WINSTON-SALEM, N.C. — A federal report on the potential safety risks of electronic cigarettes has drawn a response from Reynolds American Inc. that claims its Vuse product is designed to “minimize chances for accidental exposure.”
The federal Centers for Disease Control and Prevention released a report Thursday that found a higher level of poisoning events related to the liquid used in electronic cigarettes, particularly for those age 5 and under.
E-cigarettes are battery-powered devices that heat a liquid nicotine solution in a disposable cartridge and create a vapor that is inhaled.
The industry, advocacy groups and consumers have been waiting since 2009 for the Food and Drug Administration to decide how it will regulate e-cigs for product safety, minimum legal age for use, flavors, marketing and retail availability.
Reynolds placed on its website information about Vuse’s safety features, including that it contains a “keep out of the reach of children” warning. The Vuse e-cigs are designed and assembled domestically, with the liquid made in Winston-Salem. The company said it plans to begin national distribution of Vuse later this year.
The CDC reported 2,405 e-cig exposure calls from September 2010 through February 2014, including 215 in February 2014. About 51 percent of the e-cig exposure calls were related to individuals age 5 and under, while another 42 percent were to those over age 20.
Exposure risks came primarily from the nicotine liquid and/or the e-cig device, and included ingestion, inhalation, eyes and skin. The most common adverse health effects in e-cig exposure calls were vomiting, nausea and eye irritation.
“Given the rapid increase in e-cigarette-related exposures, developing strategies to monitor and prevent future poisonings is critical,” the CDC said in a statement.
Reynolds said Vuse was “specifically designed as a closed system product that … minimizes chances for accidental exposure to e-liquid, battery failure or other potential problems or misuse.”
“Adults using the Vuse system have no need for larger quantities of e-liquid that may unintentionally fall into the hands of children or others.”
“Vuse cartridges are designed to permanently disable when they are empty, to prevent degradation of structural materials and refilling by consumers. They are designed to minimize the possibility of any leaks, to be tamper-resistant and choke-hazard resistant.”
Reynolds spokesman Bryan Hatchell said a free recycling program allows Vuse consumers “to safely dispose of spent cartridges that might otherwise be picked up by children.”
Jason Healy, president of Lorillard Inc.’s blu E-cigs unit, told ABC News he considered the findings in the CDC report “a weak argument” against the devices and evidence of “an on-going attack on the e-cigs industry by various anti-smoking groups.”
“The product is for adult smokers, and therefore the responsibility for children’s safety falls on the parents, just like bleaches and prescription medications,” Healy said. “The focus should be on parenting and education, and not regulation.”
Anti-tobacco advocates pushing for strict limitations on e-cig sales say it is necessary to keep the products out of the hands of minors. Some of the same advocates consider e-cigs – as well as smokeless tobacco and dissolvable tobacco products – as potential gateways to the use of traditional cigarettes.
Other anti-smoking advocates say e-cigs have the potential to wean smokers off traditional cigarettes, thus playing a positive public-health role.
Wells Fargo Securities analyst Bonnie Herzog estimated there was $2 billion in overall e-cig revenue last year. She projects up to $10 billion by 2017.
U.S. Sen. Jeff Merkley, D-Ore., said at a congressional subcommittee meeting Thursday that it is “embarrassing, disgraceful and is harmful to the children of America” that the FDA hasn’t moved quicker on regulating e-cigs and other smokeless products, particularly the flavorings being marketed by small e-cig manufacturers.
He cited e-cig liquids named “Scooby Snacks” and “Gummy Bears,” some of which lack informative product labeling. “If that doesn’t prove these products are marketed to children, what will?” he asked.
He also expressed concern about the surge in unregulated vaping retail shops and smoking venues.
A draft of potential regulations, which could cover these products, was submitted to the U.S. Office of Management and Budget in December. Congress must approve the regulations in order to give FDA authority to put them into use.
“You all have got to get these deeming regulations done,” Merkley said. “Four years and four month to get the first draft over to OMB is unacceptable, and for OMB to be sitting on this is unacceptable.”
FDA Commissioner Dr. Margaret Hamburg said Merkley’s criticisms “are fair” and that “it has taken far too long. It has been a complex challenge for many reasons.”
“I do believe that very soon I will be able to say the first phase of the deeming regulations is out.”