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Public health groups sue FDA on graphic cigarette warning labels

A group of anti-tobacco and public-health groups sued the Food and Drug Administration on Tuesday in an attempt to compel it to establish graphic warnings labels on cigarette packaging and marketing.

It’s been more than 3½ years since there’s been legal or regulatory movement on graphic warnings, particularly on what they will look like and when they will appear.

The 2009 federal Tobacco Control Act required graphic warnings covering the top half of the front and back of cigarette packs and on 20 percent of cigarette advertising.

The FDA was given until June 22, 2011, to issue a final rule requiring such warnings.

The governments of more than 90 countries require similar graphic warning labels. Australia, which was among the first to introduce the labels and has some of the most graphic images, is perhaps the most noteworthy.

The FDA chose nine labels in June 2011, which were scheduled to debut in September 2012. The labels included smoke coming out of a tracheal hole, diseased lungs and gums, and a man who appears deathly ill.

A group of tobacco manufacturers that include R.J. Reynolds Tobacco Co. and Lorillard Inc. filed a lawsuit in September 2011 against the FDA regarding the labels.

Two parallel legal cases with differing judicial opinions have put the initiative on hold.

The anti-tobacco and public health groups argue that the federal Administrative Procedure Act, which governs federal agencies, gives federal courts the power to “compel agency action unlawfully withheld or unreasonably delayed.”

“The FDA is in violation of its nondiscretionary statutory duty,” according to the plaintiffs’ lawsuit.

The plaintiffs contend that one of the legal tracks gives the FDA clearance to implement its final rule on the warning labels. Some plaintiffs argue that the lack of warning labels “makes it more difficult” for them “to educate and counsel members of the public not to smoke.”

In August 2012, a panel of the U.S. Court of Appeals for the D.C. Circuit voted 2-1 that the proposed specific warning labels violated the First Amendment. That ruling did not address the law’s underlying requirement.

The FDA said in March 2013 that it declined to further appeal the D.C. Circuit ruling and would create new warning labels.

In March 2012, the U.S. Court of Appeals for the Sixth Circuit upheld the law’s requirement for graphic warnings, finding that this provision did not violate the First Amendment. The U.S. Supreme Court declined in April 2013 to hear an appeal of the Sixth Circuit ruling.

“The FDA is undertaking research to support a new rulemaking consistent with (the Tobacco Control Act),” spokesman Michael Felberbaum said Wednesday.

While the industry and advocacy groups await the next FDA warning label proposals, several studies have been published that found mixed smoker reactions to the initial nine proposed labels.

In December 2010, an FDA study found putting graphicwarning labels on cigarette packs may stir emotions, but not lead to quitting.

UNC Chapel Hill researchers said in June that 40 percent of participants in their study said they were more likely to consider quitting after exposure to the graphic images, compared with 34 percent with the text warning.

A February 2016 study published by University of Illinois researchers at the journal Communication Research suggests graphic images strike some people as manipulative, a reaction that could backfire on the attempt to steer individuals away from smoking.

Lawsuit plaintiffs

The lawsuit was filed by the American Academy of Pediatrics, the Massachusetts Chapter of the American Academy of Pediatrics, the American Cancer Society, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the Campaign for Tobacco-Free Kids, Truth Initiative, and several individual pediatricians.

Enact Total Ban on E-Cigarettes and Enlargement of Pictorial Health Warnings Promptly

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Tobacco giant warns of plain packet ‘black market’

New Zealand adopting plain packaging on cigarettes will fail to deter smokers, a global tobacco company has said.

http://www.radionz.co.nz/news/national/313004/tobacco-giant-warns-of-plain-packet-‘black-market’

A bill which will mean cigarettes can only be sold in bland brown or green packaging passed its final reading in Parliament this week.

The bill means mandatory health warnings will cover at least three quarters of the packet and tobacco company logos will be removed.

It’s taken three years for the legislation to pass after tobacco companies tried to sue the Australian government.

That legal battle failed last year, and even though the law was still facing challenges, such as by the World Trade Organisation, with other countries also introducing plain packing, legal action was less likely.

But British American Tobacco’s New Zealand spokesman Saul Derber said plain packaging in Australia had been a failure – and it would fail here too.

“Not only is the Australian tobacco plain packaging experiment failing to meet its objectives, the policy is having serious unintended consequences,” he said.

“The tobacco black market has grown by over 20 percent in Australia since the introduction of plain packs, costing the Australian government about $NZ1.5 billion in lost revenue in 2015, Mr Derber said.

He said with no graphic health warnings, no controls preventing sales to youth and no tax it was likely the introduction of plain packaging would grow the black market here as well.

Yadayadayadayada “Plain packaging is an attack on companies’ intellectual property rights and undermines the principles on which international trade is founded,” he said.

Associate Health Minister Sam Lotu-Iiga said yesterday the government was confident it could win any legal action taken by tobacco companies.

“We can’t determine what will happen in the courts, but we feel like we’ve seen the evidence from overseas, we’re pretty comfortable with that, and we’re going to move forward,” Mr Lotu-liga said.

Plain cigarette packaging is expected to hit New Zealand shelves from next year.

As world awaits WTO plain packaging decision, legislation spreads across the globe

http://www.worldtrademarkreview.com/blog/detail.aspx?g=919e2f30-9a11-4e07-82cd-da32ddd18752

The long-awaited decision of a World Trade Organisation panel on Australia’s decision to enforce standardised packaging on tobacco products has been ‘imminent’ for years. While the wait goes on, governments across multiple continents – including Africa, Asia and Europe – are introducing plain packaging legislation at an increasingly swift rate. While this suggests that the tobacco industry’s fight to hold back the spread of plain packaging is on the ropes, the anti-plain packaging lobby has not given up yet.

A major development in the last few months, which may have spurred on recent legislation announcements, was the World Bank dispute settlement body’s dismissal of a case brought by Philip Morris International against Uruguay’s implementation of enlarged label warnings on tobacco products. While this follows lawsuit losses against similar regulations in the UK, Norway and Australia, the Uruguay case has long been viewed as a test case, as it was the first time a tobacco group had taken on a country in an international court on this issue. The dismissal was therefore dubbed by commentators as “more than just a local triumph”, with one law lecturer suggesting it “may make it more difficult for tobacco companies to use lawsuits to produce a ‘chilling effect’ and so discourage countries from introducing tobacco control policies”.

In the months since that decision, a slew of national governments have announced or signed through plain packaging legislation. The push is now truly global. For instance, Gambia looks set to be the first African country to implement plain packaging, as the country seeks to maintain its award-winning anti-tobacco credentials. In Asia, both Malaysia and Thailand are well on their way to introducing a brand-free environment for tobacco, with pushes to introduce it in India and China too. Finally, following the European Court of Justice’s ruling in May that the new EU directive on tobacco products is valid, plain packaging laws came into effect in Hungary last month (with legislation that goes further than the current EU directive).

These recent developments follow similar moves in the last 12 months in Canada, New Zealand, Norway, and France. That’s not forgetting the UK following Australia’s lead by implementing its own standardised packaging laws in May (the same legislation in Ireland was delayed at the last minute). All told, the Canadian Cancer Society lists 14 countries where plain packaging is either now implemented or being formally considered (not including the aforementioned China, Gambia, India, Malaysia and Thailand).

But despite the tide appearing to turn, tobacco conglomerates are refusing to give up just yet. For example, Japan Tobacco International (JTI) recently commissioned research into the views that people hold of uniform packaging in Canada (following the Canadian government’s three-month consultation period about its possible implementation, which began in May). Some of the results were published in an op-ed in the Toronto Sun last week. They suggest low awareness of the consultation, with the results showing that “one in five Canadians had heard of the government’s intention to introduce plain packaging” and “only one in 10 understood what it was about”.

Of course, it is probable that a high proportion of citizens will be unaware of most government consultations – so those results are hardly a surprise. Additionally, plain packaging proponents will argue that this doesn’t have a bearing on the pros and cons of the regime itself. What it does show is, despite the repeated lawsuit losses, tobacco companies are refusing to give up the fight (and, as this very publication’s trip to the Dominican Republic in May demonstrates, cigar companies remain confident that the fight remains winnable).

Of course, this isn’t just a tobacco sector issue and trademark associations have long argued that plain packaging severely impairs the function of trademarks, makes counterfeiting easier and is in violation of international treaties. They have also warned that governments may decide to require plain packaging for other products or industries whose impact on public health is being scrutinised. On the latter, a ‘world first’ study released last week promotes the benefits of plain packaging on sugary products – suggesting that the predicted ‘domino effect’ could soon become reality.

Associations are therefore intent to keep fighting the spread of plain packaging. In June, for instance, INTA wrote to the Swedish government to register its opposition over the country’s decision to consider plain packaging for tobacco products.

The fight, then, goes on. However, as more countries line up to implement plain packaging regimes, it is getting harder to see how a comeback is possible – that is, unless the WTO panel delivers an upper-cut to Australia’s plain packaging regime early next year.

Desensitisation to cigarette package graphic health warnings

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Senegal to start enforcing anti-tobacco law

http://www.africanews.com/2016/08/11/senegal-to-start-enforcing-anti-tobacco-law/

Senegal’s president Macky Sall has approved the enforcement of a law that prohibits tobacco consumption in public places as well as its sale to minors.

This means it is now illegal to sell cigarettes within 200 metres of an educational institution. The law also bans general advertisement of tobacco products.

Cigarette producers have been urged to include messages on the dangers of smoking to their packages.

The approval of the law passed by the country’s parliament two years ago , has been hailed by Senegal’s anti-tobacco programme officials who say tobacco consumption has led to many cases of cancer among Senegal’s youth.

The tobacco industry has been given a six month period to comply with the new rules and regulations.

Hotel and restaurant owners on their part have been given a 9-month deadline to stop accepting tobacco in their various work places.

Tobacco is the leading cause of dead across the world.

The WHO says close to 6 million people die each year as a result of direct and indirect consumption of tobacco.

According to the NGO Action on Smoking and Health, tobacco will kill one billion people in the 21st century if left unchecked.

Big Tobacco’s controversial, ailing crusade against plain packaging

http://www.economist.com/news/business/21703424-big-tobaccos-controversial-ailing-crusade-against-plain-packaging-no-logo

THREE years ago, the government of Togo, which has a gross domestic product of $4 billion, received a letter from Philip Morris International, a tobacco giant which last year earned revenues of $74 billion. The country had been mulling bringing in plain packaging for cigarette boxes. It would risk “violating the Togolese constitution”, the firm’s subsidiary explained, “providing tobacco manufacturers the right to significant compensation.” It then outlined how plain packaging would violate binding global and regional agreements. Togo was in no position to anger its international partners, it suggested.

For health advocates, such tactics are the last refuge of firms they have long denounced. But tobacco companies will do what they can to protect their packaging. They detest warnings with repulsive images of decaying body parts. In 2010 Philip Morris sued Uruguay, claiming that big warnings on boxes violated a trade deal. Then two years later Australia became the first country to go further, banishing iconic trademarks from tobacco packs. Its law mandates that brand names—such as Marlboro, Winfield or Dunhill—appear in grey type against a background of Pantone 448C, a putrid green deemed the world’s ugliest colour by a market-research firm.

Reprints

So tobacco firms sued—in Australian courts, before a UN tribunal and by supporting countries that challenged the rule before the World Trade Organisation (WTO) on the ground that banning trademarks represents an expropriation of intellectual property (IP). Less formally, they and allies have lobbied against warnings and plain packaging in places ranging from Namibia to New Zealand. It has all been surprisingly effective. Until very recently, Australia has been the only country to ban tobacco trademarks from cigarette packs.

Such avenues may be closing. Although the WTO’s decision is still pending, firms lost their other suits against Australia. Last month arbitrators at the World Bank threw out the lawsuit against Uruguay. In May the European Court of Justice upheld a rule on big warnings and Britain’s High Court confirmed one for plain packaging. It seems likely that more governments will in future prioritise public health over IP. Canada, France and Ireland are already moving towards plain packs.

If so, ugly packaging could become the most damaging rule tobacco firms have faced in years. To date many laws have hurt firms in some ways but also, strangely, helped them in others. Bans on advertising lower their costs. Small competitors, unable to advertise, struggle to grow. High excise taxes can be another boon: when taxes are fixed and large, a big increase in the underlying price of a pack amounts to a relatively small rise in the pack’s total price. High prices have sustained tobacco firms, even as smoking rates decline. “They probably have the best pricing power of any industry,” says James Bushnell of Exane BNP Paribas, a broker.

But plain packaging clamps down on one of their last bits of advertising. The design of the box is where they must convey not only the name of the brand but abstract qualities, such as masculinity or the idea that a product is “premium”, and worth an extra outlay. If such traits are stripped from packs, consumers may choose cheaper brands. That is particularly worrisome in emerging markets, says Mr Bushnell, where standard packs would threaten the aspirational appeal of smoking. Other “sin” industries are worried. The International Trademark Association frets that governments might strip trademarks from junk food and liquor.

It may become pointless for cigarette firms to start legal proceedings. The Trans-Pacific Partnership (TPP), a pending free-trade agreement among 12 countries, shields governments from lawsuits over tobacco rules. It may unravel, but future pacts could have similar terms. Only America, where the right to free speech makes standard packs highly unlikely, may remain an anomaly (though it is a signatory to the TPP). In the past investors often viewed a new wave of rules on tobacco as a chance to buy tobacco stocks inexpensively, before they resumed their steady rise. This time may be different.

Philip Morris Gets Its Ash Kicked in Uruguay; Where Will It Next Blow Smoke?

http://www.truth-out.org/opinion/item/37106-philip-morris-gets-its-ash-kicked-in-uruguay-where-will-it-next-blow-smoke

Philip Morris International just lost a six-year battle to block Uruguay’s strong cigarette warning labels, which cover 80 percent of the front and back of cigarette packs, including graphic photos of the damages of smoking.

The decision was made by the World Bank’s trade tribunal, the International Centre for Settlement of Investment Disputes (ICSID), the world’s the leading body to settle international investment disputes.

Philip Morris became the first tobacco company to take on a country in an international court, and it took on one of the smallest. The company argued that Uruguay had violated terms of an investment treaty with Switzerland by enforcing anti-smoking laws. The operational headquarters for Philip Morris International is in Lausanne.

Philip Morris, with gross revenues of US $64 billion in 2010, sued Uruguay, with a GDP of US $32 billion that year, under the investor-state dispute settlement (ISDS) provisions of international trade deals. The tobacco company claimed Uruguay’s health warnings reduced the value of its investment and trademark rights to sell cigarettes in Uruguay. The ICSID trade tribunal upheld Uruguay’s right to protect its people’s health.

Small Country, Easy Prey

Uruguay, nestled between the southern tip of Brazil and the northern part of Argentina, has a small population — 3.4 million — but a big desire to cut tobacco usage. Its president, Tabaré Vázquez, is an oncologist.

Among other anti-smoking efforts, it bans tobacco advertising and smoking in public places.

Such efforts have paid off. A study published in 2012 in The Lancet praised Uruguay’s “substantial, unprecedented decrease” in adult cigarette smoking. The number of adults who smoke in Uruguay fell from 35 percent in 2005 to 22 percent in 2014.

At one level, Uruguay’s win seems to contradict opponents of trade deals like the proposed Trans-Pacific Partnership Agreement (TPP) and Transatlantic Trade and Investment Partnership (TTIP). These opponents say the pending trade agreements would give multinational corporations, such as Philip Morris, the ability to directly challenge public health, worker safety and environmental laws through ISDS provisions.

In this case, however, Uruguay was able to resist Philip Morris because of financial help from Michael Bloomberg in faraway New York. Indeed, before international health groups appeared, Uruguay was considering weakening the health warnings to avoid an even longer battle with Philip Morris.

Neither Bloomberg nor Uruguay disclosed the amount of Bloomberg’s financial help. It is safe to say that Uruguay would have not prevailed without this financial and international political support.

A History of Bullying

Philip Morris’ legal bullying of Uruguay is nothing new. It has bullied other countries, states and cities for years. It does this by filing lawsuits that exhaust the resources of governments that enact anti-smoking laws.

Tobacco companies routinely sued US communities in the 1980s and 1990s to deter them from enacting smoke-free laws, despite the companies almost always losing in court. This strategy often succeeded by using the mere threat of litigation to deter localities from adopting similar laws.

Although tobacco companies almost always lost in court, most localities did not go to court for fear of being sued. Few have the money and ability to hire the expensive lawyers — some of whom are paid as much as $1,000 an hour — to stay in a legal battle with tobacco companies. The threat of legal action was powerful to stop localities. More importantly, the threat of incurring expensive legal fees was enough to deter other cities from enacting laws that ban smoking.

Laurent Huber, the executive director for Action on Smoking and Health, the oldest anti-smoking group in the US, hinted at the effectiveness of this strategy in his post-trial comments. 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,” Huber said.

Likewise, in the 1990s when Australia and Canada first started thinking about requiring cigarettes to be sold in plain generic packaging, tobacco companies threatened to sue them. Standardized plain packaging, as Simon Chapman notes, removes the emperor’s clothes. The companies claimed that these proposals violated their trademark rights, one of the same claims Philip Morris made against Uruguay.

This was despite their own lawyers privately telling them that international treaties permitted governments to require such packaging. The tactic worked; both countries dropped their efforts for two decades. Canada has resumed its efforts, and Australia implemented plain packaging in 2012.

In response, Philip Morris sued Australia in domestic and international trade courts. After a four-year battle, Australia prevailed. The country still faces an industry-inspired challenge in the World Trade Organization, however.

Uruguay’s and Australia’s victories provide some legal precedent about a country’s sovereign right to implement public health regulations for other countries. Indeed, it is just these kinds of precedents that Philip Morris was trying to block. As then Philip Morris Vice President Hugh Cullman observed in 1985, “a sneeze in one country today causes international pneumonia tomorrow.”

He was right to be worried. UK, Ireland and France recently enacted plain packaging, and New Zealand, Canada, Norway, South Africa, Malaysia, Turkey, India and Chile are moving forward.

US Lagging Behind Other Countries

Uruguay’s and Australia’s wins against Big Tobacco are important reminders of how much the United States is lagging. Despite being required by the 2009 Family Smoking Prevention and Tobacco Act, we still do not have pictorial health warnings, much less plain packaging, on tobacco products.

The FDA issued a rule requiring pictorial warnings (albeit smaller than Uruguay’s) in 2011. The tobacco industry blocked this rule in court. That was in no small part because the Obama administration grossly underestimated the benefits and overstated the cost of including the pictorial warnings, including the “pleasure” that smokers would lose if they broke their addictions to nicotine or never started.

The FDA still has not issued new graphic health warnings despite the fact that 91 countries have pictorial health warnings on cigarette packages.

The administration is still pushing the TPP and TTIP, both of which will provide new avenues for Big Tobacco and other corporate interests to sue governments over strong public health policies. It also opposed excluding tobacco, also known as a tobacco “carve-out” in the TPP, and was willing to support only mild limits on Big Tobacco’s ability to use ISDS provisions to directly sue governments over their tobacco control policies.

TPP members would still need to “elect to deny” the ability of tobacco companies to sue directly, creating a loophole for them to continue intimidating governments with potential ISDS challenges.

With both the Republican and Democratic presumptive nominees for president opposing the TPP, it is time for the next president to start removing provisions of trade agreements that empower big companies to sue governments over health and environmental protections.

And, in the meantime, the administration should follow Uruguay, Australia and the rest of the world and require 21st-century warning labels on tobacco products.

Disclosure statement: Eric Crosbie receives funding from the National Institute of Health, and Stan Glantz receives funding from the National Institutes of Health and Truth Initiative. He is the president of the University of California Council of Faculty Associations.

Who really won the legal battle between Philip Morris and Uruguay?

The tobacco giant has to pay $7m to the small South American nation in a dispute over cigarette adverts. But the case could still set a worrying precedent

https://www.theguardian.com/global-development/2016/jul/28/who-really-won-legal-battle-philip-morris-uruguay-cigarette-adverts

This month, campaigners celebrated the legal defeat of tobacco giant Philip Morris by Uruguay at the World Bank-hosted international centre for the settlement of investment disputes.

Philip Morris filed its controversial $25m (£19m) claim for damages at the World Bank arbitration court six years ago, saying it had “no choice but to litigate” due to Uruguay’s introduction of graphic warnings on cigarette packets. On 8 July, two of the three arbitrators ruled that Uruguay had the right to continue its anti-cigarette campaign, and that Philip Morris should reimburse $7m (£5.3m) in legal costs.

The David-Goliath battle between Uruguay and Philip Morris is an iconic case because it so clearly illustrates the way corporations can use international investment treaties to attack regulations made in the public interest.

So does Big Tobacco’s defeat by Uruguay mean that the growing public opposition to these investment treaties is mistaken? The corporate arbitration lawyers that take up many of the cases – and their supportive political allies – are keen to say that it proves the system can work fairly.

The question however is for whom is the system working? In investment arbitration cases, states never win. States can never file lawsuits against investors, so the best-case scenario for them is if the tribunal dismisses the investor’s accusations.

In this case, although Philip Morris was required to contribute $7m for legal costs, Uruguay will still have to pay a further $2.6m in financial costs and much more in terms of the non-material resources it has taken to fight this.

And this is a case that should never have been heard as it contradicted both the terms of the bilateral investment treaty between Switzerland and Uruguay (used as the basis for the claim) as well as the framework convention on tobacco control – the only binding multilateral convention on public health.

The arbitration panel’s decision to hear the case put a brake on the adoption of similar tobacco control measures in Costa Rica, Paraguay and New Zealand, among others.

Moreover, the lawsuit may have encouraged legal threats and actions by other corporations, hopeful that they could secure either revision of government policies or financial compensation.

In the past few years, Katoen Natie (logistics), Botnia (pulp/paper) and Farmashop (pharmacy) have threatened Uruguay with lawsuits. In March, a US-based telecommunications corporation, Italba, filed a lawsuit against the country.

The real winners in this proliferation of investor-state cases – which have surged globally from six in 1996 to 696 now – have been the corporate law firms that work on these long and complex cases. Typical arbitration lawyers, employed by either the state or a corporation, earn up to $1,000 an hour.

Philip Morris hired three international law firms (Sidley Austin, Lalive, and Shook, Hardy & Bacon), whereas Uruguay was represented by Foley Hoag. The three arbitrators that decided the case also received wages: nearly $1m between the three of them.

But more disturbing than the profits lawyers make is the power that they are given. Juan Fernández-Armesto, a Spanish lawyer and expert on investment arbitrators, said (paywall):

It never ceases to amaze me that sovereign states have agreed to investment arbitration at all […] Three private individuals are entrusted with the power to review, without any restriction or appeal procedure, all actions of the government, all decisions of the courts, and all laws and regulations emanating from parliament.

The German association of judges said in February (pdf) that these arbitration systems not only fail to meet international requirements for technical and financial independence, but are also unnecessary as disputes can be resolved through national courts.

So while Uruguay can celebrate this particular win over a corporate Goliath, perhaps the victory’s most useful contribution would be to raise awareness among states of the dangers of signing up to a privatised court system that leaves decisions on public policies in the hands of corporate lawyers. Failure to do so will mean the arrival of many more transnational Goliaths, armed not with spears but legal papers.

Cecilia Olivet is a researcher at the Transnational Institute and Alberto Villareal coordinates the trade and investment programme of Redes-Friends of the Earth Uruguay

Graphic warnings on tobacco packs ready

http://www.phnompenhpost.com/national/graphic-warnings-tobacco-packs-ready

The Association of Tobacco Industry of Cambodia announced on Saturday that new cigarette packaging, including graphic images and warning text, was ready – as required by the government as of July 23 – but may not hit the market for a few months as businesses get rid of old stock.

According to a law adopted on October 22, 2015, and clarified by the Ministry of Health on February 15, graphic photos need to cover 50 per cent of the cigarette packets, and a written message in Khmer must cover another 5 per cent.

Fines are 4 million riel (about $1,000) for noncomplying tobacco companies; 2 million riel for distributors and wholesalers; and 10,000 riel for retailers.

Mom Kong, executive director of the Cambodia Movement for Health, said the cigarette companies should roll out the new packaging immediately.

“The government gave the companies nine months to prepare. That is a very long time, and I don’t think the companies need to take any more time,” Kong said.

“In Laos, the government gave companies four months, other countries had six or seven. So nine months for Cambodia is enough for companies to sell their products with the new warnings.”

“I will see if there are no new warning packages on the market by the end of July,” Kong said. “We will be a watchdog on the market and monitor how the companies obey, for Cambodians’ health.”