDA's new guidelines, particularly the prioritization of enforcement of disposable e-cigarettes, has gained support from anti-smoking organizations, Democratic lawmakers, and even tobacco companies.
Last week, tobacco giant R.J. Reynolds submitted an official citizen petition to the FDA, requesting priority enforcement of disposable e-cigarettes. Reynolds' tobacco and mint flavored e-cigarettes cannot compete with the more effective popular flavors found in disposable e-cigarettes.
On February 6th, former Democratic Congressman Jason Altmire published an op-ed in The Hill calling on the Biden administration to "plug law enforcement loopholes." This followed an article in The Hill, a citizen petition from R.J. Reynolds company, and a proposed bill from Representative Cherfilus-McCormick, all within a three-day span.
Never-before-seen vulnerability.
The term "single-use exemption" refers to the 2020 enforcement guidelines of the United States Food and Drug Administration, which exempts some single-use electronic cigarette products from priority enforcement.
As explained previously, the exemption for disposable products only includes other products that comply with regulations, such as NJOY Daily and blu disposable e-cigarette products. The FDA stated in its enforcement document that, "similar to FDA's compliance policy for deemed new tobacco products without premarket authorization, this guidance does not apply to any deemed products not on the market as of August 8, 2016." In other words, products that entered the market after 2016 will still be a focus of enforcement.
In 2019, a popular disposable flavored e-cigarette entered the market. However, from the outset, they violated regulations set by the FDA, as was explained when the FDA ordered Puff Bar to leave the market.
Currently, there is nothing stopping the agency from taking the same action against Puff Bar as they did in 2020. For single-use e-cigarette products launched after the pre-market tobacco application (PMTA) deadline of 2020 or the deadline for synthetic nicotine aerosol product applications in 2022, they are not protected from FDA enforcement unless they are still awaiting approval of their PMTA application or have obtained an enforcement discretion order from the FDA or federal courts.
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