E-Cigarettes Win Court Ruling

Electronic cigarettes moved a step closer to being regulated just like mainstream tobacco products on Tuesday when a federal appellate court unanimously upheld an injunction against the Food and Drug Administration’s attempt to ban them or regulate them more strictly as drugs.

E-cigarettes are battery-powered tubes that look like cigarettes. They deliver nicotine by vaporizing a nicotine-derived liquid without combustion. Their distributors say this makes them more healthy than cigarettes. They can even deliver steam to exhale like a clean, smoke-free smoke.

The F.D.A., concerned with marketing claims of products that deliver a highly addictive substance, has tried to ban e-cigarettes as unapproved drug delivery devices.

But the federal appeals court in Washington, D.C., upheld a lower court injunction against the F.D.A. ban. The appellate court said the F.D.A. should regulate them under the 2009 legislation that set up a Center for Tobacco Products. E-cigarettes are marketed for the pleasure of a product, not for the therapeutic benefit of a drug or medical device, the court said.

Jeffrey Ventura, an F.D.A. spokesman, said in a statement on Tuesday, “We are studying the opinion and considering next steps.”

The e-cigarettes in the case were manufactured by Sottera of Scottsdale, Ariz., doing business as NJOY. It sells the products and refill cartridges on a Web site requiring certification that the buyer is 18 years old. A starter kit costs $79.99.

Quit-smoking products like nicotine patches and gum and the Pfizer pill Chantix are regulated by the federal drug law, which requires them to be proven safe and effective. The tobacco law allows the F.D.A. to regulate ingredients and marketing claims in “any product made or derived from tobacco,” but shifts more of the burden of proof to federal regulators.

The F.D.A. tried to regulate all tobacco products as drugs in 1996. The Supreme Court ruled against that by a 5-4 vote in 2000, leading to work in Congress to develop the tobacco control act that passed last year.

The appellate court ruling was hailed by advocates of e-cigarettes, who say they are much safer than cigarettes.

“This is a huge victory for public health and civil justice,” Bill Godshall, founder of Smokefree Pennsylvania, a nonprofit group supporting e-cigarettes, wrote in an e-mail message. “It’s time for F.D.A. officials to come to their senses by reclassifying (and promulgating reasonable regulations for) e-cigarettes as tobacco products.”

The American Heart Association was among the antitobacco groups to support a drug ban or tighter regulation.

“We’re gravely concerned about the implications of today’s ruling,” the association’s chief executive, Nancy Brown, said in a statement. “The appeals court has cleared the way for the industry to peddle these products to consumers without any scrutiny as to their safety or efficacy. There is no scientific evidence that e-cigarettes are effective smoking cessation devices and, until they undergo rigorous evaluation by the Food and Drug Administration, they should be pulled from the marketplace. With this ruling, e-cigarette manufacturers will continue to make misleading claims that their products can help smokers quit.”

The Campaign for Tobacco-Free Kids, a Washington advocacy group, said the ruling would leave an unregulated period before the F.D.A. could assert jurisdiction.

“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,” the campaign’s president, Matthew L. Myers, said in a statement. “We urge the government to appeal this ruling to the U.S. Supreme Court. “

J&J to roll out Nicorette from this week

Smokers looking to give up the habit have one more alternative to choose from, with Johnson & Johnson Ltd set to bring in Nicorette, its sugar-free nicotine gum that helps reduce nicotine cravings.

Nicorette will be available at all chemist outlets beginning January 2011, a note from J&J said.

Many people choose to quit regular cigarettes like Davidoff cigarettes or Lucky Strike cigarettes and start using Nicorette.

Tobacco cessation products are already present in the country, with Pfizer having launched its Chantix (sold in India as Champix ) in 2008. GlaxoSmithKline's product Zyban was launched locally in 2001, but shelved two years later.

J&J, however, said that from later this week, Nicorette would be rolled-out in packs of 4mg (10 gums) – prescribed by doctors for “heavy smokers”, and as an over-the-counter product of 2 mg (4 & 10 gums) for “light smokers”, a note from the company said.

The cessation products are priced at Rs 22 for a 2 mg, 4 pieces box of Nicorette and Rs 50 for a 2 mg, 10 pieces box of Nicorette, besides Rs 65 for a 4 mg, 10 pieces box.

A Nicotine Replacement Therapy (NRT) product, Nicorette provides therapeutic and clean nicotine, slowly and in lesser quantities as compared to a cigarette, but also just enough to satisfy the cravings, the company said.

NRT substitutes the nicotine obtained from smoking, thus controlling craving and withdrawal symptoms, and preventing relapse to smoking.

Also, unlike tobacco smoke, it delivers nicotine that is devoid of harmful chemicals such as tar, irritants and carbon monoxide, and, hence, is safer than smoking a cigarette, it added.

Concerns

NRTs are recognised as part of cessation programmes, and its short-term use is a bridge to actual cessation, said Dr Srinath Reddy of Public Health Foundation of India.

But long term use could have adverse effects in terms of impact on the heart and fresh addiction, he said, adding that it needs to be monitored.

In fact, cessation products have in the past too had to deal with associated concerns. Late last year, Pfizer had to update the label on its smoking-cessation product Champix, to alert health professionals of behavioural changes, including depressed moods and suicidal thoughts, reportedly associated with such products.

This was after the US regulator, the Food and Drug Administration raised the concern and mandated “boxed warnings” on Chantix (varenicline) and Zyban (bupropion hydrochloride), two prescription medicines used as part of smoking cessation programmes.

NC union says menthol ban means worker hardship

A union representing workers at the company that makes the top-selling brand of menthol cigarettes says a ban on the additive would cause economic hardship.

Many tobacco brands are on top because they have good quality even if some of them do not have menthol addition. For example Camel cigarettes or Vogue cigarettes are very demanded among smokers.

The Bakery, Confectionery, Tobacco Workers and Grain Millers International Union also says it's being shut out of a Wednesday meeting in Raleigh.

The federal Center for Tobacco Products is meeting with representatives of the tobacco industry. The Food and Drug Administration is studying the use of menthol in cigarettes, and may recommend tighter regulations or an outright ban.

The union represents about 1,000 workers at Greensboro-based Lorillard Inc., makers of Newport cigarettes.

Dozens of union workers plan to rally in front of the Raleigh hotel where the meeting is being held.

Pro-smoking group petitions against EU regulations

Proposed changes to the European Commission’s Tobacco Products Directive include a ban on the display of tobacco products in retail stores, the introduction of plain packaging, the enlargement of picture warnings on packs and the prohibition of all types of smokeless tobacco products.

There are different regular cigarette brands like Davidoff cigarettes or West cigarettes.
The European Commission’s public consultation closes on Friday 17 December.
“We support measures that educate children and adults about the health risks of smoking, but we oppose unnecessarily restrictive regulations that are designed to denormalise a legal product and will threaten jobs and small businesses and inconvenience millions of law-abiding citizens throughout Europe,” said Forest director Simon Clark.
“We urge everyone who opposes these proposals to sign the petition which will be submitted to the EC as part of the consultation. It is essential that consumers make their voices heard in Brussels as well as in Westminster.”
The petition will be delivered by Forest to the European Commission in Brussels on 17 December.

Menthol Ban Could Boost Kid Smoking

A ban on menthol in cigarettes might be an obvious way to curb kiddie smoking, but a new survey of anti-smoking regulations in Canada finds that getting tough only results in a black market of smokes that are cheaper and easier for kids to get.

As the Food and Drug Administration considers a ban on menthol, cigarette makers like Lorillard, which produces Newport, have been pushing back. At a meeting today of the Tobacco Products Scientific Advisory Committee, which has until March to advise the FDA on a regulatory path, the report they presented was a reminder that those who want to smoke will find a way to do it.

The survey from the research firm Compass Lexecon found that a ban would create a sizeable black market for menthol cigarettes, boost organized crime, increase youth access and have little impact on smoking rates. The key summary paragraph: "Restrictions placed on legal menthol sales would primarily divert current sales of menthol cigarettes to non-menthol cigarette alternatives and to black market menthol cigarettes. Further, our best estimate is that the black market that will emerge will be substantial. In terms of unit sales, our estimate is that black market menthol sales will be over 70 percent of current volumes, and that aggregate revenues will approximately be close to current sales levels. Finally, our analysis suggests that there could be many unintended consequences, ranging from the more obvious outcomes, such as significant growth in organized crime activity, to other types of effects, such as greater youth access to cigarettes (especially in urban areas) and large increases in the sales of low-cost counterfeit cigarettes."

Groups like the Campaign for Tobacco Free Kids believe a ban will curb youth smoking, but Bill Wilson, the president of Americans for Limited Government, says a ban will only lead to a black market that makes cigarettes cheaper and easier to get. "This is a classic case of government interference leading to devastating outcomes. Since the charge to ban menthol cigarettes is led by the Campaign for Tobacco Free Kids, it may be time for them to change their name to the Campaign for Tobacco Access for Kids," he says.

What's happened in Canada, after it significantly raised taxes, is that a huge black market opened with cartons of cigarettes being stuffed in plastic bags for sale about a quarter of the retail price. Kids are able to buy them without having to prove their age. The industry survey and Powerpoint, provided to Whispers, found that the Canadian provinces that suffered the greatest increase in contraband sales are also those that saw teen smoking rates jump.