The products, known as premium cigars, should be subject to warning labels and pre-marketing review, the groups told the Food and Drug Administration in comments on the agency’s April proposal to oversee cigars and electronic cigarettes for the first time. The groups also want the FDA to ban flavors such as cherry and vanilla in small cigars and e-cigarettes that are proving popular with teenagers.
In its proposal, the FDA asked whether it should exempt premium cigars such as Davidoff Cigars made by Imperial Tobacco Group Plc (IMT) based on the industry’s argument that users don’t inhale and the products aren’t purchased by youth. The FDA plans to regulate cigarillos and little cigars, inexpensive products that resemble cigarettes and often are flavored.
“We know that premium cigars have health risks, they cause cancers they have cardiovascular implications and so on,” Gregg Haifley, associate director of federal relations with the American Cancer Society’s Cancer Action Network, said in an interview. “Why should a product that has known disease health consequences be exempt from a factual scientific warning label?”
The agency estimated that cigars of all types generated $8.1 billion in sales last year.
The joint comments from the advocacy groups were led by the cancer society, the Campaign for Tobacco-Free Kids, the American Heart Association, the American Lung Association and the American Legacy Foundation. Today is the last day for public comment on the FDA’s proposal.
The agency gained the authority in 2009 to regulate tobacco, including e-cigarettes and cigars pending creation of rules to deem them tobacco products. The FDA hasn’t said when it would finalize the proposal for which it has received nearly 60,000 comments.
There are 3,639 types of cigars that would be affected by the proposal, 3,276 of which are made in other countries, according to an economic analysis by the FDA.
“Some domestic producers may cease to sell their products domestically or discontinue some products,” FDA economists wrote. “Foreign producers may cease selling their products to the U.S. or reduce the number of distinct products they sell in the U.S.”
The Cigar Association of America said it met with the FDA “numerous times over nearly three years to educate officials about unique facets of the cigar market, including the differences between and among various types of cigars.” Regulation should protect adults’ right to smoke, the trade organization said when the FDA released the proposal.
On the issue of flavored tobacco, FDA Commissioner Margaret Hamburg said the agency is assessing the available research.
More than 40 percent of middle- and high-school students who smoke use flavored little cigars or menthol cigarettes, the Centers for Disease Control and Prevention found in a study last year. Imperial, based in the U.K., also makes Phillies Blunt cigars that come in flavors such as grape and chocolate. Flavored cigarettes except menthol are banned.
The groups also criticized the FDA for its economic analysis of the proposal that negated some of the benefit of smoking cessation on health and longevity because of the loss of pleasure people give up by not smoking.
“We think that’s absolutely outrageous,” Haifley said.
The groups also want the FDA to give cigar and e-cigarette manufacturers a year instead of two years to turn in an application for FDA review to sell their products.
The draft regulation also applies to hookahs and pipe tobacco. While the advocacy groups didn’t address the products, the American Cancer Society’s Cancer Action Network plans to file separate comments that urge the FDA to require warnings on hookahs and pipe tobacco in relation to the toxicity of the smoke.
“We have some concerns with the use of hookah in youth that youth perceive hookah less harmful than cigarettes,” Katie McMahon, policy principle at the network, said.
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