Category: Also in TR

Despite the approval of IQOS, the FDA’s premarket application process is still flawed.

By Michael McGrady

At the end of April, the U.S. Food and Drug Administration (FDA) approved Philip Morris Products’ premarket tobacco product application (PMTA)  for the company’s heat-not-burn device known as the I Quit Original Smoking system, or IQOS. An FDA press release states that the agency recognizes the potential improvement for population-level public health by authorizing such a product due to how heat-not-burn (HnB) systems work.

HnB systems, as we know, heat the tobacco instead of burning it, providing a cleaner nicotine-delivery system. “The agency determined that authorizing these products for the U.S. market is appropriate for the protection of the public health because, among several key considerations, the products produce fewer or lower levels of some toxins than combustible cigarettes,” the FDA admitted.

This is an astounding and surprising move by the FDA. However, there is still the elephant in the room. While the IQOS approval is undoubtedly a step in the right direction for the post-Gottlieb regulatory environment, the premarket approval process is still dangerously flawed and inefficient.

When the Obama-era Tobacco Control Act of 2009 granted the FDA the power to regulate all nicotine-containing products under the deeming provisions, the law additionally encouraged the implementation of a regulatory framework that prohibits new and modified products without agency approval. Premarket approval regulations, as promulgated by FDA guidance, cover every aspect of a tobacco product or deemed product. From the risk the product poses to health to the design of the label, a PMTA covers virtually every aspect of a product’s configuration.

According to a recently published position paper titled, “The Public Health Rationale for Recommended Restrictions on New Tobacco Product Labeling, Advertising, Marketing and Promotion,” the FDA justifies a broad regulatory query as a process that is vital to protecting not only general public health but also the country’s youth.

“Given the level of evidence indicating the direct and powerful impact of tobacco marketing on youth

tobacco use, and FDA’s statutory mandate to protect young people from the dangers of tobacco use, it

is both reasonable and critical for firms to submit planned labeling, advertising, marketing, and

promotional materials and plans for new tobacco products that are seeking or have received premarket authorization, and for FDA to place restrictions on the marketing of such products,” the agency’s position paper concludes.

While this justification is admirable, and many in the industry are employing self-regulatory measures and industry standards for marketing, product labeling, transparency as the FDA wants, the structure of the PMTA law still provides a case for government-supported market inefficiency.

PMTAs are designed to require a standard of substantial evidence that a current or new product was designed with relative risk. By consequence, the PMTA applications process requirements kick in and send product manufacturers and marketers down an expensive process.

Agency estimates put the cost of each PMTA at $300,000 per product application. Other calculations put the cost estimates into the millions. Timeframes for application reviews also average from 500 hours to 1,700 hours. At a minimum, that is about 63 days of review per product application. Applications for products that claim to offer modified-risk scenarios during use have yet to be approved despite overwhelming evidence suggesting a reduced-risk case.

However, in my opinion, the key reason why the PMTA regulation is still so inefficient is how it interacts with safety development in vapor products. For starters, consider the controversy surrounding the FDA’s block of safer e-cigarette products.

In October 2018, Joyetech released its eGo AiO to Canadian markets. This device is one of the very first to receive a safety certification that complies with Underwriters Laboratories’ (UL) 8139 standards for the manufacturing of electronic nicotine-delivery systems. UL 8139 is also a manufacturing standard that was not borne from a government agency; rather, UL coordinated with members of the industry to create a safer device.

PMTA rules prevent Joyetech from selling that product due to the process for approval. In an interview with NBC News around the release of the eGo AiO, Joyetech’s chief regulatory and compliance officer, Joshua Church said, “We’ve been frozen out of the U.S. market by the FDA, whose last concern is product innovation. So, we’re sitting here stuck in the water.” Given this design, the regulation is structured to prevent further inefficiencies when receiving a compliant status for a product.

PMTA rules also present several scenarios for concern when they conflict with the statutory mandate of other federal regulators. The Child Nicotine Poison Prevention Act (CNPPA) is a little-known product safety law that requires child-resistant packaging on liquid nicotine containers. The CNPPA is enforced and interpreted by the federal Consumer Product Safety Commission (CPSC) following the regulatory framework outlined in the Poison Packaging Prevention Act (PPPA). Since the CNPPA has gone into effect and the commission has promulgated rules, the requirements for liquid nicotine packaging have grown more stringent.

In the latest round of enforcement, CPSC leadership has begun interpreting the CNPPA requirements for packaging to include flow restrictors and provided guidance that mandate that all e-cigarette packages feature these new safety implementations. According to an analysis written on this issue by regulatory attorneys at Keller and Heckman LLP, this interpretation of rules could dramatically impact firms that are not compliant. “Companies with products that do not have both child-resistant closures and flow restrictors may be required to cease sales and initiate product recalls until their packaging is brought into full compliance,” the Keller and Heckman analysis indicates, additionally noting that changes to packaging may trigger the FDA’s PMTA requirements.

While the analysis was optimistic that the PMTA requirements would be waived to ensure product compliance with other areas of federal law, the FDA does not have the greatest track record of cooperating with the industry or its fellow regulators. Per a memorandum of understanding, the FDA and CPSC have intentions to work together in overlapping regulatory efforts. This, however, does not mean that the FDA will not attempt to add more requirements related to packaging configurations to put product manufacturers at higher levels of scrutiny during the PMTA process.

A remedy for many of the disputes outlined in this piece would be for the FDA to reinterpret the Tobacco Control Act to permit greater flexibility for the industry to voluntarily reach higher levels of safety. Existing rules are likely to stay the same as a part of the continued crusade to fight to a so-called youth vaping epidemic. If this holds, the only remedy would be a legislative fix that could come at a slower rate than amended agency guidance. Regardless, the PMTA still serves as an example of inefficient regulatory power that places industrial input last.

With no meaningful history of traditional tobacco control, Malawi may be more open than other countries to the concept of harm reduction.

By George Gay

Malawi has a tobacco control commission but makes no interventions to control tobacco product consumption. There is, however, no anomaly here, as professor Gerry Stimson, a director of Knowledge Action Change (KAC), an organization that promotes health through harm reduction strategies, pointed out during an interview in London in April. This state of affairs merely reflects a tension within the tobacco fabric of Malawi. The Tobacco Control Commission is charged only with overseeing the leaf tobacco production industry—an industry so important to the economic welfare of the country that there is a reluctance on the part of the government to engage also in consumption-control activities.

Freshly returned from a visit to Malawi, Stimson related how tobacco packs in the country carried no health warnings, how the country imposed no age restrictions on tobacco product purchases and how taxation was not used as a vehicle for reducing consumption. Malawi was not party to the World Health Organization’s (WHO) Framework Convention on Tobacco Control (FCTC) and employed none of the WHO’s MPOWER measures intended to assist in country-level implementation of interventions to reduce demand for tobacco.

Such reluctance to rigorously confront one of the greatest health issues of our time will be seen by some as concerning, but Stimson clearly senses an opportunity. When he looks at Malawi, he sees a country that, without a history of narrowly focused tobacco-consumption interventions, is perhaps open to ideas about tobacco harm reduction (THR).

KAC’s directors, Stimson and Paddy Costall, have been active in harm reduction for more than 40 years and, more recently, specifically in THR. They have helped stage the annual Global Forum on Nicotine (GNF) in Warsaw, Poland, since 2014. More recently, using funding from the Foundation for a Smoke-Free World (FSFW), KAC has introduced THR scholarships and launched the Global State of Tobacco Harm Reduction 2018 report.

That report, which was written by Harry Shapiro and launched last year in London, is currently the subject of an international roadshow, also funded by the FSFW, that has so far seen it taken to Australia, Kenya and Malawi, not all of which are necessarily the first countries that would come to mind when planning such a trip. In fact, Stimson admitted that, not long ago, he considered Africa to be off the map in respect of THR. But now, he said, there was a lot of interest and a lot of activity, and some “rising stars” among the people there. Malawi, for instance, was included on the roadshow schedule partly because two of KAC’s THR scholars based there, Chimwemwe Ngoma, who runs the campaigning organization, THR Malawi, and social scientist, Wilfred Jekete, had said they wanted to organize a THR meeting for government officials and others.

Open to ideas

That meeting, described by Stimson as “very interesting,” attracted more than 100 people representing health education and AIDS organizations, universities, nongovernmental organizations (NGOs), farming interests and tobacco community development bodies, as well as and the government departments of agriculture, health and trade, a lineup that seems to support Stimson’s contention that the country could be open to fresh ideas concerning the control of tobacco consumption.

But first there would need to be a shift in thinking away from the idea that acting against tobacco consumption locally could hurt the “health of the tobacco economy,” a shift that has been made successfully in other tobacco exporting countries, even in countries where, unlike Malawi, consumption is mainly of locally manufactured products.

Certainly, the argument that Stimson and his team presented was that the government could concern itself with the health of smokers without what it did affecting the health of the tobacco economy, because consumption of domestic tobacco was minimal. And the prospects in Malawi were good, Stimson said, because the government could develop an approach to tobacco consumption from what was almost a blank slate. It could look at consumption control from a THR approach in which it was concerned about health but was not working only with the rather heavy-handed tobacco control components of MPOWER. This just couldn’t be done in other countries, added Stimson, who made the point that the guest of honor at the meeting was the head of the country’s health service.

To a certain extent, getting across the idea of harm reduction means pushing at an open door because Malawi has a history of dealing with the effects of AIDS. In fact, the joint host of the meeting was JournAIDS, an organization that was originally set up by journalists around the fight against AIDS but that now deals with any number of health and social welfare issues. So it is possible that relaying messages about safer alternatives to smoking or quitting smoking could piggyback on health outreach structures that are already well-developed in Malawi in respect of AIDS, tuberculosis and malaria. Interestingly, there is in place a campaign aimed at raising awareness about the toxicants in smoke—but in this case the focus is on smoke from the open fires used during cooking.

However, there is one major problem with trying to introduce the idea of THR. Despite the wealth of the tobacco industry and the fact that Malawi has long been a major “stakeholder” in that industry, the country is economically constrained and many of its people are financially poor, so they could not afford to replace combustible cigarettes with, say, vapor products or Swedish-style snus. This means that THR would have to be based on alternative, acceptable, noncombustible products that could be produced in the country.

Campaigning for alternatives

Meanwhile, the roadshow in Kenya was scheduled to coincide with the launch by Joseph Magero of a pan-African THR network called the Campaign for Safer Alternatives (CASA), which has members also in other African countries, including the Democratic Republic of Congo, Malawi, Nigeria and Uganda. It included people working in slums, on AIDS and on drugs harm reduction, as well as those supportive of THR. It included, too, representatives of religious organizations, which are important operators in Kenya in the field of youth outreach.

Stimson described the situation in Kenya as fundamentally different to that in Malawi because in Kenya there was a strong alignment of anti-tobacco organizations that were part of the Framework Convention Alliance, which were strong supporters of the FCTC and for whom THR was seen as a threat. “It is a different, difficult situation,” he added, “but an interesting one because there are NGOs that have been working on harm reduction issues and that do get tobacco harm reduction as an idea. And this pan-African organization looks like it might have some traction.”

So, all in all, the Africa leg of the roadshow was a success? Well, said Stimson, the main aims of the roadshow had been to raise awareness about THR as a way to help people shift away from tobacco smoking and to strengthen the capacity of local people to promote THR. As an outsider, KAC could not do that, but it could help, nudge, support and enthuse local people, and it could provide them with the international contacts to enable them to put harm reduction and THR higher up the agenda. KAC was involved in a process of creating a conducive environment for harm reduction. It was a long process, and it was necessary to take every opportunity that presented itself. “I’m particularly enthused by the energy among the THR advocates in Malawi, and I’m particularly enthused by this new organization CASA,” he said. “You never expect things to change massively overnight, but everything seems to be pushing along the road towards harm reduction.”

Money well spent

As can be seen, Stimson is serious about the THR course he has set out on, but, having worked in harm reduction for so long, he is nothing if not a realist, and his answers are regularly punctuated with laughter as he recounts some of the obstacles that litter his path. One such is the reaction to KAC using FSFW money, which originally came from Philip Morris International (PMI) but over which PMI has no control and which cannot be returned to PMI. KAC had taken a risk accepting that money and had received a lot of flak for doing so, Stimson admitted, before going on to say, “… but … I would like to see it spent for the reason the money is there—to help shift people from smoking …. We think the money from the foundation can be well-spent.”

KAC had two Foundation-supported projects, Stimson said. One concerned the Global State of Tobacco Harm Reduction report for which KAC had made a grant application that was accepted and in respect of which there had been “absolutely no interference whatsoever from signing the contract to publishing the report. I have never experienced a donor who has been so hands-off,” he added.

And it was a similar story with its scholarships, which are funded by the Foundation but whose role is totally hands-off. “In my view,” said Stimson, “the ethical issue is no longer that PMI funded the foundation, but, given that the foundation has the money, it would be unethical not to spend it on the purposes for which it is intended.”

The Global State of Tobacco Harm Reduction 2018 report, now available in Mandarin as well as English, has been well-received, attracting a significant number of downloads for both it and the executive summary, which has been translated into a dozen languages. And, with what is now the assurance of a five-year FSFW funding agreement, the report is an ongoing project. Already since its launch, it has seen the addition of country profiles and a new tool that allows country comparisons to be made. And the latest project is adding an index that will measure how favorable governments are toward THR.

KAC has obtained a five-year funding agreement also for its scholarship program, which is run by Kevin Malloy and about which Stimson is “very excited.” The scholarships are designed to introduce and support people new to the field—to help build a new generation of people interested in research and communicating THR.

The program is nearing the end of its first year, during which it supported 15 scholars who initially were provided with a training program built around the 2018 GFN conference and who each received $7,500 to work, with the aid of a mentor, on an agreed project.

This year, the program, which attracted 50 applications, is being expanded and will see 20 scholars, 10 of them from Africa, each receive $10,000, and six who graduated with the first cohort receive $25,000 under an enhanced scholarship scheme. One of the enhanced scholars will be Malawi-based Jekete, who will be in charge of a program aimed at introducing stop-smoking and THR messages into other health organizations.

The fact that half of this year’s scholars will be from Africa was described by Stimson as “extraordinary.” Two years ago, he said, outside of South Africa, very little was happening in Africa in respect of THR.

The new EU Single-Use Plastics Directive requires cigarette manufacturers to assume greater responsibility for the environmental impact of their products.

By Stefanie Rossel

During a recent holiday, I had plenty of opportunity to watch the phenomenon: smokers discarding their cigarette butts on the ski slope or throwing them out of car windows while they were stuck in a traffic jam on the motorway. Butt littering is a bad habit, and it’s a common one as well. Studies quoted by the Truth Initiative, a U.S. not-for-profit tobacco control organization, found that 75 percent of smokers dispose of their cigarettes in the environment. Smokers are estimated to litter as many as 65 percent of their cigarette butts. Awareness continues to be low: In a survey by Keep America Beautiful, 77 percent of respondents said that they didn’t think of cigarette butts as litter.

The effect on the environment, however, is devastating. According to the Truth Initiative, cigarette butts are the most littered item on earth. Since the 1980s, they have consistently made up 30 percent to 40 percent of all items collected in annual international coastal and urban cleanups, amounting to an estimated 4.5 trillion cigarettes annually being discarded worldwide. For those who find this figure too abstract, in the southern part of Great Britain alone, cigarette butts discarded as street litter amount to 1,710 tons of waste per year—enough to fill seven Olympic-size swimming pools, according to calculations by British online vape shop Vapourcore.com.

Around 98 percent of cigarette filters are made of cellulose acetate (CA), a polymer that degrades in the environment very slowly. The time it takes a CA cigarette filter to disintegrate ranges from 18 months to 10 years, depending on the conditions of the environment in which it has been discarded. In addition, used cigarette filters are full of toxins, such as nicotine, formaldehyde, arsenic and ammonia, which can leach into the ground and harm living organisms that come into contact with them.

EU to combat plastics litter

Cigarette butts are also among the 10 single-use plastic products most often found on Europe’s beaches and in their seas. Together, these products constitute 70 percent of all marine litter items. In an effort to fight marine pollution, the European Commission in May 2018 proposed rules, the so-called Single-Use Plastics (SUP) Directive, which will ban single-use plastic items such as plates, cutlery, straws and cotton bud sticks made of plastic, as well as oxo-biodegradable plastics—i.e., plastics made of petroleum-based polymers that contain additives that accelerate their degradation when exposed to heat and/or light—food containers and expanded polystyrene cups beginning in 2021.

With regard to tobacco, the Members of the European Parliament (MEPs) proposed consumption reduction targets of tobacco product filters of 50 percent by 2025 and of 80 percent by 2030 in the original draft directive. Following several so-called Trilogue meetings—negotiations in the EU legislative process carried out within the framework of a conciliation committee—the Council of the EU and the European Parliament in December 2018 reached a provisional agreement that puts aside the MEPs’ proposal for consumption reduction targets.

Somewhat vaguely, the provisional agreement states that “the huge environmental impact caused by post-consumption waste of tobacco products with filters, discarded directly into the environment, needs to be reduced. Innovation and product development are expected to provide viable alternatives to filters containing plastic, and this development needs to be accelerated.” Through the introduction of extended producer responsibility (EPR), a reinforced application of the “polluter pays” principle, the provisional agreement seeks to further encourage innovation leading to the development of sustainable alternatives to tobacco product filters containing plastic. The SUP Directive was expected to be formally adopted in its current form at Tobacco Reporter’s press time in late March 2019.

“The directive will require producers to cover the costs of consumer awareness-raising measures and EPR schemes tackling the cleanup of litter and its subsequent transport and treatment, the costs of data gathering and reporting, and the costs of collection of waste of tobacco filters discarded in public collection systems,” explains Giovanni Carucci, vice president of EU affairs at British American Tobacco (BAT). “The deadline for EU member states to set up EPR systems is [Jan. 5, 2023].”

In particular, the obligation for member states to implement EPR schemes for tobacco filters containing plastic by 2023 is a precedent, he points out. “As yet there is no available guidance for member states as to how such EPR schemes should be implemented. Apart from a few local schemes, this is something that has never been carried out on this scale before for filters as for the other affected products. At the same time, it’s important to make sure the resulting schemes are efficient and effective and avoid unnecessary complexity.” He adds: “We believe the solution to this will be dialogue and cooperation including other affected industries, and we are open to collaborating and sharing information and expertise about our products to find the best way forward.”

Educating smokers

BAT agrees that companies should minimize their environmental impact and is committed to reducing its environmental impact across the supply chain and operations, according to Carucci. Before the SUP Directive, BAT had long been engaged in diverse projects and initiatives to prevent consumers from littering cigarette butts. “We believe consumer awareness is absolutely critical to solving the problem of butt littering, so we focused on creative projects designed to reach adult smokers,” says Carucci. “For example, in Belgium we worked together with the public authorities to contribute to a voluntary fund designed to support prevention awareness. In other countries, such as Austria, Germany, [the] Czech [Republic] and Switzerland, we distributed thousands of portable, sealable ashtrays as part of consumer education campaigns. These sorts of initiatives are also seen outside of the EU, for example in New Zealand where we contributed to a campaign that provides free purpose-designed cigarette butt bins to member councils and businesses and support to help councils and business associations educate smokers, making them more conscious of their littering and highlighting alternatives. These are just a few examples of the kinds of initiatives which we believe help mitigate the impact of our products.”

In the EU, cigarette manufacturers will have to go one step further: The SUP Directive mandates that, by the second quarter of 2021, tobacco companies put labeling on cigarette packs informing about the negative impacts of cigarettes with plastic filters thrown in the street. The labeling aspects of the proposal need to be in line with already existing tobacco labeling requirements stipulated by the revised Tobacco Products Directive (TPD2). Manufacturers are keen that regulators ensure there is no conflict with existing rules in the TPD2. “The Single-Use Plastics Directive states in Article 7(3) that the provisions of that article concerning tobacco products are in addition to those laid down in TPD2. Although the final compromise text of this legislation was published in January, we are still awaiting further details on the exact requirements on labeling. This will come in the form of secondary legislation—an implementing act—which could take some time to materialize. Until then, we can’t anticipate what such a conflict might look like. Therefore, we encourage legislators to consider the current design of products so that manufacturers can best apply them in a manner that does not conflict with existing legislation.”

For cigarette manufacturers, the cost involved from the measures mandated by the new directive remain unpredictable at this point. “Until secondary legislation materializes, it is not possible to know what additional costs this will add,” says Carucci. “However, we hope that any related costs will be efficient and proportionate.”

Searching for alternatives

While raising awareness among consumers certainly is a challenge, finding the innovative, environmentally friendly alternative to CA cigarette filters as stipulated by the directive might be an even tougher nut to crack. And it’s not just the filter material alone. Carucci says that his company’s current research shows that some constituents of its filters, such as CA derived from wood pulp, can degrade over a month to a three-year time period. “However, for other constituents in our filters, for example polymers or glues, research is inconclusive and requires further testing.”

Filters are an important part of the cigarette because they help comply with legally mandated maximum emission levels of tar, nicotine and carbon monoxide set out by the TPD2, Carucci emphasizes. “This is an essential quality to maintain when considering whether there are alternative materials that could serve the same purpose while taking environmental factors more closely into account,” he says. “At present, there are no alternatives that have been developed that will meet prescribed emission standards in various jurisdictions, while not increasing consumer exposure to certain other priority toxicants. Just to give one example, we’ve partnered with manufacturers developing these types of materials, as in 2014 when we partnered with Green Butts to evaluate some of their materials as potential filter materials. However, when we measured the smoke toxicants of the resulting filters compared to a control product, the majority of toxicants were higher than a cigarette with a standard filter. That’s why cellulose acetate remains, for the moment, as the benchmark. However, we will certainly keep up our efforts to research new materials, and we are open to new partnerships that could offer a solution.”

Solutions in the pipeline

Innovation in the filter and filter tow sectors offers some hope. With consumers becoming increasingly environmentally conscious, manufacturers of cigarette filters and filter tow have been developing alternatives with better biodegradability than the commonly used CA filter. Many of them have long been successfully used in cigarette products.

“Ever since I joined the industry in 2003, we have been running projects, both internally and with customers, to identify more biodegradable alternatives to cellulose acetate tow,” says Patrick Meredith, strategy and business development director at Essentra, a U.K. solutions provider for special filters and scientific services. “Some of the products introduced as a result of this work, such as our own Infused and BiTech filters, do bring performance closer to that of cellulose acetate filters. These may not provide identical performance to cellulose acetate over the full range of filter parameters—e.g., filtration, firmness, hot collapse, sensory and visual appearance—but they can certainly provide a base from which to develop solutions to meet any legislation that is enacted.”

Essentra has a range of solutions in its portfolio, including the Ochre filter, which is manufactured from unbleached paper, uses no chemical adhesives to bond the fibers and degrades three times faster than industry standard CA filters. At the same time, it retains higher levels of tar and nicotine compared to mono-acetate filters while it can provide a closer taste to acetate when the company’s Infused technology is applied, according to Essentra.

Next to “white” dual rod products with enhanced decomposition abilities, Essentra’s range also contains the BiTech filter, a single-segment filter that combines acetate tow with paper or other nonwoven materials and provides better filtration efficiency and greater degradability than a standard mono-acetate filter. Dependent on the raw materials selected, it also features better degradability than commonly used filters, according to the company.

“The latter two products incorporate a combination of cellulose acetate and paper, so adjusting the particular materials and their ratios should allow increased degradability to be achieved,” says Meredith. “We also have our Infused product whereby a liquid additive is applied to a paper filter, i.e., the Ochre filter, to bring the taste closer to that of a cellulose acetate filter.”

Essentra’s most recent innovation in terms of biodegradability is a hemp filter. “The hemp crop used to produce the hemp fiber source is grown without pesticides and irrigation for both seed and straw, which ensures economic stability and sustainability,” says Meredith.

Since 2014, the company also has a plugwrap material on offer that disperses in water at least three times faster than standard materials. “We have worked with a number of customers incorporating this plugwrap into our filter rods,” Meredith explains. “The plugwrap gives us an excellent tool to incorporate into the filter as part of a more degradable ‘total’ solution.”

Improving the availability of biodegradable filter solutions is essential, as regulation will not remain limited to the EU, Meredith notes. “Many other markets either have or are already looking to introduce legislation around degradability and littering of cigarette butts or are watching what happens in Europe with a view to adopting similar legislation. To meet these extended requirements [we] will need transformation across the entire industry.”

Best of both worlds

Progress has also been made with regard to the raw material used for filter production. In June 2018, Rhodia Acetow, a leading manufacturer of cellulose acetate tow, introduced DE-Tow, a fast biodegradable CA filter tow. “DE-Tow offers the tremendous advantage to meet the needs of environmental care regarding products that would be littered in nature; while traditional cellulose acetate in cigarette filters takes several years to decompose, DE-Tow biodegrades in less than six months,” says CEO Philippe Rosier. “Therefore, this innovation offers a global solution to the cigarette butt problem. We consider DE-Tow as a viable alternative to regular cigarette filter tow as referred to in the Single-Use Plastics Directive. Our product also contributes to the EU member states’ transition to a circular economy by generating a waste which, after collection, can be used for the production of biogas, composted, recycled or valorized energetically.”

Rhodia has been working on alternatives to current filters for about a decade. “Thanks to those efforts, with DE-Tow, we have been able to commercialize a biodegradable new generation of cellulose acetate filter tow,” says Rosier. “Therefore, the upcoming regulation is rather rewarding for our work and strengthens our determination to put the environment at the core of our R&D efforts.”

Upon its launch, the product’s biodegradability had already been certified in water, wastewater, and home and industrial compost. In December 2018, it received the certification of biodegradation in soil. Tests performed by external homologated laboratories have demonstrated the product’s biodegradability in marine water, according to Rhoda. “We expect official certification this year,” says Rosier.

DE-Tow can be used for the production of biodegradable cigarette filters through the same manufacturing process used for standard filters, Rosier explains. “There is no structural impact for cigarette manufacturers. With DE-Tow, cigarette manufacturers can replicate any type of filter for the simple reason that our product is made from cellulose acetate. Its main difference compared to regular cellulose acetate filter tow used for cigarette filters is its fast and certified biodegradability. It is also important to mention that DE-Tow is TiO2 free and that its classic filter tow performances, such as rod maker processability, smoke filtration, and filter design and quality, are equivalent to standard filter tow. DE-Tow is the filter material of choice not only for cigarettes but also for heat-not-burn sticks.”

Cellulose acetate has been used in the production of cigarette filters since the 1950s.

In Europe, more than 99 percent of the cigarettes currently sold are made with cellulose acetate-based filters, Rosier estimates. Rhodia Acetow is convinced that the development of sustainable alternatives to current cigarette filters has to leverage these key filtration performances of cellulose acetate. According to Rosier, customers are increasingly concerned about the environmental impact of tobacco products. “Consequently, we have been and are working closely with many cigarette manufacturers to develop, test and qualify innovative solutions respectful of the environment, such as DE-Tow. The first cigarettes with DE-Tow are now launched on the market. This synergy between our companies will be successful and meet both market expectations and environmental needs.”

The FDA commissioner’s surprise departure is unlikely to provide much relief to the beleaguered tobacco and vapor industries.

By Patrick Basham

It will never be on a par with 9/11, Neil Armstrong’s moonwalk or JFK’s assassination, but within tobacco and vaping circles the question lately was, “Where were you when Gottlieb resigned?”

I was in London evangelizing to a Women in Tobacco event about bitcoin’s role in female empowerment. At one point during my talk, an otherwise attentive audience suddenly became fixated on their smartphones. Seeking to ease my discomfort, a compassionate lady exclaimed, “We’ve all just seen Gottlieb quit!”

My performance anxiety was fleeting, but the tobacco and vapor industries’ collective anxiety is enduring, and with good reason. Despite U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb’s surprise resignation, the dark regulatory skies overshadowing the marketplace are unlikely to brighten.

An FDA deputy commissioner under former President George W. Bush, Gottlieb took office as an experienced Washington hand familiar with the FDA’s scientific and regulatory infrastructure; he was comfortable navigating the political minefield that is federal policymaking.

In May 2017, Commissioner Gottlieb began by telling manufacturers he wanted to reduce the harm of combustible cigarettes and bring to market e-cigarettes and other reduced-harm products. He appreciated that, for harm reduction to be successful, adult smokers need access to smoke-free products that deliver nicotine but with significantly lower levels of toxicants than cigarettes. That summer, Gottlieb allowed e-cigarette companies to keep their vapor devices and nicotine pods on the market for an extra four years before they had to prove their products benefit public health.

Yet, he spent the next 20 months cracking down on cigarette companies and aggressively attempting to arrest vaping’s growing popularity. As a top-down, command-and-control regulator swimming against a deregulatory tide, Gottlieb was an outlier in the Trump administration’s senior ranks.

In that vein, he asserted that teen vaping is an “epidemic.” In modern political parlance, “epidemic” is employed to suggest, with only the merest hint of statistical support, that something must be done to reduce consumption of product “X” or to solve alleged public health problem “Y.” In this case, the vapor marketplace became subject to draconian controls to prevent adolescents from gaining access to these relatively harmless products.

Professor of medicine Brad Rodu questions the magnitude of teen vaping. He writes: “The [U.S.] Centers for Disease Control and Prevention’s [CDC] 2017 National Youth Tobacco Survey shows that only about 12 percent of American high school students used e-cigarettes in the past month. Even if the CDC’s observation … is correct about a vaping increase in 2018, it doesn’t confirm an epidemic. Nearly 70 percent of the students who vape—but do not smoke—used e-cigarettes five days or less during that 30-day period, a pattern called ‘party’ or ‘weekend’ vaping, not regular, daily consumption.”

Nonetheless, Gottlieb’s FDA announced significant restrictions, which have yet to take effect, on the retail sale of flavored e-cigarettes. Consequently, Juul Labs, with 73 percent of domestic store-based e-cigarette sales, and other manufacturers of vapor products halted sales of some flavored e-cigarettes in brick-and-mortar retail outlets.

Convenience stores and gas stations will be effectively prohibited by the FDA from selling most flavored e-cigarettes. First proposed in November 2018, these measures will be introduced by this summer and are aimed at limiting access to the flavors most popular among adolescents. Only tobacco-, mint- and menthol-flavored e-cigarettes will be available for sale in these locations.

In another fillip to the illicit market, the FDA is prohibiting bulk online purchases of flavored vapor products. Furthermore, Gottlieb threatened to remove vapor products from the market entirely should the adolescent vaping “epidemic” not abate.

The crackdown on the retail market flies in the face of the fact that only a small minority of young vapers purchase e-cigarettes from brick-and-mortar locations; 86 percent purchase their e-cigarettes online or receive them from a friend or relative. The FDA’s own survey data, “The Population Assessment of Tobacco and Health Survey,” finds that less than 10 percent of teen e-cigarette users “bought them myself.”

Last November, the FDA also announced plans to ban menthol cigarettes, which constitute 35 percent to 40 percent of the U.S. market. Several years ago, the pro-regulation Obama administration consciously avoided this policy, as menthol cigarettes are disproportionately consumed by African Americans, the Democratic party’s most reliable voting bloc. Unconstrained by such electoral concerns, Gottlieb moved forward with this deeply misguided policy that would immediately create a thriving illicit trade in unregulated menthol cigarettes.

Gottlieb also threatened to limit the nicotine in cigarettes to nonaddictive levels, although the FDA arguably lacks the legal authority to do so. At Gottlieb’s urging, President Donald Trump’s latest budget proposal seeks to add a user fee to e-cigarettes to fund the enforcements of limits on flavored e-cigarettes. It is both revealing and dismaying that currently there are more pending legislative bills in Congress aimed at taxing e-cigarettes than increasing cigarette taxes.

Irresponsible

The most recent harm reduction research confirms Gottlieb’s irresponsibility in sacrificing the health of tens of millions of adult smokers at the altar of a fabricated youth epidemic. Professor John Newton of Public Health England has noted how clinical scientific experiments clearly indicate the stark contrast between the impacts of smoking combustible cigarettes and vaping. Globally, most public health experts consider vaping to be 95 percent safer than smoking.

A new study published in the New England Journal of Medicine finds people are almost twice as likely to succeed in quitting smoking if they use e-cigarettes than if they rely on licensed quitting aids, such as nicotine-replacement patches and gums. A revealing Juul Labs study found that smokers who used its popular USB drive-shaped vaporizer product over a five-day period experienced a nearly identical drop in biomarkers related to cancer compared to smokers who abstained from smoking during that period.

Philip Morris International’s new landmark study on e-cigarettes, conducted in collaboration with Altria Group, demonstrates that after six months, e-cigarette vapors with and without nicotine induce significantly lower biological responses associated with cardiovascular and pulmonary diseases than cigarette smoke.

Gottlieb also appears unaware of the law of unintended consequences. Government restrictions on e-cigarettes inadvertently increase combustible cigarette use among teens. A 2015 Yale University study found state-level bans on the sale of e-cigarettes to minors created a statistically significant increase in recent cigarette smoking rates among those aged 12 to 17.

What’s next?

Gottlieb denies he lost favor with the White House, insisting he resigned for personal reasons, namely the strain of commuting to Washington away from his Connecticut home and his wife and three young children. However, White House contacts tell me that several months ago they began to ask, “What has happened to Scott?” They pondered how, in a matter of mere months, their pro-vaping appointee became the nanny state’s poster boy?

They deduced that Gottlieb had suffered the same fate as many well-intentioned political appointees sitting atop departments and agencies throughout Washington, D.C. He was figuratively captured by the permanent institutional interests that dominate policy administration within government bureaucracies. Rather than open the FDA’s eyes on reduced-risk products, he morphed into a spokesman for the FDA’s blinkered statist outlook. A Trump advisor observes that Gottlieb “was swallowed by ‘the swamp.’”

What will happen to Gottlieb’s agenda? According to The Wall Street Journal, “Tobacco companies may have gotten a reprieve” as Gottlieb’s “departure calls into question some of the tough-on-tobacco proposals he championed.” While the affected industries hope a new commissioner will move the FDA in a more enlightened direction, they should not expect that outcome.

When asked if the vaping crackdown would continue after he leaves, Gottlieb said, “I’m very confident of that.” His confidence is well-founded. The FDA operates under the parental umbrella of the Department of Health and Human Services (HHS). HHS secretary Alex Azar was a strong supporter of Gottlieb’s draconian approach. Revealingly, Azar told a recent congressional hearing, “We are going to be carrying forward Dr. Gottlieb’s vision. His agenda is my agenda. My agenda is his agenda.”

At that same hearing, Azar named Norman Sharpless as acting FDA commissioner. A medical doctor and scientist with a respected academic track record, Sharpless is director of the National Cancer Institute, which falls under the purview of the National Institutes of Health. A close Gottlieb ally, and Gottlieb’s preferred successor, he shares Gottlieb’s diktat-driven approach to combating youth vaping.

As the administration settles upon Gottlieb’s replacement, Sharpless is in pole position. Yet, his transition from acting to permanent commissioner is not guaranteed. Another strong contender is Brett Giroir, who currently serves as assistant secretary at the HHS. He is Azar’s choice to succeed Gottlieb, having impressed as Azar’s senior adviser on the HHS’ anti-opioid campaign.

The forthcoming leadership change is likely to be a missed opportunity to reconsider the FDA’s fiat-based approach to e-cigarettes especially. If either Sharpless or Giroir are appointed, the FDA will keep its regulatory feet planted firmly on the necks of tobacco and vapor companies.

There is no reason for these companies to expect the regulatory environment to measurably improve. At best, legislative stasis on Capitol Hill, in tandem with the ebb and flow of the presidential and congressional campaigns, may slow the FDA’s regulatory momentum.

Patrick Basham directs the Democracy Institute (www.democracyinstitute.org) and authored the book, Butt Out! How Philip Morris Burned Ted Kennedy, the FDA & the Anti-tobacco Movement.

Contrary to its U.S. counterparts, Public Health England sees no evidence of a vaping epidemic.

By Marina A. Murphy

An independent report commissioned by Public Health England (PHE) reveals that the level of vaping among young people remains low in Britain, a finding that contrasts with reports from the U.S. suggesting that there has been a surge in e-cigarette use among teenagers there. The report also reveals, however, that vaping has plateaued among adults in the U.K. and says that more needs to be done to encourage smokers who want to quit smoking combustible cigarettes to try e-cigarettes.

Less than 2 percent of those in the U.K. under the age of 18 use e-cigarettes regularly, compared with reports of one in five teenagers regularly vaping in the U.S.

The PHE report, which was led by researchers from King’s College London, reveals, however, that “experimentation and use of e-cigarettes has been increasing steadily over time.” The number of children and teenagers in the U.K. trying vaping has doubled in five years, with around one in six children aged between 11 and 18 having tried e-cigarettes. A total of 15.9 percent in this age group tried vaping in 2018 compared to 8.1 percent in 2014.

The majority of those who vaped said they just wanted to give it a try. Only 1.7 percent of those under the age of 18 use e-cigarettes weekly or more, and the vast majority of those minors smoke combustible cigarettes as well. Among those who never smoked, only 0.2 percent use e-cigarettes regularly.

“While more young people are experimenting with e-cigarettes, the crucial point is that regular use remains low and is very low indeed among those who have never smoked,” said John Newton, health improvement director at PHE.

This contrasts with the U.S., where authorities have pronounced e-cigarette use by teenagers to be “epidemic.” In the U.S., the Juul brand claims some 70 percent of the e-cigarette market. But while the Juul is also available in other countries, including the U.K., there is a difference in that European law restricts the amount of nicotine in e-liquid. Nonetheless, Deborah Arnott, chief executive officer of Action on Smoking and Health (ASH) in the U.K., says that stakeholders need to remain vigilant. The 2019 ASH annual survey, which is about to start, will be asking about Juul.

Smoking, vaping, quitting …

The PHE report also reveals that while experimentation by teens has steadily increased, regular vaping has plateaued in adults. This is a problem, according to the authors, in so far as it may be negatively impacting quit rates.

“We could accelerate the decline in smoking if more smokers switched completely to vaping,” says Newton. “Recent new evidence clearly shows using an e-cigarette with stop-smoking support can double your chances of quitting. If you smoke, switching to vaping could save you years of ill health and even your life.”

PHE is well-known for having thrown its weight behind vaping, which it says is 95 percent less harmful than smoking. PHE recommends that smokers trying to quit should be offered devices like e-cigarettes.

This latest report says combining e-cigarettes with face-to-face support should be an option available to all smokers. It also calls for stop-smoking practitioners and health professionals supporting smokers to receive education and training in the use of e-cigarettes in attempts to quit.

“With just over a third of adult smokers having never tried an e-cigarette, there is a clear opportunity for more smokers to try a method which has helped many others to quit,” says Ann McNeill, professor of tobacco addiction at King’s College London and lead author of the report. “Smokers should be advised to stop smoking as soon as possible and explore all available options, including e-cigarettes.”

“With e-cigarettes currently used so rarely in services, it’s time for change,” adds Newton. “Every stop-smoking service must start talking much more about the potential of vaping to help smokers quit.”

The report is the first in a new set of three, commissioned by PHE under the government’s tobacco control plan for England. It looks specifically at the use of e-cigarettes rather than health impacts. Health impacts will be the subject of a future report.

This report was commissioned to summarize evidence that will underpin policy and regulation of e-cigarettes in England. It focuses on the latest evidence on prevalence and characteristics of e-cigarette use in young people and adults in England. The context for the report is that smoking remains the leading preventable cause of illness and premature death and is one of the largest causes of health inequalities. So, alternative nicotine-delivery systems, such as e-cigarettes, could play a major role in improving public health.

The FDA and Juul

In September 2018, the U.S. Food and Drug Administration (FDA) threatened to ban the Juul vapor device and four other leading e-cigarette products unless their makers took steps to prevent use by minors. In an attempt to curb teenage vaping, the FDA has also proposed a ban on most e-cigarette flavors.

Many public health experts think the FDA is overreacting. In a letter in November 2018 to FDA Commissioner Scott Gottlieb, who announced his upcoming resignation from the agency on March 5, several of these public health experts pointed out that the U.S. figures fail to distinguish between occasional and regular users, thereby potentially greatly overestimating the number of regular users. They also point out that most regular vapers are likely to be smokers and that vaping in youth should only be a concern to the extent that it may lead to smoking combustible cigarettes but that there is little evidence to suggest that this is the case.–M.M.