Proposed New FDA Regulations Would Require Safety Warnings and Childproof Packaging for Liquid Nicotine

Proposed new regulations from the Food and Drug Administration (FDA) would require liquid nicotine products to carry warning labels and be packaged in childproof containers.

Last week, the FDA posted an Advanced Notice of Proposed Rule Making, CNN reports. The 15-page document spells out the proposed rules and requests “comments, data, research results or other information that may inform regulatory actions FDA might take.” CNN reports. The 60-day public comment period began on July l. Manufacturers, health care and public health experts, and the public may submit comments via email or postal mail.

Nicotine liquid is used in electronic cigarettes. E-cigarettes are usually battery-operated and come with a replaceable or refillable cartridge that contains liquid nicotine. The device heats the liquid and delivers nicotine vapor to the user. In the rule-making notice, the FDA said the rise in popularity of e-cigarettes has coincided with a an increase in calls to poison control centers and visits to hospital emergency rooms “related to liquid nicotine poisoning and other nicotine exposure risks.” Before proposing new regulations, the FDA evaluated data and science related to the risks, especially to infants and children, from accidental exposure to nicotine, including exposure to liquid nicotine.

Before the advent of e-cigarettes, young children suffered nicotine poisoning from eating cigarette(s), but with e-cigarettes, poisoning is not limited to ingestion. Children can also inhale the liquid or vapor or absorb it 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, ingesting as little as a teaspoon of liquid nicotine can be fatal for a small child. Many nicotine liquids come in candy and fruit flavors that appeal to children and, because the products do not currently come in childproof packaging, the dangerous liquid can be easily accessible to children. In addition, 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 in 2014 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 mostly commonly adverse health effects mentioned in the calls, according to the CDC.

The proposed regulations would also cover 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, which it currently does not regulate. The agency now regulates traditional cigarettes, smokeless tobacco, and roll-your-own tobacco.

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