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FDA Rule that Would Limit Nicotine in Tobacco Products Sent to Biden White House for Review
WASHINGTON, DC (December 12, 2024) - On December 10th, the U.S. Food & Drug Administration (FDA) submitted a proposed rule that would sharply limit nicotine in tobacco products. This radical new step is expected to have far-reaching implications for the entire industry and could represent the first salvo in an attempt by the Agency to “sunset” all combustible tobacco.
Although the text of FDA’s proposal has not yet been made public, members of the Center for Tobacco Products have suggested that it intends to ban cigarettes and “other tobacco products” unless they reduce their nicotine content to “non-addictive” levels - by around 95%. It is currently unknown how broadly the proposal would apply beyond cigarettes. It is likely to apply to combustible products as well, but it could omit limits on electronic nicotine devices.
While premium cigars are not currently subject to this or any other FDA rules as a result of the CRA-led lawsuit against the Agency, we remain gravely concerned about this proposal. Should FDA prevail in its appeal of our court-ordered exemption - or should the Agency attempt to otherwise regulate premium cigars again in the future, our products could be subject in the future to these draconian limits.
Premium cigars are handcrafted, natural products, and there is no way for our industry to comply with the standard that we fear FDA is suggesting. In fact, such a proposal would effectively prohibit all premium cigars and be tantamount to a ban on the category - which the Tobacco Control Act specifically forbids FDA from doing.
The rule has been submitted by FDA to the Office of Management and Budget, which is coordinating a White House review of the document before it is released to the public. Typically, such internal reviews can last up to 90 days, but with the incoming Trump Administration, it is almost certain to be formally proposed before the end of the current Administration.
Before any rule became effective, FDA would have to take extensive comment from the public and regulated industry, respond to those comments, and issue a Final Rule - a process that typically takes at least a year. The incoming Trump Administration’s views on such a rule are not currently known.
CRA remains committed to defending premium cigar consumers' rights and small business manufacturers' ability to make their artisan products. We are actively engaging with the White House to remove any misguided rules on premium cigars. Should the Biden Administration propose such a rule, we will work closely with the incoming Trump Administration to ensure that it is never finalized. CRA is also continuing to advocate for HJ Res. 99, a legislative solution that would protect premium cigars from being subject to regulation in the future.
For more information, contact: Cody Carden Director of Communications Cigar Rights of America cody.carden@cigarrights.org