FDA to Ban Electronic Cigarettes


Bill Godshall of Smokefree Pennsylvania reports in a mass email message that the Food and Drug Administration plans to proceed with a ban on electronic cigarettes, devices that deliver nicotine vapor without tobacco or combustion products. Godshall reproduces the following message from Heather Zawalick of the FDA's Office of Legislation, which says the agency will announce enforcement actions against the three largest e-cigarette distributors on Tuesday:

Subject/Headline: FDA Takes Enforcement Action on Electronic Smoking Products

Planned Release Date: May 5

Driving Event: Compliance action

Rollout Plan: Extensive rollout planned including press conference at HHS, press release, fact sheet, video for upload to YouTube, podcast, consumer article, consumer Q &A, key message points, internal media Q & A, Op-Ed, photos of products for posting on Internet.

Other background, hidden factors: Action involves three largest distributors. One of the distributors has just sued FDA seeking a restraining order to prevent us from holding their product at the border.

There is keen interest in this subject. E-cigarette kiosks are all over town, including Montgomery Mall. They're being advertised as a safer alternative to cigarettes. Our concern is that this might introduce nonusers to nicotine use. This is a drug delivery device. The content of the products have not been analyzed by FDA. To be sold, they would have to be approved by the agency.

Our concern is that this might introduce nonusers to nicotine use. And what if it did? Separated from the dangers of smoking, nicotine use is not a big health concern. The FDA itself has approved various nicotine replacement products (gum, patches, even an inhaler), some of them for over-the-counter sale, even though they theoretically might "introduce nonusers to nicotine use." That possibility is an incredibly lame justification for preventing smokers from switching to a product that eliminates virtually all the risks associated with standard cigarettes.

In an open letter to Zawalick, Joel Nitzkin of the American Association of Public Health Physicians says the pending FDA ban seems to be "based entirely on the undocumented assumption that electronic cigarettes may have the potential to attract additional teenagers to nicotine use and addiction." That concern seems to be fanciful: Godshall says "there is no evidence that e-cigarette products have been marketed to youth, nor is there evidence of youth use of e-cigarette products (most of which cost more than $100)." In any case, Nitzkin notes, the government can impose age restrictions without stopping "current adult smokers who are unwilling or unable to quit" from enjoying "the health benefits this product can offer." By Nitzkin's reckoning, based on the available research, smokeless nicotine products "promise a risk of illness and death well under 1% of the risk posed by cigarettes."

In his own letter to Zawalick, Godshall argues that "denying 45 million cigarette smokers access to exponentially less hazardous smokefree nicotine alternatives would result in millions of preventable deaths among smokers, millions of nonsmokers continuing to be exposed to tobacco smoke pollution, and tens of thousands of e-cigarettes users reverting back to smoking cigarettes." He adds that "it is absurd for the FDA to even contemplate protecting the deadliest nicotine products (cigarettes) from market competition by the least hazardous nicotine products."

More on the e-cigarette controversy here and here. E-cigarette testimonials here and here. A report on testing of the Ruyan e-cigarette here (PDF).