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May 5th, 2016:

FDA takes significant steps to protect Americans from dangers of tobacco through new regulation

Rule extending oversight to all tobacco products, including e-cigarettes, allows agency to address public health concerns such as youth access to tobacco products

Today, the U.S. Food and Drug Administration finalized a rule extending its authority to all tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others. This historic rule helps implement the bipartisan Family Smoking Prevention and Tobacco Control Act of 2009 and allows the FDA to improve public health and protect future generations from the dangers of tobacco use through a variety of steps, including restricting the sale of these tobacco products to minors nationwide.

“We have more to do to help protect Americans from the dangers of tobacco and nicotine, especially our youth. As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap. All of this is creating a new generation of Americans who are at risk of addiction,” said HHS Secretary Sylvia Burwell. “Today’s announcement is an important step in the fight for a tobacco-free generation – it will help us catch up with changes in the marketplace, put into place rules that protect our kids and give adults information they need to make informed decisions.”

Tobacco use is a significant public health threat. In fact, smoking is the leading cause of preventable disease and death in the United States and responsible for 480,000 deaths per year. While there has been a significant decline in the use of traditional cigarettes among youth over the past decade, their use of other tobacco products continues to climb. A recent survey supported by the FDA and the Centers for Disease Control and Prevention shows current e-cigarette use among high school students has skyrocketed from 1.5 percent in 2011 to 16 percent in 2015 (an over 900 percent increase) and hookah use has risen significantly. In 2015, 3 million middle and high school students were current e-cigarette users, and data showed high school boys smoked cigars at about the same rate as cigarettes. Additionally, a joint study by the FDA and the National Institutes of Health shows that in 2013-2014, nearly 80 percent of current youth tobacco users reported using a flavored tobacco product in the past 30 days – with the availability of appealing flavors consistently cited as a reason for use.

Before today, there was no federal law prohibiting retailers from selling e-cigarettes, hookah tobacco or cigars to people under age 18. Today’s rule changes that with provisions aimed at restricting youth access, which go into effect in 90 days, including:

• Not allowing products to be sold to persons under the age of 18 years (both in person and online);
• Requiring age verification by photo ID;
• Not allowing the selling of covered tobacco products in vending machines (unless in an adult-only facility); and
• Not allowing the distribution of free samples.

The actions being taken today will help the FDA prevent misleading claims by tobacco product manufacturers, evaluate the ingredients of tobacco products and how they are made, as well as communicate their potential risks.

Today’s rule also requires manufacturers of all newly-regulated products, to show that the products meet the applicable public health standard set forth in the law and receive marketing authorization from the FDA, unless the product was on the market as of Feb. 15, 2007. The tobacco product review process gives the agency the ability to evaluate important factors such as ingredients, product design and health risks, as well as their appeal to youth and non-users.

Under staggered timelines, the FDA expects that manufacturers will continue selling their products for up to two years while they submit – and an additional year while the FDA reviews – a new tobacco product application. The FDA will issue an order granting marketing authorization where appropriate; otherwise, the product will face FDA enforcement.

For decades, the federal government and the public health community have fought to protect people from the dangers of tobacco use. Since the first Surgeon General’s report on Smoking and Health in 1964, which warned Americans about the risks associated with smoking, significant progress has been made to reduce smoking rates among Americans. In fact, tobacco prevention and control efforts have saved at least 8 million lives in the last 50 years, according to the 2014 Surgeon General’s Report on the Health Consequences of Smoking. In 2009, Congress took a historic step in the fight for public health by passing the bipartisan Family Smoking Prevention and Tobacco Control Act (TCA) giving the FDA authority to regulate the manufacturing, distribution and marketing of tobacco products to protect the public health.

Today’s action marks a new chapter in the FDA’s efforts to end preventable tobacco-related disease and death and is a milestone in consumer protection.

“As a physician, I’ve seen first-hand the devastating health effects of tobacco use,” said FDA Commissioner Robert M. Califf, M.D. “At the FDA, we must do our job under the Tobacco Control Act to reduce the harms caused by tobacco. That includes ensuring consumers have the information they need to make informed decisions about tobacco use and making sure that new tobacco products for purchase come under comprehensive FDA review.”

Today’s actions will subject all manufacturers, importers and/or retailers of newly- regulated tobacco products to any applicable provisions, bringing them in line with other tobacco products the FDA has regulated under the TCA since 2009.

These requirements include:

• Registering manufacturing establishments and providing product listings to the FDA;
• Reporting ingredients, and harmful and potentially harmful constituents;
• Requiring premarket review and authorization of new tobacco products by the FDA;
• Placing health warnings on product packages and advertisements; and
• Not selling modified risk tobacco products (including those described as “light,” “low,” or “mild”) unless authorized by the FDA.

“This final rule is a foundational step that enables the FDA to regulate products young people were using at alarming rates, like e-cigarettes, cigars and hookah tobacco, that had gone largely unregulated,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “The agency considered a number of factors in developing the rule and believes our approach is reasonable and balanced. Ultimately our job is to assess what’s happening at the population level before figuring out how to use all of the regulatory tools Congress gave the FDA.”

To assist the newly-regulated tobacco industry in complying with the requirements being announced today, the FDA is also publishing several other regulatory documents that provide additional clarity, instructions and/or the FDA’s current thinking on issues specific to the newly-regulated products.

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.

California smoking: Legal age for buying tobacco raised

California has raised the legal age for buying tobacco products from 18 to 21, as part of anti-smoking legislation that also regulates e-cigarettes.

The law makes it illegal to sell tobacco products to people under 21, except to active military personnel.

Supporters of the law say it will deter adolescents from the harmful effects of nicotine addiction.

Under the measures signed on Wednesday, electronic cigarettes, like traditional ones, will be banned in public spaces.

Democratic Governor Jerry Brown signed a total of five bills to restrict tobacco use in various ways, including regulating e-cigarettes and expanding funds for anti-smoking programmes.

‘Long overdue’

From 6 June, any company caught selling tobacco products for smoking, dipping, chewing and vaping (inhaling vapour through a personal inhaler, similar to an electronic cigarette) to under-21s will be fined up to $5,000 (£3,450).

Health officials have welcomed the legislation, saying it will stop adolescents from becoming addicted to nicotine.

“It is long past due for California to update our approach to tobacco,” said Steven Larson, president of the California Medical Association. “There has been an alarming rise in the use of e-cigarettes by teens, putting them at risk for lifelong addiction.”

The Institute of Medicine reports that 90% of daily smokers began using tobacco before turning 19.

It said increasing the smoking age to 21 would immediately deter 15% of people between 18 and 20 from taking up a lasting tobacco habit.

Veterans’ organisations and Republican lawmakers had objected to the bill, saying people old enough to die for their country were old enough to use tobacco.

The California proposal stalled for six months until lawmakers agreed to retain the 18-year-old legal tobacco age for military personnel and passed it in early March.

The tobacco industry has so far not commented, but it has previously threatened to try and overturn the bill. It would need to collect 366,000 valid signatures by early August to ask voters to reject the new laws.

In April, Hawaii became the first US state to raise the legal smoking age to 21.

Local authorities in the US including New York, Chicago and San Francisco have also made the change.

E-Cigarettes to Be Regulated as Tobacco Products

E-cigarettes, hookah tobacco and cigars are now officially under the purview of the FDA

E-cigarettes will be regulated as tobacco products, federal authorities announced on Thursday.

In a long-awaited ruling, the U.S. Food and Drug Administration (FDA) finalized rules that give the agency authority to regulate all tobacco products including e-cigarettes, cigars, hookah tobacco and pipe tobacco, as well as other products. Until now, e-cigarettes were not regulated by the FDA and there was no national law to prohibit the sale of e-cigarettes, hookah tobacco or cigars to people under 18.

“The actions being taken today will help the FDA prevent misleading claims by tobacco product manufacturers, evaluate the ingredients of tobacco products and how they are made, as well as communicate their potential risks,” the agency said in a statement.

The new rule means the agency will have to approve all products that made it to market as of Feb. 15, 2007—a point at which the e-cigarette market was virtually non-existent. “What we know is absence of federal restriction means that enforcement is uneven and at times nonexistent,” HHS Secretary Sylvia Burwell said during a news conference.

The risks of e-cigarettes has been a public health debate for some time and the FDA initially announced its proposal to increase its jurisdiction in 2014. The HHS and FDA said on Tuesday that surveys show 1 in 4 high school students and 1 in 13 middle schoolers report being tobacco users. 16% of high schoolers also reported using cigarettes in 2015, a 900% increase from 1.5% in 2011. While e-cigarettes do not contain the same carcinogens as traditional cigarettes, they do contain nicotine, which is addictive. Early research has also cast doubt on the safety of some of the chemicals used inE-cigarettes when inhaled into the lungs.

Small and medium sized e-cigarette companies have responded to the news with concerns that undergoing the new approval process will be costly. “This gigantic price tag is affordable to Big Tobacco companies, but small and medium-sized businesses will be crushed,” said Gregory Conley, President of the American Vaping Association. “If the FDA’s rule is not changed by Congress or the courts, thousands of small businesses will close in two to three years.”

Burwell addressed these concerns during a news conference with reporters, saying the agencies understand the concerns small businesses will have, and that the FDA will allow them to have more time to comply.

The FDA says after 90 days they will begin enforcing portion of the rule that says the products cannot be sold to people under 18. This rule also requires ID to purchase tobaccos products and bans sales in vending machines as well as free samples

“The health of the nation will continue to suffer the consequences of any further delay in implementing a law intended to protect public health,” Chris Hansen, president of the American Cancer Society Cancer Action Network, said in a statement.

Supreme Court refuses to hear appeal by cigarette manufacturer

A Quebec law that was adopted to facilitate the recovery of the costs of medical treatment to smokers has stood up to a cigarette manufacturer’s attempts to invalidate it.

On Thursday, the Supreme Court of Canada refused to hear an appeal by JTI-MacDonald, which was the company’s last recourse to invalidate the law. As is usual in such cases, the top court did not provide grounds for its refusal.

The Tobacco-related Damages and Health Care Costs Recovery Act was sanctioned in June 2009 and its purpose is to establish special rules for the recovery of tobacco-related health care costs that are attributable to a wrong committed by one or more tobacco product manufacturers and for the recovery of damages for a tobacco-related injury.

Quebec Superior Court declared the law constitutional in 2014, and its decision was upheld by the Quebec Court of Appeal in 2015

JTI-MacDonald claims the law infringes the protection that is conferred by Section 23 of the Quebec charter of human rights and freedoms, which provides for the right to a full and equal, public and fair hearing by an independent and impartial tribunal.

The company argues the law has the effect of placing tobacco product manufacturers at a substantial disadvantage compared to government and private litigants because of the “cumulative effect” of the special rules foreseen in the law.

The manufacturers claim they are “handcuffed” and not in a situation to fully defend themselves.

The justices of the Court of Appeal didn’t agree with the manufacturers’ arguments.

However, Justice Geneviève Marcotte, speaking in her name and of those of her colleagues on the bench, called the law “particularly severe” towards cigarette manufacturers and said it “significantly reduces” the government’s burden of proof. The judge also talks in the ruling about “hefty” means in terms of civil responsibility.

Despite the finding, Marcotte declared it’s not for the Court of Appeal to question the choices made by the legislator nor the opportunity for a law.

In June 2012, with the help of the law, Quebec filed a C$60-million claim for damages and interest against JTI-MacDonald and other tobacco manufacturers.

Other provinces in Canada have adopted similar laws to recover health care costs

UK’s policy on standardised tobacco packaging given EU backing

Plans to introduce plain, standardised packaging for cigarettes in the UK have been given European backing.

The European Court of Justice ruled (link is external) that the EU Tobacco Products Directive is lawful and has overturned the tobacco industry’s challenge to it.

The court also confirmed that EU Member States can go further than the requirements set out in the Directive with regard to packaging.

This, essentially, allows countries to bring in standardised packaging. The directive, along with standardised packaging, will now enter into force on May 20.

George Butterworth, Cancer Research UK’s tobacco policy manager, said: “This court decision tells us what we knew all along – that the Tobacco Products Directive is an effective and proportional set of measures to stop children taking up smoking.

“This will help to lower smoking rates in the UK and protect more people from developing cancer.

“It’s truly shameful that the tobacco industry has poured so much time, effort and money trying to undermine it. UK laws can now continue as planned and from May 20 the rollout of plain, standardised packaging begins.”

The UK, France and Ireland have already passed legislation on standardised packaging.

This new ruling will give support to other member states who also wish to proceed with the measure.

The Court also dismissed other legal challenges claiming regulations on e-cigarettes were disproportionate and the ban on menthol flavouring was unjustified.

Deborah Arnott, Chief Executive of health charity ASH said the Court’s decision was “welcome”.

“The Directive is lawful and the UK is allowed to go further than the Directive in standardising tobacco packs with respect to matters not harmonised by the Directive,” she added.

“We await the UK court judgement, which is expected shortly, but we expect that the court will also confirm that the introduction of standardised packaging in the UK is lawful.

“From May 20, all packs manufactured for sale in the UK will have to be plain, standardised in the same drab green colour with the product name on the pack in a standard font.”

What the EU has done to take on Big Tobacco

Three landmark cases in the EU Court of Justice have dealt an important blow in the long-running campaign by Big Tobacco to use legal challenges to avoid regulation. The big question at stake is about how effective is the EU at taking on the might of the multinationals – the huge and well-funded companies in the tobacco industry – in the name of health protection.

The decisions, which unequivocally support the EU’s latest package of tobacco regulation, will be warmly greeted by pro-Europe campaigners in the UK’s referendum – such as Scientists for EU – who argue that on balance, staying in the EU is better for health.

One case was brought by the Polish government and the others were referred by the English High Court, which asked the EU court to interpret EU law. Based on this judgment, the English court will now decide claims brought by tobacco companies, or suppliers to the industry and a retailer of e-cigarettes.

The EU began to regulate tobacco in the late 1980s, as information about the dangers of tobacco came to greater public awareness and the EU’s competence to regulate in its market expanded. Of course, the world knew about the dangers of tobacco well before that – see, for instance, the US Surgeon General’s Report of 1964 and earlier research such as the work of Doll and Hill in Oxford in the 1950s.

But it is notoriously difficult for governments or international organisations to control the tobacco industry. Tactics include undermining anti-tobacco cancer research, relying on ideas such as freedom or human rights, appealing to social norms or drawing shocking historical parallels – which have included calling anti-smoking campaigners “Nicotine Nazis”.

Then factor in the level of lobbying and persuasion of law and policy-makers, which is considerable. And the power of these companies to engage in expensive litigation tactics, which – in the case of tobacco – include repeatedly making the legal argument that the EU has exceeded its powers.

Setting the rules

The question in these recent cases was whether the EU is competent to adopt the latest Tobacco Products Directive of 2014, which must be implemented in national law by May 20 2016. That directive revises and tightens up existing EU rules about cigarette packaging, prohibits vouchers and discounts, and strengthens health warnings.

The directive also prevents misleading words on cigarette packaging (such as “natural”, “slim” or “light”) and regulates the size of packages, banning what have been called “lipstick-style” packs of fewer than 20 cigarettes which are targeted at women and young people. It also sets rules about flavourings and additives such as menthol or cinnamon, which are used to make cigarettes more palatable – especially for young people when they first try them – and regulates e-cigarettes and other novel tobacco products.

The EU’s court has ruled that the EU’s powers allow it to adopt the directive. The judgment stressed that the EU must secure high levels of health protection in all its policies, including its trade law. It rejected arguments that relevant EU laws are a disproportionate paternalistic incursion on autonomy, by emphasising that the rules seek especially to protect young people.

The court confirmed that EU law may adopt a precautionary approach when the dangers associated with new products, such as e-cigarettes, are still being explored. It also rejected arguments based on freedom of expression, including the freedom of companies to advertise, saying that these entitlements are outweighed by the “proven harmfulness of tobacco consumption”.

The EU court confirms that the directive does leave discretion to member states. In the UK there has been discussion about whether this includes power to adopt plain packaging (as in Australia), or standardised packaging – which was called for in the independent report by Sir Cyril Chantler, and adopted by the Children and Families Act 2014.

Note that the current UK government does not intend to adopt plain packaging, and the question of whether it could lawfully do so was debated only as a theoretical or hypothetical one in the legal hearing.

Taking on the smoking guns

The EU’s track record on tobacco regulation is far from perfect from a health point of view. The imbalances of lobbying power are legendary: the WHO noted that some 20 people advocated the health policy aspects of this directive, whereas more than 160 lobbyists represented the industry.

In October 2012, the EU health commissioner John Dalli resigned amid allegations uncovered by the European Anti-Fraud Office regarding links between Dalli and the tobacco industry. Dalli was unsuccessful in subsequent legal claims about the nature of the resignation process and the European Union’s ombudsman has recommended release of all pertinent documents after the conclusion of those proceedings.

The EU’s tobacco law has been hailed as a public health success story – and perhaps with some justification. From a position in which several EU countries had no effective tobacco regulation at all, by the early 1990s the EU had adopted a suite of laws on tobacco product regulation, labelling and packaging, and taxation.

From the 1990s onwards, EU anti-tobacco law has proceeded at a slower pace, involving a “nudging” approach focused mainly on young people. There is undoubtedly more that the EU could do to stop Big Tobacco, especially as it develops new products. But the EU has been more effective than its member states acting alone. And its transparency rules mean citizens have greater abilities to track industry influence on policy than in many of its member states.

The example of EU tobacco regulation is important for the UK referendum. There are understandable concerns about the impacts of EU membership on health issues. But let’s look beyond the discussions of the NHS and TTIP – important as they are. If there is political will to go further in regulating tobacco than EU law requires, our government has the discretion to do so. But EU laws provide a public health baseline, which even the tobacco industry cannot easily undermine.