Two tobacco companies went to court against U.S. health regulators on Friday, seeking to block consideration of an imminent advisory panel report that could recommend a ban on menthol-flavored cigarettes. Lorillard Inc and Reynolds American Inc’s R.J. Reynolds Tobacco Co unit filed a lawsuit against the Food and Drug Administration charging there were “conflicts of interest and bias among members” of the FDA advisory panel.

The advisers have been weighing the health impact of mint-flavored cigarettes and are expected to deliver their final report on March 23.

Mentholated cigarettes make up roughly 30 percent of U.S. annual cigarette sales of more than $83 billion, according to Euromonitor International.

The top-selling menthol cigarette is Lorillard’s Newport brand. R.J. Reynolds sells the Kool brand and a menthol version of its Camel cigarettes product.

A 2009 law gave the FDA regulatory power over tobacco products and specifically banned chocolate, fruit and other flavorings that lawmakers said enticed children to start smoking.

The legislation called on the FDA to seek advice from a panel of outside experts before determining whether menthol cigarettes should also be taken off the U.S. market.

The lawsuit filed in U.S. District Court for the District of Columbia accuses three tobacco advisory panel members of having “severe financial and appearance conflicts of interest and associated biases.”

The suit says these advisers have received funding for research or consultation work from drugmakers that make smoking-cessation products.

Two others on a panel subcommittee also have biases, according to the suit, because they have served as paid expert witnesses in lawsuits against tobacco companies.

Health advocates denounced the lawsuit as a frivolous attempt to keep the FDA panel’s recommendation from coming to light.

“They fear that the committee, having examined the evidence, will recommend effective actions that reduce or eliminate the lucrative market for menthol cigarettes, said Matthew Myers president of the Campaign for Tobacco-Free Kids. “Once again, they are putting profits ahead of lives and health.”

Altria Group Inc’s Philip Morris unit, which is not part of the lawsuit, also sells a menthol version of its Marlboro cigarette.

All three companies have spoken out against any menthol ban since the FDA’s panel began holding meetings last year. The advisers are scheduled to meet on March 2 and March 17 ahead of issuing its report.

As with other advisory panels, the FDA is not bound to follow its recommendations. The law did not set a deadline for any action on menthol.

FDA spokesman Jeff Ventura said: “As a matter of general policy, the FDA does not comment on possible, pending or ongoing litigation.”

Tobacco products that look, smell or taste like candy are in the cross hairs of a local lawmaker.
Rep. Paul Ray, R-Clinton, sponsored House Bill 170, which would have banned any tobacco product from resembling candy in any way, shape or form. But the House Business and Labor Committee voted 4-8 against the bill Friday in a committee room packed with anti-tobacco activists wearing buttons reading, “Three can kill.”

“I’ll see you next year,” Ray said after the vote.

Some of those who voted against the bill said tobacco products such as chewing tobacco, cigarettes and cigars are legal for those 19 and older to buy in Utah.

They also said adults should be able to choose if they want to buy flavored nicotine products.

Ray brought samples of nicotine products that looked like candy for committee members to see.

“Three of these (Camel) Orbs can kill a small child,” Ray said.

Currently, the candy-like forms of nicotine are not available in Utah, Ray said, “but they’re coming.”

He sponsored a similar bill last year, but it was killed in the Senate after tobacco lobbyists said tobacco companies would sue Utah.

Ray said the Utah Attorney General’s Office looked at federal regulations and Utah can ban any tobacco product it wants to. New York recently won a lawsuit filed by tobacco companies after it banned tobacco-type candy.

Bonneville High School Principal Art Hansen said it’s not just small children who could die or become seriously ill from ingesting nicotine products. Several years ago, a student was given a nicotine prescription patch by another student at school, which he put in his mouth, Hansen said.

Within minutes, the student was convulsing and paramedics were called, Hansen said.

Rep. Gage Froerer, R-Huntsville, said he struggles with the bill because “how far do we go when we ban products?”

Froerer and Ray worked together on a bill to ban spice and Ivory Wave that was signed into law earlier Friday. The products were being used in place of marijuana or cocaine.

Ray warned that the nicotine products will be sold not in smoke shops but in convenience stores and across the street from elementary schools.

“Who you have heard from mostly today are the paid lobbyists from the tobacco companies,” he said.

“We’ve never had the opportunity to ban tobacco because it has been around for so long. You have the opportunity today to make history.”

Rep. Francis Gibson, R-Mapleton, said adults should have the right to buy nicotine products.

“We have fruit wine coolers,” he said.

Gibson said he does not use nicotine or tobacco products but thinks the bill goes too far in regulating what adults can or cannot buy.

Christy Jones, with Weber-Morgan Health Department, said the products, no matter how well regulated they are, will end up in the hands of teenagers and even younger children.

“The teens will get it and will conceal it from their parents, law enforcement and teachers,” she said.

“They will pull out what looks like gums or mints and then share with their friends.”

A statewide ban on flavored nicotine candy failed in House Business and Labor Committee on Friday. Representative Paul Ray’s bill would have banned stores from selling gum, dissolving strips and other candy-like products that have not been approved by the FDA for helping someone quit smoking. A frustrated Ray addressed his supporters in the hallway after his bill was voted down.

“What they’re telling us is their profits, tobacco companies’ profits are a lot more important than the health of Utah children and Utah families, and that is not to be tolerated,” he said. “I say we come out there, we work the legislature, we do not let this issue die. Do not feel like you’ve been beaten. You got duped.”
Lawmakers on the committee argued they would support restrictions on nicotine candies, but an outright ban that would impact the rights of responsible adults goes too far.
Bonneville High School’s Nick Porter, who came to the hearing to support the measure, was in tears outside the committee room when it was voted down.
“I’m just disappointed that our state officials can’t make a decision to serve the families and to protect the kids,” he told KCPW. “This is something I feel passionately about that we should keep out of Utah something that’s so deadly.”
The bill was rejected on a 4-to-10 vote. But Ray said he still has a chance to bring it back to committee, which he plans to do.

Convenience store retailers have found initial trial levels of the new Newport Non-Menthol cigarettes to be about average, with much of the initial consumer interest attributed to temporary pricing, according to an exclusive CSP-UBS Tobacco Survey. “Most customers buying Newport Non-Menthol don’t have a strong loyalty to another brand and are trying them because of the price and the Newport name recognition,” one retailer stated. “After the buy down expires, only those customers that have developed a loyalty to the brand will continue to buy them.”

Retailers ranked the trial level at an average of 5.1 on a scale of one to 10, according to the survey, which included 108 retailers representing more than 15,000 convenience stores.

Trial primarily was attributed to the temporary $1.65 buydown, which is set to expire in January. About 76% of respondents said they didn’t feel Newport Non-Menthol would sell as well when the buy-down ends.

As one retailer put it: “Sales will fall when off-invoice is pulled. The drop will be predicated on the amount of discounting removed and when. If moved in line with other Newport discounting, sales will fall by 66% minimum.”

Lorillard declined to comment on the survey. “We do not comment on future marketing and/or promotional plans for any of our brands,” a company spokesman said, adding that it is also too soon to comment on how Newport Non-Menthol is doing as it only entered the market in November.

UBS tobacco analyst Nik Modi, however, explained that now was a good time to begin tracking Newport Non-Menthol sales. “While we realize it’s still too early to make an ultimate assessment on the success of Newport Non-Menthol, we wanted to pursue this survey in order to create a point of comparison for future surveys.”

A majority (89%) of respondents said Newport Non-Menthol users switched from other brands, with the remaining 11% saying they were new customers. Retailers also ranked expectations of initial repeat levels at a little below average, at about 4.4 on a scale of one to 10.

“It appears that it will pull from Pall Mall and some of the low-ends for now,” one retailer stated. “It could also pull from Marlboro and Camel, if they keep emphasizing that this is an introductory price on a well-known brand-name extension.”
Most respondents characterized the overall in-store execution of the launch as good (38%) or excellent (16%). “Product was available the day they said it would be; there have been no out-of-stocks or shortages,” one retailer said. “The sales have been very strong, which I expected with the deep discount.”

However, not all retailers were happy with the launch, with 30% rating it fair, and 17% rating it as poor: “Some stores struggled to get reps in upon launch. Many stores had advertising placed in unauthorized positions not following instructions agreed to by the account manager.”

An area of optimism for Lorillard is that it newest cigarette appears to be drawing from other non-menthol brands, such as Marlboro and Camel, and not from the core users of Newport Menthol. Although 78% percent said Newport Non-Menthol was competing with the core Newport product, 77% said they did not believe Newport Non-Menthol was confusing the core Newport customer. “Most trials are not from menthol customers; it is Marlboro and Camel customers trying it,” one retailer said.

“The good news is that Newport Non-Menthol is largely incremental to the Newport franchise with minimal cross-over consumption,” Modi told CSP Daily News.

In late October, UBS tobacco analyst Nik Modi estimated that Newport Non-Menthol could take 0.5% share of the total cigarette category over a 12-month period. Factoring in the $1.65 off-invoice discount, the report estimated that the launch could produce $100 million in incremental sales but remain neutral to earnings.

In late October, Lorillard’s director of investor relations Bob Bannon told CSP Daily News, “As the non-menthol segment of the cigarette industry accounts for approximately 70% of total sales, our recent national launch of Newport Non-Menthol was an opportunistic move designed to leverage Newport’s strong brand equity among adult smokers into this large market segment.”

So what might the future hold for the product? Modi summarized, “The true test will be how Newport Non-Menthol sells once the introductory pricing ends. Retailers don’t seem to think it will, but it’s still very early.”

A Chicago Sun-Times article this past weekend highlighted the battle over menthol cigarettes and the FDA’s meeting in Raleigh last week with tobacco executives and public health officials. Outside the meeting, workers from Lorillard Tobacco in Greensboro, “paced in the bitter cold,” anxious to learn the fate of the product that they help produce. “This is about my livelihood,” said Darsey Campbell, who has worked at Lorillard for 40 years. “We have to worry when the government starts messing with one more thing. Don’t they have enough to do?”

Public health officials maintain that menthol improves the flavor of cigarettes and thus makes it more appealing for consumers. Additionally, it tempers the burn that cigarettes bring to the throat.

Lorillard produces one-third of the menthol cigarettes sold in the U.S., which accounts for 10 percent of the total cigarette market.

A report on menthol is due in March, though there are no expectations after that.

“The FDA has made no statements about potentially banning menthol,” said Lawrence R. Deyton, director of the FDA’s Center for Tobacco Products.

That cool, throat-numbing sensation some smokers find in their cigarettes could go the way of other products the federal government has deemed dangerous. Menthol, a natural compound found in the mint plant, soothes throats and helps tame an achy tummy. But in cigarettes, some health experts argue, it makes the poison that is tobacco go down more smoothly, tricking the youngest and most foolhardy smokers. Last year, Congress passed far-reaching tobacco regulations that, among other things, banned chocolate- or strawberry-flavored cigarettes, saying they lured kids to smoke by dressing up cigarettes as candy.

But Congress passed on regulating menthol cigarettes, which account for one-third of cigarettes sold in the United States. Instead, it called for a study and more discussion by the Food and Drug Administration.

The FDA brought the debate to Raleigh last week, when big tobacco executives and public-health officials met at a downtown hotel to discuss the new law on cigarettes and how the FDA would enforce it.

Outside, dozens of workers from Lorillard Tobacco in Greensboro, N.C., paced in the bitter cold. They produce Newports, menthol cigarettes that have been their ticket to a middle-class life.

“This is about my livelihood,” said Darsey Campbell, who has cleaned and serviced Lorillard equipment for 40 years.

“We have to worry when the government starts messing with one more thing. Don’t they have enough to do?”

Public health officials want cigarettes to taste as bad as they are for a smoker’s health, and menthol undermines that.

The product, which can be made synthetically, tempers the burn cigarettes bring to the throat.

If kids feel that burn, they may never pick up another cigarette, some health officials argue. The biggest consumers of menthol cigarettes are young people and minorities, studies show.

Lorillard’s corner of the cigarette market depends on menthol, which workers spray on tobacco before rolling it in paper.

They make a third of the menthol cigarettes sold in the U.S., accounting for about 10 percent of the total cigarette market.

A report on menthol is due to the FDA secretary in March, but there are no deadlines or expectations after that.

“The FDA has made no statements about potentially banning menthol,” said Lawrence R. Deyton, director of the FDA’s Center for Tobacco Products.

That cool, throat-numbing sensation some smokers find in their cigarettes could go the way of other products the federal government has deemed dangerous. Menthol, a natural compound found in the mint plant, soothes sunburns, tempers coughs and helps tame an achy tummy, but on cigarettes, some health experts argue, it’s a ruse. It makes the poison that is tobacco go down more smoothly, tricking the youngest and most foolhardy smokers. Last year, Congress passed far-reaching tobacco regulations that, among other things, banned chocolate- or strawberry-flavored cigarettes, saying they lured kids to smoke by dressing up cigarettes as candy.
But Congress passed on regulating menthol cigarettes, which account for one-third of cigarettes sold in the United States. Instead, it called for a study and more discussion by the Food and Drug Administration.

The FDA took the debate to Raleigh, N.C., on Wednesday, when big tobacco executives met public health officials in a conference room at the Marriot Hotel downtown to discuss the new law on cigarettes and how the FDA would go about enforcing it.

Outside, dozens of workers from Greensboro, N.C., who make their living manning machines that make menthol-laced cigarettes, paced in the bitter cold. For Lorillard Tobacco workers, who produce Newport cigarettes, menthol is an ingredient that makes their brand pop with flavor, and those cigarettes have been their ticket to a middle class life.

“This is about my livelihood. I’ve got responsibilities,” said Darsey Campbell, who has logged 40 years at Lorillard Tobacco, cleaning and servicing equipment. “We have to worry when the government starts messing with one more thing. Don’t they have enough to do?”

The conundrum for federal officials is clear: Cigarettes are bad; jobs are good. Can there be a winner?

“Undeniably, this is a very controversial issue with a lot of moving parts,” said Jeff Ventura, spokesman for the FDA.

With cigarettes, the federal government is now engaged in an awkward dance. On one hand, America needs jobs more than ever, and government officials want to avoid jeopardizing the product, and market share, of a major U.S. manufacturer. Cigarette makers who use menthol insist that banning menthol will simply push production overseas or into an unregulated black market.

But the government also doesn’t want people to smoke; it is the No. 1 preventable cause of death in the U.S. Smoking attacks the lungs, making smokers prone to chronic sickness and heavily reliant on health care. The FDA is adamant about not wanting kids to pick up a cigarette and start the habit.

Public health officials want cigarettes to taste as bad as they are for a smoker’s health, and menthol undermines that. The product, which can be made synthetically, tempers the burn cigarettes bring to the throat. If kids feel that burn, they may never pick up another cigarette, some health officials argue. Studies show that the biggest consumers of menthol cigarettes are young people and members of minority groups.

Campbell, the Lorillard worker, smokes Newports flavored with menthol. She has almost all her life and wants government to stay out of her business.

“I’m grown. It’s my choice,” she said.

Campbell’s biggest concern, though, isn’t her smoking habit but rather her job. She’s one of about 2,000 people working for Lorillard in Greensboro, where generations of families have found jobs that pay enough for them to buy homes and take care of their families.

Lorillard executives won’t predict what would become of the Greensboro plant should the FDA ban menthol in cigarettes. The company just started making a menthol-free Newport last month, but it’s too soon to say whether it will catch on, said Bob Bannon, Lorillard’s director of investor relations.

Lorillard’s corner of the cigarette market depends on menthol, which workers spray on tobacco before rolling it in paper. They make a third of the menthol cigarettes sold in the U.S., accounting for about 10 percent of the total cigarette market.

“It’s tough to say what impact we’ll feel,” Bannon said. “We’re trying to measure what adult smokers’ reaction would be in the scenario that it disappears. We just don’t know, but we think the number of people who would quit altogether would be low.”

FDA officials say they are a long way from having an answer to the menthol question. And they may simply decide to not answer it. Congress obliged them to study, and scientists have been meeting to do just that. A report is due to the FDA in March, but after that, there are no deadlines or expectations.

“The FDA has made no statements about potentially banning menthol,” said Lawrence R. Deyton, director of the FDA’s Center for Tobacco Products.

Campbell and about 30 of her co-workers didn’t want to take chances. Outside the Marriot on Wednesday, they pushed signs into the air, reminding tobacco executives and FDA officials that they, too, have a stake in the future of menthol in cigarettes.

THE POWER OF MENTHOL

Menthol has been commonly used to flavor cigarettes since the 1950s. About 30 percent of all cigarettes sold in the U.S. contain menthol. A third of those are made by Lorillard Tobacco in Greensboro, N.C., which produces Newport cigarettes.

Scientists have reported that menthol dulls the senses and makes smoking easier for new smokers and harder for regular smokers to quit.

How does menthol do it?

-Soothes the respiratory tract

-Masks harshness of smoke

-Anesthetizes the throat

-Tastes good

-Increases production of saliva

GREENSBORO — Pierre Lorillard could hardly have imagined that the small tobacco company he started 250 years ago in New York City would ship 36.3 billion cigarettes a year in the 21st century, 87 percent of which would be flavored with menthol. But the little ingredient found naturally in mint oils poses a serious threat to his legacy: a $3.8 billion cigarette colossus that employs 1,800 people in Greensboro.

Lorillard Tobacco Co. makes more than 91 percent of its revenue from Newport menthol cigarettes.

On Tuesday, however, Lorillard announced the first nonmenthol version of Newport in the brand’s 53-year history.

Although Lorillard makes other nonmenthol brands, including Kent, it has specialized in Newport and sells 35 percent of all menthol cigarettes — a niche that accounts for 29 percent of all cigarettes sold in the country.

The Food and Drug Administration is working on a report about the risks of menthol in cigarettes. Specifically, it wants to know how the companies use menthol in their cigarettes, what research they’ve done on the physiological impact of menthol and details on how the companies market the products.

Although the inquiry will concentrate on scientific issues, there also are sensitive matters that involve the people who smoke menthol cigarettes. Among menthol smokers, there are twice as many white smokers as African American smokers. Among African American smokers, however, 75 percent prefer menthol cigarettes.

Analysts say the FDA will surely try to determine what factors are behind that trend.

Lorillard, the No. 3 cigarette maker in America, and the two other major companies — No. 1 Altria Group and No. 2 Reynolds American — submitted their answers to a list of questions from the FDA committee last month.

The FDA could make its ruling later this month, but analysts say a delay of 90 days or more is likely.

A restriction or outright ban on menthol, say analysts, would be a big problem for Lorillard — one of Greensboro’s top employers.

The company built its plant here in 1955 and moved its headquarters from New York here in 1997. It’s the last vestige of a shrinking industry, along with Reynolds, that still flourishes in the Triad.

The FDA earned the right to regulate cigarette ingredients when President Barack Obama signed the Family Smoking Prevention and Tobacco Control act in 2009.

Analysts for FitchRatings, an investor service, say the FDA could take one of four options with its review of menthol:

Study the issue further.
Restrict marketing of menthol.
Begin a partial or phased ban of menthol.
Completely ban the product simply because of the demographic profile of its smokers.
Bob Bannon, Lorillard’s director of investor relations, says that the expansion of Newport is the company’s way of seizing growth in the nonmenthol market, not a defensive maneuver against menthol regulation.

“We do have other nonmenthol brands that the company has sold for many years,” Bannon said. But he said he understands “it is difficult to entirely disassociate the concept of a nonmenthol product in the context of what’s going on with the FDA.”

One analyst said a company that makes even a small change in its top brand is taking a major step.

“Since it is a core product and a core feature of a core product, even subtle changes in the product could have significant impact,” said Richard Hastings, a macro and consumer strategist for Global Hunter Securities of Newport Beach, Calif.

Imagine, for example, that the government was investigating some ingredient in the secret formula for Coca-Cola.

“How would that change the perception of the core product?” Hastings asked. “What would investors think? What would analysts think? How would you build a marketing program to get through that? That’s a way of looking at it.”

Bannon declined to speculate about how Lorillard would devise a marketing plan to expand nonmenthol brands in the event of a potential ban of menthol.

But Hastings said Lorillard is clearly opening its options while still marketing menthol as a natural and benign substance, as it does in its website http://understandingmenthol.com.

It’s a big step for Lorillard, but not a radical one yet.

“I wouldn’t say it’s like taking the oats out of Cheerios,” Hastings said.

Lorillard’s report to the FDA says in great detail that the company uses menthol only as a flavoring that smokers prefer.

Some scientific reports have concluded that menthol makes it harder for smokers to quit the habit. One study asserted that because menthol makes cigarette smoke seem less harsh, a smoker inhales it more deeply.

A report from the University of Medicine and Dentistry of New Jersey reported that the director of a tobacco dependence program, Jonathan Foulds, said: “These results build on growing evidence suggesting that menthol is not a neutral flavoring in cigarettes. It masks the harshness of the nicotine and toxins, affects the way the cigarette is smoked, and makes it more deadly and addictive.”

Lorillard has a distinctly different view based on its own research, presented in detail to the FDA and on http://understandingmenthol.com.

“The science is clear and compelling,” William R. True, senior vice president of research and development for Lorillard, writes on the site. “The best available scientific evidence demonstrates that menthol cigarettes have the same health effects as nonmenthol cigarettes. Menthol neither causes people to smoke, nor deters them from quitting. A menthol cigarette is just another cigarette — and should be treated no differently. Menthol cigarettes simply give adult smokers a taste choice.”

Further, according to True, “the evaluation of menthol provides an important opportunity for the FDA to follow sound science exclusively, and not pay heed to political or anti-tobacco influences. Regulators have a responsibility to understand the facts about menthol as they consider this important decision.”

But FitchRatings analysts write that the FDA could see science in a different way: “The risk for tobacco companies lies in the FDA potentially choosing to give more weight to studies that find menthol cigarettes harmful for reasons of better data collection, better study methodology, or other factors.”

An artfully disguised racket to promote smoking among young children with the use of cigarette-shaped candy has been detected in many parts of the country. This candy is now freely available for sale at various outlets in the main towns including Colombo.The candy which wraped with a cigarette shaped cover is meant to be sucked by placing it between the lips – similar to how a cigarette is smoked.

Professor Carlo Fonseka, the chairman of the National Commission to curb the use of Tobacco and Alcohol and Drugs said he was unaware of this latest racket.

“However, if anyone wishes to make a complaint regarding such material they can inform the District Tobacco Control Centres (DTCC) and necessary action will be taken against the sellers,” he assured.

The DTCC are regional units of NATA and comprises officials from the Excise Department and other government bodies.

Professor Fonseka said the public could also inform NATA regarding such matters by dialing the toll-free hotline No: 1948.

The promotion of cigarettes and liquor through advertising and other means is banned.