Some people were disturbed by the fact that the FDA didn't respond to commentary [image-nocss] during the sessions, said Norm Sharp, president of the Cigar Association of America Inc., Washington. He described his own reaction as "not satisfied, but not dissatisfied."
"I just didn't think that given their lack of knowledge about the industry and the newness of their organization, and the need to meet these tight deadlines, I just didn't expect there to be anything beyond a listening session," he told CSP Daily News.
Thomas Briant, executive director of the National Association of Tobacco Outlets Inc. (NATO), Minneapolis, attended both of the sessions (one for manufacturers and the other for retailers, importers and distributors), as well as a media briefing. He said that one of the major concerns discussed was the ban on color advertising on tobacco products in retail stores, "which violates the constitutional protection afforded to free speech." (Current litigation from tobacco manufacturers and a NATO retailer challenges the ban.)
Another major concern was whether the flavored-cigarette ban includes flavored little cigars. The FDA had issued a letter to the industry September 14 that said the standard applies to "all tobacco products that meet the definition of a 'cigarette' in section 900(3) of the Act even if they are not labeled as 'cigarettes' or are labeled as cigars of some other product."
Briant, however, told CSP Daily News, "Our understanding of the law is that flavored cigar products are not banned at this time, but the FDA has not provided clear guidance to clarify the issue.... There's no question that we were confused." He added that the FDA referred people back to the definition of what a cigarette was under the law, as opposed to directly answering if the flavored-cigarette law extended to the ban to flavored little cigars.
"I think they truly do not understand the tobacco industry or the different tobacco products sold to consumers, and without a good underlying knowledge of these products and why they are different from one another, the FDA does not yet know how to apply the new law," he said.
As for any good that came out of the calls, Briant said, "I believe the listening sessions showed that the FDA may have acted too quickly without consulting the industry on the scope of the flavored-cigarette ban."
The FDA also did extend a deadline for public comments from September to December. "The comment period was extended for a variety of reasons," said FDA spokesperson Kathleen Quinn, "including an understanding on our part that people needed more time to digest the law and organize comments and to receive input on the flavor ban, which didn't take place until a week prior to the original close date of the docket."
While the comments won't change the law, Briant said, "If the FDA staff takes the time to review all those comments, I think they will become educated about tobacco products and make more reasonable decisions on how to implement the law; however, that presupposes they're going to read these thousands and thousands of pages of comments."
One of the concerns Briant cited about the reading of the comments was the lack of staffing at the FDA's Tobacco Products Center. Quinn said that the center actually has three full-time employees and that at least 25 FDA staff members have been "detailed over" to the center while other full-time employees are hired. "Plans for going forward include hiring and implementing the law," she said, adding that the agency "cannot comment on enforcement issues and strategy."
When it comes to enforcement, according to a transcript of the media briefing, provided by Briant, Catherine Lorraine, a lawyer on FDA staff, said, "I think we will be working with our enforcement team to find the most effective ways of identifying violations of this act, and we will be bringing appropriate enforcement actions when we do document violations." The FDA has also set up a toll-free number and website for the public to report violations.
Also on deck: "Menthol will come in front of our tobacco scientific advisory committee for review," according to Quinn.
Lyle Beckwith, senior vice president of government affairs at NACS, told CSP Daily News his participation in the call was to be able to provide retailers with information. "Our edict is we sell legal product responsibly; we don't get involved in the debate of what's legal," he said. "We just get involved in the debate of what is responsible and how to sell responsibly."
NACS is working to ensure that any violations are sent to a company's headquarters or to the place the company specifies so they can quickly get on top of an issue, rather than sending them to the store where the management will never know about it. He said NACS also hopes to make sure that there's an approved training program for age compliance.
"We want that to be the We Card program, or at least to have We Card-approved, because that's what retailers use and know," Beckwith said. NACS also seeks to ensure that all retailers (especially Internet and Native American retailers) are equally enforced, that retailers don't get double fined for state and federal penalties, and that retailers (as the law states) aren't held liable for faulty labeling.
"The thing that we're going to be focusing on is making sure that any enforcement is done in a way that can best allow the retailers to effectively respond to the FDA.... It was a chance for people to go on the docket and express points of view on things they're concerned about, and I suspect it's going to be a long ongoing process."
According an frequently asked questions (FAQ) document, the FDA has a busy docket ahead, including:
By January 2010, tobacco manufacturers and importers will submit information to FDA about ingredients and additives in tobacco products. By April 2010, FDA will reissue the 1996 regulation aimed at reducing young people's access to tobacco products and curbing the appeal of tobacco to the young. By July 2010, tobacco manufacturers may no longer use the terms "light," "low," and "mild" on tobacco products without an FDA order in effect. By July 2010, warning labels for smokeless tobacco products will be revised and strengthened. By October 2012, warning labels for cigarettes will be revised and strengthened. The FDA plans to update the FAQ as questions come in to the agency.Click here to view the document.
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