Yesterday, the U.S. Senate Committee on Appropriations approved S. 2599, the 2022 Agriculture Appropriations bill. In it, language is included that would direct the U.S. Food & Drug Administration (FDA) to update Congress regarding its regulatory plans for premium cigars and also encourage FDA to reconsider exempting premium cigars.
The language is, as of now, still a proposal. While the Senate Appropriations Committee reported the bill out of committee, it will still need to be approved by the full Senate and the U.S. House of Representatives. Further complicating the matter is that increasingly these standalone funding bills have become part of larger omnibus funding bills, which has made it easier for special interest groups to get language like this removed than compared to standalone bills.
Furthermore, the language itself only asks for FDA to produce reports and then encourages the agency to reconsider less stringent regulation, including exemption:
Premium Cigars.—The Committee notes that the issuance of regulations under the Family Smoking Prevention & Tobacco Control Act may place burdens on the legal production of premium cigars that were in production before this rule was finalized. The Committee directs FDA to periodically report back to Congress on the status of premarket review with regard to premium cigars. The Committee encourages the FDA to re-evaluate these regulations. Further, the agency may want to develop recommendations that consider the concerns of premium cigar manufacturers while taking a risk based approach to public health. The Committee directs the FDA to provide a report to the Committee with its recommendation within 90 days, including a recommendation on whether or not to exempt premium cigars from this rule.
Where this language would be helpful is to show that the Congressional intent is to not have FDA regulating premium cigars. If passed, it would also mean that FDA would have to produce a report about premium cigar exemption sometime in 2022, which could be insightful to the agency’s long-term thinking.
This is different than other attempts to have language placed into previous agriculture appropriations bills, which are the annual bills that provide FDA its funding. Those prior attempts have been more forceful, directing FDA to exempt premium cigars or change the grandfather date for premarket approval, otherwise, the agency would not receive funding. Unfortunately, while some of those previous attempts made it out of committee(s), none of them survived the omnibus process and made it into law.
Featured Image By Scrumshus (Own work) [Public domain], via Wikimedia Commons