WINSTON-SALEM, N.C. — RAI Services Co. is calling on the Food and Drug Administration (FDA) to adopt a new enforcement policy directed at illegally marketed disposable electronic nicotine delivery system (ENDS) products.
"As the agency well knows, use of ENDS products in the United States has shifted to disposable products. And a new enforcement policy, one that is specifically directed at these disposables that are on the market illegally, is needed to better protect public health," RAI wrote in petition to Xavier Becerra, secretary, Department of Health & Human Services; Robert Califf, commissioner of the FDA; and the Divisions of Dockets Management Food and Drug Division.
The manufacturer requests that the FDA endorse an enforcement policy targeting illegally marketed disposable ENDS products. The policy would close an existing loophole in the FDA's current tobacco enforcement efforts, especially when it comes to youth, according to RAI.
RAI requests that the FDA prioritize enforcement for:
- Any flavored disposable ENDS, except for tobacco- or menthol-flavored products;
- Any disposable ENDS containing nicotine derived from any source other than tobacco that lacks premarket authorization;
- Any disposable ENDS containing nicotine derived from tobacco that was not on the market as of Aug. 8, 2016, or for which the manufacturer either failed to submit an application by Sept. 9, 2020, or submitted a premarket tobacco application (PMTA) to FDA by that deadline, but received a negative action that is not being challenged in court;
- Any disposable ENDS for which the manufacturer has failed to take, or is failing to take, adequate measures to prevent minors' access; and
- Any disposable ENDS targeted to, or whose marketing is likely to promote use by, minors.
"The action requested will better protect the public health and ensure a level playing field by discouraging illicit products and maintaining the availability of legally marketed, potentially less harmful options for current and former adult smokers who have transitioned or wish to transition from combustible cigarettes," RAI wrote. "Enforcement action should occur at both retail establishments and ports of entry."
Under the Tobacco Control Act, Congress granted the FDA the authority to regulate the manufacturing, marketing and distribution of cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco products to protect the public health and reduce the use of tobacco products by minors. The act also gave the FDA authority to issue regulations deeming other products that meet the statutory definition of a tobacco product to be subject to FDA authority.
On May 5, 2016, the FDA finalized its deeming rule, extending its regulatory authority to additional tobacco products, including ENDS. After the rule's effective date, newly deemed tobacco products (those not commercially marketed in the United States as of Feb. 15, 2007) were required to obtain marketing authorization.
Pursuant to its enforcement discretion, FDA provided that any such products that were already on the market as of Aug. 8, 2016, could remain on the market for designated periods provided they met the agency's deadline for submission of a request for marketing authorization. After repeated adjustments of the deadlines for PMTAs for ENDS products and ensuing litigation, FDA gave manufacturers of ENDS products until Sept. 9, 2020, to file applications.
To read the petition in its entirety, click here.
Winston-Salem Reynolds America Inc.'s (RAI) subsidiaries include R.J. Reynolds Tobacco Co., American Snuff Co. LLC, Santa Fe Natural Tobacco Co. Inc., R.J. Reynolds Vapor Co. and Modoral Brands Inc.
Following a recent independent report from the Reagan-Udall Foundation, U.S. Senate Majority Whip Dick Durbin (D-Ill.) led a bipartisan letter to Becerra condemning the FDA's delay in regulating e-cigarettes, its failure to enforce the law and take action against companies marketing illegal vaping products, and the harm to children's health from the agency's inaction.
The FDA is currently 16 months past a court-ordered deadline to finish reviewing e-cigarette applications. Recently, the FDA submitted filings disclosing that it will take nearly another year for the agency to complete its work — until Dec. 31, 2023 — for the e-cigarettes with the largest market share.
Approximately 1 million children are at risk of newly picking up vaping in the intervening time that FDA misses the court order, according to the Reagan-Udall Foundation.
"We write to once again draw your attention to the repeated failures of the FDA to regulate the tobacco and e-cigarette market. While we understand the incredible pressures that FDA is under across its portfolio of regulated products, the FDA's failures cannot be excused away by a heavy workload," the senators wrote. "For nearly a decade, the agency has neglected its duty under the law to regulate e-cigarettes, jeopardizing the health of millions of children. Now, after yet another delay in FDA’s efforts to regulate the e-cigarette marketplace, it is now clear to us that FDA is adrift and lives are at risk …
"To be clear, FDA's hapless e-cigarette oversight began when the prior administration made the decision in 2017 to delay implementation of the deeming rule, which had provided FDA with the authority to regulate vaping products. This delay led to millions of e-cigarettes illegally flooding the market without proper authorization as required under the Tobacco Control Act," the letter continued. "These delays, coupled with aggressive and misleading advertising — targeted at children and pulled straight from Big Tobacco's playbook — helped to ignite the youth vaping epidemic."
In addition to Durbin, the letter was signed by Sens. Mitt Romney (R-Utah), Jeff Merkley (D-Ore.), Lisa Murkowski (R-Ark.), Richard Blumenthal (D-Conn.), Ed Markey (D-Mass.), Tammy Duckworth (D-Ill.), Sherrod Brown (D-Ohio), Elizabeth Warren (D-Mass.), Tammy Baldwin (D-Wis.), Jack Reed (D-R.I.), Jeanne Shaheen (D-N.H.) and Sheldon Whitehouse (D-R.I.).
The senators noted that some of the most popular e-cigarettes used by children today do not have market authorization, but are on store shelves because the FDA has exercised enforcement discretion. Additionally, the grace period runs contrary to the Tobacco Control Act's requirement that manufacturers demonstrate their product is "appropriate for the protection of public health" prior to market entrance.
"This enforcement discretion should have ended years ago. It must end today," the senators wrote.
The full text of the letter is available here.