A US federal court yesterday ordered the Food and Drug Administration (FDA) to issue expeditiously a final rule requiring graphic health warnings on cigarette packs and advertising, as mandated by a 2009 federal law, according to a statement posted on the Campaign for Tobacco-Free Kids website.
The statement was attributed to 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 and the Truth Initiative
The ruling by district judge Indira Talwani of the district court for the District of Massachusetts was said to have been in response to a lawsuit filed in October 2016 by eight public health and medical groups and several individual pediatricians.
‘Judge Talwani agreed with the health groups that the FDA has both “unlawfully withheld” and “unreasonably delayed” agency action to require the graphic warnings,’ the statement said.
‘Judge Talwani set a deadline of September 26, 2018, for the FDA to “provide to this court an expedited schedule for the completion of outstanding studies, the publication of the proposed graphic warnings rule for public comment, review of public comments, and issuance of final graphic warnings rule in accordance with the Tobacco Control Act.’
The statement described the ruling as a major victory in the fight against tobacco use, which was said to be the nation’s number one cause of preventable death.
‘In accordance with the court’s order, we urge the FDA to quickly issue, finalize and implement a rule requiring graphic cigarette warnings,’ the statement said. ‘The current US cigarette warnings, which are printed on the side of cigarette packs and haven’t been updated since 1984, are stale, unnoticed and a major impediment to greater progress in reducing cigarette smoking.
‘Studies around the world have shown that graphic warnings are most effective at informing consumers about the health risks of smoking, preventing children and other non-smokers from starting to smoke, and motivating smokers to quit.
‘Requiring graphic cigarette warnings in the US will protect kids, save lives and reduce tobacco-related health care costs, which total $170 billion a year.’
Category: Regulation
Graphic warnings on order
The rules rule
The US Food and Drug Administration, which has come under criticism for its cumbersome processes and which is fighting a lawsuit over its August 2017 Guidance Document, Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule, says it is spotlighting tobacco regulations as part of its Understanding Tobacco Regulation and Guidance series.
In a note issued through its Center for Tobacco Products, the FDA said that in 2009, the Family Smoking Prevention and Tobacco Control Act (TCA) amended the Food, Drug, and Cosmetic (FD&C) Act, establishing FDA’s authority to regulate the manufacture, distribution, and marketing of tobacco products. ‘FDA implements the FD&C Act by issuing regulations (commonly referred to as rules) and guidances,’ the statement said. ‘A regulation is a government statement that carries out or explains a law or policy. Regulations can also describe the agency’s organization or procedures. FDA regulations are created through a formal notice-and-comment rulemaking process and have the full force and effect of federal law.’
The FDA said it went through a number of steps that invited participation from the public as it considered, developed, and finalized a regulation.
For instance, the agency might choose to issue an Advance Notice of Proposed Rulemaking (ANPRM) before issuing a proposed rule. An ANPRM, the FDA said, was a document published in the Federal Register that generally described the regulatory action the agency was considering, explained the underlying issues, and asked for public comment on specific questions.
A Proposed Rule (also known as a Notice of Proposed Rulemaking or NPRM), meanwhile, was an official document published in the Federal Register that announced the agency’s proposal of a new rule or regulatory change. It explained the need and authority for the proposed rule and the issues involved, and it provided also a period for the public to comment. A proposed rule and accompanying public comments shaped the final rule.
A Final Rule was a regulation published in the Federal Register that explained the basis for the rule, described and responded to public comments received on the proposed rule, explained any changes from the proposed rule, contained a variety of analyses of the rule’s potential impacts, and provided a specific date on which the rule became effective. A final rule was law.
A more detailed overview of the federal rulemaking process is available here. And it is possible to explore FDA’s searchable list of ANPRMs, proposed rules, and final rules here.
The FDA included information in its statement on its ‘public health mission’.
‘As a science-based regulatory agency, FDA examines areas of its legal authority under the FD&C Act and prioritizes issues for rulemaking in accordance with the agency’s public health mission,’ it said. ‘FDA’s traditional “safe and effective” standard for evaluating medical products does not apply to tobacco products. When FDA develops certain regulations, the TCA requires the agency to apply a public health approach that considers the effect of the regulatory action on the population as a whole, not just on individual users, with respect to initiation and cessation of tobacco use. FDA also considers the impact of the regulation on the regulated tobacco industry.’
In addition, the FDA said, when considering a new tobacco regulation there were many other factors involved in the process, ‘some of which may include the following’:- ‘New technologies or data related to the issue;
- Subject matter expertise, research findings and recommendations of agency staff;
- ‘Concerns arising from accidents or other health risks affecting the public;
- ‘Recommendations from congressional committees or federal advisory committees;
- ‘Requests from other agencies;
- ‘Petitions from interest groups, corporations, and members of the public;
- ‘Lawsuits filed by interest groups, corporations, states, and members of the public;
- Presidential directives.
Evidence plainly missing
Lithuania’s Prime Minister Saulius Skvernelis has said that there are no compelling arguments in support of the claim that the introduction of standardized tobacco production would cut smoking prevalence, according to a Baltic News Service story relayed by the TMA.
Proposed amendments to Lithuania’s Law on the Control of Tobacco, Tobacco Products and Related Products drafted by the Ministry of Health would require standardized packaging for cigarettes, ban the retail display of tobacco products, and prohibit smoking on residential balconies, in outdoor cafés, at beaches and other outdoor areas.
Skvernelis said that while the Government supported a ban on tobacco product displays in shops, it did not see sufficient arguments for introducing standardized packaging for cigarettes.
He said the proposal should be amended to protect non-smokers’ rights while balancing the interests of smokers, “because imposing bans and restrictions without offering alternatives is a simple way, but it was not approved”.
The introduction of standardized packaging was a highly-debatable measure, he added, and there were no clear arguments that it would cut smoking prevalence.It's time for action
The US Food and Drug Administration has failed to approve a single reduced-harm nicotine product in the past year, despite having unveiled a new ‘roadmap’ in July 2017 that emphasized the role such products can play in reducing tobacco-related illness, according to a piece by Michelle Minton at cei.org.
‘That lapse does a huge disservice to millions of smokers who could benefit from switching from cigarettes to a far less harmful product,’ Minton said.
‘A year ago, the FDA claimed it would balance regulation against encouraging the development of harm-reducing products. But with each passing week it’s become clear that the biggest roadblock on the path to tobacco harm reduction is the agency’s own cumbersome product approval process.’
Minton pointed out that it would be easy for the FDA to encourage the development of less harmful nicotine products for smokers. The market already provided alternatives in the form of e-cigarettes, smokeless tobacco, and heat-not-burn devices, she said. All that was needed to make these products available and viable as smoking cessation tools was for the FDA to establish a regulatory structure that made it easier and cheaper for manufacturers to earn FDA approval to sell the products and advertise them as being of lower risk than combustible cigarettes.
But the FDA seemed to have done nothing to reform its pre-market tobacco approval gauntlet. During the past two years, the agency had received 367 premarket tobacco applications, which are required for the products to be sold legally in the US. None had been approved. The agency had received also 35 Modified Risk Tobacco Product applications (MRTP), which would allow tobacco products to be advertised as lower risk. The agency had not approved any such application, ever.
Minton pointed out that snus had helped Sweden get its smoking rate down to five percent, lower by far than any other EU nation and the US; and, as a result, Sweden had one of the lowest incidences of lung cancer and oral cancers in the EU.
While snus could be sold in the US, it could not be advertised as being of lower risk than cigarettes, even though it was. Consequently, US consumers saw little reason to switch from smoking to smokeless tobacco.
So far, the FDA had considered MRTPs from several snus companies, including Swedish Match, which submitted an application in 2014 and was denied two and half years later. Currently, R.J. Reynolds, which submitted an MRTP in March 2017, was still waiting on a decision from the FDA.
[In December 2016, the FDA announced a partial ruling offering Swedish Match two years to submit an amended application, and TR understands that the company is finalizing its amendment and plans to submit it soon.]More bans, more coming
Israel has ramped up its restrictions on tobacco smoking in public places, according to a BBC Online story quoting a Ynet news report.
A ban on smoking tobacco, which applied to government offices, courts, religious councils, hospitals and clinics, is being extended to concerts, demonstrations and all open-air events attended by more than 50 people.
It is being extended also to swimming pools, open-air sports facilities, playgrounds, zoos, the entrances to pre-schools, and in enclosed car parks.
Some venues are allowed to designate smoking areas at least 10 meters from the entrance ‘as long as they do not inconvenience other parts of the facility, or residences’.
The new restrictions, which were set out in a bill in May, came into force on September 1 after years of complaints by campaigners that the health ministry had not done enough to tackle the relatively high rate of smoking in the country.
Further restrictions are planned. The Health Ministry’s Moshe Bar Siman Tov promised parliament in May that the government would ban smoking areas in bars and restaurants.E-cig stance challenged
The recent advisory issued by India’s Union Ministry of Health and Family Welfare to the State government seeking a ban on the sale of electronic nicotine delivery systems (ENDS) is based on poor advice and a lack of scientific evidence, according to a story by Bindu Shajan Perappadan at thehindu.com quoting a group representing electronic cigarette users across the country.
The Association of Vapers India (AVI) has hit back at the Center and questioned the motive behind the advisory.
‘ENDS products are being examined across the world for their benefit in harm reduction and as a pathway to smoking cessation,’ the AVI said in a press note. ‘The advisory must be withdrawn immediately…’
Evidence that had been produced during the past two years had shown that a smoker who switched to vaping cut her health risk by more than 95 percent, the AVI said.
And it questioned why the government had not banned tobacco cigarettes if it was so concerned about nicotine.
At the same time, the AVI rubbished the government’s contention that vaping would increase smoking rates among teenagers, citing evidence to the contrary based on a survey of 60,000 teenagers by UK-based Public Health England.
“This claim is bogus as smoking rates among the youth are declining in all countries that have allowed vaping,” said AVI director Samrat Chowdhery. “In fact, overall smoking rates have declined at a historical rate after vaping was introduced. This clearly points to the tremendous harm reduction potential of vaping.”
Meanwhile, Deepak Mukarji of The Alternatives, which advocates harm reduction in respect of people and the planet, said the Alternatives was disappointed with the Central government’s directive on e-cigarettes. This retrograde step denied harm reduction and potentially lifesaving alternatives to smokers by ignoring science and its emerging technologies.
Evidence that the government claimed to have, the AVI said, was either outdated or intentionally misinterpreted; and it was out of line with the view widely accepted by all major scientific institutions that the use of e-cigarettes was substantially less harmful than was smoking combustible cigarettes.
The association blamed the government also for presenting a wrong picture by selectively citing World Health Organization data that 30 countries had banned e-cigarettes, while holding back information that 65 nations had allowed and regulated such products.UAE looks at dropping ban
The United Arab Emirates could be set to lift its ban on vaping products, according to a story by Nick Webster for The National Newspaper.
The Government’s consumer watchdog, the Emirates Authority for Standardization and Metrology (Esma) is said to have begun a preliminary project to assess whether electronic nicotine devices should be allowed to be used in the country.
Currently, electronic cigarettes are banned in the UAE.
“We believe that Esma is seriously considering how to best regulate all novel tobacco products to ensure product safety and the highest quality,” said Lana Gamal El Din, director of corporate affairs for Philip Morris International.The evidence is in
Electronic-cigarette campaigners have headed to Australia’s capital Canberra to convince federal politicians to lift bans on nicotine vaping products, according to a story by Michael Black at abc.net.au.
A recent CSIRO [Commonwealth Scientific and Industrial Research Organisation, an independent Australian federal government agency responsible for scientific research] report found regular use of vaping devices was likely to harm a person’s health, but it suggested there were likely benefits in replacing regular cigarettes with e-cigarettes.
Brian Marlow, the campaign manager for Legalise Vaping Australia, said the report quantified points his organization had been making for years.
“They’ve shown the gateway theory, that vaping leads to smoking, just doesn’t exist; they’ve shown that vaping reduces smoking rates; they’ve shown that it’s safer than smoking,” he said.
“This is not a harmless technology, it’s just significantly less harmful than tobacco and that’s what we’re trying to get across.”
Currently, there are various bans across Australia that restrict the sale of e-cigarettes and liquids containing nicotine.
Many vapers purchase products online and some don’t know that it’s technically illegal to do so.Smoking incidence down
The incidence of tobacco use in the Americas has dropped to 17 percent, which is below the global average of 20 percent, according to a new report by the Pan American Health Organization (PAHO).
However, while the PAHO says that progress has been made to address the ‘tobacco epidemic in the Americas’, it adds that more than one-third of countries in the region have yet to implement the highest level of effective tobacco control measures.
Governments must urgently increase efforts to apply these measures and save lives, says the PAHO’s Regional Report on Tobacco Control in the Americas 2018.
“While we are certainly heading in the right direction when it comes to reducing the number of tobacco users and protecting the population from the adverse effects of tobacco exposure, we are just not moving fast enough,” said Dr. Anselm Hennis, director of the Non-communicable Diseases and Mental Health Unit at PAHO.
“The fact remains that more than 2,000 people die each day in the Americas as a direct consequence of tobacco use and this epidemic will continue unless countries accelerate the speed at which effective policies are being implemented.”
The report highlights the progress that countries in the Americas have made towards implementing the measures outlined in the World Health Organization’s Framework Convention on Tobacco Control. These measures include regulations to protect people from tobacco smoke by establishing 100 percent smoke-free environments; the mandatory inclusion of large, graphic health warnings on all tobacco packaging; raising taxes on tobacco; and a total ban on tobacco advertising, promotion and sponsorship.
But it reports that 12 out of 35 countries in the Americas have yet to implement even one of these ‘effective tobacco control measures’.
And it says that while implementation of tobacco control measures has increased in the region over the past decade, progress has recently slowed down.What price truth?
The US Food and Drug Administration is being urged by The Heartland Institute to recognize the reduced harm of Camel Snus products
The FDA recently issued a ‘public comment of modified risk tobacco product applications (MRTPAs) for six Camel Snus smokeless tobacco products submitted by R.J. Reynolds Tobacco Company’.
In a comment to the FDA, Lindsey Stroud, state government relations manager at the Institute said the Institute had researched the effects of smokeless tobacco and tobacco harm reduction products for more than 20 years.
‘According to our research, the smoke in combustible cigarettes poses the biggest threat to smokers,’ Stroud said. ‘Therefore, smokeless tobacco can deliver nicotine more safely. Evidence indicates snus products, including Camel Snus, deliver nicotine effectively without the associated harms of combustible cigarettes.
‘FDA recognizes a continuum of risk among tobacco products: Combustible cigarettes are the most harmful and smokeless tobacco and snus are less harmful. However, despite this acknowledgement, FDA regulations prevent snus manufacturers from marketing their products as less harmful than combustible cigarettes. In fact, the warnings required on snus products misinform the public.
‘Therefore, The Heartland Institute urges FDA to regulate Camel Snus products and combustible cigarettes differently.
‘Because FDA has recognized and accepted the continuum of harm posed by different tobacco products, FDA should approve the modified risk tobacco product application. Approving the application would clarify the health effects of different tobacco products and hopefully incentivize smokers to quit using combustible cigarettes.’
