FDA Funding Bill Delays Proposed Tobacco Regulations on E-cigarettes

According to a report by Halfwheel on June 17, a recently passed bill funded by the U.S. Food and Drug Administration (FDA) includes a language provision that, if passed, would delay the proposed tobacco regulations until the FDA completes regulatory adjustments for e-cigarette products.

Last week, the House Agriculture Subcommittee, Rural Development, Food and Drug Administration, and related agencies passed their expected appropriations bill for the 2025 fiscal year. The vote followed party lines, with Republicans voting in favor and Democrats voting against. The bill has now been referred to the full House Appropriations Committee, which may make amendments before the bill is taken to a full vote in the U.S. House of Representatives.

In this situation, the language provisions in the bill text typically reflect certain senators' attitudes towards FDA actions. As an executive agency, the FDA essentially has the authority to make policies without congressional approval. Annual appropriations bills give elected officials the opportunity to withhold funding to force the FDA to change its course of action.

The bill includes provisions relating to tobacco and nicotine products, prohibiting the FDA from using funds to enforce three key regulatory policies.

It is prohibited to sell mint-flavored cigarettes in the United States, as well as flavored cigars. There are restrictions on nicotine content in products. When legislators introduce these provisions, they often provide direct instructions, such as stating that the FDA cannot use funds for a specific purpose. In this case, the provision specifies that funds cannot be used to enforce the above-mentioned policies unless the FDA completes a series of adjustments related to the regulation of e-cigarette products. These adjustments include:

1. The updated "Industry Priority Enforcement Guidance" (January 2020) expands the priority enforcement scope for disposable flavored e-cigarette products (technical term for e-cigarette products) beyond pod-based products. 2. Issuing final rules requiring foreign manufacturers to register. 3. Collaborating with Customs and Border Protection as well as the United States Postal Service to prevent the import of products that have received market refusal orders (i.e. FDA refusal letters). 4. Publicly authorizing a list of approved products. 5. Issuing "Import Alerts" for products that may be in violation. 6. Submitting quarterly reports to Congress on the progress of non-compliant products.

Even if these provisions are passed, they may not necessarily affect the FDA's regulation of tobacco and e-cigarette products. In April of this year, the White House announced a delayed proposed ban on menthol cigarette sales. Most people believe that this delay also impacted the proposed ban on flavored cigars, possibly due to the upcoming elections.

Although the FDA proposed creating limits on nicotine in early 2018, there has been little progress in actually implementing these restrictions since then.

It is more likely that these funding restrictions will not ultimately become law. The committee markings are just the first step in the FDA funding approval and allocation process. Recently, Congress typically relies on omnibus appropriations bills, a process of packaging various appropriations bills into one large funding bill. The language passed by the committee is usually seen as the starting point for the omnibus appropriations bill, but last-minute changes are also common in this process.

For example, last year, the committee approved a stricter provision that directly prohibits the FDA from implementing a ban on menthol cigarettes, flavored cigars, and nicotine restrictions, without any proposed changes for e-cigarette products.

Earlier, according to Axios, Republican lawmakers lost a private space in the Capitol building where they could enjoy cigars due to changes in the role of the House committee chair. This has made them nervous and prompted them to request House Speaker Mike Johnson to address the issue.