Introduction
In the United States of America, federal lawmakers, who fund the FDA, are demanding stricter enforcement of regulations against vaping products that have not obtained marketing authorization from the agency. Faced with potential inaction by the FDA, lawmakers are proposing sanctions against the agency.
Bipartisanship Against Popular Vaping Products
Over the past week, the Appropriations Committees in both the Democratic-led Senate and Republican-controlled House of Representatives passed funding bills for fiscal year 2025 that would punish the FDA if the agency fails to strengthen its crackdowns, particularly on flavored vaping products and popular disposable vapes.
Criticism of disposable vaping and other standalone products is bipartisan. Senate Democrats have adopted language from anti-smoking activists in their legislation, while House Republicans have incorporated language from tobacco industry-backed bills introduced in many state legislatures this year.
Convergence of interests of the tobacco industry and anti-smoking activists
The convergence of interests between the tobacco industry and anti-smoking activists is not unusual. The Tobacco Control Act of 2009, which gave the FDA regulatory authority over tobacco and created the FDA’s Center for Tobacco Products (CTP), was developed and passed with the participation and support of the Campaign for Tobacco-Free Kids and Marlboro maker Philip Morris (now Altria Group).
So far, all of the vaping products on the FDA’s restricted list of approved products come from companies owned by tobacco conglomerates Altria Group, Japan Tobacco and RJ Reynolds. That’s unlikely to change if policymakers in both parties have their way.
Democratic Senate: Ban on vapes to protect young people
The Democratic-controlled Senate Appropriations Committee, chaired by longtime vaping opponent Patty Murray (D-WA), has drafted a bill threatening to withhold some of the FDA’s funding next year unless the agency updates its 2020 guidance to include disposable vapes as a primary target for crackdowns and issues a rule requiring foreign manufacturers to register with the CTP.
The senators also call for regular import alerts to combat the importation of tobacco products in violation of applicable laws and require the agency to submit quarterly reports detailing the number of pending tobacco product marketing applications and when they were received.
If the FDA fails to meet the requirements set forth in the bill, the agency would lose approximately $25 million in funding for salaries and expenses. The Senate bill also includes an additional $2 million for a recently announced multi-agency task force, led by the FDA and the Justice Department, to enforce FDA restrictions on vaping products. The report accompanying the bill encourages the FDA to deny marketing applications for all products, particularly flavored ones, that have increased or are likely to increase initiation among youth or non-tobacco users.
Republican House: Ban vapes to protect tobacco industry
The FDA budget bill passed by the Republican-controlled House Appropriations Committee, chaired by Tom Cole (R-OK), checks most of the boxes the tobacco industry likely wanted when lobbying the committee. The result is similar to the Senate bill, although the incentives and penalties used to influence the FDA are different.
The House committee bill would prevent the FDA from implementing its stated plans to ban menthol cigarettes and flavored cigars, or limit the level of nicotine in cigarettes, until the agency updates the 2020 guidance, requires foreign manufacturers to register with the CTP, issues import alerts and provides a quarterly report to both Appropriations committees on the Center for Tobacco Products' progress in removing all noncompliant nicotine products from the market.
The House also wants the agency to create a list of products that are authorized for sale in the United States (or subject to protection due to court orders or other circumstances) and "publicly disclose the authorized list to manufacturers, wholesalers, and retailers, with instructions to cease distribution, sale, and/or marketing of any product deemed not to be on the list."
This language may have been lifted directly from several Altria-backed marketing application registration bills that have been introduced in state legislatures this year.
Both bills would protect the traditional tobacco industry, though no member of either committee would likely admit that. Both bills would make it harder for current smokers to find attractive and effective nicotine alternatives. Neither bill would stop youth vaping.
