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It’s Been A Bad Year For Big Tobacco

Dec 18th, 2015
by Editor.
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http://www.huffingtonpost.com/entry/big-tobacco-losses_5673f7e0e4b06fa6887cebe2

Cigarette companies found themselves the targets of tighter regulations and lawsuits.

Anti-smoking activists have for years targeted the global behemoths that control the tobacco industry — and this year they made headway. Some of the largest tobacco companies suffered financial and PR setbacks in a series of lawsuits, and anti-smoking initiatives worldwide are further curbing their power.

Here are the losses big tobacco suffered this year:

Packs of Philip Morris International Inc. Marlboro Menthol cigarettes in the new packaging are arranged for a photograph at a tobacco store in Melbourne, Australia, on Monday, Oct. 1, 2012. Tobacco products complying with the world?s first plain-packaging laws have started arriving in stores, as an Oct. 1 manufacturing ban on the country's A$10 billion ($10 billion) tobacco industry comes into force. Photographer: Carla Gottgens/Bloomberg via Getty Images

Packs of Philip Morris International Inc. Marlboro Menthol cigarettes in the new packaging are arranged for a photograph at a tobacco store in Melbourne, Australia, on Monday, Oct. 1, 2012. Tobacco products complying with the world?s first plain-packaging laws have started arriving in stores, as an Oct. 1 manufacturing ban on the country’s A$10 billion ($10 billion) tobacco industry comes into force. Photographer: Carla Gottgens/Bloomberg via Getty Images

Australia Can Keep Its Plain Cigarette Packaging

The Australian government won a major lawsuit against Philip Morris this week. It can continue using plain packaging — logo-less packaging that is the same for all tobacco brands — on cigarette packs sold across the country.

Australia introduced “the world’s toughest laws on tobacco promotion” in 2011, according to then-health minister Nicola Roxon. That year the government voted to implement packaging that, instead of logos, displays the frightening illnesses associated with smoking.

Philip Morris Asia unsuccessfully sued the Australian government in 2011, claiming that the law violated a trade agreement between Australia and Hong Kong.

The UK, France and Ireland Will Use Standardized Packaging, Too

Several countries have followed suit on Australia’s anti-smoking measures. Britain and Ireland approved plain packaging laws in March.

France’s parliament also approved a law Thursday that will place plain packaging on all cigarettes sold in the country starting in May 2016. The products’ brand name will only appear in small type.

The country has made several attempts to diminish its large number of smokers. In 2008, it prohibited smoking in enclosed public spaces like restaurants and bars. In October, the city of Paris also raised the fine for dropping a cigarette butt into the street to 68 euros.

Boston Raises Age For Buying Tobacco To 21

Boston’s board of health voted last week to raise the tobacco purchasing age from 18 to 21 in an effort to prevent teen smoking.

Boston followed the lead of many other cities and towns across Massachusetts that had already increased the age limit. “These changes send a strong message that Boston takes the issue of preventing tobacco addiction seriously,” Boston mayor Marty Walsh said.

New International Trade Laws Block Tobacco Companies From Suing Countries

The Trans-Pacific Partnership, a trade agreement between the U.S. and 11 countries in the Pacific Rim, ruled in October that tobacco is exempt from Investor-State Dispute Settlement rules. In other words, tobacco companies will no longer be able to challenge TPP member countries’ anti-smoking measures the way that Philip Morris did in Australia in 2011.

Anti-tobacco lobbyists and a few senators helped make it happen. “It was time to take action to get trade agreements to stop treating tobacco like it’s just another product and the tobacco industry like any other business,” said Gregg Haifley, federal relations director of the American Cancer Society Cancer Action Network.

The FDA Forced One Tobacco Company To Stop Selling Several Products

The Food and Drug Administration banned R.J. Reynolds from selling four different types of cigarettes in September — Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13 cigarettes.

The company changed the product ingredients so that they no longer complied with a 2007 federal health law, The Hill reported. The products “fail[ed] to meet the public health bar set forth under law,” explained Mitch Zeller, director of the FDA’s Center for Tobacco Products.

A Jury Imposed $35 Million In Damages On That Same Tobacco Company

R.J. Reynolds was also at the center of a lawsuit in Florida after Garry O’Hara, a U.S. Air Force sergeant who earned the Bronze Star, died of lung cancer in 1996, at the age of 50. O’Hara’s family’s lawyers argued that the company masked the risks associated with smoking for years.

A Florida jury awarded the family $34.7 million in damages in September.

The company tried to argue that the executives responsible for decisions at the time are no longer around. “The R.J. Reynolds leadership that you heard about, they’re gone. … Those people who stood up before Congress and raised their hand, they’re gone,” David Monde, a lawyer for R.J. Reynolds, said in court.

Shady Activity Uncovered Within A Big UK Tobacco Company

The BBC conducted an investigation into British American Tobacco and found that the company bribed politicians and civil servants in East African countries in an effort to “undermine anti-smoking legislation.”

One BAT employee, the BBC said, illegally paid a civil servant in Burundi in exchange for a copy of the country’s Tobacco Control Bill.

The BAT said it was the target of false accusations.

“Our accusers in this programme left us in acrimonious circumstances and have a vendetta against us, clearly demonstrated by the false picture they present of how we do business,” it said in a statement.

The company could face prosecution in the U.K. and the U.S.

Three Cigarette Companies Ordered To Pay CA $15 Billion To Canadian Smokers

Two separate lawsuits, filed by Canadians sickened from smoking and Canadians unable to quit smoking, culminated in the country’s biggest class-action lawsuit to date.

Three tobacco companies — Imperial Tobacco; Rothmans, Benson & Hedges and JTI-Macdonald — were accused of lying to consumers about the health risks associated with their products. They were ordered earlier this year to pay $15 billion (about $10.8 billion USD) to the plaintiffs.

All three companies said they planned to appeal the decision, claiming that Canadians are well-versed in the risks of smoking.

Budget Agreement Protects Kids and Health by Rejecting Tobacco Industry Giveaways

Dec 16th, 2015
by Editor.
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http://www.tobaccofreekids.org/press_releases/post/2015_12_16_budget

Statement of Matthew L. Myers, President, Campaign for Tobacco-Free Kids

Dec. 16 2015

WASHINGTON, DC – The budget agreement reached by congressional negotiators delivers critical victories for America’s kids and health over the tobacco industry by rejecting proposals to greatly weaken FDA oversight of electronic cigarettes and cigars and slash funding for the CDC’s programs to reduce tobacco use. By rejecting these special interest giveaways to the tobacco industry, this agreement bolsters the nation’s fight against tobacco use, the number one cause of preventable death.

The budget agreement does not include a provision, approved by the House Appropriations Committee, to limit FDA oversight of e-cigarettes and cigars already on the market, including many candy- and fruit-flavored products that have been introduced in recent years and proven popular with kids. The agreement preserves the FDA’s ability to review these products and take action to protect our kids.

Now the White House must quickly issue the long-overdue rule extending the FDA’s jurisdiction to all tobacco products, including e-cigarettes and cigars. As the new Monitoring the Future survey confirmed today, youth e-cigarette use has skyrocketed and now exceeds use of regular cigarettes, and teens are using flavored little cigars at the same rate as cigarettes. We cannot afford more delays that allow tobacco companies to continue targeting kids with a new generation of products.

The budget agreement also provides $210 million for the CDC’s programs to prevent kids from smoking and help smokers quit, rejecting a House Appropriations proposal that slashed funding to just $105.5 million (Senate appropriators had provided $216.5 million). The CDC will be able to continue initiatives such as the Tips from Former Smokers media campaign that has proven so successful and cost-effective at helping smokers quit, as well as its assistance to state tobacco prevention programs and state quitlines that help smokers trying to quit.

While the U.S. has greatly reduced smoking, tobacco use still kills nearly half a million Americans and costs us $170 billion in health care expenses each year. It is great news for the nation’s health that the budget agreement rejects tobacco industry efforts to undo this progress.

E-Cigarette Industry Faces Prohibition After Crucial Rider Fails To Make Omnibus Spending Bill

Dec 16th, 2015
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http://dailycaller.com/2015/12/16/e-cigarette-industry-faces-prohibition-after-crucial-rider-fails-to-make-omnibus-spending-bill/

A policy rider that could’ve saved 99 percent of the e-cigarette of from de facto prohibition failed to make it into the House’s omnibus spending bill released Tuesday night.

The rider would’ve changed the Food and Drug Administration‘s (FDA) rules requiring all e-cigarette products released after February 15, 2007, to undergo the costly Pre-Market Tobacco Applications (PMTA) process. This provision was vitally important to vaping businesses and advocates because the cost of the PMTA process for each individual product can run between $2-10 million.

Since e-cigarettes are a relatively new innovation and the industry has grown so rapidly, the vast majority of vaping products would fall under the FDA’s proposed rule. Further, a major portion of the market consists of small, self-proprietary business. As a result, such an enormous tax burden would likely bankrupt 99 percent of the industry.

Small vaping businesses — which typically sell dozens if not hundreds of these products in their stores — will not be able meet this financial burden, putting thousands of jobs at risk and ultimately limiting options for vapers. Indeed, the only companies that would be able to meet this financial and regulatory burden are major tobacco companies that typically stock an extremely limited range of vaping products compared to most e-cigarette shops.

Ironically, the FDA’s regulations, which are intended to safeguard public health, could have the perverse effect of helping the tobacco industry by destroying one of its largest sources of competition — independent e-cigarette companies.

“This deal protects cigarette markets,” said Gregory Conley, President of the American Vaping Association. “Congressional leaders have squandered a real opportunity to benefit both public health and small businesses across the country.”

“Without a change in the 2007 grandfather date, 99.9 percent-plus of vapor products on the market today will be banned. This is nothing more than modern-day prohibition. The FDA’s proposal is an unmitigated disaster and Congress’ failure to act will cost jobs and lives.”

The rider was not only supported by the e-cigarette industry but it also received strong backing from Americans for Tax Reform (ATR) – one of the most powerful advocacy groups in Washington D.C.

In November, ATR president Grover Norquist wrote a letter urging Congress to support the rider saying “it would simply help avoid the looming economic and public health disaster associated with status quo prohibition.”

Dangerous Molecules Discovered in E-Cigarette Aerosols

Dec 5th, 2015
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http://examinerpost.com/dangerous-molecules-discovered-in-e-cigarette-aerosols/

Researchers at Penn State College of Medicine says they have found that electronic cigarettes produce free radicals, which are molecules that cause cell damage and can lead to cancer.

E-cigarettes will soon fall under the same rules as normal cigarettes – not for sale to persons under the age of 18 and restrictions on advertising, RTL Nieuws reports.

Instead of burning tobacco, e-cigarettes work by delivering nicotine in the form of water vapor, giving users an alternative to the many unsafe byproducts of burning tobacco.

Electronic cigarettes are often thought to be safer than cigarettes because they don’t produce smoke or contain the tar and chemical of tobacco.

Commenting on the potential dangers of e-cigarettes, John P. Richie Jr., Professor of Public Health Sciences and Pharmacology at Penn State College of Medicine said, “There’s a perception that e-cigarettes are healthier than regular cigarettes, or at least not as harmful as regular cigarettes”.

“While e-cigarette vapour does not contain numerous toxic substances that are known to be present in cigarette smoke, it’s still important for us to figure out and to minimize the potential dangers that are associated with e-cigarettes”, he said in a statement.

To model the possible harmful effect of e-cigarette vapor, which contains among other things nicotine and flavorings, British American Tobacco partnered with tissue engineering firm MatTek to use a smoking robot with respiratory tissue.

Previous studies have found low levels of aldehydes, which are chemical compounds that can cause oxidative stress and cell damage, in e-cigarette vapor. However, no-one has paid attention to the ‘free radicals’ that can also potentially be produced by e-cigs – even though these are considered to be the primary reason for smoking-related cancer, cardiovascular disease and chronic obstructive pulmonary disease.

“This is the first study that demonstrates the fact that we have these highly reactive agents in e-cigarette aerosols”, Richie said. The researchers measured free radicals in e-cigarette aerosols. Results were published in the journal Chemical Research in Toxicology.

Further research is needed to determine the health effects of highly reactive free radicals from e-cigarettes.

Richie says there’s a perception that e-cigarettes are healthier than regular cigarettes, but his team’s findings suggest the devices may not be free from harm. They are potentially harmful.

Researchers are hoping to eventually measure total numbers in e-cigarette aerosols in order to see how exactly these may impact human health.

National Institute on Drug Abuse of the National Institutes of Health and the Center for Tobacco Products of the U.S. Food and Drug Administration funded this research

Business and Health Interests Push Agendas on E-Cig Regulations

Dec 4th, 2015
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http://www.nacsonline.com/News/Daily/Pages/ND1204151.aspx#.VmFZmeKE4hw

More than 30 meetings are planned with White House officials as the final review of new regulations takes place.

WASHINGTON, D.C. – Ahead of some of the most sweeping changes to rules governing cigars and e-cigarettes, industry groups and health advocates have been bending the ear of the White House to press their suggestions, The Hill reports. The Office of Management and Budget (OMB) is conducting a final review of the new regulations, which move cigars and e-cigs under the U.S. Food and Drug Administration (FDA) for the first time.

Thus far, 21 meetings have been held to talk about the deeming rule, with another dozen or so on the books for December. This means that the new rules will likely not be ready until 2016. Tobacco and electronic cigarette industry representatives constitute the bulk of the meetings, especially because of a potential “grandfather date” for e-cigs in an earlier version of the rules. The proposed rules say that any tobacco product first on the shelves after February 15, 2007, would need to retroactively apply for FDA approval.

“If these rules went through, the only ones left standing would be big tobacco—what you see in convenience stores,” said Schell Hammel of The Vapor Bar Inc., which has seven retail locations. She told OMB that small “vape” shops like hers would have to pay millions of dollars for the required testing for agency approval.

Meanwhile, health advocates have pushed for release of the rules sooner. “E-cigarette manufacturers have been on notice since at least 2011 that FDA planned to regulate their products, but they have taken advantage of the delay in regulation to introduce kid-friendly flavors, and now they want to limit FDA review of those products, which we think is absurd,” said Vince Willmore, vice president of communications for the Campaign for Tobacco-Free Kids.

However, the debate centers more on who has the power to change the grandfather date: the administration, or an act of Congress? The FDA has noted it lacks the authority to do so because the date was set in the Family Smoking Prevention and Tobacco Control Act of 2009.

In March of 2014, NACS issued a statement of position to encourage stores selling e-cigarettes to adopt, as a best practice, a policy of treating these products as age restricted and subjecting them to the same age-verification procedures as those applicable to tobacco products.

AAP Recommends Age of Tobacco Use Products should be raised to 21

Oct 29th, 2015
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http://nycity.today/content/286690-aap-recommends-age-tobacco-use-products-should-be-raised-21

The American Academy of Pediatrics (AAP) has recently recommended that the minimum age to purchase tobacco products and electronic cigarettes should increase to 21. Though a huge decline in tobacco use among teens has seen since 1970s, smoking has been a major health concern for young as well as adult people.

The U.S. Food and Drug Administration (FDA) has also been requested by the AAP to regulate e-cigarettes the same way other tobacco products are regulated. Dr. Karen M. Wilson, chair of the AAP Section on Tobacco Control and section head of Pediatric Hospital Medicine at Children’s Hospital Colorado, said the reason that why the growing popularity of e-cigarettes among adolescents is so dangerous to their long-term health is that the developing brains of children and teens are vulnerable to nicotine.

As per survey results reported by the Centers for Disease Control and Prevention (CDC) in 2104, young adults were increasingly attracting towards e-cigarettes as compared to other tobacco products. Though e-cigarettes are considered as tool to help smokers quit their habit, some researchers suggest it as a gateway to conventional cigarettes. Dr. Claire McCarthy, a primary care pediatrician at Boston Children’s Hospital and an assistant professor of pediatrics at Harvard Medical School, said “We don’t have a lot of good information about the effect of e-cigarettes on youth, because they haven’t been around very long”.

According to the American Association of Poison Control Centers, more than 3,700 children exposed to liquid nicotine were reported at poison control centers in 2014. The AAP agency also recommends to expand smoke-free laws that already govern secondhand smoke to include e-cigarettes as well along with promotion of smoke-free homes and vehicles.

Teens Say They Are Drawn to Flavored or Fruity Tobacco

Oct 28th, 2015
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http://www.scientificamerican.com/article/teens-say-they-are-drawn-to-flavored-or-fruity-tobacco/

New FDA study shows flavored hookahs or e-cigarettes are “gateway” products for children

NEW YORK (Reuters Health) – A survey of teen smokers has added more evidence that flavored tobacco products are particularly attractive to people younger than the legal smoking age.

“Consistent with national school-based estimates, this study confirms widespread appeal of flavored products among youth tobacco users,” the authors, led by Bridget K. Ambrose of the Center for Tobacco Products at the U.S. Food and Drug Administration in Silver Spring, Maryland, wrote in their research letter.

Most tobacco use begins during youth and young adulthood, and although cigarette use has been declining, other products like e-cigarettes and hookah are becoming more common, they wrote.

The researchers used data from a nationally representative study of nearly 46,000 U.S. adults and youth ages 12 to 17 who answered questions about use of cigarettes, e-cigarettes, hookahs, cigars, pipe tobacco, smokeless tobacco, dissolvable tobacco, and other products.

Respondents answered whether or not the first product they ever used had been flavored to taste like menthol, mint, clove, spice, candy, fruit, chocolate, alcohol, or other sweets.

Of 13,651 teens in the survey, 2,900 reported ever using a tobacco product, most commonly cigarettes or e-cigarettes, and 1,152 said they had used tobacco products over the previous month.

Almost 90% of teens who had used hookah, 81% of ever e-cigarette users, 65% of ever users of any cigar type, and 50% of ever cigarette smokers said the first product they used was flavored.

Of the teens who had used any tobacco product over the previous month, 80% had used a flavored one, including 60% of cigarette smokers.

Many youth said flavoring was a reason to use e-cigarettes, hookahs, cigars, smokeless tobacco, and snus pouches, the researchers reported online October 26 in JAMA.

A 2014 study in the journal Tobacco Control found that cigar use is more common among youth age 18 to 25 than any other age group, which may be driven by the popularity of flavored cigars (bit.ly/1l8jX4X).

“A lot of times they’re bubble gum or chocolate or candy flavored, and in many cases the packages are also framed in a manner to appeal to kids,” Centers for Disease Control and Prevention epidemiologist Dr. Brian King told Reuters Health when the 2014 study was published.

They are also less expensive than cigarettes because they are not subject to the same taxes, despite containing the same carcinogens, said Dr. King, who was not involved in the JAMA research letter.

“In many states these products can be purchased for mere pocket change,” he said.

The Food and Drug Administration continues to monitor new and novel tobacco products, Michael Felberbaum, a press officer for the FDA, told Reuters Health by email.

“The FDA evaluates studies as part of a larger body of evidence aimed at assisting in our mission to protect public health and furthering our understanding on particular issues,” Felberbaum said. “Flavored tobacco products have become increasingly common in the United States and are especially attractive to youth.”

“As such, the FDA is particularly interested in monitoring and assessing the use of flavored tobacco products among youth,” he said.

Deeming regulations reach their final hurdle: the White House

Oct 21st, 2015
by AdminCTA.
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http://ecigintelligence.com/deeming-regulations-reach-their-final-hurdle-the-white-house/

Federal control has come a step closer for the U.S. e-cigarette market this week, with the Food and Drug Administration (FDA) sending its proposed deeming regulations to the White House office responsible for their final review.

On Monday, the FDA sent the regulations – which deem e-cigs to be tobacco products, and thereby bring them under the agency’s authority – to the Office of Information and Regulatory Affairs (OIRA) within the Office of Management and Budget (OMB) in the White House.

The OMB’s main role in the deeming regulations process is to ensure that they comply with overall federal policies set by the White House.

Its approval is the final step before the deeming regulations are published and become effective. It could send the regulations back to FDA for further revisions, but will likely approve them and allow them to move forward to publication.

There is no strict timetable for the OMB to comment, although it typically responds to agencies within 60 days.

However, its review could take weeks or months. During this time, the OIRA will consult with stakeholders to assess any unintended consequences that the regulations could have on the vapour industry.

They have been labelled as “economically significant” priorities, which “will be likely to have international trade and investment effects, or otherwise be of international interest”. Several industry groups have said that they will be in contact with the OIRA, including the Smoke Free Alternatives Trade Association (SFATA) and the Consumer Advocates for Smoke-Free Alternatives Association (CASAA).

These groups’ representations to the White House are likely to focus on widely-expressed concerns over the deeming regulations, including the cost of obtaining approval from the FDA for each e-cigarette product – reportedly estimated by the regulatory consultancy SciLucent at $2m-10m per item – and the lack of a meaningful “grandfathering” exemption for existing products.

It is not certain, however, exactly what the FDA has submitted to the OMB. The latest version of the deeming regulations could well differ from the text published for public comment last April, if the agency has decided to make changes based on that feedback.

The OMB previously reviewed the proposed rule before its publication last April by the FDA.

What This Means: The mere fact that the deeming regulations have moved to the OMB provides few clues as to the FDA’s final decisions on their content, although it certainly raises the possibility that no measures on child-proofing have been included, despite being called for by many in Washington and elsewhere.

After all, the FDA omitted those from the first published version, and a public consultation period on their inclusion only finished a few weeks ago: can there have been time for the agency to digest the comments and craft a policy accordingly?

In any case, what the progress of the regulations to the OMB surely does mean is that we can now expect their final publication in a few months at the most, unless – as seems unlikely – the OMB demands substantial changes.

Meanwhile, there may now also be renewed Congressional interest in the Cole bill that would provide a workable grandfathering date for e-cigs, allowing existing products to stay on the market without going through the full FDA approval procedure. That might be a bigger victory for the sector than anything else which could be achieved with the OMB.

– Carly Souther ECigIntelligence staff

FDA launches national public education campaign to prevent and reduce tobacco use among multicultural youth

Oct 7th, 2015
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http://www.healthcanal.com/public-health-safety/67574-fda-launches-national-public-education-campaign-to-prevent-and-reduce-tobacco-use-among-multicultural-youth.html

“Fresh Empire” empowers teens who identify with hip-hop community to live tobacco free

The U.S. Food and Drug Administration today announced the launch of a national public education campaign to prevent and reduce tobacco use among multicultural youth who identify with the hip-hop peer crowd ‒ a group that is often hard to reach and frequently exposed to pro-tobacco images and messages. While multicultural teens identify with more than one group, the FDA is focusing on those in the hip-hop peer crowd because research estimates that they are more likely to use tobacco than other youth.

“Unfortunately, the health burdens of tobacco use disproportionately affect minority teens – particularly African American and Hispanic youth,” said Jonca Bull, M.D., the FDA’s Assistant Commissioner for Minority Health. “The ‘Fresh Empire’ campaign will help reach teens at a key point in their lives when experimenting with smoking can lead to addiction.”

The “Fresh Empire” campaign, which targets youth ages 12-17, works to associate living tobacco free with a hip-hop lifestyle through a variety of interactive marketing strategies, including the use of traditional paid media, engagement through multiple digital platforms, and outreach at the local level. The ads, and particularly the local events, feature community influencers who reinforce that tobacco use is not a part of the hip-hop lifestyle. The ads will air nationally for the first time in conjunction with the 2015 BET Hip-Hop Awards on October 13.

“We know from our research that remaining in control is an important pillar of hip-hop culture. But smoking represents a loss of control, so tobacco use is actually in conflict with that priority,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “The ‘Fresh Empire’ campaign underscores that important message to hip-hop youth, empowering this at-risk peer crowd to live tobacco free.”

Fresh Empire’s messaging reflects hip-hop ideals such as being authentic, powerful, confident, fashionable, creative and trendsetting. The ads are intended to deliver tobacco education in a manner that is straightforward and relevant to hip-hop youth who relate to values such as working hard to achieve success and attaining or regaining control.

The “Fresh Empire” campaign will launch the week of October 12 in approximately 36 markets throughout the United States for at least 24 months. The $128 million campaign is funded by tobacco user fees.

Tobacco use is almost always initiated during adolescence ‒ close to 90 percent of established adult smokers smoked their first cigarette by age 18 ‒ making early intervention critical. In fact, youth initiation numbers show that each day in the United States more than 2,600 youth under the age of 18 smoked their first cigarette, and nearly 600 became regular smokers. Approximately 4.4 million multicultural youth are open to smoking or are already experimenting with cigarettes (i.e., have smoked fewer than 100 cigarettes in their lifetime), highlighting a critical need for targeted youth tobacco prevention efforts.

“Fresh Empire” is part of the FDA’s ongoing efforts to combat tobacco uptake and use among youth, and complements the FDA’s general market at-risk youth education campaign, “The Real Cost,” which launched in February 2014. The FDA’s campaigns are based on the best available science and are evaluated to measure effectiveness in preventing and reducing youth smoking over time.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Tobacco manufacturers revive lawsuit against FDA

Oct 1st, 2015
by Editor.
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http://www.journalnow.com/news/local/tobacco-manufacturers-revive-lawsuit-against-fda/article_e61a0419-c358-57a2-a415-5cda473f2b82.html

The FDA issued an interim enforcement policy May 29 on new tobacco products that appeared to be a response to the lawsuit.

The manufacturers agreed to drop the lawsuit June 2 based on the FDA’s willingness to consider regulatory comments and delay enforcing the initial guidelines.

The FDA’s new guidelines were issued Sept. 8. The manufacturers said in the revived lawsuit that the guidelines imposed similar restrictions.

In the revival of the lawsuit, ITG Brands LLC has taken the place of Lorillard. Although Reynolds spent $29.25 billion to buy Lorillard — essentially to get top-selling menthol brand Newport — the bulk of Lorillard went to Imperial Tobacco Group Plc in a $7.1 billion side deal. ITG Brands is Imperial’s U.S. subsidiary.

The FDA has wanted to broaden its power of prior restraint on the companies’ marketing communications, foremost by saying that its approval is required for changes to labeling of tobacco products and the quantities of products within a package. That includes being able to declare any tobacco product whose label is modified as a new “distinct” product — even if the product’s ingredients and characteristics are not changed.

For example, a modified label could be simply changing the background color.

According to the lawsuit, “over the past four years, FDA has suggested varying interpretations of the act that would improperly broaden the agency’s regulatory authority over tobacco product labels and product quantities.”

“Each time, when challenged, FDA devised a new rationale for the same predetermined conclusion that the changes create a new tobacco product subject to premarket review under the act — a results-oriented approach that is antithetical to proper agency decision-making and inconsistent with the plain language of the act.”

The FDA did not comment Wednesday on the revival of the lawsuit, citing a policy of not commenting on pending litigation.

“Reynolds American’s operating companies are in compliance with the act, and believe that FDA does not have the authority to impose the restrictions outlined in the guidance,” David Howard, a Reynolds spokesman, said.

“The act’s substantial equivalence provisions regulate the introduction of new tobacco products into the market. These provisions address the characteristics of the product itself, not how the product is described. Congress provided different mechanisms for changes to how the product is described in its packaging and labeling.

“FDA is trying to do an end run around these other mechanisms by using the substantial equivalence pathway to regulate packaging and labeling,” Howard said.

Tobacco companies increasingly rely on packaging to build brand loyalty and grab consumers — one of the few advertising avenues left to them after the government curbed their presence in magazines and on billboards and TV.

Some manufacturers changed their packaging labels to associate a certain color with a certain style after the FDA banned the words “light,” “mild,” “medium,” and “low tar” in advertising in June 2010. For example, the blue packaging associated with Camel Lights has become the main identifier of the style; the same with gold and Marlboro Lights.

The revival of the lawsuit comes as the FDA has stretched its regulatory muscles in recent weeks.

On Sept. 15, the FDA prohibited the sale of four brands of R.J. Reynolds Tobacco Co.’s traditional-style cigarettes: Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13.

On Aug. 27, the FDA sent warning letters to a Reynolds American Inc. subsidiary and ITG Brands LLC, saying that advertising traditional cigarette products as “additive free” or “natural” is in violation of federal regulations. The brands are Natural American Spirit for Santa Fe Natural Tobacco Co., Winston for ITG Brands and Nat Sherman for Sherman’s 1400 Broadway N.Y.C. Ltd.

When asked if the two decisions had anything with the revival of the lawsuit, Howard said, “not at all; completely separate issues.”

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