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Progress against ‘global tobacco epidemic’ made but not enough

Tobacco treaty has helped cut smoking rates, yet more work is needed

http://www.timesofmalta.com/articles/view/20170325/health-fitness/Progress-against-global-tobacco-epidemic-made-but-not-enough.643389

The WHO warns against tobacco use which kills about six million people a year globally and imposes a huge burden on the world economy.

A global tobacco treaty put in place in 2005 has helped reduce smoking rates by 2.5 per cent worldwide in 10 years, researchers said, but use of deadly tobacco products could be cut even further with more work on anti-smoking policies.

In a study published in the Lancet Public Health journal, researchers from Canada’s University of Waterloo and the World Health Organisation (WHO) found that while progress against what they called the “global tobacco epidemic” has been substantial, it has still fallen short of the pace called for by the treaty.

The WHO Framework Convention on Tobacco Control (FCTC), which came into effect in 2005, obliges the 180 countries signed up to have high tobacco taxes, smoke-free public spaces, warning labels, comprehensive advertising bans and support for stop-smoking services.

Smoking causes lung cancer and is a major risk factor for cardiovascular illnesses such as heart disease and strokes, which kill more people than any other diseases.

The WHO says tobacco kills about six million people a year globally and imposes a huge burden on the world economy. Annual healthcare and lost productivity costs for those made ill from smoking are estimated at around $1 trillion.

The study analysed WHO data from 126 countries – 116 of which are signatories to the FCTC – and tracked and compared the implementation of the five key measures from 2007 to 2014 to look at links between strong policies and smoking rates.

It found that, on average, smoking rates dropped to 22.2 per cent in 2015 from 24.7 a decade earlier. But the trends varied, with rates falling in 90 countries, rising in 24 and remaining steady in 12.

Countries that fully implemented more FCTC measures saw significantly greater reductions in smoking rates, the study found. Overall, each additional measure was linked with a drop in smoking rates of 1.57 percentage points – corresponding to 7.1 per cent fewer smokers in 2015 compared with in 2005.

The study was not a full global analysis, since only 65 per cent of countries had the data needed, but it did include countries from all income levels and regions. The researchers also noted that the lower smoking rates could be influenced by factors other than FCTC policy recommendations.

“The data did not allow a detailed analysis of the impact of individual policies,” said Geoffrey Fong of Waterloo University, who co-led the work.

He called for more studies that are specifically designed to evaluate the impact of all FCTC policies and would “help provide guidance to countries about what policies may offer the greatest benefits”.

FCTC cut smoking 2.5 per cent over 10 years; study

A decade of tobacco control efforts by the Framework Convention on Tobacco Control (FCTC) has reduced the global smoking rate by 2.5 per cent, according to an evaluation by the International Tobacco Control Policy Evaluation Project.

http://www.tobaccojournal.com/FCTC_cut_smoking_2_5_per_cent_over_10_years_study.54157.0.html

Although the international treaty, an adjunct of the World Health Organisation, has made substantial progress in combatting use of tobacco products, implementation of FCTC measures has fallen short of its objectives, according to the study. “While the progress of WHO Framework Convention on Tobacco Control has been remarkable, there are still far too many countries where domestication of the treaty and its implementation has fallen short,” said Dr Geoffrey Fong, a study author from the University of Waterloo, Canada. “One important cause of this is the tobacco industry’s influence, particularly in low- and middle-income countries.”

Conducted with assistance from WHO, the study analysed data from 126 countries and determined the smoking rate in those countries declined on average from 24.7 per cent in 2005 to 22 per cent in 2015. FCTC obligates 180 signatory countries to raise tax on tobacco products, create smoke-free public spaces, implement warning labels on packaging, ban advertising and support stop-smoking services.

FDA delays ‘other use’ rule for tobacco-derived products

The Food and Drug Administration (FDA) pushed back by one year a rule to clarify when products derived from tobacco face regulation as drugs or combination products.

http://www.tobaccojournal.com/FDA_delays_other_use_rule_for_tobacco-derived_products.54153.0.html

Initially set to take effect in February, the FDA first delayed implementation by one month and now intends for it to take effect on 19 March 2018. An additional comment period will expire on 19 May 2017. Additional information is available at: https://goo.gl/BrQooq

WHO Letter to HK Government on Tobacco Control Efforts

Download (PDF, 81KB)

Addressing the tobacco industry vector

The tobacco industry’s escalating attacks on public health are replicated across the world, as is the harm caused by its products.

http://www.jpost.com/Opinion/Addressing-the-tobacco-industry-vector-482330

‘THE TOBACCO industry attempts to impede tobacco regulation have changed over the years, but have not abated – they have instead mutated, and on a global scale.’

I was privileged recently to deliver the keynote address to the annual meeting of the Israel Society for Smoking Cessation and Prevention. The title was “Advocacy efforts in countering tobacco industry tactics.”

In the address I quoted Dr. Margaret Chan, director- general of the World Health Organization, who in 2008 said, “I want to remind governments in every country of the range and force of counter-tactics used by the tobacco industry – an industry that has much money and no qualms about using it in the most devious ways imaginable.”

Just as the primary vector for malaria is the mosquito, the primary vector for the tobacco epidemic is the tobacco industry. The industry attempts to impede tobacco regulation have changed over the years, but have not abated – they have instead mutated, and on a global scale.

When the WHO’s first and only internationally binding treaty – the Framework Convention on Tobacco Control (WHO FCTC) – entered into force (Israel became a signatory in 2005), there was a dramatic increase in the number of countries implementing tobacco control policies. The industry determined to adapt to the new situation.

According to WHO, the tobacco industry has continued to use advertising, promotion and sponsorship to undermine tobacco control efforts. In addition, it has sought to interfere with tobacco control on a global scale using a variety of tactics. For example, it lobbies and funds politicians and political parties to hijack the political and legislative process. It exaggerates the economic importance of the industry, while remaining silent on the massive health and economic costs of tobacco use. It manipulates public opinion to gain the appearance of respectability, often under the guise of corporate social responsibility, while irresponsibly playing down or denying the real harms its products.

It fabricates support by developing and resourcing front groups who advocate on the industry’s behalf. It continues to attempt to discredit proven scientific and economic evidence – often erroneously claiming that evidence from one country isn’t applicable in another.

And, increasingly, it intimidates governments with litigation or the threat of litigation, or trade threats.

Tobacco companies have recently launched a spate of international legal challenges to oppose the implementation of legitimate and robust tobacco control measures. Bilateral investment treaties have been used as the premise for international commercial arbitration challenges against Uruguay and Australia. This typifies the tobacco industry’s response to countries exercising their regulatory autonomy in the tobacco space: one of untenable intimidation.

This intimidation of governments is important because only governments can ratify and implement UN treaties, such as the WHO FCTC, mandate public health legislation and implement taxation policies that increase the price and reduce the affordability of tobacco products – the single most effective way of reducing tobacco use.

Legal and trade challenges typically have a delaying effect upon the country concerned – the implementation of tobacco control measures is paused until the case is resolved, they are expensive for governments (typically costing millions of US dollars) and have a regulatory chill effect on other countries that might be contemplating similar measures. However, these challenges have been repeatedly dismissed by high courts, constitutional courts and courts of justice in jurisdictions including Australia, the UK, Kenya, France, the European Union, South Africa, Thailand and Uruguay.

In addition, more and more countries are dismissing tobacco industry opposition, and introducing plain packaging. Responding to the industry’s increased use of trade law, Bloomberg Philanthropies and the Gates Foundation announced an $ 4 million fund to support countries against such threats – but we need to adopt other strategies too.

For example, research is often directed toward establishing the rates of smoking prevalence, health and mortality, and the economic impact of tobacco. This research is invaluable, but more effort also should be directed at tracking tobacco industry behavior so we can more efficiently monitor and resist the tobacco industry vector. Many advocates do not even know whether the tobacco industry donates to front groups or politicians in their country; whether the International Tax and Investment Center (funded by the tobacco industry) has visited their Finance Ministry with the mantra of not raising tobacco taxes; or whether the industry has met with government (and under WHO FCTC Article 5.3, the tobacco industry should have no part in formulating tobacco control policy).

This is perhaps why recent allegations regarding tobacco industry bribes to the Israeli government came as such a shock.

The tobacco industry’s escalating attacks on public health are replicated across the world, as is the harm caused by its products. The global tobacco epidemic, which will kill six million people this year, cannot be addressed unless we are equipped to counter all the industry’s tactics and all governments – including Israel’s – stand firm in stopping the tobacco industry from influencing health policy development and implementation.

The current prevalence of smoking in Israel is about 20%. Israel’s next step could be, as many countries have already done, to announce a target of 5% prevalence rate by 2028, and work annually to achieve this target. This is an ambitious target, but challenging rather than impossible.

FDA’s New Database on Grandfathered Tobacco Products

Industry group offers additional clarity on resource

Thomas A. Briant

MINNEAPOLIS — Feb. 15, 2007, is an important date in the Family Smoking Prevention and Tobacco Control Act, the law that Congress passed to authorize the U.S. Food and Drug Administration (FDA) to regulate tobacco products. That date is known as the “predicate date” or “grandfather date.” Every tobacco product that was on the market as of Feb. 15, 2007, is grandfathered, which means that special applications do not need to be filed with the FDA to keep those products on the market.

Just last week, the FDA announced that it has included on its website a searchable database to determine whether a tobacco product is grandfathered. Click here to access that database. To use it, type in the tobacco product name, the name of the manufacturer, select the product category from the drop-down list and then click the search button. The search results will inform you if the product is grandfathered.

However, there is some confusion about the completeness and accuracy of the FDA’s grandfathered database. The Coalition of Independent Tobacco Manufacturers of America (CITMA), Richmond, Va., has issued a letter to its members outlining the issues with the FDA grandfathered database and allowed NATO to disseminate the letter.

Specifically, the CITMA letter indicates that a FDA grandfather determination is not required to sell a grandfathered tobacco product and this has resulted in some grandfathered tobacco products not being included in the database. This means the FDA database only includes those tobacco products that were the subject of a voluntary grandfather-determination request submitted to the agency by a manufacturer. In other words, the database does not include those grandfathered tobacco products for which a voluntary grandfather-status application was not submitted. Also, CITMA indicates that the grandfathered database does not include those tobacco products that receive grandfather status through a substantial-equivalency application submitted to the FDA by a manufacturer.

In its letter, CITMA reports that the coalition has requested the FDA to issue a statement clarifying that the grandfathered database does not include all legally marketed, grandfathered tobacco products.

Download (PDF, 1.15MB)

Cole-Bishop Bill Reintroduced in Congress

http://tobaccobusiness.com/cole-bishop-bill-reintroduced-congress/

By Tobacco Business –

FDA Congress

U.S. Representatives Tom Cole (R-Oklahoma) and Cole Bishop (D-Georgia) reintroduced legislation in Congress in an effort to change the FDA predicate date under the FDA tobacco regulations. Known as the FDA Deeming Clarification Act of 2017 (HR 1136), this legislation would also adopt new regulations relating to e-cigarette and vapor products. HR 1136 is an updated version of HR 2058 and the Cole/Bishop amendment.

The re-introduced bill would change the predicate date from Feb. 15, 2007 to Aug. 8, 2016, the date when the FDA deeming regulations took effect.

This move would allow newly deemed tobacco products that were on the market as of Aug. 8, 2016-including e-cigarettes, vapor, cigars, pipe tobacco, hookah tobacco, nicotine gels and dissolvable nicotine products-would not need a special Substantial Equivalency Application or Pre-Market Tobacco Application to be filed with the FDA in order to remain on store shelves and in the market. These products would still be required to comply with the other FDA tobacco regulations, however.

Specifically for vapor products, the bill would also establish a product standard for vapor product batteries. The product standard would include technical characteristics that batteries for vapor products would need to meet in order to be used in an e-cigarette or vapor product. Vapor product manufacturers, wholesalers, and retailers would not be allowed to advertise a vapor product in a newspaper, magazine, periodical or other publication except an adult publication whose readers younger than 18 years old constitute no more than 15 percent of the total readership and fewer than 2 million people younger than 18 years older.

This bill would have a major impact on various part of the tobacco industry. First, it would relieve some of the burden placed on manufacturers of varying ages and sizes. Companies founded after Feb. 15, 2007 would be able to continue operating with their products readily available in the market. As is, compliance costs could drive many newer manufacturers out of business. Second, changing the predicate date would give many manufacturers more product on the market. This also could drastically change the course of the vapor industry, much of which was established long after 2007. The vapor industry is also greatly founded in technology and the ongoing improvement and development of said technology. Anything that was on the market prior to the 2007 predicate date, which is very little, would likely not be promoted or used by vapor consumers today. There are also a great deal of questions and concerns regarding the FDA approval process for tobacco products like cigars, pipe tobacco and vapor products, which is likely to be a very long, costly and confusing process.

Many in the vapor industry view HR 1136 as the first necessary step in developing appropriate regulation for the vapor industry. On its website, the Consumer Advocates for Smoke Free Alternative Association (CASAA) commented, “Different efforts and strategies are required to keep moving the ball forward. Looking to the future, fair regulatory treatment of vapor products is part of the larger campaign to change the tobacco control culture int he United States. Ultimately, policy makers, regulators, and public health advocates must change their abstinence-only approach to one of the comprehensive harm reduction in order to humanely reduce the morbidity and mortality associated with smoking cigarettes.”

The passing of HR 1136 would be a major breakthrough for those hit by the FDA deeming ruling. You are encouraged to reach out to your state representatives and voice your support for the bill, either through email, phone or attending a town hall meeting.

Trump’s Administration on the FDA Regulating Cigars

http://www.counselheal.com/articles/31659/20170128/trump-administration-on-the-fda-regulating-cigars.htm

President Donald Trump and his administration are about to get busy in the coming months. The present administration is expected to review the regulatory powers of the Food and Drug Administration of the United States over tobacco products.

The Daily Caller reports that organizations like the Campaign for Tobacco Free Kids and the Robert Wood Johnson Foundation are petitioning the FDA with its programs to discourage young people from smoking pipes and cigars. The group sees the idea of the government arm of paying up to $25 per cigar as absurd.

Last year, the FDA announced that its plans to regulate tobacco products and e-cigarettes did not push through in August because of injunctions filed by tobacco organizations against the FDA and the Department of Health and Human Services in July 2016. The additional regulations aim to prohibit walk-in humidors in stores, ban colorful and artistic labels on cigars and cigar boxes and will require pipe shop owners to secure a manufacturer’s license prior to taking bulk tobacco orders.

The H.R. 563, known as the Traditional Cigar Manufacturing and Small Business Preservation Act of 2017, when taken into effect will override the FDA’s regulations for cigars and was originally sponsored by Congressman Bill Posey and Florida Democrat Kathy Castor.

Forbes reports that Trump’s views against regulations and how they hamper the U.S. economy is backed up in his First 100 Days of Action Plan where is plans on cutting the red tape at the FDA. The Family Smoking Prevention and Tobacco Control Act that was signed by former U.S President Barack Obama gave the FDA the regulatory powers over tobacco products.

The new President’s move against or in favor of new and existing policies in the administration is now creating speculations not only in the FDA issue but as well as in healthcare. Trump has been very expressive against the Affordable Care Act and has pledged that an appeal to Congress will be in the works once he is elected.

Modifications of his stance on these issues and how far he will deconstruct existing policies is what the nation awaits.

Anti-Tobacco Groups Worried About Trump, Congress

Lawmakers considering efforts to weaken FDA’s regulatory power

http://www.medpagetoday.com/pulmonology/smoking/62788

The federal government and most states continued to receive mostly failing grades from the American Lung Association (ALA) for efforts to reduce tobacco use among adults and teens during 2016, despite the enactment of the long-awaited “deeming” rule giving FDA regulatory authority over all tobacco products, including e-cigarettes and cigars.

The failure to require graphic warning labels on cigarette packaging and to move toward banning menthol cigarettes earned federal administrators and lawmakers an “F” grade from the ALA for tobacco regulation, according to the group’s annual State of Tobacco Control report, released late this week.

But despite these shortcomings, anti-tobacco advocates who spoke to MedPage Today say there is no question that regulatory and other actions taken at the state and federal level during the Obama administration’s 8-year tenure helped spur the record decline in tobacco use among adults and teens.

And they expressed concern that many of these hard-fought gains will be rolled back by the new administration and Congress.

“There is no question that what government does makes a big difference,” Matthew L. Myers of Campaign for Tobacco-Free Kids told MedPage Today.

“During the last eight years we have seen tobacco advertising restricted through the FDA, there have been sustained (anti-tobacco) mass media campaigns, tobacco taxes have increased and internet sales have been curtailed. All of these things contributed to the dramatic decline in tobacco consumption,” Myers asserted.

Speaking with a group of corporate leaders on Monday, President Trump vowed to do away with 75% or more of government regulations and he repeated his campaign promise of massive tax cuts.

Myers said Trump’s views on specific tobacco regulations and taxes are not known.

“President Trump has not spoken about this, so it is still unclear what position he will personally take,” Myers said. “To date, the physical manifestation of our concern comes from the cigarette and e-cigarette industries urging Congress to curtail funding for successful mass media campaigns and critical regulatory measures.”

The ALA’s Erika Seward said two specific attempts now before Congress to weaken FDA’s regulatory authority over tobacco are of particular concern.

On Jan. 13, Rep. Bill Posey (R-Fla.) reintroduced a bill in the House to exempt premium cigars from FDA regulation. The agency’s deeming rule announced last May extended its authority to cigars, e-cigarettes, pipe tobacco, and hookah. Posey first introduced the legislation in 2015, but it failed to pass under the previous Congress.

Congress is also considering legislation to grandfather flavored e-cigarettes and other non-traditional cigarette tobacco products, which would allow them to stay on the market.

“This is especially troubling because the Surgeon General has found that these flavors are particularly attractive to kids,” Seward said, noting that flavorings are believed to be a major driver of the more than 10-fold increase in e-cigarette use among high school-age kids between 2011 and 2015.

She added that there is “real concern about what lies ahead for reducing tobacco use and, specifically, whether the FDA’s existing authority will be weakened.”

While President Trump has not yet named a new FDA director, past actions by his pick for Health and Human Services (HHS) secretary have not lessened this fear.

Rep. Tom Price, MD (R-Ga.), was one of the few members of Congress to vote against giving FDA authority over tobacco, and he also voted against continuation of the Children’s Health Insurance Program (CHIP), which is largely funded by tobacco taxes.

As head of HHS, Price would have authority over the FDA, the CDC, the National Institutes of Health, and other major health agencies.

Myers said lobbyists from the e-cigarette industry are working to convince lawmakers to effectively prevent the FDA from regulating the products, as are groups that oppose government regulation on ideological grounds.

On Jan. 17, a coalition of a dozen free-market and anti-tax activist groups opposed to e-cigarette regulation, including FreedomWorks and Campaign for Liberty, sent a letter to Congress urging that all products on the market before the regulations went into effect last August be exempt from key provisions of FDA oversight, arguing that regulation “is depriving smokers of a demonstrably safer alternative (to traditional cigarettes).”

“While everyone’s focus seems to be on the White House, the tobacco industry has made it clear that it intends to urge Congress to dramatically curtail what has been working to reduce tobacco use,” Myers said.”It may feel like we’ve been back this year for a really long time, but it’s still early.”

Jamaica to evaluate WHO’s call for heavy taxation on tobacco industry

Health Minister, Dr Christopher Tufton says he along with stakeholders will be evaluating the call by the World Health Organisation (WHO) for heavy taxation on the tobacco industry.

http://jamaica-gleaner.com/article/news/20170124/jamaica-evaluate-whos-call-heavy-taxation-tobacco-industry

Addressing the WHO’s Executive Board in Geneva, Switzerland, yesterday Director-General, Dr Margaret Chan, said heavy taxation is one way of controlling tobacco use.

According to Tufton, Jamaica, which is a member of the WHO board, shares the concerns about the financial costs to treat tobacco-related illnesses and the associated cost to public health, globally and nationally.

He says any measure to discourage smoking and support public health is worth considering.

In a landmark report on the economics of tobacco and tobacco control, the WHO and the US National Cancer Institute concluded that smoking costs the global economy more than $1 trillion yearly.

The researchers also said smoking will soon kill more than six million people worldwide each year.

They show how tobacco control, through heavy taxation can save lives while generating revenues for health and development.