In a controversial decision yesterday that will likely cause considerable confusion in smoke-free venues, US District Court Richard Leon issued an order to lift the FDA ban on the importation of electronic cigarettes. The words of the judge were harsh, stating "This case appears to be yet another example of FDA's aggressive efforts to regulate recreational tobacco products as drugs or devices” and "[the FDA’s] tenacious drive to maximize its regulatory power” appear loaded with criticism of the Family Smoking Prevention and Control Act recently passed by Congress. This act gave the FDA authority to regulate, but not ban, tobacco products.

The crux of the ruling seems to rest on the premise that ecigs are exempt from FDA ban because (according to the plaintiff Njoy) they fit the definition of a tobacco product and the FDA had banned them on the premise that they were a “drug/device combination” and therefore the FDA had exceeded their authority. “There being no dispute that the nicotine in plaintiffs' electronic cigarettes is naturally distilled from actual tobacco and is intended for human consumption (FDA Supp. Br. [#41] at 5 n.3), plaintiffs assert that their electronic cigarettes qualify as a tobacco product and are therefore exempt from regulation as a drug-device combination.” I find this a bit odd because the nicotine in nicotine replacement products (such as nicotine patches, gum, lozenges, etc.) are also distilled from actual tobacco. So does this mean the FDA has no jurisdiction over NRT?

The FDA had contended that the ecig met the definition of a “drug/device combination” because the manufacturer’s (Smoking Everywhere) promotional materials "represent and suggest that the product[s] will provide the same drug effects on the structure and function of the human body as cigarettes. The FDA further argued that Smoking Everywhere's promotional materials suggest that its electronic cigarettes are intended to have a therapeutic effect. “According to FDA, "[t]he assertion that E-Cigarettes provide a 'healthier way' to obtain the effects of nicotine establishes that E-Cigarettes are intended to prevent or alleviate nicotine withdrawal symptoms." (FDA Opposition [# 14] at 21). Consequently, FDA claims that Smoking Everywhere's products also satisfy the FDCA's other definition of a drug-device combination as an article "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease."

According to Reuters, “FDA spokesman George Strait said the agency was reviewing the judge's decision, adding that the public health issues surrounding electronic cigarettes are of serious concern. The agency has said it is worried about safety issues and last year warned that some samples it tested contained carcinogens and toxic chemicals. The World Health Organization has also warned against their use, saying there was no evidence to prove they were safe or helped smokers break the habit.”

The Campaign for Tobacco-Free Kids and other consumer advocacy groups blasted the ruling, saying it puts U.S. consumers at risk. "This is a misguided and mind-boggling decision by the court," said National Research Center for Women & Families President Diana Zuckerman. "Nicotine is an addictive drug, and therefore e-cigarettes are a drug delivery system."

I agree. I see no problem allowing mechanisms that deliver nicotine SAFELY to adults wanting to ingest nicotine. But it is also clear that the manufacturers of ecigs have not proven the safety of their products.  Tell us what you think.

Click here to see the full order by Judge Richard Leon.