The Food and Drug Administration is saying in letters to two tobacco companies that flavored, dissolvable tobacco products — that the agency compares with candy and says contain a lot of nicotine — could be particularly appealing to kids and young adults.
The FDA's Center for Tobacco Products wrote to R.J. Reynolds Tobacco Co., maker of Camel cigarettes, and the smaller Star Scientific Inc. on Monday voicing concern over smokeless products that are consumed like breath mints but made from finely milled tobacco.
"CTP is concerned that children and adolescents may find dissolvable tobacco products particularly appealing, given the brightly colored packaging, candy-like appearance and easily concealable size of many of these products," Dr. Lawrence Deyton, director of the Center for Tobacco Products, told the companies.
Deyton said regulators are worried the products' nicotine content and rapid dissolution could cause nicotine dependence and addiction and be especially dangerous to children and young adults.
He asked the two best known makers of dissolvable tobacco products to provide their research and marketing information on how people under age 26 perceive and use the products.
Exercising new power to regulate tobacco that the FDA was granted in June, Deyton also requested research on misuse of the products, including potential accidental nicotine poisoning.
Regulators also want a summary of user demographics, including at what age "tobacco-naive consumers" start using the products.
The products are available in few markets and account for a small share of the tobacco industry.
Star Scientific, based in Petersburg, Va., markets its Ariva and Stonewall tablets in wintergreen, coffee and tobacco flavors. The first versions appeared about nine years ago.
R.J. Reynolds, which is owned by Reynolds American Inc. in Winston-Salem, N.C., is test-marketing dissolvable tablets, strips and a toothpick shape under the names Camel Orbs, Camel Strips and Camel Sticks in mint and other flavors.
The Orbs last about 15 minutes, the strips dissolve in five minutes or less and the sticks, which are slightly bigger than toothpicks, last 15 to 20 minutes.
The FDA is seeking the information as its Tobacco Products Scientific Advisory Committee prepares to study the issue later this year.
Reynolds spokesman David Howard said that company is reviewing the FDA's request and plans to help regulators evaluate the products.
"Our products are made for, and marketed to, adult tobacco consumers," Howard said. He said dissolvable items are sold on the same shelves as other tobacco products and carry the same warnings and age restrictions.
Star Scientific, which has been involved in a patent dispute over some of the technology behind its dissolvable products, disagrees with the FDA's characterization of them and looks forward to speaking with regulators, spokeswoman Sara Troy Machir said.
"The challenge that we have faced in attempting to meet the needs of adult smokers ... is to develop a product that is palatable to the customer while at the same time not making it attractive to the non-tobacco user," she said
Machir said flavors are added to the products to make them taste less harsh.
Tobacco companies are focusing on cigarette alternatives — such as cigars, snuff and chewing tobacco, as well as other forms of nicotine replacement — for future sales growth as demand for cigarettes continue to decline.
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