Author: GTNF Trust Staff

Altria’s Nu Mark has told the US Food and Drug Administration that its pre-market tobacco application (PMTA) requirements for electronic cigarettes are unduly burdensome, unnecessary, and beyond the scope of the agency’s jurisdiction under the Tobacco Control Act (TCA), according to Dr. Michael Siegel, a professor in the Department of Community Health Sciences, Boston University School of Public Health.

Siegel said that in the comments made by Altria Client Services on behalf of Nu Mark, the maker of Mark Ten electronic cigarettes, particular concern was expressed that the burdensome PMTA requirements would force many manufacturers out of business, undermining the TCA’s public health goals.

‘The Draft Guidance is not aligned to the FSPTCA’s [Family Smoking Prevention and Tobacco Control Act – TCA] goal of promoting public health because the complexity of information recommended for the application process and the short compliance period for FDA to complete PMTA reviews may result in some existing ENDS [electronic nicotine delivery systems] products being forced off the market,’ Altria was quoted as saying.

Altria noted also that the FDA had acknowledged that a large number of electronic cigarette companies would go out of business, yet had failed to account for this in its regulatory impact analysis.

Siegel said that in order to remedy the situation, Altria had suggested an approach similar to one that he had been advocating. He quoted Altria as saying that the FDA should ‘establish baseline performance standards for ENDS products that, when met, would serve as the basis for an abbreviated or alternative marketing authorization pathway to satisfy the statutory PMTA requirements’.

Two of Altria’s main goals, as stated in the comments, were to:

1) ‘support manufacturers’ efforts to develop and bring to market innovative products that may advance the public health’.

2) ‘allow industry participants to engage and compete in a dynamic market’.

Siegel opened his piece by saying that Altria’s intervention had cast ‘serious doubt on anti-tobacco groups’ maligning of the motives of the tobacco companies in marketing vaping products’.

Siegel’s full blog, The Rest of the Story is at: http://tobaccoanalysis.blogspot.co.uk/2016/07/altria-urges-changes-in-fda-e-cigarette.html

The Health Ministry in Greece has drafted a bill that would prohibit the use of electronic cigarettes in enclosed public places, according to a story by Kerry Kolasa-Sikiaridi for the Greek Reporter.

The bill was tabled in parliament on Friday by the ministry, which has decided that electronic cigarettes are a potential gateway to nicotine addiction.

The bill also transposes provisions of the revised EU Tobacco Products Directive.

The bill’s vapor-product provisions have met with much objection from vapers, who say the government should have conducted more research and consulted scientists and researchers on vaping before drafting a bill that equates them with smokers.

The Kathimerini newspaper reported last week that electronic cigarette users in Greece had held a press conference to denounce government plans to outlaw them from vaping in enclosed public places.

The association of Greek vapers was said to have criticized the government for preparing the bill without first consulting with researchers, scientists, former smokers and electronic cigarette users.

Vapers said that by lumping them together with regular smokers, the new legislation denied them the right to avoid tobacco smoke.

During the press conference, the vapers presented an open letter with their grievances addressed to Prime Minister Alexis Tsipras and a letter of support signed by vapers’ associations from 16 European countries.

A US public health expert has accused the Food and Drug Administration of botching the cost-benefit analysis of its electronic cigarette deeming regulations.

In a blog, Dr. Michael Siegel, a Professor in the Department of Community Health Sciences, Boston University School of Public Health, said the FDA had drastically underestimated the costs of the regulations and not attempted to quantify the benefits.

‘As such, this represents a violation of the Administrative Procedures Act, providing strong grounds for the D.C. District Court to overturn the regulations,’ he wrote.

Siegel made his assessment after reviewing the declaration of Nicopure Labs’ CEO Jeff Stamler in the company’s lawsuit against the FDA,

‘In its declaration, Nicopure reveals that it has 2,400 stock keeping units (SKUs), including e-liquids, vaporizers, and component parts,’ Siegel said. ‘This means that in order to keep its products on the market, Nicopure will have two years to complete 2,400 pre-market tobacco applications (PMTAs), each of which is estimated by the FDA itself to cost approximately $300,000 and to require 1,500 hours to complete. ‘Nicopure estimates the actual cost of each PMTA to be between $3 million and $5 million. ‘But even if we use FDA’s more conservative estimate, it would cost Nicopure $720,000,000 ($720 million) to keep its products on the market. ‘The company estimates that at very best, it could complete PMTAs for 12 of its products.

‘Thus, the regulations – if not overturned – will decimate the overwhelming majority of Nicopure’s offerings to vapers.’

Siegel’s blog, The Rest of the Story, is at: http://tobaccoanalysis.blogspot.co.uk/.

Three Alabama-based e-cigarette companies challenged the finalized rule that expands the U.S. Food and Drug Administration’s (FDA) ability to regulate all tobacco products, contending in a lawsuit filed on Tuesday that the measure goes too far and will likely push them out of business.

Cyclops Vapor 2, Tiger Vapor and Karma S Clouds object to the FDA’s rule, which goes into effect  August 8, requiring manufacturers to show the agency that vapor products brought to market after February 2007 meet federal public health standards and will have to submit applications to market new products, according to a story published on Law360.

The rule doesn’t reflect that vaping devices are a safer alternative to tobacco products and consequently puts an unfair burden on e-cigarette companies, which are often small operations that can’t afford to go through the rigorous approval process, the complaint says.

“Because the deeming rule ignores the health benefits of vaping products, as opposed to tobacco products, the burdens imposed by the deeming rule appear to be nothing more than an arbitrary and capricious regulatory system designed to regulate the entire vaping industry out of existence,” the complaint says.

Cyclops is a distributor of e-liquids and Tiger and Karma both manufacture e-liquids and sell vaping devices, the complaint says. All of the companies offer e-liquids that contain nicotine derived from tobacco, as well as products that don’t, according to the complaint.

Studies confirm that those vaping products are far less harmful than cigarettes and that most of the chemicals leading to smoking-related disease aren’t present in e-cigarette vapor, the complaint says.
Although the FDA recognizes this reduced risk, the rule subjects vaping devices and e-liquids to the same regulatory requirements designed for cigarettes and smokeless tobacco, which Congress has said cause more than 400,000 deaths in the United States every year, the companies allege.

The agency estimates that a single pre-market tobacco application will cost hundreds of thousands of dollars, a tall order for vaping companies that produce scores of e-liquids, each of which would require its own approval, according to the complaint. Ultimately, the cost-prohibitive and lengthy process will force existing products out of the market and make it incredibly difficult to introduce new ones, likely driving consumers back to cigarettes and undercutting the purpose of the Family Smoking Prevention and Tobacco Control Act, a 2009 statute intended to address the cancer, heart disease and other health issues associated with tobacco use, the companies say.

The complaint asks the court to vacate the rule and declare that it exceeds the FDA’s authority, is arbitrary and capricious, applies an unlawful cost-benefit analysis and defies the First Amendment. Four other lawsuits also challenge the rule, one in Los Angeles and three in Washington, D.C., bringing primarily the same claims.

Joe Hubbard of the Joe Hubbard Law Firm, a lawyer for the three Alabama companies, said that the litigation comes down to the FDA’s overreach of its constitutional and statutory authority in issuing regulations that are intended to “regulate this industry out of existence, according to the story.

“The vapor industry and these three businesses have no objection to reasonable and lawful regulations,” he said. “What they object to is the FDA using its power not to regulate, but to annihilate their business.”

The suit is Cyclops Vapor 2 LLC et al. v. U.S. Food and Drug Administration et al., suit number 2:16-cv-00556, in the U.S. District Court for the Middle District of Alabama.

People in Saudi Arabia have been told by the executive director of the Anti-Smoking Association (Naqa), Dr. Mohammed bin Sulaiman Al-Mayouf, that electronic cigarettes cause as much harm to users and those around them as do traditional tobacco cigarettes, according to a story in the Arab News.

Al-Mayouf was quoted as saying also that there was ‘great need to change the common perception among people that nicotine in electronic cigarettes is less concentrated’.

He cited the World Health Organization as having issued ‘serious warnings’ against electronic cigarettes.

However, many tobacco control advocates believe that nicotine is not in itself harmful and that vaping electronic cigarettes is hugely less risky than is smoking traditional tobacco cigarettes.

Public Health England, an executive body of the UK Department of Health, has published a report saying that the use of electronic cigarettes is 95 percent safer than is smoking cigarettes and that electronic cigarettes are an important tool to help smokers quit altogether.

The Arab News story opened with Al-Mayouf saying that studies had shown that 6.1 percent of Saudis smoked shisha.

He said that this was an ‘alarming indicator’ of the power of the tobacco companies’ propaganda, which portrayed smoking as a sign of urbanization and self-assertion.

“It makes it easier to convince adolescent girls to take up the habit, especially when it is propagated by the media, mostly soap operas that are very popular among them,” he said.

Studies, said Al-Mayouf, had indicated that one session of shisha smoking lasted two to three hours, which was equivalent to the time taken to smoke about 25 cigarettes, and that one cigarette contained 4,000 toxic and 43 carcinogenic substances.

Al-Mayouf said shisha smoking was one contributor to lung, bladder and stomach cancer. It also contributed to lower birth weights, to gum and throat diseases, and to the spread of tuberculosis when one shisha was used by several people.

‘Many sites promote the electronic shisha, arguing that it helps gradually quit smoking, but this is a delusional solution and profitable propaganda spread by tobacco companies and the marketers of electronic cigarettes, against which the WHO has issued serious warnings,’ the story said.

‘Al-Mayouf stressed that e-cigarettes harm the smokers and those around them, the so-called passive smokers, as much as regular cigarettes, so there is great need to change the common perception among people that nicotine in electronic cigarettes is less concentrated.’

The clock is ticking for the more than 130 small vape shops in Western New York that the federal government now wants to treat as though they were tobacco manufacturers, according to a story by Samantha Christmann for Buffalo News.

When sweeping new Food and Drug Administration rules go into effect next month, local shops will have two years to complete an expensive licensing application or close up shop for good.

The regulation process is so long, confusing and expensive that coming into compliance will be impossible for local independent retailers, shop owners say. As a result, most, if not all, of the small shops in Western New York are likely to close once the two-year ‘grandfathering’ period expires.

That could leave storefronts vacant, hundreds of people out of work and consumers with far fewer choices.

The new laws don’t treat the vape shops that sell the supplies as stores. Instead, because most of them mix their own e-juice, the FDA is requiring those vape shops to register as tobacco manufacturers.

Along with that, they’ll have to register every single e-juice flavor, e-cigarette component and e-cig accessory, providing the FDA with full documentation of each product’s ingredients and manufacturing process.

The cost to do all of that is out of reach for most retailers, critics say. The FDA estimates that the licensing process would cost from $285,000 to $2.6 million per product. Some analysts estimate that the cost could be closer to $10 million per product.

With hundreds of e-juice ingredients, there are billions of flavor combinations. Registering even a fraction of them would cost these mom-and-pop shops millions of dollars.

Even if a retailer could afford to register one or two e-juice flavors with the FDA, the return on investment wouldn’t be enough to even recoup the licensing costs. It certainly wouldn’t be enough to keep them in business.

That’s because a big part of the appeal of vape shops is the endless variations of e-juice flavors custom-made by each retailer. A shop with just one or two flavors – registered or not – would not likely be able to keep the doors open.

Christmann’s story is at: http://www.buffalonews.com/city-region/fdas-costly-new-rules-may-sink-local-vape-shops-20160703.

Construction companies in the UK have been told that they should not treat smoking and vaping in the same way.

According to a note on the website of The Construction Index, new guidance from Public Health England (PHE) instructs employers to make a clear distinction between smoking and vaping.

The Construction Index is a building industry and construction company directory and magazine.

The Index said that the new guidance ran counter to common practice in the construction industry where, according to its research, employers generally regarded vaping no differently to smoking.

However, PHE says specifically that electronic-cigarette use is not covered by smoke-free legislation and should not routinely be included in the requirements of an organization’s smoke-free policy.

‘Vapers should not be required to use the same space as smokers, as this could undermine their ability to quit and stay smoke-free,” the PHE says.

And it further says that employers should make a clear distinction between vaping and smoking. ‘E-cigarette use does not meet the legal or clinical definitions of smoking, it says.

‘Furthermore, international peer-reviewed evidence suggests that e-cigarettes carry a fraction of the risk of cigarettes and have the potential to help drive down smoking rates, denormalise smoking and improve public health. So policies need to be clear on the differences between vaping and smoking.’

Professor Kevin Fenton, national director of health and wellbeing at PHE, was quoted as saying that the evidence was clear that vaping was much less harmful than was smoking, and that electronic cigarettes were helping many smokers to quit.

“This new framework will encourage organizations to consider both the benefits and the risks when developing their own policies on e-cigarettes,” he said. “Different approaches will be appropriate in different places, but policies should take account of the evidence and clearly distinguish vaping from smoking.”

PHE said also that there was currently no evidence of harm from second-hand electronic cigarette vapour and that the risks were likely to be extremely low.

The Smoke-Free Alternatives Trade Association (SFATA) has announced that Cynthia Cabrera is stepping down as its president and executive director. During her tenure, Cabrera has helped grow SFATA into the largest trade association representing and protecting the interests of the vapor industry, surpassing more than 1,000 business members while establishing 28 local chapters in 26 states throughout the country.

A well-respected advocate of the vapor industry, Cabrera is currently in negotiations to continue her relationship with SFATA moving forward as the organization transitions to a new executive director.

“At the same time, we are proud to announce the appointments of Cap O’Rourke as president and Schell Hammel as vice president. Working with the full board, these directors will lead in this transitional period as we continue the great work accomplished by Cynthia in helping achieve our organization’s goals at the federal and state levels, advocating for sensible regulations of vapor products in Congress and in various statehouses across the U.S.,” according to a statement from SFATA’s board of directors. “SFATA remains committed to lobbying for passage of H.R. 2058 and the Bishop-Cole Amendment, legislation that will create a less costly market pathway of vapor products. We also will continue to work with our state lobbyists to help ensure that vapor products are not equated and taxed like combustible tobacco products.”

Cabrera has told Vapor Voice that she plans on continue her work with the vapor industry and in helping smokers quit combustible tobacco.

An estimated 6.1 million EU citizens have quit smoking by switching to vaping, according to a story by Kaleigh Rogers for Vice media citing a paper published online this week in Addiction.

The study highlights the need for more data on how useful vaping might be as a stop smoking aid.

As part of the study, researchers made a close analysis of data collected in 2014 and released last year through the European Commission.

The Commission data indicated that two percent of respondents were currently using electronic cigarettes, and 14 percent had been able to quit smoking completely by switching to vaping.

However, the figures included any smoker who had tried just one puff of an electronic cigarette, which could not be considered to be a sustained effort to quit.

In the Addiction paper, the researchers broke down the numbers further and found a more impressive quit rate.

When they looked at respondents who were currently using electronic cigarettes, 35 percent were former smokers who had successfully quit.

The researchers extrapolated their figures to the total EU population and estimated 6.1 million people had quit through vaping, and 9.2 million had been able to cut back on smoking by becoming dual users.