News: Thirteen Premium Cigars Gain FDA Grandfather Status, Study Shows Youth Aren’t Smoking Handmade Cigars
26 Apr 2017
Although no one knew it at the time, one of most important dates for cigars sold within the United States would be February 15, 2007. Under the Tobacco Control Act and subsequent rulemaking, cigars marketed before that date are grandfathered in as exempt from FDA regulations, while those introduced afterwards will eventually need FDA approval to be legally sold and marketed within the U.S.
Although a determination of grandfather status isn’t yet needed for a cigar to be sold without going through one of the FDA approval tracks, the FDA has begun accepting submissions requesting a grandfathered status review of a tobacco product regulated under the deeming regulations that went into effect last year. Earlier this month, the FDA issued the first such determinations for 13 handmade cigars.
Two companies had cigar products established as grandfathered and thus exempt from FDA approval rules: Altadis USA, one of the largest sellers of handmade cigars in the United States, and Ortega Premium Cigars, a boutique company.
Altadis submitted five cigars from five different brands, each in a corona format: Montecristo Classic Collection Especial No. 1, Romeo y Julieta 1875 Exhibicion No. 1, H. Upmann Vintage Cameroon Corona, Saint Luis Rey Corona, and Don Mateo Natural No. 5 (a bundle cigar). The approach of establishing one size first may be a legal strategy, with the company likely to next seek to expand grandfather determinations to other formats.
Ortega Premium Cigars received grandfather determinations for four sizes in each of two brands: VIBE and REO. In 2007, VIBE and REO were under EO Brands, then co-owned by current VIBE and REO owner Eddie Ortega with his former business partner Erik Espinoza. Both cigars were collaborations between EO and Rocky Patel.
The Ortega determinations were shepherded through by attorney Frank Herrera, whose boutique law firm specializes in cigar trademark and FDA compliance issues. Ninety-eight other cigars have also received grandfather determinations, but those cigars would not be considered handmade or premium cigars.
FDA-Funded Study Confirms Minors Not Smoking Premium Cigars
One of the main arguments against the deeming rules that regulate premium cigars in a similar manner as cigarettes is that youth smoking of premium cigars is not an issue. This is also a reason frequently cited for the need for legislation exempting handmade cigars from FDA regulations.
Even the studies cited by the FDA when they rejected a proposed exemption for premium cigars over a certain price did not point to handmade cigar usage by minors, but relied on a more nebulous “youth and young adults.” As we noted at the time, that included usage rates for adults as old as 29.
A recent study published in the prestigious New England Journal of Medicine buoys the arguments made by opponents of FDA regulation of traditional cigars. The study was funded by the National Institute on Drug Abuse and the Food and Drug Administration and conducted by the Department of Health Behavior of the Roswell Park Cancer Institute in Buffalo, New York.
As reported elsewhere, the study shows extremely low usage rates (2.3%) among those aged between 12 and 18, even with extremely broad definitions of usage (even just “one or two puffs” ever). Fewer than one percent of the 13,651 youth surveyed said they used a cigar once (even “just one or two puffs”) in the 30 days prior to being surveyed.
A deeper look at the study’s numbers shows even less cause for concern for youth smoking of cigars. Of the tiny percentage of those who claim to use traditional cigars virtually all used other tobacco products too, while the number who exclusively used traditional cigars was so small that “estimates were suppressed” because the number was not statistically significant.
Though the conclusion that youth smoking of traditional cigars is virtually zero came as no surprise to those in the handmade cigar community, having FDA-funded research to back up these claims may prove useful in lobbying for the FDA to ease regulations on handmade cigars and for pushing Congress to pass an exemption.
photo credits: Stogie Guys