FDA Guidance Details How Manufacturers Can Make E-Cigs Safer From Battery Explosions And Toxic Nicotine Doses
In response to growing concerns about the safety of e-cigarettes, federal regulators have issued new guidance explaining how manufacturers can make improvements to vaping products to reduce the risk of battery explosions and nicotine overdoses.
The FDA issued a new guidance for industry on November 25, called “Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products”, which sets out premarket review requirements for limited modifications to battery-operated tobacco products and liquid nicotine products.
The agency notes it does not intend to enforce violations of premarket review requirements against products modified according to the guidance. However, the agency is encouraging manufacturers to remove the currently marketed products from the market before introducing the new, modified products.
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“We recognize there are certain modifications manufacturers can make to their tobacco products to address a voluntary industry battery standard and to comply with requirements related to safe packaging of liquid nicotine products, known as flow restrictors,” Mitch Zeller, the head of the FDA’s Center for Tobacco Products said in a press release. “We encourage these limited safety-related modifications because they are intended to ensure the public is protected from risks such as battery explosions or accidental exposure to toxic levels of nicotine.”
At issue are a series of e-cigarette explosions which have occurred in recent years, mostly linked to lithium ion batteries, and incidents of child nicotine poisoning.
The FDA’s Center for Tobacco Products released a report in March 2016 in the journal Tobacco Control, which identified at least 92 reports of electronic cigarette explosions between 2009 and September 2015.
Other reports around the same time placed the number of incidents much higher. A report in April 2016 by Ecigone.com indicated there had been nearly 160 exploding or combusting e-cig incidents reported through the media at that time, with many likely going unreported due to the user’s right to privacy or embarrassment to report. It is unclear how many e-cigarette explosions have occurred since.
On August 8, 2016, all e-cigarettes and electronic nicotine delivery systems (ENDS) became subject to FDA authority. The agency, along with the U.S. Consumer Product Safety Commission, industry, and Underwriters Laboratories developed a voluntary industry standard known as UL 8139 to address battery-related risks.
In addition, in 2015 Congress passed a new law requiring liquid nicotine containers to have special packaging making them difficult for children to open.
However, making those changes will mean some products classify, technically, as new tobacco products, which would usually require a premarket review. The FDA is indicating it will not enforce that if they are changing the products to meet the UL 8139 battery standard, or the restricted-flow requirements for liquid nicotine containers in the Child Nicotine Poisoning Prevention Act of 2015.
Electronic Cigarette Health Problems
The guidance, which is not legally binding on manufacturers, comes as e-cigarettes and similar products face extensive scrutiny due to widespread underage use and an outbreak of vaping-related lung injuries.
The U.S. Centers for Disease Control and Prevention (CDC), the FDA and state agencies are currently investigating about 2,200 cases of vaping lung injuries, which have resulted in about 50 deaths. Investigators suspect the cause of the illnesses were aftermarket THC products used with vaping devices that contained Vitamin E acetate, but the illnesses are still under investigation.
In addition to the risk of e-cigarette respiratory illnesses, there is also now a new generation of teens addicted to JUUL, which contains high levels of nicotine and was aggressively marketed to individuals who were not prior cigarette smokers.
A growing number of JUUL injury lawsuits are now being pursued against the manufacturers, alleging that the products were illegally marketed to kids while failing to disclose that each of the e-cigarette pods contain more nicotine than a pack of tobacco cigarettes.
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