June 2013 - CigarettesReviews.com | CigarettesReviews.com

Monthly Archives: June 2013

FDA announces first decisions on new tobacco products

In March, I became the director of the FDA’s Center for Tobacco Products (CTP), after spending more than three decades working on FDA-related issues, including a seven-year stint at FDA from 1993-2000. From 1997-2000 I was the first director of the agency’s office of tobacco programs. Since I returned FDA, CTP has made significant progress on many fronts. I look forward to discussing my strategic goals and priorities for the future blog post, but today I want to share some information about priority-review decisions regarding tobacco products.

tobacco_iconToday, for the first time since received FDA authority to regulate tobacco products identified, the agency authorized the marketing of two new tobacco products through substantial equivalence (SE) pathway, while denying the marketing of the four other new products.

These actions are unprecedented and mark the beginning of other upcoming decisions related to the marketing of new tobacco products. Substantial equivalence is one way manufacturers can use to market new tobacco product. To do this, the manufacturer must prove that their product has the same characteristics as the actual formerly marketed tobacco products, which we call the predicate product, or if the new product has different characteristics that it does not raise different questions of public health.

SE representations require careful study. FDA is responsible for protecting public health, and to do that, we are working to ensure that any new tobacco product brought to market by the way does not introduce more harm to public health than the actual product predicate specified by the manufacturer.

Today’s SE orders allow the marketing of two new Lorillard Tobacco Company Tobacco Newport Non-Menthol gold box 100s and Newport Non-Menthol gold box. The agency has found these two products are substantially equivalent to the predicate products based on materials of the company and other readily available science and information to demonstrate that each product will not pose more harm to public health than the predicate.

It is important to emphasize that the decision does not in itself mean that the Agency considers the product to be safe, and its not-FDA approved. SE decision only means that the new product does not cause various public health issues, compared to the predicate product.

The FDA has also released the first non-equivalent, or NSE, orders denying marketing of four new tobacco products after discovering that the products have different characteristics from their products predicate and that the applicant does not fully show that the new products did not raise different questions of public health.

FDA had been working diligently to address all the pending SE submissions. We know it took some time, but expect that the process will move more quickly in the future all the participants get more experience. FDA proposed to feedback from the industry about the requirements for substantial equivalence, and will continue to provide such feedback. We also created a new Web page that tracks SE decision on the date and provides general information on how the FDA to market new tobacco products. Our goal is to work through the remaining SE submissions in a consistent, transparent and predictable manner.

Zambia, Malawi tobacco income loss

Zambia and Malawi continue to lose revenue as a result of illegal cross-border trade in tobacco, despite the measures taken to curb the vice.

money-cigaretteThe revelation came to light during a bilateral meeting between the Tobacco Board of Zambia and the Commission on Tobacco Malawi recently.

The meeting of the two sides to address the illegal cross-border trade in tobacco which has become rampant between the two countries.

This is contained in the statement used in the Daily Mail on Friday, the first secretary for press at the embassy in Zambia, Malawi Chansa Kabwela.

Officials at the meeting, Malawi’s Minister of Agriculture Peter Mwanza said the illegal trade occurs providers who act as intermediaries for buyers and purchasing points along the border.

Mr Mwanza said vendors in some cases contribute to the farming of tobacco farmers to get after the tobacco harvest.

“The problem of illegal cross-border trade in tobacco continues to permeate every border and efforts put in place to combat it, have not been effective,” he said.

He said that measures such as confiscation of illegal tobacco traders and the use of local police, were not effective, that criminals are complex.

The minister called for concerted action between Zambia and Malawi to address the problem of illegal smuggling.

He urged the two bodies of tobacco to focus on border patrols and a review of the regulatory framework of the two countries in order to maximize synergies.

Mr. Mwanza stressed the importance of involving tobacco associations, manufacturers, and security services in the fight against illicit trade in tobacco if meaningful results are to be realized.

Meanwhile, Mr. Mwanza has commended Zambia for security personnel confiscated 27 bales of flue-cured tobacco from illegal traders and passing it to the Malawian authorities.

Marlboro maker Altria Group to sell their first electronic cigarette

The tobacco company Altria Group Inc. is launching its first electronic cigarette under the MarkTen brand in Indiana, beginning in August and extending its smokeless product offerings.

images!The owner of the country’s biggest cigarette maker, Philip Morris USA, has announced details of its foray Numark subsidiary in the fast growing business Tuesday.

This is the last of the largest tobacco companies in the country at the market of electronic cigarettes in the industry-wide push to diversify beyond the traditional cigarette business, which is becoming more rigid in terms of raising taxes, smoking bans, health concerns and social stigma.

Richmond, Va.-based company declined to comment on whether it plans to move beyond the initial state of the market test or whether he plans to advertise on TV – the place of the tobacco companies have long been prohibited marketing of traditional cigarettes.

During a presentation to investors on Tuesday, CEO Marty Barrington said the company “spent a lot of time studying the categories and business opportunities.”

“The category is at an early stage, and time will tell how it will develop,” said Barrington.

Electronic Cigarette battery powered devices that heat the liquid nicotine solution, creating steam that mainstream users. Devotees say e-cigarettes address both addiction and the behavioral aspects of smoking. Smokers to get their nicotine without the more than 4,000 chemicals found in cigarettes. And they get to hold something shaped like a cigarette, while puffing and exhaling something that looks like smoke.

More than 45 million Americans smoke cigarettes, and about half of smokers try to quit each year, according to the Centers for Disease Control and Prevention.

Markten is a disposable e-cigarette, but can be re-used, buying individual battery charging and extra set of cartridges as tobacco and menthol flavors. The company said that the electronic cigarette “Four Draw” technology is designed to give users a “more consistent work,” which is very similar to drawing traditional cigarettes.

Electronic cigarette made in China by a contract manufacturer, is expected to sell for about $ 9.50. Prices for additional ammo and recharge kit were not available. Liquid cartridge made in the USA

Last week, Reynolds American Inc., the owner of the second-largest tobacco company in the country, has announced that he is launching an updated version of its Vuse brand of electronic cigarettes in Colorado in July, with an eye to expanding nationally. Lorillard Inc., the third-largest tobacco company of the country, has acquired the electronic cigarette maker Blu Ecigs in April 2012 and has expanded to more than 80,000 retail outlets.

The market of electronic cigarettes, which includes more than 250 brands, has grown to thousands of users in 2006 to several million worldwide. Analysts estimate that sales could double this year to $ 1 billion. Some even said to consumption of electronic cigarettes can outperform traditional cigarette consumption in the next decade.

Tobacco company executives said that even electronic cigarettes have gone the total volume of the cigarette industry down about 600 million cigarettes, or about 1 percent, in the first quarter, with the exception of online sales – the main way for electronic cigarette purchases.

The Food and Drug Administration is planning to assert regulatory authority for electronic cigarettes in the near future. State health officials say the safety of electronic cigarettes and their effectiveness in helping people quit smoking regular, have not been fully explored.

Njoy Electronic Cigarette manufacturer Inc. said Monday it has raised $ 75 million in funding from investors including Napster founder and entrepreneur Sean Parker and Homewood fixed capital Douglas Teitelbaum be used for marketing, clinical trials, research and development, and international expansion. Musician Bruno Mars also has invested company whose Njoy King disposable electronic cigarettes are available in more than 60,000 retail stores.

Like other tobacco companies, Altria also is focusing on cigarette alternatives for future sales growth because of declining cigarette smoking is expected to continue.

The company said Tuesday it is expanding its chewy Verve, Disposable nicotine disks from 60 stores to 1,200 for Virginia in the second half of this year. He also plans to debut gum containing tobacco in Denmark this summer called Tew (pronounced “chew”) through a previously announced joint venture with a subsidiary Fertin Pharma A / S to develop smokeless nicotine products.

Altria, whose brands include the best-selling cigarettes Marlboro, Skoal smokeless tobacco and Black & Mild cigars, also on Tuesday reaffirmed its full 2013 adjusted earnings forecast of between $ 2.35 and $ 2.41 per share. The company also owns a wine business, holds a voting stake in brewer SABMiller, and has the financial department of the company.

FDA graphic health warnings

When the U.S. Food and Drug Administration (FDA) imposes new graphic health warnings for tobacco products, they can survive First Amendment challenge if they depict the health consequences and their effectiveness is confirmed by adequate scientific data, says Georgetown University Medical Center, an expert on public Health and counsel.

imagesGraphic tobacco warning labels that combine images with health warnings, a widely used tool for reducing tobacco use in other countries, but the tobacco industry claims that they are unconstitutional in the United States.

In the analysis of the legal and scientific issues for graphic health warnings published in the American Journal of Preventive Medicine, John Kremer, JD, MPH, defines how the courts are likely to analyze the graphic warnings and determine what health evidence must be presented in order to survive legal challenge. Kramer is an assistant professor of health systems administration at Georgetown University School of Nursing and Medical Research, and a member of the O’Neill Institute for National and Global Health Law.

Despite the fact that smoking kills 443,00 Americans each year, Kramer says, “The United States has some of the weakest tobacco warning labels in the world, and they have not been updated in nearly 30 years.”

In 2009, Congress passed the Family Smoking Prevention and Control Act requiring graphic warning labels on tobacco products, giving the FDA authority to specify the images and text that should be included. FDA released nine graphic warnings in June 2011, but withdrew them after two federal appeals courts have come to opposite conclusions about their constitutionality.

Although there is ambiguity over what constitutional rule will be applied in a lawsuit to labels, Kramer argues that it is possible for the FDA to address the two most likely standards of rational basis review and an interim review, with the right scientific data.

Kremer says the label is likely that, in accordance with a rational basis review, and will almost certainly prevail “if the court will issue a warning against deception past the industry.” He says that some courts have applied this review to be unquestionable, factual warnings such as information intended to help consumers make healthier decisions.

The second possibility is an interim review, which requires a strong public interest and greater confidence that the warning labels are effective.

“Under this review, the FDA, could probably win, but it will turn on how well the government will be able to convince the courts of some empirical evidence”, explains Kramer. “Providing clear evidence of graphic warning labels impact on smokers themselves or for a causal mechanism by which they reduce smoking will meet the test of the court.”

He adds that the FDA should also take care to avoid images that can be interpreted as an opinion and not the facts or do not show the negative health consequences of smoking, such as images previously received FDA, which depicted a man with no – smoking sign on his shirt.

Raise taxes on tobacco is reasoned

The desire of the legislator and the possibility to increase the tax on tobacco products throughout the state as part of putting together the budget for the fiscal year beginning July 1, legislation that would once again allow their dooms Oregon counties levy taxes tobacco.

part2-2-taxesIn so far failed budget negotiations between Democrats and Republicans legislative leaders the issue of raising taxes on cigarettes Oregon $ 1.18 per pack from 10 to 50 cents.

For the states, the increase will be part of a package of fixed-¬ nebulous increase personal, corporate, and “sin” taxes are designed to provide at least $ 200 million over the next two years combined. The new money, most of which the Democrats want in exchange for the introduction of curbs to public employee pension costs are deep, will increase funding for public K-12 education, colleges and youth mental health services.

Such a deal, if materialized, would it mean the end for House Bill 2870, a bill favored by Lane county officials, who will lift the ban on the county state tobacco tax, lawmakers recognize.

“It’s fair to say that if a user (tobacco tax) increase occurs, the county will not pass the bill,” Sen said. Ginny Burdick, Portland Democrat and chairman of the Senate Committee on Finance and Revenue Committee, WHERE HB 2870 was assigned.

Some county political leaders – including financial difficulties Lane County – lobbied for HB 2870 this session as a new “tool” for potentially raise funds.

Under the bill, county commissioners could levy a tax- which may not exceed the amount of tax on tobacco state. At least 40% of the revenue would have to go to tobacco prevention programs, mental health programs, or services to drug and alcohol abuse.

For both the state and counties, tobacco tax increases on tobacco can produce a healthy amount of income.

A 50-cent-per-pack increase in the state tax would generate more than $50 million a year. In Lane County, a 50-cent tax would generate around $8.5 million annually.

However, a significant increase in major states may tax the tobacco industry to seek voter referendum to change. In 2007, voters easily defeated a proposed 84.5 cents per pack increase, after a multi-million dollar campaign to which tobacco Interests exhausted opponents 3-to-1.

Lane County lobbyist said Alex Cuyler environment is that HB 2870 Effective policy in more than a slight increase in staff.

“District of view 10 cent tax on tobacco products as a victory for the tobacco industry,” he said. “It will not take up a large income, and it will not do anything to curb teen smoking.”

Unlike many other tax-related bills, HB 2870 does not require the support of 60 percent of the legislature to become law.

However, the House of Representatives passed a bill in early April on 31-29 vote.

Should a bipartisan budget deal completely fall through and the state tobacco tax remain flat, Burdick said, can it still be a “challenge” to pass HB 2870 through the Senate, where Democrats hold narrow 16-14 edge.

In 2009, the same bill passed the House but died in the Senate.

Reynolds American launch of the e-cig updated

Reynolds American Inc. launches an updated version of its Vuse brands of electronic cigarettes – which promises to give users a “perfect puff” – in Colorado, with its sights set on expanding nationally.

images (1)The expansion represents a further push the tobacco giant in fast-growing business and this trend will continue.

The move announced Thursday the owner of the second-largest tobacco company in the country is his first State of the e-cigarette distribution and is the latest in industry-wide push to diversify beyond the traditional cigarette business, which is becoming more rigid in terms of raising taxes, smoking bans, health concerns and social stigma.

Winston-Salem, NC, company that sells Camel, Pall Mall and Natural American Spirit cigarettes and Grizzly smokeless tobacco, do not reveal the exact size of Colorado retailers should begin in July or deadlines for national implementation. Will include the launch of an advertising campaign that will include TV commercials – a place companied tobacco marketing has long been a traditional cigarette smoking.

Electronic Cigarette battery powered devices that heat the liquid nicotine solution, creating steam that mainstream users. Some e-cigarettes are made to look like a real cigarette with a tiny light on the tip that glows. The devotees tout them as a way to break the dependence on real cigarettes. They insist address of the device and the nicotine addiction and the behavioral aspects of smoking without the more than 4,000 chemicals found in cigarettes.

Although many smokers try e-cigarettes, some switch completely, because “products on the market today simply do not meet their expectations,” Stephanie Cordisco, president of the RJ Reynolds Co. couple, told the Associated Press before the announcement. The company has tested the electronic cigarette in North Carolina and Virginia for about a year.

E-cigarettes to maintain “a familiar ritual of cigarettes,” but most of the more than 250 brands – hand-built and imported from abroad – have a taste and performance problems, Cordisco said. And unlike their Marlboro or Camel cigarette smokers who can see the empty package delivery, smokers using their electronic counterparts often can not tell when they are close to running out of battery or vapors.

Reynolds believes that its updated electronic cigarette “supplies that smokers want” to deal with these problems, Cordisco said.

Vuse Rechargeable Electronic Cigarette is a technology that controls and regulates the heat and power more than 2,000 times per second, which provides a constant delay. It also has a smart light on the tip, so that users know when it gets low, replace or recharge.

Single e-cigarette cartridges and lasting for about as long as one pack of traditional cigarettes is expected to cost about $ 10 and will include a charger USB. Reynolds is also set to be sold for about $ 30, which will include one electronic cigarette, three cartridges and charger USB. Additional cartridges both original and menthol flavor will also be sold as a two-for about $ 6.

The market of electronic cigarettes has grown to thousands of users in 2006 to several million worldwide. Analysts estimate that sales could double this year to $ 1 billion. Some even said to consumption of electronic cigarettes can outperform traditional cigarette consumption in the next decade. Tobacco company executives said that even electronic cigarettes have gone the total volume of the cigarette industry down about 600 million cigarettes, or about 1 percent, in the first quarter, with the exception of online sales – the main way for electronic cigarette purchases.

Altria Group, owner of the country’s biggest cigarette maker, Philip Morris USA, announced in April, a subsidiary plans to introduce an electronic cigarette during the second half of this year. The company is expected to provide detailed information about their products to an investor meeting on Tuesday. Lorillard Inc., the third-largest tobacco company of the country, has acquired the electronic cigarette maker Blu Ecigs in April 2012.

In recent comments to the industrial group, Mitch Zeller, the new head of the tobacco Food and Drug control efforts, said that changes in the market have forced the public health, to deal with the fact that some tobacco products such as electronic cigarettes may be less of a danger health than others. FDA intends to assert regulatory authority for electronic cigarettes in the near future. State health officials say the safety of electronic cigarettes and their effectiveness in helping people quit smoking regular, have not been fully explored.