Fda Article On Recent Court Decision

[Jeffb]

Court Rejects FDA Bid To Regulate Nicotine Products Outside Tobacco Law

By Alaina Busch

FDA Week

December 9, 2010

A federal appeals court ruled that nicotine products, including electronic cigarettes, are to be regulated as tobacco, reaffirming previous decisions while going against recent FDA actions to regulate the products as drugs and devices. While opponents of the decision are raising safety concerns saying it will lead to an uptick in nicotine items and be detrimental to public health, some anti-smoking advocates have long pushed for the products to be regulated as tobacco, not requiring safety and efficacy data, to keep them on the market for former smokers who rely on them as cessation aids.

One opponent of the decision, which reaffirmed that FDA cannot ban electronic cigarette imports, equated the ruling to the creation of a "wild west" of nicotine products, while a longtime anti-smoking advocate lauded it as a public health victory saying FDA's attempt to strictly regulate the products has bolstered the tobacco industry.

The U.S. Court of Appeals for the District of Columbia Circuit on Tuesday (Dec. 7) affirmed a January ruling that tobacco-derived products are subject to the Family Smoking Prevention and Tobacco Control Act, which brought tobacco under FDA's power in 2009.

The ruling comes three months after FDA announced that it would regulate the products as drugs and devices under the Food, Drug and Cosmetic Act, requiring safety and efficacy studies. The agency sent letters to five distributors and a trade group announcing its intentions. The distributors received warning letters for making unsubstantiated claims and poor manufacturing practices (see FDA Week, Sept. 10).

Citing FDA v. Brown & Williamson Tobacco Corp., a Supreme Court case that denied FDA's efforts to regulate cigarettes as a drug-device combination in the 1990s, the court ruled that the tobacco law that has since passed further established that other tobacco products cannot be regulated as such either.

"To the extent that Congress believed Brown & Williamson left an insufficiently regulative environment for cigarettes, smokeless tobacco, cigars, and other tobacco products, it found the Tobacco Act an adequate remedy," according to the court decision, written by Circuit Judge Stephen Williams.

A federal judge had previously ruled that electronic cigarettes are not drug-device combinations and FDA could not block their shipment. The agency had been taking action against the products since 2008 (see FDA Week, Jan. 22).

Groups like Campaign for Tobacco-Free Kids said the decision will lead an unsafe level of nicotine in products. The group's president, Matthew Myers, said the ruling will have harmful implications for public health.

"While the court found that the FDA could regulate electronic cigarettes as tobacco products, it will take the FDA time to assert jurisdiction over these products and issue regulations governing them, leaving these products unregulated in the meantime," he said in a statement. "This ruling invites the creation of a wild west of products containing highly addictive nicotine, an alarming prospect for public health."

Other anti-smoking advocates, like Smokefree Pennsylvania, have lauded the decision as a public health victory. The group, in addition to the Washington Legal Foundation, filed an amicus curae brief on behalf of Sottera, Inc., the company listed in the lawsuit. The American Association of Public Health Physicians has also filed citizen petitions requesting the agency reclassify electronic cigarettes as tobacco products.

Bill Godshall, executive director of Smokefree Pennsylvania, said FDA's move to strictly regulate the products, which are mostly used by former smokers, has bolstered the tobacco industry because the most harmful products are still on the market. The majority of the e-cigarette companies, he said, were not making therapeutic claims, which would have made them subject to stricter regulations.

By reclassifying the products as tobacco, the 2009 tobacco law allows for safety monitors, he said. Quality concerns about the products, which are primarily imported, were cited when FDA announced its regulatory plans earlier this year.

"A lot of these things people are claiming are problems with the products can be resolved," Godshall said. The Tobacco Control Act would give FDA power to regulate health claims and require manufacturer registration as well as laboratory analyses of the products.

Depending on whether FDA appeals the decision, he said he expects tobacco companies to get into the product's market. Other nicotine products that had previously been banned, like lollipops, water and skin cream, will likely resurface, he said. "And that's good because these are all far less hazardous tobacco alternative products," he said.

The ruling comes as a collaborative study on the safety of electronic cigarettes was released by Legacy, Georgetown University School of Medicine and Johns Hopkins Bloomberg School of Public Health. After an analysis of several electronic cigarette brands, researchers found that there was no consistency in the delivery of nicotine, suggesting poor quality controls.

Nathan Cobb, a researcher at Schroeder Institute for Tobacco Research and Policy Studies at Legacy, said the poor standards present a new set of risks associated with e-cigarettes. "These devices and accessories present a new and wholly different set of risks apart from those of tobacco, including the real risk of inadvertent nicotine overdose," Cobb said in a release. "The variation in design and poor quality control emphasizes that they should not be on the market until and unless regulation to ensure device safety has been established."

[owutaqt]

interesting

[snubber]

While I know that this ruling is sort of a victory in our favor, I'm still wondering how they can be regulated as a tobacco product when there is not tobacco in them?

Personally I think they should just leave us the hell alone.

[Burn]

I believe it is because nicotine is derived from tobacco.

I don't want e-cigs to be taken away but I do think we are in desperate need of regulation and standards. There is the obvious issue of the mall kiosks and their reputation for selling to minors. Also, as stated before, there isnt any control standards for a product that we do take into our bodies. This creates a pretty significant vulnerability for accidental, irresponsible and even terrorist behavior.

This whole mess with the FDA and the struggle of how it will be regulated reminds be of the frustration I often have in a corporate environment where people spend WEEKS talking about doing something while the problem continues to exist as they speak.

Hurry up and freakin' regulate e-cigs already; get some standards in place to provide some assurance of product quality and safety. What are we paying these jackholes (FDA) for anyway?

[DerStadtschutz]

Why do we need these to be regulated? So what if they're inconsistent. Then don't buy pre-filled cartridges or cartos. Even if you do, I'm sure Nicotine could kill you in a high enough dose, but long before you get to that point, you'd feel a headache, and if you're too dumb to stop vaping for a while at that point, then you would have done something equally dangerous and stupid eventually anyway. You can't blame an inanimate object for a mistake made by a human being; that's just ridiculous.

I'm all for no sales to minors(for the most part), but I don't want any regulations beyond that, with the exception of maybe some sort of quality standards in terms of cleanliness and accuracy of advertised ingredients/required listing of ingredients. The problem, though, that I see with regulating anything beyond no sales to minors is this: It would seem to be a rather large pain in the butt to try and go to every juice maker's place of making said juice to make sure they're doing things "right." My guess is they'll probably require some sort of license, or they'll make it so that only the government or tobacco companies/pharmaceutical companies can make the juice. One way or another, they're gonna try to make this more expensive and give us more hoops to jump thru. I don't want people poisoning each other with bad juice, but I don't want the other extreme either. Some sort of happy medium would be nice, but I figure what we'll get will lie somewhere nearer the latter extreme.

I want to clarify something here. As I said, I'm all for not selling e-cigs or juice to minors, for the most part... What I mean by "for the most part" is this: I don't want kids getting addicted to nicotine because of electronic cigarettes, but at the same time, if they're already addicted to analog cigarettes, then I would MUCH rather have them use these instead. And in all honesty, I don't see it as such a big deal if they DO get hooked on nicotine via e-cigs and never touch analogs. That would be much better than smoking the analogs first, right? I don't really see the big deal with it, but I know sales will have to be restricted to adults only, just like analogs. That's okay with me. I just don't want them taking away my flavors or tainting juice to bring the industry down. The FDA contains a lot of crooked people more concerned about money than health.

[Michelle]

Can anyone point me toward a discussion on VT about what all of this means for PVs? Have we discussed this?