U.S. Court of Appeals Says FDA Cannot Regulate E-Cigarettes under the drug/device provisions of the Federal Food, Drug, and Cosmetic Act, while New Study Finds Many Fall Short of Marketing Claims
WASHINGTON, Dec. 7, 2010 /PRNewswire-USNewswire/ -- What do some pesticides and "electronic cigarettes" have in common? According to a new report published in the American Journal of Public Health, the answer is unregulated concentrations of nicotine that may pose unknown risks to consumers who are exposed to them.
E-cigarettes – designed to mimic cigarettes but containing concentrated nicotine rather than tobacco – have emerged as an important area of discussion for the public health and tobacco control communities, smokers and those trying to quit. Today, the U.S. Court of Appeals for the D.C. Circuit upheld a U.S. District Court decision finding that the U.S. Food and Drug Administration does not have authority to regulate the products under the drug/device provisions of the Federal Food, Drug, and Cosmetic Act. E-cigarettes will remain on the market at least for the time being even though the health consequences of the products are still unknown.
"Legacy is disappointed in today's decision. Despite claims that electronic nicotine delivery systems (ENDS) are a safer alternative to smoking, their novel construction has raised challenging concerns for other risks, including their appeal to young people with flavors like strawberry or chocolate as well as their appeal to people who would use them to bridge times when they cannot smoke and might otherwise be trying to quit," said Cheryl G. Healton, DrPH, President and CEO of Legacy.
The publication, "Novel Nicotine Delivery Systems and Public Health: The Rise of the 'E-Cigarette,'" examined several brands of the products formally dubbed by the World Health Organization as (ENDS). The study, conducted jointly by researchers at the Schroeder Institute for Tobacco Control and Georgetown University's Lombardi Center, sought to gain insight into ENDS with the goal of informing tobacco control policies. (Copies are available upon request.)
Researchers found that in spite of marketing claims, there is no consistency in the delivery of nicotine to users who inhale the vapor from ENDS. Using simulated puffing and gas chromatography in a controlled laboratory setting, researchers reported nicotine delivery varied across manufacturers, device constructions, cartridges and even from puff to puff.
"This inconsistency suggests poor quality control measures, which contributes to the list of unknowns about ENDS and adds to the public health community's skepticism surrounding the products," Nathan Cobb, MD, Research Investigator at the Schroeder Institute and lead author of the study. While manufacturers claim ENDS may be a reduced harm alternative to the toxic consequences of tobacco smoke, because of poor quality controls and a vast range of types of products, the researchers point out that ENDS also present a new set of risks to users – not unlike the risks associated with nicotine-based liquid pesticides.
While the data show that the level of nicotine delivered through ENDS cartridges tested was highly variable and was 3-5 times less than claimed, ENDS refill "juice" bottles may contain lethal amounts of nicotine (over 1.5 grams) in bottles the size of a shot glass. According to the report, novel risks of the devices and their refill solutions include "...variable nicotine delivery leading to unclear absorption mechanics or even potentially lethal systemic delivery, and accidental ingestion by young children because ENDS and ''juice'' are generally not sold in child resistant containers..."
"These devices and accessories present a new and wholly different set of risks apart from those of tobacco, including the real risk of inadvertent nicotine overdose. The variation in design and poor quality control emphasizes that they should not be on the market until and unless regulation to ensure device safety has been established," said Dr. Cobb.
The study was conducted through a collaborative effort by the Schroeder Institute for Tobacco Research and Policy Studies at Legacy, the Lombardi Comprehensive Cancer Center at Georgetown University School of Medicine and The Johns Hopkins Bloomberg School of Public Health.
Legacy is dedicated to building a world where young people reject tobacco and anyone can quit. Located in Washington, D.C., the national public health organization helps American live longer, healthier lives. Legacy develops programs that address the health effects of tobacco use, especially among vulnerable populations disproportionately affected by the toll of tobacco, through grants, technical assistance and training, partnerships, youth activism, and counter-marketing and grassroots marketing campaigns. The foundation's programs include truth®, a national youth smoking prevention campaign that has been cited as having contributed to significant declines in youth smoking; EX®, an innovative public health program designed to speak to smokers in their own language and change the way they approach quitting; and research initiatives exploring the causes, consequences and approaches to reducing tobacco use. The American Legacy Foundation was created as a result of the November 1998 Master Settlement Agreement (MSA) reached between attorneys general from 46 states, five U.S. territories and the tobacco industry. Visit http://www.legacyforhealth.org/.