FDA to Weigh Safety of Tobacco Lozenges

They may look and smell a lot like candy, but soluble, smokeless tobacco products are not for children. Security risks and “soluble” is the subject of a three-day U.S. Food and Drug Administration meeting this week.
“Dissolvable” are flavored mints, strips and rods of smokeless tobacco. These products do not stop smoking aids. Instead, they are designed to allow people to satisfy their cravings for nicotine in places where smoking is prohibited.
R.J. Reynolds Tobacco Co. is Camel test marketing Camel Orbs, Camel Strips and Camel Sticks in two cities, and Star Scientific Inc., is marketing two other dissolvable tobacco products, Ariva and Stonewall. Many public health advocates are concerned about the risks these products pose to children and teens, namely possible addiction and nicotine poisoning.
“If you want to design a product that would appeal to young people and drug addict younger teens and adults to nicotine, it would be,” said Dr. Jonathan Winickoff, a pediatrician at Massachusetts General Hospital in Boston. “These products are designed to look like candy addict users on an ongoing basis.”
Teens can pop these products without any obvious signs of cigarette smoking or disorder associated with snus that bag like pouches placed between the upper lip and a gun. Soon, he says, they are dependent.
Another worry is accidental ingestion, resulting in nicotine poisoning. An April 2010 study in the journal Pediatrics found that smokeless tobacco products are the second most common cause nicotine poisoning in children, after cigarettes.
“If children are already ingesting cigarettes, we can not doubt that they will ingest soluble tobacco, which is specifically designed to taste good,” said Winickoff. “Just because they smell like chocolate or mint and look harmless, they contain nicotine and are potentially harmful to young people and can start a life of nicotine dependence. Parents of young children should be aware that these products have the potential to cause serious overdose.”
Mild symptoms of nicotine poisoning include vomiting, nausea, diarrhea and headaches. Severe nicotine poisoning can lead to involuntary twitching, muscle paralysis, heart palpitations, seizures or death.
One milligram (mg) of nicotine can cause vomiting and diarrhea in a small child, according to the study. The Camel dissolvable contain between 0.6 mg and 3.1 mg of nicotine, depending on the product. Smokers inhale about 1 mg of nicotine in a typical cigarette.
In the investigation of Pediatrics was released, Orbs manufacturer RJ Reynolds announced that it has taken steps to prevent the accidental ingestion of soluble Camel tobacco youth, including child-resistant packaging and raising of poison control centers on the products and the possible consequences of accidental ingestion.
“The bottom line: Tobacco products, along with many other types of goods, need to be kept out of the hands of children,” the statement concluded.
Now all eyes are on FDA. 2009 Family Smoking Prevention and Tobacco Control Act gives the agency authority over production, distribution and sale of cigarettes and smokeless tobacco products. Winickoff expressed hope that the FDA will do everything possible to keep these products away from children and adolescents.
“We could consider capping the amount of nicotine in each piece, so you can eliminate or greatly reduce the potential to lead to a fatal overdose of nicotine if the entire package has been absorbed,” he said.
Other pediatricians and public health advocates raise similar fears about these products.
“You can sneak them in the classroom,” said Dr. Lee Beers, a pediatrician Children’s National Medical Center in Washington, DC “This increases the potential for early adoption of tobacco and increase the level of dependence. It really does not seem any reason to tobacco in a format that is easier to be taken by mouth and with a lot of drawbacks, especially when I think of children and adolescents. Children can and get into something, even if the packets reach of children, “she said.
Dr. Thomas Glynn, director of cancer science and trends at the American Cancer Society, said there are many unknowns about the soluble tobacco products. “At the moment, we do not know the full range of what is in them,” he said. “I do not see any potential in these soluble products, in addition, to keep people smoking.”