FDA Proposes Safety Warnings and Childproof Packaging for Liquid NicotineJul 2, 2015
The agency posted an Advanced Notice of Proposed Rule Making on Tuesday, a 15-page document spelling out the proposed rules and requesting "comments, data, research results or other information that may inform regulatory actions FDA might take," CNN reports. The public has 60 days to weigh in via email or postal mail; the comment period began on July 1.
Liquid nicotine is used in electronic cigarettes, which heat the liquid and deliver nicotine to the user as a vapor. They are usually battery-operated and come with a replaceable cartridge that contains liquid nicotine. In the notice, the FDA said the rise in popularity of e-cigarettes coincided with a an increase in calls to poison control centers and visits to emergency rooms "related to liquid nicotine poisoning and other nicotine exposure risks." The agency said it has evaluated data and science related to the risks, especially to infants and children, from accidental exposure to nicotine, including exposure to liquid nicotine.
For young children, poisoning from conventional cigarettes generally occurs when the child eats cigarette(s), but with e-cigarettes poisoning can occur through ingestion, and through inhalation or absorption of the liquid through the skin or eyes. Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention (CDC), said, "E-cigarette liquids as currently sold are a threat to small children." According to the New York Times, as little as a teaspoon of liquid nicotine can be fatal for a small child. Many of the liquids come in candy and fruit flavors that appeal to children and the lack of childproof caps means the dangerous liquid can be easily accessible to children. Because the liquids currently carry no warnings, many e-cigarette users are not aware of the serious risks and may leave nicotine liquid within reach of children.
In a study published last year in Morbidity and Mortality Weekly Report (MMWR), the CDC reported that calls to poison control centers involving nicotine liquids rose from one per month in September 2010 to 215 per month in February 2014. More than 50 percent of the e-cigarette calls involved children under 5. Nausea, vomiting, and eye irritation were the adverse health effects mostly commonly mentioned in the calls, according to the CDC.
The proposed regulations would also extend to other "novel tobacco products," including lotions, gels, dissolvables, and drinks, CNN reports. Last year, the FDA proposed rules to regulate e-cigarettes, cigars, pipe tobacco, nicotine gels, water pipe tobacco and hookahs. The agency currently regulates traditional cigarettes, smokeless tobacco, and roll-your-own tobacco.