Era of the Electronic Cigarette Officially Begins.

Court blocks FDA from prohibiting e-cigarettes.

It’s official: The e-cigarette is here. The right of a distributor of Chinese electronic cigarettes to market the product in the U.S. was solidly affirmed last week by a three-judge ruling in the U.S. Court of Appeals for the District of Columbia. The Food and Drug Administration’s refusal last year to allow importation of e-cigarettes by Sottera Inc. had been the basis for a lower court decision in Sottera’s favor. The earlier court ruled that e-cigarettes did not require FDA approval because they were neither new drugs nor new drug delivery devices. (The FDA is prohibited by an act of Congress from barring the sale of tobacco products outright.)

Last month, under a consent judgement worked out with California state Attorney General Jerry Brown in a related case, Florida-based Smoking Everywhere Co., another distributor of Chinese electronic cigarettes, had agreed not to target minors in its advertising, or to make claims that its products are safe alternatives to tobacco. The move came shortly after the FDA announced plans to regulated battery-powered e-cigarettes as new drug delivery devices, culminating in the Sottera lawsuit.

The legal argument before the appeals court hinged largely on semantics. The court found that electronic cigarettes are “battery-powered products that allow users to inhale nicotine vapor without fire, smoke, ash or carbon monoxide. The liquid nicotine is derived from natural tobacco plants.”

Here is the catch: “The FDA may only approve a product for marketing under the Federal Food, Drug and Cosmetic Act (FDCA) if it is safe and effective for its intended use,” the Appeals Court Justices ruled.  However, the FDA has “exhaustively documented” that tobacco products are unsafe for pharmacological use of any kind. The earlier court had concluded, stealing a page from “Alice in Wonderland”: “If they cannot be used safely for any therapeutic purpose, and yet they cannot be banned, they simply do not fit” within any conceivable regulatory scheme.

Hence the difficulties in the FDA’s attempt to regulate by agency fiat. E-cigarette manufacturers and distributors, having sensed an opening, are now ready to drive a convoy of semis right through it. This wasn’t a completely straightforward march, as the e-cigarette forces, in the appeals presentation, were required to thread the needle on such conundrums as: Does it matter that e-cigarettes do not, strictly speaking, contain “tobacco products?” Nicotine is a component of, not a product of, tobacco.

You see the problem. The relevant statutes have not been written with pure nicotine delivery devices in mind. In fact, having nicotine--but not the evil substance tobacco--in your product turned out to be a definitional advantage for the e-cigarette marketers: The court pointed out that, unlike products containing tobacco, which the FDA has found to be associated with “cancer, respiratory illnesses, and heart disease,” the FDA has manifestly NOT found that nicotine or tobacco-free products that deliver nicotine are inherently unsafe. And second, the “tobacco-specific legislation” invoked in earlier court cases “simply does not address products that deliver nicotine but contain no tobacco.”

Matthew Myers, president of the Campaign for Tobacco-Free Kids, said in a prepared statement: "This decision will allow any manufacturer to put any level of nicotine in any product and sell it to anybody, including children, with no government regulation or oversight at the present time. We urge the government to appeal this ruling."

Among the many  questions the ruling leaves open is the status of e-cigarettes under existing no-smoking regulations. That litigation has not even gotten underway.

See my earlier post on the e-cigarette question HERE.

For the full court decision, click HERE.

Graphics Credit:  http://thestrobel3.blogspot.com/

New Warning Labels for U.S. Cigarettes; Big Tobacco on the Rampage

Philip Morris Intl. sues Uruguay and Brazil.

Lots of developments on the nicotine front these days. On opposite ends of the news spectrum, so to speak, the Food and Drug Administration (FDA) announced plans to slap new and much more graphic warning stickers on cigarette packs--while elsewhere in the world, the world’s major tobacco companies got busy fighting tougher regulations on cigarette marketing. Meanwhile, the state of California has set limits on the marketing of e-cigarettes, disallowing companies from promoting the nicotine inhalers as “smoking-cessation devices.”

So let’s get busy. In the first significant change for cigarette advertising in 25 years, the FDA, freed by Congress last year to regulate tobacco products, will select nine new designs from among 36 contenders for new, far more graphic warning labels on cigarette packages. The new warning labels will begin appearing in about a year. To view the contenders, go to www.fda.gov/cigarettewarnings.

But will new, grisly images of dying smokers and rotted lungs really make a difference to the roughly one-quarter of adult Americans who still smoke?  “I am pleasantly shocked that [they are] doing this,” Stanton A. Glantz, a tobacco researcher at UC San Francisco, told the Los Angeles Times.  “There is no question but that strong graphic warning labels work,” he said. “Right now we have the weakest warning labels in the world. Now we will be right up there tied for the strongest.”

No so fast, counters John F.  Banzhaf, the executive director of Action on Smoking and Health and a George Washington University law professor. In the same L.A. Times article, Banzhaf said he was “quite disappointed,” stating that the agency “has done nothing more than exactly what Congress told them to do, and not one iota more.” So far, the FDA has banned advertising in magazines for young people, nixed the marketing ploy of handing out free samples on the street, and forbidden tobacco companies from marketing cigarettes by using the words “light” or “low-tar.”

Perhaps a more important result of Congressional approval of FDA oversight is that Medicare has now changed its rules to include smoking cessation products for covered beneficiaries. Previously, only people dying of lung disease were approved for smoking cessation products—a bit late in the disease cycle to do anybody much good.

According to a variety of estimates from government and research agencies, as many as half a million Americans die prematurely from smoking-related diseases. The Department of Health and Human Services has lately been stymied by a smoking rate of about 20%, basically unchanged since 2004. In 1965, about 42% of Americans smoked. The Department of Health and Human Services (HHS) has a stated goal of bringing smoking levels down to 12% by 2020.

That will not be an easy target to hit. And neither Congress nor the FDA nor HHS can count on anything amounting to cooperation from the cigarette giants. The New York Times, in an article by Duff Wilson, notes that worldwide cigarette sales rose 2% last year, as cigarette companies increasingly shift their marketing efforts toward a hunt for new customers in developing countries.  The aggressive nature of the worldwide cigarette marketing push was underscored this year when Philip Morris International sued the governments of Uruguay and Brazil, claiming that those countries had enacted tobacco regulations that were excessive and a threat to the company’s trademark and property rights.

Dr. Douglas Bettcher of the World Health Organization’s Tobacco Free Initiative accused the company of “using litigation to threaten low- and middle-income countries.” Philip Morris subsidiaries are also filing suits in Ireland and Norway over display advertising prohibitions. (Philip Morris USA, a separate division, is not involved in these lawsuits, and did not join with R.J. Reynolds and other tobacco companies in filing suit against the FDA last year.)

In the New York Times article, Wilson writes:

Companies like Philip Morris International and British American Tobacco are contesting limits on ads in Britain, bigger health warnings in South America and higher cigarette taxes in the Philippines and Mexico. They are also spending billions on lobbying and marketing campaigns in Africa and Asia, and in one case provided undisclosed financing for TV commercials in Australia.

As tobacco expert Dr. Cynthia Pomerleau points out on her blog, low smoking rates among women in the developing world make them a particularly tempting marketing target for the tobacco industry. Pomerleau, research professor emerita in the University of Michigan’s Department of Psychiatry, also reminds us that “the real goal here is not to remove health warnings altogether—health warnings have actually worked well for them by legitimizing the claim that if people choose to smoke, it’s not their fault—just to prevent them from dominating the package and actually becoming salient.”

It is important for the industry, says Pomerleau, to publicize “effects that can be achieved or problems that can be addressed by smoking.” In this respect, Pomerleau is concerned about the likelihood that the tobacco industry will seize upon the relationship between smoking and thinness as the wedge for sales campaigns aimed at women. “If it worked in the U.S., why not in Africa or Asia or South America?”

And finally, under a consent judgment worked out with California state Attorney General Jerry Brown, the Florida-based Smoking Everywhere company, a distributor of electronic cigarettes, has agreed not to target minors in its advertising, or to make claims that its products are safe alternatives to tobacco. The move comes shortly after the FDA announced plans to regulated battery-powered e-cigarettes as new drug delivery devices. Smoking Everywhere distributes e-cigarettes manufactured in China. The consent judgment also bars the company from selling its products in vending machines, and requires the products to contain warning labels about the dangers of nicotine.

And don’t forget: Thursday, November 18 marks the 35th annual Great American Smokeout.

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/