PHOENIX-- On August 27, Rep. Henry Waxman (D-Calif.) wrote a letter to the head of the U.S. Food & Drug Administration (FDA), urging the agency to assert jurisdiction over cigars and pipe tobacco, claiming that "forceful and timely intervention by FDA can stop the tobacco companies from exploiting loopholes and endangering our youth." This letter has now prompted cigar manufacturer Prime Time International, Phoenix, to send its own letter to the FDA, defending the cigar industry against claims made by Waxman and the CDC.
"It is the purpose of this letter to bring some additional facts to your attention and to correct the record in regard to certain of Rep. Waxman's statements," reads the document, drafted by Prime Time's secretary and general counsel, James Deer, and sent on September 21. "Given the historic charge to the [FDA] to regulate on the basis of science, we believe that the agency should proceed on the basis of sound science and not in reaction to political pressures to any group or individual."
(See File Attachments below to read the full text of the letter.)
Specifically, Prime Time's letter takes offense to the size and nature of the study from which Waxman made his claims: a CDC report entitled "Consumption of Cigarettes and Combustible Tobacco--United States, 2000–2011."
"We're simply asking them to consider the broad-based studies of more validity rather than the smaller CDC study," Deer told Tobacco E-News, specifically citing the Substance Abuse and Mental Health Services Administration (SAMHSA) report, which annually interviews 67,500 persons a year. "The gold standard for scientific studied for the FDA has always been broad-based studies. They have the additional validity [of examining local fads, customs, what else]."
Data from these broad-based studies often directly contradict many of the claims made by both Waxman and the CDC. While Waxman argued that cigars should be regulated by the FDA because cigarette smokers are switching to the lesser-taxed alternative (as suggested in the CDC report), Prime Time's letter points out that statistics released by the U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB) "clearly show that cigar products are not being used in any material way as a replacement product that decreases in cigarette sales experienced in recent years."
Compiled out of tax reports audited periodically by the agency, the TTB's taxable product statistics between 2008 and 2011 show that taxable removals of cigarette products decreased from 346.4 billion to 292.8 billion (a decrease of 53.6 billion units), while cigars (small and large) increased from 11.5 billion units in 2008 to 13.7 billion units in 2011 (an increase of 2.2 billion).
"This increase of 2.2 billion units was far less than the 53.6 billion unit decrease in the numbers of cigarettes posted over the same period by the TTB," reads Prime Time's letter. Meaning, even if all of the increase in cigar units came from cigarette smokers, it would still be an insignificant number compared to the entire loss of cigarette smokers.
Another Waxman claim refuted by broader scientific evidence is the concept that cigars must be regulated because they're drawing in underage smokers: according to the 2010 SAMHSA Study, the rate of smoking cigars among children has actually declined. From 2009-2010, the SAMSHA study reported the cigar smoking rate among youths aged 12 to 17 decreased from 4% to 3.2%.
"That's a huge decline in usage. It's somewhat at odds with what they would like you to believe in the more narrowly based CDC study," said Deer, referencing a claim in the CDC study that 15.7% of high school boys smoke cigars.
Prime Time is hoping for a response from not only the FDA, but other cigar manufacturers and retailers as well.
"I think that the industry needs to be a little more forthright about correcting a lot of the things that become matters of so-called public knowledge, which are really incorrect," Deer said. "We need to help correct the record as it is being made and we need to push back against those who trying to manufacture a situation that leads to the next level of regulation."