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Uruguay Defeats Philip Morris In Major Win For Anti- Smoking Advocates

Uruguay has defeated Philip Morris, the global tobacco giant, in a major international lawsuit over the country’s tough anti-smoking regulations. The Swiss-based company sued Uruguay at the World Bank’s International Center for Settlement of Investment Disputes under the terms of a 1991 bilateral investment treaty between Uruguay and Switzerland.

Philip Morris, which was founded in London in 1847, is now the world’s largest cigarette manufacturer with annual revenues of over $80 billion. It has been waging an aggressive battle around the world against national laws requiring tobacco companies to print graphic warnings about the health impacts of smoking. So far it has lost  lawsuits in courts in Australia, Norway, Thailand and the UK.

On March 26, 2010, Philip Morris filed a complaint against Uruguay at the World Bank arbitration tribunal. The action was intended to escalate the fight to an international level and to take advantage of trade agreements that typically favor major corporations by allowing them to claim damages from laws that deny them profits from their investments.

“This is like David and Goliath,” Silvina Echarte Acevedo, the legal adviser in charge of the Uruguayan ministry of public health’s case, told the Independent newspaper.

“They are bullying us because we are small.”

In suing the small South American country, Philip Morris also hoped to strike down some of the toughest anti-smoking laws in the world. Uruguay requires tobacco companies to print health warnings and graphic images such as diseased lungs and rotting teeth that cover 80 per cent of both sides of cigarette packets. It also requires companies to use the same image for all its products making it hard for the company to promote sub-brands like lights or mild cigarettes. Taxes have been hiked and smoking in public places have been banned.

On October 13, 2014, Paul Reichler, a lawyer with Foley Hoag, in Washington DC, responded on behalf of the Uruguayan government, citing the country’s obligations under the World Health Organisation’s 2005 Framework Convention on Tobacco Control.

The case was heard by a three person panel under arbitration rules that allow each party to appoint a judge each and mutually agree on a third. Not surprisingly when the verdict was delivered on July 8, 2016, Piero Bernadini, appointed by Uruguay, sided with the country, while Gary Born, apppointed by Philip Morris, sided with the company. The deadlock was broken by James Crawford, an Australian judge appointed by the World Bank, who sided with Uruguay.

“It is not acceptable to prioritize commercial considerations over the fundamental right to health and life,” Uruguay’s President Tabaré Vázquez announced in a victory speech to his citizens. “The health measures that we have imposed to control tobacco and protect the health of our people have been recognized as legitimate and adopted as a sovereign function of our republic.”

Other politicians and anti-smoking advocates applauded the verdict, notably Michael Bloomberg, the billionaire former mayor of New York city who helped fund Uruguay’s
defense.

“This is a major victory for the people of Uruguay — and it shows countries everywhere that they can stand up to tobacco companies and win,” Bloomberg said. “No country
should ever be intimidated by the threat of a tobacco company lawsuit, and this case will help embolden more nations to take actions that will save lives.”

The company attempted to put its best face forward. “We’ve never questioned Uruguay’s authority to protect public health,” Marc Firestone, general counsel at Philip Morris. “The arbitration concerned an important, but unusual, set of facts that called for clarification under international law, which the parties have now received. For the last seven years, we have already been complying with the regulations at issue in the case, so today’s outcome doesn’t change the status quo.”

However the company’s previous statements make it clear that this is a significant defeat.

“The large size of these warnings prevents us from effectively displaying our trademarks and goes beyond what could reasonably be considered appropriate to inform consumers of the well-established health risks of smoking,” Morgan Rees, a spokesperson for Philip Morris, told Investment Arbirtation Reporter. “This is without precedent anywhere in the world.”

New Lawsuit Risks for Philip Morris International Inc. as EU Anti-Smuggling Deal Expires

http://www.nwitimes.com/business/investment/markets-and-stocks/new-lawsuit-risks-for-philip-morris-international-inc-as-eu/article_ee55dad7-8e5f-5d1e-99d6-025b394384f7.html

The litigation risk of Philip Morris International (NYSE: PM) just rose exponentially as its decade-old agreement with the European Union to combat cigarette smuggling expires and the commission has opted to not extend it. With its cloak of legal protection now removed, investors ought to expect anti-smoking activists to launch lawsuits against the tobacco company for its alleged role in the illicit cigarette trade.

It’s been argued that as government taxation of tobacco products approached usurious levels, the tobacco companies sought to minimize the duties they had to pay by conspiring with smugglers who were often connected to organized crime to trade cigarettes on the black market.

Investigations purported to show that executives of Philip Morris, Reynolds-American (NYSE: RAI), British American Tobacco (NYSEMKT: BTI), and others were well aware of the nefarious connections their shady partners had, and with lawsuits piling up against them, they entered into an agreement with the EU to be shielded from liability for smuggling in exchange for making annual payments to the European Commission (EC) that would go to programs to combat cigarette smuggling.

The deal was signed on July 9, 2004 and would run for a period of 12 years. Similar agreements were subsequently signed with British American Tobacco, Imperial Tobacco (NASDAQOTH: ITYBY), and Japan Tobacco (NASDAQOTH: JAPAF), but lawsuits against Reynolds’ R.J. Reynolds division are still going on.

Philip Morris says the agreements are effective and noted that seizure of its own branded cigarettes has declined by 85% since 2006.

According to an annual survey conducted by accounting giant KPMG for the EC at the behest of the tobacco companies, illegal cigarettes accounted for 9.8% of all cigarettes consumed in the European Union in 2015, or 53 billion cigarettes, representing a loss in tax revenues of 11.3 billion euros. Yet most of the illegal cigarettes, or 88%, come from markets outside of the EU, with Belarus being the biggest source of the illicit trade. That, says the tobacco industry, highlights the effectiveness of the agreement it has had with the member states.

Philip Morris noted, “With or without (the agreement’s) renewal, PMI’s priority remains the measures contained within it. PMI’s ongoing commitment to continued efforts and investments around the world to tackle illicit trade remains intact and stronger than ever.”

Anti-smoking activists would beg to differ, saying the tobacco companies have gotten off cheap, paying almost $2 billion over the life span of the agreements, thus insulating themselves from lawsuits, which, if successful, would undoubtedly be a much larger cost.

Tobacco Company Payments Made Expiration Date
Philip Morris $1.2 billion over 12 years July 9, 2016
Japan Tobacco $400 million over 15 years Dec. 14, 2022
Imperial Tobacco $300 million over 20 years Sept. 27, 2030
British American Tobacco $200 million over 20 years July 15, 2030

Data source: Tobacco Control.

The activists are calling for immediate investigations of the tobacco companies following the expiration of their respective agreements. Because Philip Morris’ agreement is the first to expire, it is the one that will have the anti-smoking lobby’s guns trained on it.

While the member states of the EU were reportedly in favor of extending the agreements, no doubt enjoying the cash that flowed into their coffers from the tobacco companies, the commission said it was no longer necessary as strict new laws enacted this year that require tracing of tobacco sales while banning certain types of cigarettes made the agreements obsolete.

The industry had also angered the commission by suing to prevent the new laws from taking effect. Now Philip Morris, as the biggest and most visible symbol of that opposition, and no longer possessing its cloak of legal protection, could very soon see a wave of lawsuits wash over it.

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PAHO/WHO congratulates Uruguay for successfully defending tobacco control policies, “a model for the region”

The Pan American Health Organization/ World Health Organization (PAHO/WHO) congratulated n Friday the Government of Uruguay for winning an international legal case brought by the Philip Morris tobacco company. Philip Morris challenged tobacco control regulations implemented by Uruguay in compliance with its obligations under the Framework Convention on Tobacco Control (FCTC), the world’s first international public health treaty negotiated under the auspices of WHO.

http://en.mercopress.com/2016/07/09/paho-who-congratulates-uruguay-for-successfully-defending-tobacco-control-policies-a-model-for-the-region

The World Bank’s International Centre for Settlement of Investment Disputes (ICSID) confirmed today that the measures applied by the Government of Uruguay to reduce tobacco consumption did not violate Philip Morris’ trade rights as established in investment agreements between Uruguay and Switzerland, where the company is headquartered.

“This decision serves not only as recognition of Uruguay’s continuing efforts to protect its population against tobacco consumption and exposure to secondhand smoke but also as a precedent and a call to all countries in the Americas and indeed worldwide to implement these measures without fear of violating any treaty, despite challenges by the tobacco industry,” said PAHO Director Carissa F. Etienne.

She added that, “PAHO/WHO supported Uruguay’s defense of these measures, which were aimed at saving lives. This is a very important day for all, as this case becomes a model for the Region of the Americas and the world in fighting the tobacco epidemic irrespective of threats from the tobacco industry.”

In a letter to Tabaré Vázquez, President of Uruguay, Dr. Etienne offered her congratulations and said that the decision “reaffirms the sovereign right of States to protect the lives and health of their populations over commercial interests.”

In his address to the nation, President Vasquez stated, “We reaffirm our commitment to continue a direct and frontal fight against tobacco consumption to reduce more and more the heavy burden this epidemic places on our people and to continue to promote the full implementation of the Framework Convention on Tobacco Control, inviting all countries to join us in fighting this plague, without fear of reprisals from the powerful tobacco industry, just as Uruguay has done”.

PAHO/WHO views Uruguay’s laws and regulations aimed at reducing tobacco consumption as being fully aligned with the provisions of the FCTC. In force since 2005, the FCTC obliges its States Parties to apply a series of policies and measures to reduce tobacco consumption and protect their populations against secondhand smoke.

Philip Morris first presented its claim in February 2010, after Uruguay implemented regulations requiring health warnings to cover 80% of the main surface of tobacco packages, and limiting tobacco manufacturers to one unique package per cigarette brand. Uruguay presented written arguments defending its tobacco control efforts at ICSID, and PAHO/WHO supported the country’s defense with an amicus brief.

Despite the industry’s legal challenge, in 2014 Uruguay accomplished a full ban on tobacco advertising, promotion and sponsorship by including a new prohibition on product promotion and display at the point of sale. In addition, Uruguay became the second country in the Americas (after Nicaragua) to ratify the Protocol to Eliminate Illicit Trade in Tobacco Products, a new international treaty and the first FCTC protocol.

A 2012 study published in The Lancet showed an average 23% decline in tobacco consumption in Uruguay between 2005 and 2011. The decline was more pronounced among young people. A separate 2011 study showed an association between the implementation of regulations mandating smoke-free public places in Uruguay and a
22% decline in hospitalizations due to acute myocardial infarction.

Currently 30 of 35 countries in the Americas have ratified the FCTC, which calls for tobacco control measures including the use of graphic warnings on tobacco packaging; monitoring of tobacco consumption; measures to protect the population from secondhand smoke; support for smoking cessation; enforcement of bans on tobacco advertising, promotion and sponsorship and increased taxes on tobacco.

Tobacco kills some 6 million people worldwide each year, both through direct consumption and exposure to secondhand smoke. At least 1 million of these deaths occur in the Americas.

Tobacco giant loses lawsuit in Uruguay

http://www.odt.co.nz/news/world/389834/tobacco-giant-loses-lawsuit-uruguay

The World Bank’s International Centre for Settlement of Investment Disputes has ruled in favor of Uruguay in a suit filed by Philip Morris International seeking compensation for economic damages caused by the nation’s anti-tobacco measures.

Uruguay imposed a ban on smoking in public spaces in 2006, as it raised taxes on tobacco products and forced firms to include large warnings and graphic images including diseased lungs and rotting teeth on cigarette packages.

It also banned the use of the words “light” and “mild” from cigarette packs to try to dispel smokers’ misguided beliefs that the products are safer.

“The health measures we implemented for controlling tobacco usage and for protecting the health of our people have been expressly recognised as legitimate and also adopted as part of the sovereign power of our republic,” Uruguayan President Tabare Vazquez said in a televised speech.

Vazquez, an oncologist, helped spearhead the measures during his first term in office from 2005 to 2010.

In a lengthy decision published on Friday, the ICSID said it had ruled to dismiss Philip Morris’ demand that the regulations be withdrawn, or not applied to the company, or that it be paid $US22 million ($NZ30 million) in damages instead.

It ordered the tobacco company to pay Uruguay $US7 million and to cover “all the fees and expenses of the Tribunal and ICSID’s administrative fees and expenses.”

Phillip Morris said it respected the tribunal’s decision.

“We’ve never questioned Uruguay’s authority to protect public health, and this case wasn’t about broad issues of tobacco policy,” Marc Firestone, Philip Morris International senior vice president and general counsel, said in a statement.

“The arbitration concerned an important, but unusual, set of facts that called for clarification under international law,” added Firestone.

The tobacco company said that it would like to meet with Uruguay’s government, to explore regulatory frameworks that would enable smokers “in the country to have informed access to reduced-risk alternatives to smoking.”

Action on Smoking and Health (ASH), the oldest anti-tobacco organization in the United States, applauded Uruguay for winning the case, but said Phillip Morris “accomplished its primary goal.”

Phillip Morris “will no doubt shed some public crocodile tears, but their main goal in launching the suit has been realized, six years and millions of dollars have been spent defending a nondiscriminatory law that was intended purely to protect public health,” said Laurent Huber, executive director for ASH.

“This has already resulted in regulatory chill in other countries, preventing tobacco legislation that would have saved lives,” Huber said.

Uruguay: The little country that changed tobacco laws

Uruguay won a major case against Philip Morris in a World Bank ruling that could embolden other small countries that want to deter tobacco use.

http://www.csmonitor.com/World/Global-News/2016/0709/Uruguay-The-little-country-that-changed-tobacco-laws

The Latin American nation of Uruguay, with a GDP of $50 billion, went up against a tobacco company that takes in $80 billion annually – and won, ruled an international court on Friday.

Uruguay is a small country that impacts world politics only rarely. But that is precisely the point, say its allies in the fight against tobacco.

“The lesson here is that when a small country like Uruguay gets attacked, the public health community around the world will rally behind them so that these countries don’t have to fight these cases alone,” Matthew L. Myers, president of the Washington, D.C.-based Campaign for Tobacco-Free Kids, tells The Christian Science Monitor.

That Uruguay triumphed so completely in its litigation against Philip Morris International – the court even ordered Philip Morris to pay Uruguay’s court costs – suggests packaging laws for tobacco have friends in high places.

“What the tobacco companies do in these cases is just hunker down and look ugly and say, ‘We’re going to spend more money than you’ve got,’ ” Stanton Glantz of the Center for Tobacco Control Research and Education told the Monitor in May. “So the train of losses will embolden other countries to not be so frightened.”

The case was a risky one for Uruguay, Mr. Myers says. Some suggested Philip Morris would bankrupt the country if the government refused to settle a lawsuit over cigarette packaging regulation out of court, but Michael Bloomberg, three-term New York City mayor and founder of Bloomberg Philanthropies, promised the country financial support for court fees.

In 2015, a fund was established through the Campaign for Tobacco-Free Kids to help smaller countries fight for their anti-tobacco laws in court. Bloomberg Philanthropies and the Bill & Melinda Gates Foundation contributed money, meaning future efforts by tobacco companies to litigate restrictive packaging laws could become cases of billionaires fighting billionaires.

“It shows countries everywhere that they can stand up to tobacco companies and win,” Mr. Bloomberg said in a press release. “No country should ever be intimidated by the threat of a tobacco company lawsuit, and this case will help embolden more nations to take actions that will save lives.”

With this decision, the court upheld two strict laws on cigarette packaging. Throughout the seven years of litigation, Uruguay has required graphic warnings about the health dangers of tobacco to cover 80 percent of the cigarette pack, both front and back. It also limits each company to a single pack design, undercutting color-coded brands and use of words such as “light,” and forcing the company to pull seven of its twelve brands off Uruguay’s shelves, the Financial Times reported.

“We’ve never questioned Uruguay’s authority to protect public health,” Marc Firestone, general counsel at Philip Morris, told the Associated Press. “The arbitration concerned an important, but unusual, set of facts that called for clarification under international law, which the parties have now received.”

The debate around tobacco marketing has moved into the judicial sphere, where governments and tobacco companies are fighting cases around both domestic trademark laws and international trade agreements. This marks the second case this summer in which a government has won the right to restrict tobacco packaging in court. The first nation to win such a case was Australia, and then in May a British court upheld the government’s right to require plain, green packaging on cigarette cartons, the Monitor has reported previously.

“Because Australia was successful, the UK was successful, and because the UK was successful the EU can be successful, and because of this whole cascading impact, you see a lot of countries going above and beyond,” Timothy Mackey, a professor specializing in health law at the University of California San Diego, told the Monitor at the time.

The most immediate impact could come from Latin America itself, Meyers says, where governments in Uruguay and Chile have been weighing the implications of even stricter laws to require unadorned, uniform packaging plain on cigarette cartons. The court’s decision could embolden these countries to further regulate the tobacco industry inside their borders.

Uruguay defeats Philip Morris test case lawsuit

Uruguay has won a landmark lawsuit against Philip Morris International, which was suing the South American country for its strict regulations on smoking in what was seen as a test case for the tobacco industry.

Friday’s decision sets an important precedent for other countries considering implementing similar legislation, with anti-tobacco campaigners accusing Philip Morris of using litigation to scare others from following Uruguay’s example.

“The attempts of the tobacco companies have been roundly rejected,” said Uruguay’s President Tabaré Vázquez, an oncologist who has made the fight against tobacco one of his flagship policies. “It is not acceptable to prioritise commercial considerations over the fundamental right to health and life,” he added in a televised address to the nation.

In its lawsuit at the World Bank’s International Center for Settlement of Investment Disputes, which marked the first time a tobacco group had taken on a country in an international court, Philip Morris argued that Uruguay had violated terms of a bilateral investment treaty with Switzerland, where it has its headquarters in Lausanne.

The world’s biggest tobacco company — whose annual revenues of more than $80bn across 180 countries far exceed Uruguay’s gross domestic product of closer to $50bn — claimed that a 2009 anti-tobacco law damaged its intellectual property rights and hit sales.

Philip Morris — which has lost lawsuits in Norway, Australia and the UK — opposed the Uruguayan anti-tobacco law’s requirements that graphic health warnings cover 80 per cent of both sides of cigarette packets, and that brands have a single image, thereby prohibiting sub-brands such as Marlboro Red or Marlboro Gold. That forced Philip Morris to withdraw seven of its 12 brands from shops in Uruguay.

“We’ve never questioned Uruguay’s authority to protect public health,” said Marc Firestone, general counsel at Philip Morris, who clarified that the company had been complying with the regulations at issue in the case for the past seven years. “The arbitration concerned an important, but unusual, set of facts that called for clarification under international law, which the parties have now received,” he added.

Some observers have remarked on the apparent irony that in 2013 Uruguay legalised marijuana, which is due to start being sold in pharmacies this month, while at the same time it is clamping down on tobacco. But others say that Uruguay’s trailblazing efforts to regulate marijuana and tobacco are consistent, arguing that both industries are insufficiently controlled.

“This is a major victory for the people of Uruguay — and it shows countries everywhere that they can stand up to tobacco companies and win,” said former New York City Mayor Michael Bloomberg, who provided Uruguay’s lawsuit with financial support. “No country should ever be intimidated by the threat of a tobacco company lawsuit, and this case will help embolden more nations to take actions that will save lives,” he added.

According to health ministry figures, the number of Uruguayans who smoke had fallen to 22 per cent of the population by 2014, from 35 per cent in 2005. The number of young smokers fell to 8 per cent in 2014, from 23 per cent in 2006, when Uruguay became the first country in the region to ban smoking in enclosed public spaces.

Phillip Morris loses tough-on-tobacco lawsuit in Uruguay

http://www.reuters.com/article/us-pmi-uruguay-lawsuit-idUSKCN0ZO2LZ

The World Bank’s International Centre for Settlement of Investment Disputes (ICSID) ruled in favor of Uruguay on Friday in a suit filed by Philip Morris International seeking compensation for economic damages caused by the nation’s anti-tobacco measures.

Uruguay imposed a ban on smoking in public spaces in 2006, as it raised taxes on tobacco products and forced firms to include large warnings and graphic images including diseased lungs and rotting teeth on cigarette packages. It also banned the use of the words “light” and “mild” from cigarette packs to try to dispel smokers’ misguided beliefs that the products are safer.

“The health measures we implemented for controlling tobacco usage and for protecting the health of our people have been expressly recognized as legitimate and also adopted as part of the sovereign power of our republic,” Uruguayan President Tabare Vazquez said in a televised speech.

Vazquez, an oncologist, helped spearhead the measures during his first term in office from 2005 to 2010.

In a lengthy decision published on Friday, the ICSID said it had ruled to dismiss Philip Morris’ demand that the regulations be withdrawn, or not applied to the company, or that it be paid $22 million in damages instead.

It ordered the tobacco company to pay Uruguay $7 million and to cover “all the fees and expenses of the Tribunal and ICSID’s administrative fees and expenses.”

Phillip Morris said it respected the tribunal’s decision.

“We’ve never questioned Uruguay’s authority to protect public health, and this case wasn’t about broad issues of tobacco policy,” Marc Firestone, Philip Morris International senior vice president and general counsel, said in a statement.

“The arbitration concerned an important, but unusual, set of facts that called for clarification under international law,” added Firestone.

The tobacco company said that it would like to meet with Uruguay’s government, to explore regulatory frameworks that would enable smokers “in the country to have informed access to reduced-risk alternatives to smoking.”

Action on Smoking and Health (ASH), the oldest anti-tobacco organization in the United States, applauded Uruguay for winning the case, but said Phillip Morris “accomplished its primary goal.”

Phillip Morris “will no doubt shed some public crocodile tears, but their main goal in launching the suit has been realized, six years and millions of dollars have been spent defending a nondiscriminatory law that was intended purely to protect public health,” said Laurent Huber, executive director for ASH.

“This has already resulted in regulatory chill in other countries, preventing tobacco legislation that would have saved lives,” Huber said.

(Reporting by Anthony Esposito and Malena Castaldi; Writing by Anthony Esposito; Editing by Tom Brown)

Philip Morris and Uruguay ICSID Case No. ARB/10/7

Download (PDF, 3.36MB)

E-cig explosions blamed for facial injuries, severe burns

Dozens of lawsuits allege serious injuries caused by exploding batteries

https://www.consumeraffairs.com/news/e-cig-explosions-blamed-for-facial-injuries-severe-burns-070516.html

The exploding cigar was a mainstay of slapstick humor back in the day. But there’s nothing funny about an exploding e-cigarette, according to those who’ve had the experience.

Dozens of lawsuits have been filed by consumers who say their e-cigs blew up, causing serious and expensive injuries. The Food and Drug Administration has found 134 reports of overheating, fires, and explosions of the devices in the U.S. between 2009 and January 2016, the Wall Street Journal reports. The FDA is phasing in rules covering the devices, which will eventually require government approval before they can be marketed.

Most of the lawsuits allege that the explosions and injuries were caused by the lithium-ion batteries used in the devices, which are mostly made by Chinese companies. The industry argues that the number of explosions and fires is small considering how many of the devices are in use and says many of the mishaps are the result of user error.

Severe burns

A jury in Riverside, Calif., recently awarded $1.9 million in damages to a woman who suffered severe burns when her e-cigarette exploded while hooked up to a car charger. Like most such suits, hers named the retailer, distributor, and wholesaler rather than the manufacturer, since it’s difficult to sue an overseas company.

The Journal article notes another case, that of Rachel Berven of Modesto, Calif. She had been using her vaping device — as the e-cigs are called — for about a year. One day she inserted a new battery and when she fired the device up, it exploded, ripping a hole in her mouth and spewing acid across her body, leaving her with three cracked teeth and scars on her legs and elsewhere.

In another gruesome case, a school counselor in California alleges that his e-cig exploded and tore through his eye, smashing two cheekbones and starting a fire.

Joseph Cavins said he was working at his computer on April 15 when his e-cig “suddenly exploded, striking Joseph in the left eye, continuing past his head, hitting the ceiling, ricocheting off the wall and landing on top of the computer station, where it started a fire,” according to his complaint in Orange County Court, Courthouse News Service reported. He has sued four distributors and retailers.

Cavins said the explosion smashed his orbital and sinus bones, “left several pieces of shrapnel inside the eyeball itself,” causing doctors to remove the eyeball. He will need more surgery to fix his broken bones, reconstructive surgery on his sinus cavity, and he and his wife have both missed work. He sued four distributors and retailers.

The vaping industry contends that many of the incidents are the result of consumers using the wrong chargers. Others involve the more complex “mechanical mods,” which are more customizable than the smaller, cigarette-like e-cigs.

“When used and charged properly, vapor products pose no more of a fire risk than any other product that is powered by lithium-ion batteries, like cellphones or laptops,” Gregory Conley of the American Vaping Association told the Journal.

The FDA’s Deeming Rule On Vapor Products Must Be Challenged

http://www.forbes.com/sites/realspin/2016/06/30/the-fdas-deeming-rule-on-vapor-products-must-be-challenged/#58f5a11f3e0e

Legal challenges to the U.S. Food and Drug Administration’s (FDA) final deeming rule on vapor products are mounting, with lawsuits focusing on various aspects of the regulations, including claims ranging from violations of the Regulatory Flexibility Act and Administrative Procedure Act, to infringement of freedom of speech under the First Amendment and encroachment of the Fifth Amendment’s due process clause.

It is likely that more lawsuits will follow. In fact, the Smoke-Free Alternatives Trade Association (SFATA) supports the Right to Be Smoke-Free Coalition (RSF) who have filed a suit of their own challenging the FDA’s industry-crushing rule.

One of our fundamental objections to the deeming rule is that the FDA lacks the authority to regulate vapor products in the absence of therapeutic claims. Many legal experts agree that the Tobacco Control Act was never intended to apply to vapor products.

FDA is trying to extend its jurisdiction over e-cigarettes

The courts have been vigilant in policing the FDA’s over assertion of jurisdiction. The Supreme Court rejected the agency’s attempt to regulate nicotine as a “drug” and cigarettes and smokeless tobacco as “devices” in FDA v. Brown & Williamson Tobacco Corporation. Likewise, in Sottera Inc. v. FDA, the U.S. Court of Appeals for the D.C. Circuit rejected the FDA’s attempt to regulate e-cigs as unregulated medical devices, holding that unless a vapor product is marketed for therapeutic purposes, the agency may not regulate them as drugs, devices or combination products.

At the time the D.C. Circuit issued its ruling in Sottera, the FDA had not yet deemed e-cigs to be subject to its authority. Thus, the question presented in Sottera was not whether e-cigs are tobacco products, but whether they were, as FDA then asserted, “drugs” or “devices.” The D.C. Circuit rejected the FDA’s position, noting that the agency had frequently expressed the view that “cigarettes are beyond the scope of the Food, Drug and Cosmetic Act (FDCA) absent health claims establishing a therapeutic intent on behalf of the manufacturer or vendor.”

The FDA’s final regulations purport to address the jurisdictional lines established by Sottera by deeming vapor products as tobacco products subject to the FDCA. However, vapor products do not meet the definition of a “tobacco product.” As defined in Section 201 of the FDCA, as amended by the Tobacco Control Act, a “tobacco product” is “any product made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product.”