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 judge in the District of Columbia issued a ruling on August 9, 2023 that exempts luxury cigar manufacturers from their obligations to the Food and Drug Administration (FDA), including claims for prior marketing authorization[1].
So-called “luxury” or “Premium” cigars are distinguished from other types of cigars if they are entirely and solely composed of tobacco leaves, contain at least 50% whole leaves, are produced or rolled by hand, have no filter or mouthpiece, have no characteristic flavor, contain only tobacco, water and vegetable gum, without any other additives and weigh more than six pounds (2.7 kg) per 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 tried to subject luxury cigars to the same requirements as other tobacco products; on the other hand, because it would have neglected the data of certain studies, such as those suggesting the fact that cigars are less addictive products, in particular 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 evidence” that luxury cigars – or ‘Premium’ – are less harmful than other tobacco products, despite these studies.
This judgment thus cuts into an FDA regulation dating from 2016, which was to align health regulations for cigars with those of other tobacco products. As a result, luxury cigars will also not be required to display health warnings on their packages.
A questionable regulatory exception
The Cigar Association of America (CAA), Cigar Rights of America (CRA) and Premium Cigar Association (PCA), three organizations that unite cigar producers and had filed the lawsuit, welcomed the announcement. of this judgment. The FDA complained that these types of cigars are becoming “fully deregulated at the federal level”[2] and that this decision opened a loophole in the legislation on tobacco products.
The market for luxury cigars is quite small, but far from trivial. Its position in the luxury product segment contributes to maintaining a “noble” and valued side of tobacco products. The argument of the producers, justifying the fact of not submitting luxury cigars to laboratory expertise on the grounds that they are artisanal products, seems “curious”.
Finally, the allegation that the consumption of these products does not lead to fatal pathology seems debatable; the jaw cancer from which Sigmund Freud died would be an example among others. While it is true that exclusive cigar smokers are less affected by lung cancer and COPD, they develop many 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
MF
[1] Minato C, Premium cigar industry beats FDA in court, regulations vacatedHalfwheel, published August 9, 2023, accessed August 11, 2023.
[2] Pierson B, Judge throws out FDA rule regulating premium cigars like cigarettesReuters, published August 10, 2023, accessed August 11, 2023.
National Anti-Smoking Committee |
2023-08-28 08:01:28
#Luxury #cigars #escape #FDA #scrutiny
