Leave E-Cigarettes Alone, Judge Tells FDA

Ruling halts FDA confiscations.

The Food and Drug Administration (FDA) lost its battle Thursday to keep electronic cigarette manufacturers from bringing e-cigarettes to America. According to a report in the Washington Post, U.S. District Judge Richard J. Leon “determined that electronic cigarettes are tobacco products and are not subject to such restrictions.” The FDA had been contending that e-cigarettes were in fact novel and untested drug delivery devices, and as such, had not been approved by the agency for sale to U.S. consumers.  "This case appears to be yet another example of FDA's aggressive efforts to regulate recreational tobacco products as drugs or devices," the judge wrote in his decision.

The FDA had been confiscating imports of e-cigarettes but had not put together an entirely coherent strategy with respect to the smokeless electronic cigarettes, which heat liquid nicotine into an inhalable vapor. Two suppliers of e-cigarettes brought suit against the agency for the confiscations.  According to the Washington Post article, the judge took a further slap at the FDA, callings its stance on e-cigarettes a “tenacious drive to maximize its regulatory power."

For its part, the FDA maintains that e-cigarettes are more akin to nicotine gum, which is subject to  FDA regulation. The agency also questions claims by e-cigarette manufactures that their products "alleviate nicotine withdrawal symptoms." Furthermore, the FDA has voiced health concerns, based on studies showing that electronic cigarettes contain carcinogens and toxic chemicals such as diethylene glycol. (See my earlier post). The e-cigarette makers had argued before the judge that their products are not substantially different than the Marlboros and Salems sold everywhere.

According to the Wall Street Journal: “Health groups including the American Lung Association have called for e-cigarettes to be removed from the market, saying their safety is unproven and children may be attracted to them.”

As a reader commented on another e-cigarette post here: “I think it will be interesting to see how this all plays out. Judge Leon just gave the FDA a slap for trying to stop the import of e-cigs, some places are allowing them because it doesn't violate the Clean Air act and some places, like NJ are restricting the sale and use. We'll see a lot of battles over the next year or two.”

Graphics Credit: http://topnews.net.nz/

E-Cigarettes: Another Look

FDA remains conflicted over safety concerns.

The Food and Drug Administration (FDA) issued a controversial Safety Alert over electronic cigarettes, known as “e-cigarettes,” then held a press conference to explain itself. The agency’s muddled response to the issue has prompted increased advertising and online sales for Asian e-cigarette manufacturers, as well as a countering burst of criticism about the newest nicotine delivery system under the sun.

The FDA conducted a small-scale lab analysis of two different brands of e-cigarettes, and found “carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze.” The FDA’s Division of Pharmaceutical Analysis also found evidence of small amounts of cancer-causing nitrosamines. “These products do not contain any health warnings comparable to FDA-approved nicotine replacement products or conventional cigarettes,” the agency bulletin said. Therefore, the agency “has no way of knowing, except for the limited testing it has performed, the levels of nicotine or the amounts or kinds of other chemicals that the various brands of these products deliver to the user.”

The agency did not seek to ban e-cigarettes, as Canada did in March. However, in a written statement to CNN in March, the FDA admitted it had been detaining or refusing importations of electronic cigarettes for more than a year.

Debate has raged recently over the safety of e-cigarettes, which are battery-operated cigarette substitutes that technically dodge no-smoking bans, since no actual smoke is emitted. When a smoker inhales on the e-cigarette, the battery warms liquid nicotine stored in a plastic filter, producing a smokeless but inhalable form of synthetic nicotine. Upon exhalation, there is a small puff of vapor that quickly evaporates (See my earlier post, "E-Cigarettes and Health").

Michael Levy, director of compliance for the FDA’s division of drug evaluation and research, said he believes the products are illegal. However, “There is pending litigation on the issue of FDA’s jurisdiction over e-cigarettes,” he said.

Proponents of the e-cigarette claim that the devices are self-evidently safer than smoking cigarettes, and can help people stop using tobacco products. Critics respond that the safety of synthetic nicotine drug-delivery devices has not been established. Moreover, the range of fruit and candy flavors offered by e-cigarette manufacturers suggests to Jonathan Inickoff of the American Academy of Pediatrics Tobacco Consortium that the devices seem “tailor-made to appeal to kids,” while addicting them to nicotine and turning them into future cigarette smokers.

With half a million Americans dying prematurely each year from smoking, according to figures from the Centers for Disease Control (CDC), some doctors and tobacco researchers have pointed out that nitrosamines are also found in everything from nicotine patches to bacon. According to one researcher, “FDA should be encouraging, not maligning the manufacture and sale of electronic cigarettes, and working with manufacturers to assure the highest possible quality control.”

For a robust discussion of the e-cigarette question, see www.e-cigarette-forum.com


Photo Credit: www.politech.wordpress.com

addiction drugs smoking nicotine

Can Obama Quit Smoking?

Does nicotine addiction matter in a president?

Presidents Eisenhower, Kennedy, Johnson, Ford, and Clinton all enjoyed their occasional cigarettes and cigars. Laura Bush as been accused of bumming a cigarette or two since entering the Oval Office.

Presidential candidate Barack Obama smokes, too, but I could not find a picture of him actually doing it--and neither can anybody else, it seems. By all accounts, Barack Obama continues to struggle mightily in his current quitting attempt, which began in the form of a campaign promise to his wife. Sources say he’s getting by—barely--with the “strenuous” use of nicotine chewing gum.

Is there any way for Obama to connect with FDR and his rakish cigarette holder? Or is a president who smokes simply out of step with a nation seemingly bent on emptying all workspaces and gathering places of tobacco smoke? In a smoke-free nation, will the next president be forced to huddle on the rear portico of the White House, with the serving staff, and fieldstrip the odd Marb?

The fact that Obama may have messed with a little weed, a little blow, back in the day, seems, at long last, to be a non-starter as a wedge issue of any consequence. If Newt Gingrich smoked pot in college, everybody smoked pot in college. Even before Obama had officially entered the race last year, Michael Currie Schaffer of the Dallas Morning News ventured to guess that “youthful coke-dabblers probably outnumber adult smokers among Mr. Obama’s fellow 1980s, Harvard law students.”

On the other hand, as Maureen Dowd cooed in the New York Times, the smoking habit made Obama “intriguingly imperfect.” Ah, that touch of the rogue. Simply irresistible. Clearly, this is meant to separate Obama as a candidate from that oh-so-perfect and impeccably smoke-free Hilary Clinton, who in point of fact was personally responsible for the first official no-smoking regulations in the White House.

Nonetheless, as Schaffer points out, nowadays smoking is “actuarially foolish and hopelessly out of fashion,” and as such, can do Obama no good, even as a humanizing gambit. Fox News called it “Obama’s dirty little secret.” The fact that Obama hasn’t officially overcome the habit means he cannot lean on any sort of triumph over adversity, any type of uplifting self-help story, as even George Bush was able to do with his former drinking.

Some anti-smoking advocates want Obama to come out of the closet and embrace his inner nicotine fiend in public. According to the New York Times, “Smoking cessation experts say they hope Mr. Obama’s example of using a nicotine gum will encourage smokers to try a nicotine replacement product to help them quit.” But for ABC News, as correspondent Jake Tapper put it, the big question is: “Will Nicorette be enough to get him through Iowa and New Hampshire? Or will he inhale?”

One of the problems with nicotine gums and lozenges, as a British health report recently made clear, is that nicotine replacement is not widely used, because it is expensive--and because it is subject to greater regulation than cigarettes themselves. Warning labels on a pack of Nicorette far exceed the side effects listed on a pack of Camels.

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