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)
"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”;
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 (703) 527-8418
