FDA listening sessions for tobacco stakeholders..

October 7, 2009 - FDA held listening sessions for tobacco stakeholders in September. 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.

While many attendees were pleased to know their concerns would be heard, they also were less than satisfied by the lack of answers. Some people were disturbed by the fact that the FDA didn't respond to commentary 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."

One of the major concerns discussed was the ban on color advertising on tobacco products in retail stores. 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..

Briant: "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.

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. Briant: 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." Also on deck: "Menthol will come in front of our tobacco scientific advisory committee for review," according to Quinn.

One of the concerns Briant cited about the reading of the comments was the lack of staffing at the FDA's Tobacco Products Center.

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.

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 Frequently Asked Questions (FAQ) as questions come in to the agency..

See reference to read the complete article..

Reference: FDA Gets an Earful "Listening sessions" on tobacco regulation leave retailers with unanswered questions by Linda Abu-Shalback Zid, CSP Daily News, 10/6/2009.

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