In the United States, luxury cigars escape FDA control

After seven years of proceedings, a judgment has just confirmed that Premium cigars are not required to submit a request for prior marketing authorization to the FDA.

A District of Columbia judge issued a ruling on August 9, 2023, that exempts luxury cigar manufacturers from their obligations to the Food and Drug Administration (FDA), including requests for premarket approval.[1].

So-called "luxury" or "premium" cigars are distinguished from other types of cigars if they are composed entirely and solely of tobacco leaves, contain at least 50 % of whole leaves, are produced or rolled manually, have no filters or mouthpieces, have no characteristic flavoring, contain only tobacco, water and vegetable gum, without any other additives and weigh more than six pounds (2.7 kg) per lot of one thousand units.

The harmfulness of luxury cigars in question

This district judge had already ruled in July 2022 that the FDA's request was "arbitrary and capricious", on the one hand because it attempted to subject luxury cigars to the same requirements as other tobacco products; on the other hand, because it allegedly ignored data from certain studies, such as those suggesting that cigars are less addictive products, particularly among young people, and that their consumption does not lead to excess mortality. The judge thus criticized the FDA for having considered that there was "no proof" that luxury cigars - or 'Premium' - are less harmful than other tobacco products, despite these studies.

The ruling also cuts into a 2016 FDA regulation that was supposed to align health regulations for cigars with those for other tobacco products. As a result, luxury cigars will also not be required to display health warnings on their packaging.

A questionable regulatory exception

The Cigar Association of America (CAA), Cigar Rights of America (CRA) and the Premium Cigar Association (PCA), three organizations that represent cigar producers and had filed the lawsuit, welcomed the ruling. The FDA, for its part, deplored the fact that these types of cigars were becoming "completely deregulated at the federal level"[2] and that this decision opened a breach in the legislation on tobacco products.

The luxury cigar market is quite small, but is far from trivial. Its position in the luxury product segment helps to maintain a "noble" and valued side of tobacco products. The argument of producers, justifying the fact of not submitting luxury cigars to laboratory expertise on the grounds that they are artisanal products, seems "curious".

The claim that the consumption of these products does not lead to fatal pathologies finally seems questionable; the jaw cancer from which Sigmund Freud died would be one example among others. While it is true that exclusive cigar smokers are less affected by lung cancer and COPD, they develop much more cancers of the mouth, esophagus and pharynx, and present cardiovascular risks of the same nature as cigarette smokers.

Keywords: Premium cigars, FDA, CCA.

©Tobacco Free Generation

M.F.

[1] Minato C, Premium cigar industry beats FDA in court, regulations vacated, Halfwheel, published August 9, 2023, accessed August 11, 2023.

[2] Pierson B, Judge throws out FDA rule regulating premium cigars like cigarettes, Reuters, published August 10, 2023, accessed August 11, 2023.