The FDA (Food and Drug Administration) had planned to regulate premium cigars (artisanal cigars) based on the Deeming Rule (a rule under which the FDA has regulatory authority over nicotine products not listed in the Tobacco Control Act). However, on August 9, 2023, Judge Mehta of the US District Court for the District of Columbia ruled that the FDA's regulatory plan for premium cigars wasinvalid because the FDA (Food and Drug Administration) had ignored public comments on the Deeming Rule. As a result, premium cigars are no longer subject to FDA regulation. This ruling will not have an immediate impact on the FDA's regulatory plan for nicotine vapes, but it is the biggest defeat in the history of the FDA.
- Ignoring FDA public comments
According to the cigar company Halfwheel, the FDA (Food and Drug Administration) definition of a premium cigar is: "It must be unflavored, made from whole tobacco leaves, have 100% cigar binder, have a minimum of 50% long filler, and be hand-rolled (no machinery except with simple tools)."
In 2022, Judge Mehta called on the FDA (Food and Drug Administration) to revoke or revise the deeming rule , stating that " FDA's ignoring the actual record and evidence of public comments in formulating the deeming rule is a deliberate and unfair act ."
If the FDA were to regulate premium cigars in the future, it would have to start the process all over again by publishing a draft of the Deeming Rule and accepting public comments to develop the rule. It remains to be seen whether the FDA will start over from scratch, appeal to the Federal Circuit, or give up on regulating premium cigars altogether.
- The ruling will have no immediate impact on nicotine vaping.
The ruling does not directly affect products covered by the Deeming Rule, such as nicotine vapes, heat-not-burn tobacco products, nicotine pouches, or small cigars . Attempts by the nicotine vape industry to challenge the Deeming Rule in court have so far failed, and the FDA intends to announce rules soon to ban flavored cigars .
However, this ruling may encourage judges in future cases regarding nicotine vapes to think more carefully about the FDA's scientific claims and its regulatory processes.
Gregory Conley of the American Nicotine Vape Manufacturers Association told Vaping360, "Premium cigar lovers, the cigar business, and their interest groups should all be celebrating this ruling. If FDA regulation had been allowed, small cigar manufacturers would have gone out of business. The court's decision strongly criticized the FDA's scientific evidence and made a fact-based decision based on the characteristics of cigars. Unfortunately, this ruling will not bring about any immediate changes in the nicotine vape industry, but we can expect more judges to oppose FDA rules."
Source: https://vaping360.com/vape-news/125776/federal-judge-hammers-fda-in-premium-cigar-decision/
