Three of FDA’s top anti-tobacco proposals are under threat from the U.S. House Committee on Appropriations.
Earlier today, the committee, which is responsible for allocating funds to various federal government entities, unveiled the draft of the FY24 Agriculture, Rural Development, Food And Drug Administration, And Related Agencies Bill, i.e. the proposed funding bill for various things, including the U.S. Food & Drug Administration (FDA). Language in the proposal would prevent FDA from banning flavored cigars, banning menthol cigarettes and enacting nicotine limits for cigarettes. All three of those things are major proposals that FDA has announced as regulations the agency expects to enact in the future.
Because this is the Appropriations Committee, the method is related to funding. The proposed language says that FDA cannot use any of the money Congress allocates for it to enact something like a ban on menthol cigarettes, effectively preventing the agency from carrying out the regulations.
The language in question is:
SEC. 768. None of the funds provided by this Act or provided from any accounts in the Treasury of the United States derived by the collection of fees available to the agencies funded by this Act, may be used by the Secretary of Health and Human Services to finalize, issue, implement, administer, or enforce any rule, regulation, or order setting a tobacco product standard that mandates a maximum nicotine level for cigarettes.
SEC. 769. None of the funds provided by this Act, or provided from any accounts in the Treasury of the United States derived by the collection of fees available to the agencies funded by this Act, may be used by the Secretary of Health and Human Services to finalize, issue, or implement any rule, regulation, notice of proposed rule- making, or order setting any tobacco product standard that would prohibit menthol as a characterizing flavor in cigarettes or prohibit characterizing flavors in all cigars and their components and parts.
In addition, the current language keeps the funding for FDA’s Center for Tobacco Products (CTP) at $712 million, the same as it currently is. That money is generated by user fees, which are paid for by tobacco companies. Due to language in older laws, vaping and e-cigarette companies do not pay user fees.
This bill is still in its early stages and is likely to undergo many modifications; even then, it’s unclear what chances the bill has of becoming law. Recently, Congress has generally relied on omnibus funding bills, where various funding bills are packaged into one large funding bill. Typically, the language that passes the committees is seen as a starting point for an omnibus funding bill, but last-minute changes are common as part of the process.
A markup hearing will take place tomorrow.
In March, Dr. Brian King, the director of FDA’s Center for Tobacco Products, announced that FDA was planning on announcing finalized rules that would ban flavored cigars and menthol cigarettes this fall. Previously, the agency has said that it will not enforce compliance for at least one year, and it is widely expected that there will be lawsuits filed in response to these rules.
Last year, it emerged that a proposed rule regarding nicotine limits would come in May 2023. Shortly after that information became public, FDA walked back the timeline but said that it was serious about the new rule.