R.J. Reynolds submits information on Camel Dissolvables to FDA as requested..





April 5, 2010 - R.J. Reynolds Tobacco Co. said yesterday that it has complied with a federal request for information about three innovative dissolvable smokeless products.

The company had until yesterday to provide research information regarding Camel Orbs, Camel Sticks and Camel Strips to the Tobacco Products Scientific Advisory Committee of the Food and Drug Administration. (Star Scientific and Reynolds hade two months to respond.)

The FDA in its letters to the two companies, RJR and Star Scientific, asked both manufacturers for extensive information on research and marketing practices for the products. Both companies had to respond. (U.S. FDA - concerned that dissolvable tobacco products could draw in children and teenagers..)

U.S. FDA Center for Tobacco Products seeking opinions on dissolvable products by September 18, 2010..

Earlier this week, the same committee began its initial review of the use of menthol flavoring in cigarettes.

Reynolds said that the flavored, finely milled tobacco products serve as an alternative to cigarettes, giving adults a discreet option in venues where smoking is not convenient or is banned out of concern for secondhand smoke exposure.

The products are being sold in three test markets, none in North Carolina.
In February, the committee sent a letter to Reynolds and Star Scientific Inc., another producer of smokeless products containing nicotine.

The FDA acknowledged that Reynolds is marketing the products to adult consumers.

Dr. Lawrence Deyton, the director of the FDA's Center for Tobacco Products, wrote in his letter of the center's concern that "brightly colored" packaging and "candy-like appearance" of the products may appeal to children. He also is concerned about whether the nicotine content in the products "may facilitate initiation of tobacco use, nicotine dependence and addiction in adolescents, and may serve as a mechanism for inadvertent toxicity in children."

The results of the committee's review could play a role in determining how well can Reynolds live down -- and learn from -- its past in its quest to be a "total tobacco company," according to Susan Ivey, the company's top executive. "We provided both summary results and underlying data related to our product and consumer testing to date on Camel dissolvables, including consumer feedback and results of scientific testing of the products," said Maura Payne, a spokeswoman for Reynolds.

Payne said that complying with the request required providing "confidential commercial information and trade secrets, which are exempt from public disclosure under several sections of the Food, Drug and Cosmetic Act."

"Therefore, Reynolds requested its response be treated as confidential by the agency."

The direction of the FDA committee's concerns appears obscure, said Brad Rodu, the chairman of the Tobacco Harm Reduction Research University at the University of Louisville. He said that describing the products as resembling candy is inaccurate considering dissolvable tobacco does not contain candy or other nutritive ingredients. He said he doesn't consider the packaging as brightly colored or easy to open by children.

Dr. Rodu, a dentist with training in oral pathology, is a professor of medicine and the first holder of the endowed chair in Tobacco Harm Reduction Research The endowed chair and accompanying research fund were created by tobacco companies U.S. Smokeless Tobacco Co. and Swedish Match AB, who committed nearly $3.4 million. It has been pointed out that much of the research on the relative health impact of smokeless tobacco has been funded by the tobacco industry (Smokeless Tobacco Poses Challenge for Stop-Smoking Advocates, Join Together, 9/20/2006). (see snus.biz)
"These features make the risk of accidental nicotine toxicity through use of dissolvable tobacco products extremely unlikely," Rodu said. He said he does not believe any complaints have been filed regarding marketing prohibitions in the Master Settlement Agreement.

Reference: RJR gives requested data on products to FDA panel by Richard Craver (rcraver@wsjournal.com), Winston-Salem Journal, 4/2/2010.

1 comments:

  Brian

April 6, 2010 at 5:23 PM

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