Wednesday, January 26, 2011

Federal Appeals Court to FDA: E-Cigarettes Are Tobacco Products, Not Medicines

One month ago a federal appeals court affirmed Judge Richard Leon’s decision requiring the FDA to regulate e-cigarettes as tobacco products, rather than as drug-delivery devices, as the agency had attempted to do. This week the appellate court rejected the FDA’s request to review the decision, so the only remaining option for the agency is to appeal to the Supreme Court (here).

The FDA had decided that e-cigarettes were being sold without sufficient evidence of safety and efficacy – the expensive and time-consuming regulatory challenge that all drug manufacturers must address. The agency had begun seizing shipments, triggering the suit.

As I noted one year ago (here), Judge Leon found that the 2009 “Tobacco Act applies to ‘tobacco products,’ which Congress defined expansively as ‘any product made or derived from tobacco that is intended for human consumption’…Congress enacted the Tobacco Act to confer FDA jurisdiction over any tobacco product – whether traditional or not – that is sold for customary recreational use, as opposed to therapeutic use. As such, the Tobacco Act, in effect, serves as an implicit acknowledgment by Congress that FDA's jurisdiction over drugs and devices does not, and never did, extend to tobacco products, like electronic cigarettes, that are marketed in customary fashion for purely recreational purposes.”

The reaction from nicotine prohibitionists has been predictable. Matthew Myers, president of the Campaign for Tobacco-Free Kids, called the decision “wrong on the law, wrong on the facts…” and he urged “the government to appeal this ruling.”

Why is Mr. Myers so upset? According to the New York Times, he was a primary author of the Tobacco Act (link here). The legislation placed “any product made or derived from tobacco that is intended for human consumption” under FDA control.

It is wonderful irony that the courts have interpreted Myers’ legislation to free a potentially broad array of recreational nicotine products from drug regulation. It is also a dramatic, positive development for tobacco harm reduction, public health and millions of inveterate smokers, effectively accomplishing what I first advocated in 1995 – deregulation of nicotine. (link here)

This week I was interviewed about the e-cigarette issue by, which focuses on ways of making treatment and recovery more accessible to anyone struggling with addiction. That interview is available here.


Anonymous said...

My electronic cigarette pack says "Tar Free. Tobacco Free." So why is Matthew Myers, president of the Campaign for Tobacco-Free Kids, after my ecig? There is no tobacco in it, ... so why is a tobacco-free agency even allowed to comment on the product? If they chose to change their title (and their mission statement) to The Campaign for Nicotine-Free Kids, that would be a little different (yet impossible since nicotine is in a whole list of organic foods). But the new title still would have an error in it. I'm not a kid, either. That doesn't apply to me or any other (age appropriate) tobacco user. Electronic cigarettes (as well as tobacco products) are for adults and are marketed as such.

James at The Ashtray Blog said...

So why is Matthew Myers, president of the Campaign for Tobacco-Free Kids, after my ecig? Probably because they are anti-smoker rather than anti-cigarette - they would rather smokers died than switch to a safer form of electronic cigarettes. And, of course, let's not forget the grant they receive from GlaxoSmithKline, which manufactures nicotine cessation aids which are threatened by the electronic cigarette.