Tuesday, January 19, 2010

Federal Judge to FDA: E-Cigarettes Are Tobacco Products, Not Drugs or Devices

On January 14, federal judge Richard J. Leon ruled that the FDA does not have the authority to regulate e-cigarettes as drug-delivery devices. (The 32-page opinion, available here is required reading for anyone interested in American tobacco policy). In addition to being a victory for e-cigarette manufacturers, this decision has enormous positive implications for tobacco harm reduction and for American smokers.

In 2008 and 2009, the FDA detained e-cigarette shipments being imported by two American distributors, Smoking Everywhere and NJoy, on the grounds that the items were unapproved drug-delivery devices. Judge Leon ordered that “the FDA shall not detain or refuse admission into the United States of [Smoking Everywhere's and NJoy’s] electronic cigarette products on the ground that those products are unapproved drugs, devices, or drug-device combinations.”

The judge 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.”

Finding that e-cigarettes, like all tobacco products, are subject to FDA oversight but fall outside of both drug and device categorization, Judge Leon characterized the FDA’s attempt to apply pharmaceutical standards to e-cigarettes as “bootstrapping run amuck.”

Judge Leon’s decision was not popular with tobacco prohibitionists. Matt Myers, president of the Campaign for Tobacco-Free Kids, seethed: “"Nicotine in products currently regulated as drugs and devices is derived from tobacco products, but that doesn't make them tobacco products.” The federal court, thankfully, found otherwise.

According to the New York Times, Myers was a primary author of the Tobacco Act. His goal was to cast the regulatory net widely and subject all tobacco-related products to FDA control. It is therefore ironic that the court has interpreted his legislation to free a potentially broad array of recreational nicotine products from the most stringent categories of regulation.

Judge Leon’s opinion may open up other commercial opportunities for recreational nicotine. Currently, pharmaceutical companies market nicotine gum, patch and lozenges as temporary “medications” for smokers who are attempting to achieve nicotine abstinence, the holy grail of tobacco prohibition. This has been an utter disaster, since the products are successful for only about 7% of smokers who try them, as I explained in a previous post. In addition, the FDA has refused to respond to a petition by New York State Commissioner of Health Richard Daines to revise package labeling and sale of nicotine that would greatly expand consumer awareness and availability.

But Judge Leon’s decision removes nicotine from FDA jurisdiction as a medicine as long as no therapeutic claims are made. If this ruling stands, it will allow pharmaceutical companies to reposition nicotine gum, patches and lozenges as recreational devices with higher doses that satisfy smokers, and sell them at prices competitive with cigarettes. This would liberate nicotine from the onerous and unnecessary restrictions and warnings currently mandated by the FDA.

This would be a revolutionary development for tobacco harm reduction. It would in effect accomplish what I first advocated in 1995 – deregulation of nicotine.


electronic cigarette said...

thanks for your article you given good info.

E cigarette reviews said...

FDA produces total nonsense. They just want to keep the tax money on cigarettes coming, that's why they are against electronic cigarettes.

Sparky said...

I find it interesting that you think that pharmaceutical companies will now sell the gum and patch more for "recreational" purposes.

What then will become of the old "candy and fruit flavored cigarette" targeting children argument and current ban when big pharma starts selling stuff that is literally GUM and CANDY with nicotine in it for rec purposes? Won't they be targeting children?

I wrote about how I think the whole candy and fruit flavored cigarette ban argument is bull on my blog and I just don't see how big pharma could spin that one. Who knows though. They have extremely deep pockets when it comes to marketing and advertising.


Electronic Cigarette said...

The fda is crappin their pants,feeling pressure from big tobcacco and pharmacutial special interest groups to kill the e-cig,why? $$$$$ money ,no cig profits, no tax profits, millions in maketing and research to create gums and patches,all gone. FDA looks foolish though: E-cigs are unsafe, so here is a pack of tobbaco cigarettes for you instead?!

Joye 510 said...

The first published study of the effectiveness of electronic cigarettes was released yesterday by Tobacco Control. The study, funded by the National Cancer Institute, was conducted by Dr. Thomas Eissenberg of the Virginia Commonwealth University Behavioral Pharmacology Laboratory.

vapor cigarettes + best said...

Thanks for sharing all of your hard earned lessons learned.

David - E Cigarettes said...

Great Post! Thanks for sharing your views on this subject. I've had conversations with many smokers who have switched to e cigarettes and although they either don't smoke cigarettes or have cut down on the number of cigarettes they smoke I don't think e cigarettes are quit smoking devices. They do however contain much less toxic chemicals then regular cigarettes and don't give off second hand smoke. This is a big win for e cigarette smokers IMHO. I'm not totally against the FDA trying to regulate nicotine products but I do think they should do research on them before they start trying to regulate them. I really think they took the wrong approach with e cigarettes and apparently the courts have as well.

e cigarettes said...

Great article on electronic cigarettes. It's true how people that have health problems due to tobacco still keep smoking cigarettes. Glad there is now the e cigarette here for people to get over their toxic addiction to tobacco.