With talk of cigarette-pack graphic health warnings arising again in the U.S., the government watchdog group, the Center for Regulatory Effectiveness (CRE), has issued a mild warning about the effectiveness of shocking warnings.
The CRE’s warning comes in the form of a 2003 piece from Regarding the Pain of Others by the late Susan Sontag, in which she commented on a decision by health authorities in Canada to add shocking photographs to existing textural cigarette-pack warnings.
Sontag said a study had ‘somehow calculated’ that packs with such pictures would be 60 times more likely to inspire smokers to quit than would packs with only textural warnings.
‘Let’s assume this is true,’ Sontag was quoted as saying. ‘But one might wonder, for how long? Does shock have term limits?
‘Right now the smokers of Canada are recoiling in disgust, if they do look at these pictures. Will those still smoking five years from now still be upset?
‘Shock can become familiar. Shock can wear off. Even if it doesn’t, one can not look. People have means to defend themselves against what is upsetting – in this instance, unpleasant information for those wishing to continue to smoke. This seems normal, that is, adaptive.
‘As one can become habituated to horror in real life, one can become habituated to the horror of certain images.’
In 2011, the US Food and Drug Administration was poised to roll out a series of graphic warning labels for use on tobacco products, as mandated by the Family Smoking Prevention and Tobacco Control Act. However, a legal challenge by the tobacco industry led to the labels being rejected, in large part because they were found to be emotional rather than factual.
The FDA withdrew their original labels and began to rethink the labels.
Earlier this month, researchers at the Penn Tobacco Center of Regulatory Science at the Annenberg School for Communication were quoted in a ScienceDaily story as saying that they hoped the data from their study, along with findings from similar studies, would lead to the adoption of more effective warning labels.
The researchers said they had shown that warning labels featuring photos of real smokers who were harmed by their habit were more effective in getting smokers to quit than were the text-only labels currently in use
In addition, their study had shown that the ‘testimonial images’ were equally as effective as the photo-based labels that the FDA tried to impose previously.
The new study, Potential Effectiveness of Pictorial Warning Labels That Feature the Images and Personal Details of Real People, was due to be published in Nicotine & Tobacco Research.
Cigarettes in France are due to be sold in standardized packs following the passage of a law in parliament on Thursday, according to an Agence France Presse story.
The new regulations will be imposed despite objections from the country’s conservative opposition and tobacconists.
In a move that reflects the imposition of a standardized-packs requirement in Australia in December 2012, all cigarettes sold in France will, from May next year, have to be sold in packs of uniform size and color.
Brand names will appear, but in a small, uniform typeface, and packs will be shorn of logos.
Last year, health minister Marisol Touraine estimated that about 13 million people light up in France and that smoking, the leading cause of premature death in France, accounts for about 78,000 deaths annually.
Next Generation Labs (NGL), the makers of proprietary TFN Nicotine – non-tobacco derived synthetic nicotine liquid and crystals – says that it has noted court statements made by the US Food and Drug Administration (FDA) in the Nicopure vs. FDA lawsuit that confirms products not made or derived from tobacco are not regulated tobacco products under the recent deeming rule, according to a cstoredecisions.com story.
The story said that, in a response brief to the court dated November 1, the FDA had stated that not all nicotine-free e-liquids (NFLs) were subject to the deeming rule. “Assuming an NFL is not made or derived from tobacco, it is subject to the rule only if it meets the definition of a ‘component or part’ – that is, if it is ‘intended or reasonably expected’ either…(1) To alter or affect [a] tobacco product’s performance, composition, constituents, or characteristics; or (2) To be used with or for the human consumption of a tobacco product; and is not an accessory,” the FDA was quoted as having said.
‘The FDA’s Deeming Rule was designed to extend the agency’s regulatory authority over a variety of tobacco products, which greatly impacts the vape industry,’ according to cstoredecisions. ‘However, the recent clarification from FDA attorneys appears to confirm that the deeming rule does not extend to e-liquids that are either nicotine-free, or not made or derived from tobacco, when marketed and sold appropriately.
‘TFN Nicotine is not made or derived from tobacco, nor is it a component or part of any tobacco product; as such Next Generation Labs does not believe e-liquids made with TFN Nicotine are required to list their product as a tobacco product with the FDA, or prepare a Pre-Market Tobacco Application (PMTA) submission before launching a new vape liquid brand in the USA.’
“The FDA’s statements to the court seem to confirm our long-held position: TFN Nicotine products cannot be regulated under the deeming rule as they simply are not tobacco products,” said Vincent Schuman, CEO of NGL. “In order to comply with the FDA, the onus is on e-liquid manufacturers to consider how their TFN Nicotine product is marketed, distributed and positioned to adult consumers to ensure a complete disassociation from tobacco and tobacco devices.”
While the EU Commission has no immediate plans to review the regulation of electronic cigarettes within its revised Tobacco Products Directive, it will continue to monitor developments relating to the use of these products and will submit a report in 2021 in line with the requirements of the directive.
This was part of a Commission answer given in response to a question by the French member of the European Parliament, Jean-François Jalkh.
In a preamble to his question, Jalkh said that electronic cigarettes, which had been introduced in France in 2013, had become increasingly popular as a ‘scientifically-proven alternative to smoking’. ‘Studies and individual testimonies welcome the contribution made by e-cigarettes in helping people to cut down on smoking normal cigarettes, and even to quit altogether,’ he said.
‘However, the World Health Organization refuses to consider e-cigarettes as an alternative solution and is even encouraging Member States to increase the price of ordinary tobacco, which it believes to be the only way to tackle smoking addiction.
‘Contrary to what studies on e-cigarettes suggest, the EU and the WHO are together pursuing a punitive policy against the smoking population, favouring taxation over prevention and thus putting financial interests before public health.’
Jalkh asked: ‘In view of this state of affairs, will the EU ditch its crusade against the consumer in favour of a risk reduction policy?’
In response, the Commission said it was following closely developments related to electronic cigarettes, in particular any scientific evidence emerging on their use patterns, long-term health effects and potential to facilitate smoking cessation.
‘This evidence is currently inconclusive,’ the Commission said. ‘Indeed a recent Commission report COM(2016) 269 points to a number of potential risks to public health relating to the use of e-cigarettes whilst highlighting the need for further research.
‘Article 20 of the Tobacco Products Directive … adopts a precautionary approach to their regulation, introducing for the first time EU-wide safety and quality rules for e-cigarettes and refill containers. These rules nevertheless allow e-cigarettes to remain widely available to consumers.
‘The Commission has no immediate plans to review the regulation of e-cigarettes within Directive 2014/40/EU. It will continue to monitor developments relating to the use of these products and will submit a report in 2021 in line with Article 28(1)(g) of the Directive.’
Starting April 17, business and individuals carrying out any operation in the U.K. using raw tobacco must get approval from HM Revenue and Customs.
Interested parties can submit their applications from Jan. 1-31, 2017.
The objective of the measure is to prevent tax evasion by prohibiting the use of raw tobacco by an unapproved person, to prevent the illegal manufacture of tobacco products.
The US Food and Drug Administration has deferred a decision on whether to allow Swedish Match North America (SMNA) to claim that use of its General snus brand causes less harm than is caused by smoking combustible cigarettes. It said in a press note issued through PRNewswire that it had ‘issued a response that offers the company an option to amend its applications’.
In January 2011, SMNA started the formal process of making a modified risk tobacco product (MRTP) application and, on August 27, 2014, it became the first company to complete such an application.
The application involved the submission of something of the order of 1,000 pages of evidence with about 120,000 pages of supporting documents, some of which related to studies that pre-dated the start of the application.
On July 31, 2015, at the request of the FDA, SMNA supplied additional information.
SMNA made the application because it wanted to be able to modify, for a number of products within its General snus brand, the health warnings currently applied to all smokeless products sold in the US and to advertising for those products. These warnings declare: this product can cause mouth cancer; this product can cause gum disease and tooth loss; this product is addictive; and this product is not a safe alternative to cigarettes.
The company wanted the first two warnings dropped, the third warning about addictiveness left in place, and the fourth warning replaced with one reading: no tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.
SMNA made the warning labels the target of its application because research had indicated that consumers were confused by, on the one hand, seeing dire warnings on snus packs, while, on the other, reading third party reports of studies showing that the consumption of snus was less risky by a factor of 90 percent and upwards than was the consumption of cigarettes.
The US Congress made provision for companies to make MRTP applications to the FDA when it passed the Tobacco Control Act in 2009.
Yesterday, the FDA said it had taken action on the first applications reviewed through the MRTP pathway for eight SMNA snus smokeless tobacco products sold under the General brand name.
‘The agency denied the company’s request to remove a currently required warning stating that the products can cause gum disease and tooth loss,’ it said. ‘With respect to the company’s other requests to remove or revise two additional currently required warnings, the agency deferred final action and issued a response that offers the company an option to amend its applications.’
“The lessons learned through these first applications provide key insights moving forward,” said Mitch Zeller, J.D., director for the FDA’s Center for Tobacco Products. “For example, companies should carefully consider how they plan to present and substantiate a modified risk claim. While the FDA is not authorizing modified risk orders for these products at this time, our guidance to the company will enable it to amend its applications if it chooses.”
‘Based on the scientific evidence provided in the applications, as well as other available data, the agency determined that the request to remove the warning related to gum disease and tooth loss should be denied because these products can cause gum disease and tooth loss,’ the FDA said in its note. ‘On the other two requests, for which the FDA has deferred final action, the agency believes that the applications could be amended to support issuance of modified risk orders and has requested that the company amend the applications within two years if it chooses to proceed.
‘In its review, the FDA must look at whether a product, as actually used by consumers, will significantly reduce harm and the risk of tobacco-related disease to individual users and benefit the health of the population as a whole. In making this assessment, the agency must consider whether those who do not use tobacco products would start using the product or whether existing tobacco users who would have otherwise quit would switch to the modified risk product instead.’
In response to the FDA’s announcement Swedish Match (SM), in a note posted on its website, said that the agency had outlined the process forward and encouraged SM to continue its efforts to seek modified risk status for General Snus. ‘Swedish Match interprets their position as wanting to further discuss on how to best communicate a modified risk message to the general public,’ said SM.
‘Although the FDA has not yet approved Swedish Match’s MRTP-application, the Agency had previously determined that the General Snus products are protective of the public health and contain significantly lower levels of harmful constituents compared to over 97 percent of the smokeless products on the US market. These findings are part of the premarket tobacco application (PMTA) decision announced by FDA in November 2015.
‘Swedish Match praises the open, active and constructive dialogue Swedish Match has had with the FDA and the dialogue will now continue.’
“Swedish Match snus products in the US will maintain their current classification, and General Snus will continue to be sold under current regulations,” Fredrik Peyron, senior vice president, regulatory affairs and group communication, SM, was quoted as saying. “Swedish Match is the first and, to date, the only tobacco company ever to have completed and thus [had] accepted [an] MRTP application filed with the FDA. That is a major achievement in itself and has encouraged employees of Swedish Match to work even harder towards Swedish Match’s vision A world without cigarettes.
“Our goal has been to work to communicate truthfully to consumers about our snus products and that snus is a less harmful alternative to cigarette smoking. We took a major step towards our vision A world without cigarettes by having the first MRTP application ever accepted as complete by the FDA, and we believe it’s a sign that we’re moving in the right direction. We will adhere to the invitation by the agency to continue our constructive dialogue in order to understand the next steps necessary for issuance of a modified risk order.”
The Czech Prime Minister, Bohuslav Sobotka, and Health Minister, Miloslav Ludvik, have both welcomed the passage of a previously-rejected anti-smoking bill through the Chamber of Deputies, the lower house of Czech parliament, according to a Czech News Agency (ČTK) story. Deputies rejected the bill in May.
Sobotka said he was glad that the deputies had supported the bill on Friday, though he described as absurd the more than two-hour debate that took place before it was passed.
Ludvik, meanwhile, said he expected a stormy debate on the legislation in the Senate, the upper house, but that he hoped a “sensible healthy opinion” would prevail there as well.
The agency report said that, if passed, the bill would ban smoking in ‘all restaurants and other similar facilities’ as of the end of May, 2017. It would bring in too ‘further restrictions on smoking’ as well as on alcohol sales and consumption.
The approval of the bill was a victory for the protection of people’s health over commercial interests, Sobotka told reporters.
“We have sent a signal that the government really means its effort to include the Czech Republic among civilized countries that protect the health of their citizens and are also able to suppress other interests, for instance, commercial ones, because of it,” Sobotka said.
Ludvik told reporters that health protection had finally won over the tobacco producers’ lobby and interests.
“This is the best piece of news for the Czech Republic,” he said.
The Smoke-Free Alternatives Trade Association (SFATA), the largest trade association representing and managing the interests of the vapor industry, issued the following statement regarding the Food & Drug Administration’s (FDA) final deeming rule on e-cigarette and vapor regulations:
“As the Royal College of Physicians, one of the world’s leading medical associations, recently released its historic report endorsing vaping as a harm reduction option, stating that regulations should not inhibit the development or use of vapor products, the FDA today issued its final rule classifying vapor products as tobacco, essentially banning 99 percent of all vapor products on the market as a result of the Feb. 15, 2007 predicate date.
“Although the FDA states it has found a vapor product on the market in 2006, it has yet to be determined whether the far more technologically advanced vapor products on the market today can be considered substantially equivalent to that product.
“Our industry has a long history of supporting sensible science-based regulations, including license requirements, as well as banning sales to minors and adopting child-resistant packaging. Today’s final rule pulls the rug out from the nine million smokers who have switched to vaping, putting them in jeopardy of returning back to smoking, which kills 480,000 Americans each year and costs the U.S. more than $300 billion in annual health care expenses.
“These new regulations create an enormously cost-prohibitive regulatory process for manufacturers to market their products to adult smokers and vapers. It also limits access to the 40 million adult smokers in the U.S. yet to make the switch to vaping and cripples a multi-billion dollar job-creating industry, the majority of which are made of small businesses.
“Since a growing body of scientific evidence confirm that vapor products are more than 95 percent less harmful than combustible cigarettes, it is essential that Congressional action be taken so vapor products can remain on the market as highly effective replacement tools for smokers. The only viable option at this time is to change the predicate with federal legislation, such as H.R. 2058 (aka Cole Bill), as well as a recent bi-partisan amendment introduced by U.S. Representatives Tom Cole (R-OK) and Sanford Bishop (D-GA) that recently passed the House Appropriations Committee, so that a more reasonable substantial equivalency pathway to market is created.”
The Consumer Advocates for Smoke-free Alternatives Association (CASAA) is condemning the FDA’s deeming regulations that will effectively ban 99.9 percent of the vapor products currently on the market.
CASAA is especially troubled by the FDA’s move in light of the Royal College of Physicians’ recent endorsement of e-cigarettes as a valuable tool in helping reduce harms associated with smoking. In its 206-page report issued last month, Nicotine Without Smoke: Tobacco Harm Reduction, the Royal College of Physicians states:
Smoking is the biggest avoidable cause of death and disability, and social inequality in health.
Provision of the nicotine that smokers are addicted to without the harmful components of tobacco smoke can prevent most of the harm from smoking.
E-cigarettes are marketed as consumer products and are proving much more popular than NRT as a substitute for and competitor for tobacco cigarettes.
E-cigarettes appear to be effective when used by smokers as an aid to quitting smoking.
The hazard to health arising from long-term vapor inhalation from e-cigarettes available today is unlikely to exceed 5 percent of the harm smoking tobacco causes.
“Today’s action by the FDA is a choice of politics over genuine public health, imposing an almost insurmountable burden on the diverse vapor industry, essentially handing the entire marketplace to the large tobacco companies,” said Julie Woessner, executive director for CASAA.
“These regulations are nothing short of a boon to the tobacco companies, demonstrating a clear preference for the status-quo, which keeps dangerous combustible products in place while stifling their low-risk competitors.
“These regulations will eliminate choice and diversity in the marketplace, the very things that have made vapor products such an incredibly successful low-risk alternative to smoking,” Woessner explained. “This is an appalling breach of public trust by the FDA.”
With talk of cigarette-pack graphic health warnings arising again in the U.S., the government watchdog group, the Center for Regulatory Effectiveness (CRE), has issued a mild warning about the effectiveness of shocking warnings.
