It's been a little while since we've had an update on e-cigarettes. When last we left the issue in April, the FDA had decided to back off its previous crackdown on e-cigarette companies and regulate them as tobacco products, rather than under stricter rules for drug-delivery devices. This is despite the fact that electronic cigarettes are nicotine-delivery devices that include a heating element that vaporizes chemicals in replaceable plastic cartridges. The FDA's hand was forced by a federal appeals court ruling late last year that upheld the industry's contention that they are more like mainstream tobacco products.
This ruling still has many in the medical community steamed and Science Daily tells us about a "Perspective" column published in the New England Journal of Medicine blasting the decision and analyzing the current regulatory climate surrounding electronic cigarettes. It's written by Nathan K. Cobb of Georgetown University Medical Center and David B. Abrams, executive director of the Schroeder Institute.
"The court's decision that e-cigarettes should be regulated as tobacco products and not as drug-delivery devices has substantially delayed the FDA regulatory process that normally protects the public health. It has the practical effect of allowing manufacturers to sell potentially dangerous refined nicotine products directly to consumers," Cobb says in a statement. "It is entirely possible that future modifications to the products will improve the efficiency of nicotine delivery and could dramatically increase the risks of addiction, abuse and serious overdose."
The authors argue that what is needed is cooperation between Congress, the courts and the FDA to ensure the public's health is protected against e-cigarettes.