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The Beauty of the Cigar Box Threatened by New FDA Regs

As the US Food and Drug Administration (FDA) initiates its regulation of premium cigars, one thing that cigar enthusiasts will begin to notice is that the beautiful ornate cigar boxes will undergo a significant change. One of the new FDA mandates, as included in the 499-page regulation released on Thursday, May 6, is that cigar packages include prominent new warning labels with the intent to remind smokers of the health risks associated with tobacco use.

All cigar manufacturers will be required to cycle through six warnings displayed prominently on their packages, covering at least 30% of the package and be printed in at least 12-point font:


WARNING: This product contains nicotine. Nicotine is an addictive chemical.


WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do not inhale.


WARNING: Cigar smoking can cause lung cancer and heart disease.


WARNING: Cigars are not a safe alternative to cigarettes.


WARNING: Tobacco smoke increases the risk of lung cancer and heart disease, even in nonsmokers.


WARNING: Cigar use while pregnant can harm you and your baby.*


SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of Infertility, Stillbirth and Low Birth Weight.*


The requirement to submit a cigar warning plan for FDA review and approval will take effect 12 months after the date of publication of the final rule (which is May 10, 2016), which means that cigar warning plans must be submitted to FDA for review no later than 12 months after the date of publication of the Deeming Rule for currently marketed tobacco products. However, for products not on the market 12 months after the date of publication of the Deeming Rule, they must submit a warning plan for FDA review and approval 12 months before advertising or commercially marketing. The Guidance for Industry on health warning requirements for packages and advertisements published by the Office of Regulations in the Center for Tobacco Products at the FDA may be found here (in its entirety).


The beauty of the cigar box threatened by new FDA regulations on premium cigars


The FDA would like for the US to join other countries that use graphic warning labels which display gruesome images along with warnings about the danger of smoking, which cover anywhere from 30% to 80% of cigarette packs. One study published in 2013 that examined cigarette graphic warning labels and smoking prevalence in Canada, demonstrated that the adoption of graphic warning labels on cigarette packages reduces smoking prevalence. Further, the authors reported that based on this analysis, they estimated that if the US had adopted graphic warning labels in 2012, the number of adult smokers in the US would have decreased by 5.3–8.6 million in 2013. No other such studies have been published. However, the US Court of Appeals assessed this literature as well and concluded that the FDA "has not provided a shred of evidence … showing that the graphic warnings will 'directly advance' its interest in reducing the number of Americans who smoke.”


Given the current state of affairs, I have a grave feeling that now that premium cigars are not exempt from FDA tobacco regulations, our decorative, collectible cigar boxes (particularly the wooden boxes of fine craftsmanship) will no longer be ours to appreciate.


*Cigar manufacturers may choose to display either one of the warning statements regarding reproductive health.

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