Appeals Court Stays E-Cigarette Ruling Leaves FDA Free to Block Imports Again The U.S. Court of Appeals for the District of Columbia has just stayed an injunction issued by a lower court judge which would have prohibited the Food and Drug Administration [FDA] from blocking imports of e-cigarettes into the United States. The FDA maintains that such devices are illegal because -- unlike other products which administer nicotine such as gums, patches, inhalers, and sprays -- e-cigarettes have not been submitted to the FDA with proof they are safe and effective.
Recently Judge Richard Leon granted the stay, arguing that, while the FDA does now (under new legislation) have jurisdiction to regulate e-cigarettes, they should be regulated in the same category as ordinary tobacco cigarettes because they resemble cigarettes and likewise administer nicotine. However, e-cigarettes are functionally very different from conventional tobacco cigarettes, and the FDA believes they should be regulated differently.
"This new ruling doesn't necessarily mean that the U.S. Court of Appeals disagrees with Judge Leon's ruling, but it may signal some concerns with the way the lower court judge decided the case," says public interest law professor John Banzhaf, Executive Director of Action on Smoking and Health, who participated in the case.
Deciding how to regulate new products designed to administer nicotine involves complex scientific and medical issues, and perhaps some experience based upon the regulation and testing of other nicotine administration products, says Banzhaf, something a federal judge new to the field presumably doesn't have. Indeed, notes Banzhaf, the FDA is now involved in an extensive legal procedine to determine just how to regulate these and other products.
The FDA has reported that the e-cigarettes it tested contained detectable levels of known carcinogens and toxic chemicals to which users could potentially be exposed. The FDA said the toxic chemicals included diethylene glycol, "an ingredient used in antifreeze, [which] is toxic to humans"; "certain tobacco-specific nitrosamines which are human carcinogens"; and that "tobacco-specific impurities suspected of being harmful to humans - anabasine, myosmine, and B-nicotyrine - were detected in a majority of the samples tested."
PROFESSOR JOHN F. BANZHAF III Professor of Public Interest Law at GWU, FAMRI Dr. William Cahan Distinguished Professor, FELLOW, World Technology Network, and Executive Director and Chief Counsel Action on Smoking and Health (ASH) America's First Antismoking Organization 2013 H Street, NW Washington, DC 20006, USA (202) 659-4310
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