Clear The Air News Tobacco Blog Rotating Header Image

May 19th, 2016:

Case No: CO/2322/2015, CO/2323/2015, CO/2352/2015, CO/2601/2015 & CO/2706/2015

Download (PDF, 2.65MB)

Ex-FDA Commissioner faces RICO charges, helped form e-cig regulations

Current FDA head Califf also has ties with Johnson & Johnson, corruption may be inevitable.

You wouldn’t think of “corruption” in any form when you think of the Food and Drug Administration (FDA). Certainly, you wouldn’t think of conspiracy and intent to conceal detrimental information to the public. Certainly, you’d be wrong. Those employed by the government have the responsibility and duty to “protect” the public. They are supposed to be in the care and custody of information and decisions that may endanger or save lives via regulations. They’re not doing a very good job of it.

Racketeering and corrupt organizations

Margaret Hamburg, former FDA Commissioner (May 2009 to March 2015) is facing charges under the “Racketeer Influenced and Corrupt Organizations” (RICO) act for concealing deadly consequences of the drug Levaquin made by Johnson & Johnson. Along with her abuse of power, her husband Peter Brown was a hedge-fund manager at Renaissance Technologies and is also facing RICO charges along with drug giant, Johnson & Johnson. According to the Alliance for Human Research Protection (AHRP) report, Brown’s reported income was “$10 million in 2008 to an estimated $125 million in 2011 and an estimated $90 million in 2012″ due in whole or in part to Defendants’ racketeering conspiracy to withhold information about the devastating, life threatening, and deadly effects of Levaquin.”

Corruption by design or default

While Hamburg was acting Commissioner, she was instrumental in forming e-cigarette regulations before she left the FDA. Her replacement, Dr. Robert Califf also has financial ties to pharmaceutical giants AstraZeneca, Johnson & Johnson, GlaxoSmithKline and more. While he was the director of the Duke Translational Medicine Institute (DTMI) he received a consulting payment from Johnson & Johnson of $87,500. Taking over where Hamburg left off, Califf released the FDA e-cigarette regulations, and litigation is already pending on the rule. Regulations, by design or default, may be heavily strewn with conflict of interest. With the makers of nicotine reduction therapies and drugs like Johnson & Johnson having an FDA Commissioner and former commissioners ear, corruption may be inevitable.

Are decisions based on health?

Senator Ron Johnson (R-Wis.) wants answers from the FDA about regulations. In a letter, the chairman of the Senate Homeland Security and Governmental Affairs Committee asked Commissioner Califf a few specific questions. Burdensome expenses related to the application and approval costs and public health were of importance in his letter. As he stated, “the FDA’s attempt to improve the public’s health by scrutinizing the e-cigarette industry could ultimately result in negative unintended health consequences.” Another observation made by Senator Johnson stated:

“The final rule notes that the FDA does “not currently have sufficient data about e-cigarettes and similar products to fully determine what effects they have on the public health.”

Then Senator Johnson asked, in part:

“How is the FDA’s regulation of e-cigarettes not a premature restriction on an industry given the FDA’s admission that it does not have “sufficient data” about e-cigarettes to determine the effects on the public’s health”?

The Committee on Homeland Security and Governmental Affairs is authorized to investigate “the efficiency and economy of operations of all branches of the Government.”

Senator Johnson stated he wanted all material “no later than 5:00 p.m. on May 31, 2016.”

France and UK join Australia as plain packaging leaders

Congratulations to France and the UK, which on 20 May 2016 join Australia as countries that have adopted plain packaging for tobacco products.

Plain packs are free of colours and all other branding, except for the manufacturers’ name written in a uniform plain style. Plain, or standardised, packaging is recommended in the tobacco control treaty, the WHO Framework Convention on Tobacco Control (FCTC).

In France and the UK, all packs manufactured after 20 May 2016 must be in plain packages. In France it will be an offence to sell branded tobacco packages after 1 Jan 2017. In the UK, plain packs must be on retail shelves by 20 May 2017.

Ireland on the way

A start date has not yet been set for plain packaging to come into force in Ireland.

As you’ll see on the map, many other countries are working towards plain packaging, despite predictable, costly legal challenges from the tobacco industry.

The Government of Australia, which adopted plain packaging in 2012, faced multiple lawsuits from Philip Morris, within the country and via an international investment agreement. The industry lost them all.

Industy ‘airily dismisses’ research

On 19 May 2016 a UK High Court rejected an industry challenge to plain packaging. The judge damned the evidence presented by the industry because it largely “ignores or airily dismisses the worldwide research and literature base which contradicts evidence tendered by the tobacco industry; and, is frequently unverifiable”.

Japan Tobacco and Imperial Tobacco have already said they will launch suits against the French Government’s plain packaging law.

Get ready for plain packaging is the theme for World No Tobacco Day 2016 (31 May). On our website you’ll find resources for tobacco control advocates and information about what FCA members are doing to get ready.

– See more at:

UK court quashes tobacco firms’ packaging challenge

LONDON — A High Court judge Thursday quashed the tobacco industry’s challenge to U.K. rules to require drab packaging stripped of logos and other branding on cigarettes and other products.

The 386-page judgment addressed all 17 grounds on which the tobacco industry challenged the U.K.’s rules, and sided with the government.

“I have found that the Secretary of State has adduced ample evidence to support the suitability and appropriateness of the Regulations,” the ruling reads.

The U.K. law is part of the country’s effort to implement the EU’s tobacco products directive, which comes into force on Friday.

The British standardized packaging regulations also take effect that day. Health warnings will have to cover 65 percent of the front and back of cigarette packaging. Anti-smoking advocates praised the decision.

“This landmark judgment is a crushing defeat for the tobacco industry and fully justifies the government’s determination to go ahead with the introduction of standardized packaging,” said Deborah Arnott, chief executive of ASH, an anti-smoking charity.

Cigarettes and hand-rolling tobacco will be sold in plain brown packages, which have had all the attractive features and colors removed. This so-called plain packaging is not required by the EU, but member countries can go beyond the floor set by the directive.

However, new packets will not be on sale until stocks of existing cartons have been sold over the next year.

The U.K.’s biggest tobacco firm, JTI, and British American Tobacco, both said they will challenge the ruling.

“We will continue to challenge the legality of plain packaging. The fact remains that our branding has been eradicated and we maintain that this is unlawful,” Daniel Sciamma, U.K. managing director of JTI, said in a statement on the decision.

ASH supported the government’s defense and provided written evidence and gave oral testimony to the court.

According to Arnott, who was in the London court, the judgment rejected every argument the industry put forward.

It was “highly critical” of the industry’s use of commissioned expert evidence, its failure to disclose any internal assessments on how packaging design affects children and young people, and the effect of standardized packaging on sales, according to Arnott.

The case was the first challenge to plain packaging laws, coming into force in France and Ireland among other countries.

Tobacco giants to appeal High Court dismissal of plain packaging challenge

British American Tobacco (BAT) will seek leave to appeal a decision by the High Court rejecting its attempt to overturn UK legislation introducing plain packaging for tobacco products.

The ruling, handed down on Thursday (19 May), dismissed the judicial review brought by BAT and other global tobacco giants.

Plain packaging laws, which BAT said breached its intellectual property rights, will come into force on 20 May.

BAT revealed following the ruling it will seek leave to appeal the decision through its lawyers, Herbert Smith Freehills (HSF). JT International and Imperial Tobacco confirmed they will join BAT in the appeal, but Philip Morris – one of the lead claimants on the initial action – said it would not.

The judicial review brought by the four tobacco companies was dismissed on Thursday (19 May) in a 400-page ruling by Mr Justice Green.

Green J upheld the lawfulness of the new regulations and rejected the grounds of challenge in their entirety. He said the regulations were “proportionate”, both when they were first drafted by Parliament and in light of recent evidence following similar legislation in Australia.

The tobacco giants had sought to challenge the law on the grounds it was unlawful under international law, EU law and domestic common law.

Earlier this month the EU’s highest court similarly upheld a law that will standardise packaging and ban the advertising of e-cigarettes. Philip Morris and BAT challenged the proposed legislation and said the EU was overstepping its authority to direct laws in member states.

Ashurst, Freshfields Bruckhaus Deringer, HSF and Skadden Arps Slate Meagher & Flom were instructed to bring the legal challenges in the UK. Leigh Day also appeared during the court proceedings last December for the intervener, Action on Smoking and Health.

In a statement, BAT said: “This decision by the English High Court is by no means the final word on the lawfulness of plain packaging. We believe that the judgment contains a number of fundamental errors of law and we are applying for leave to appeal the decision.

“The judgment, if left to stand, should also raise real concerns for many other legitimate businesses as it creates a worrying precedent whereby public policy concerns can ride roughshod over long established fundamental commercial rights.”

The legal line-up:$$$

For the first claimants, British American Tobacco

39 Essex’s Nigel Pleming QC, One Essex Court’s Geoffrey Hobbs QC and Philip Roberts and Brick Court Chambers’ David Scannell, instructed by Herbert Smith Freehills partner Andrew Lidbetter

For the second claimants, Philip Morris

Brick Court’s Marie Demetriou QC and Daniel Piccinin, instructed by Skadden partner Karyl Nairn QC

For the third claimants, JT International

Brick Court’s David Anderson QC and Jennifer MacLeod, and One Essex Court’s Emma Himsworth QC, instructed by Freshfields partner Tom Snelling

For the fourth claimants, Imperial Tobacco Ltd

Blackstone Chambers’ Dinah Rose QC, Brian Kennelly QC and Jason Pobjoy, and 8 New Square’s Lindsay Lane and Maxwell Keay, instructed by Ashurst

For the defendant, the Secretary of State for Health

Blackstone Chambers’ James Eadie QC and Catherine Callaghan, 8 New Square’s Martin Howe QC, Monckton Chambers’ Ian Rogers QC, Julianne Kerr Morrison and Nikolaus Grubeck, and 8 New Square’s Jaani Riordan, instructed by the Government Legal Department

For the intervener, Action on Smoking and Health

Monckton Chambers’ Peter Oliver and Ligia Osepciu, instructed by Leigh Day

700,000 deaths a year: tackling smoking in the EU


More than one in four Europeans smoke. Half of them will die prematurely, shortening their life by 14 years on average. From 20 May new European legislation will be in place to make smoking and cigarettes less attractive, especially among young people. Read on to find out what will change and check out our infographic about smokers in the EU.

What is changing

The new directive, which enters in force in all EU countries on Friday 20 May, sets more stringent rules regarding tobacco and related products.

Some of the new rules aim to make smoking less attractive for young people by banning cigarettes and rolling tobacco with charactering flavours, as well as small and cheaper packages for certain tobacco products.

Health warnings – including both picture and text – need to cover 65% of the front and the back of cigarette and roll-your-own tobacco packages, while all promotional and misleading elements on tobacco products are banned.

Manufacturers are obliged to notify novel tobacco products before placing them on the EU market, while they are also required to submit detailed reports to EU countries on the ingredients used in tobacco products, in particular cigarettes and roll-your-own tobacco.

In addition EU countries are allowed to prohibit internet sales of tobacco and related products and e-cigarettes are regulated either as medicinal products – if they are used to help people quit smoking – or as tobacco products.

End of gimmick tobacco products

Tobacco companies tried to prevent the new rules entering into force, but the European Court of Justice ruled against them.

UK S&D member Linda McAvan, who was responsible for steering the new rules through Parliament, welcomed the legislation entering into force this week: “People across the whole of the EU will see tobacco packs change from now on as gimmick tobacco products disappear from the market and tobacco packs carry more health warnings than adverts. These new clear rules, together with other national measures such as bans on smoking in public places, should help stop the tobacco industry from recruiting a new generation of young smokers in Europe. And now that the big tobacco companies lost their case in the European Court of Justice, those member states who have still not fully transposed the directive need to get on and do it.”

The lethal habit

Tobacco consumption is responsible for nearly 700,000 deaths in the EU every year. Smokers suffer more from poor health (as they are more at risk of cancer, cardiovascular and respiratory diseases) and half of them die prematurely (14 years on average).